Exelixis Announces Third Quarter 2024 Financial Results and Provides Corporate Update
Exelixis (EXEL) reported strong Q3 2024 financial results with total revenues of $539.5 million, including net product revenues of $478.1 million from its cabozantinib franchise. The company achieved GAAP diluted EPS of $0.40 and non-GAAP diluted EPS of $0.47. Following strong commercial performance, Exelixis increased its 2024 guidance for total revenues to $2.150-$2.200 billion. The company received a favorable ruling on cabozantinib patent litigation and expanded its zanzalintinib development program through a new collaboration with Merck.
Exelixis (EXEL) ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con entrate totali di 539,5 milioni di dollari, comprese entrate nette da prodotti di 478,1 milioni di dollari provenienti dalla sua franchigia cabozantinib. L'azienda ha registrato un utile per azione diluito GAAP di 0,40 dollari e un utile per azione diluito non GAAP di 0,47 dollari. Dopo la forte performance commerciale, Exelixis ha aumentato le previsioni per il 2024 relative alle entrate totali a 2,150-2,200 miliardi di dollari. L'azienda ha ricevuto una sentenza favorevole riguardo alle controversie sui brevetti del cabozantinib e ha ampliato il proprio programma di sviluppo dello zanzalintinib attraverso una nuova collaborazione con Merck.
Exelixis (EXEL) reportó resultados financieros sólidos para el tercer trimestre de 2024, con ingresos totales de 539.5 millones de dólares, incluyendo ingresos netos por productos de 478.1 millones de dólares de su franquicia de cabozantinib. La compañía logró una utilidad por acción diluida GAAP de 0.40 dólares y una utilidad por acción diluida no GAAP de 0.47 dólares. Tras un fuerte desempeño comercial, Exelixis aumentó su guía para 2024 en ingresos totales a 2.150-2.200 millones de dólares. La compañía recibió un fallo favorable en la litigación de patentes de cabozantinib y amplió su programa de desarrollo de zanzalintinib mediante una nueva colaboración con Merck.
Exelixis (EXEL)는 2024년 3분기 강력한 재무 결과를 보고했으며, 총 수익이 5억 3천 9백 50만 달러였고, 그 중 카보잔티닙 제품에서의 순수익이 4억 7천 8백 10만 달러를 차지했습니다. 이 회사는 GAAP 희석 주당 순이익이 0.40 달러이고 비 GAAP 희석 주당 순이익이 0.47 달러를 달성했습니다. 강력한 상업적 성과에 따라 Exelixis는 2024년 총 수익에 대한 전망을 21억 5천만 달러에서 22억 달러로 상향 조정했습니다. 이 회사는 카보잔티닙 특허 소송에 대한 유리한 판결을 받고, 머크와의 새로운 협력을 통해 잔잘린틴 개발 프로그램을 확장했습니다.
Exelixis (EXEL) a annoncé de solides résultats financiers pour le troisième trimestre 2024, avec des revenus totaux de 539,5 millions de dollars, dont des revenus nets de produits de 478,1 millions de dollars provenant de sa franchise cabozantinib. La société a réalisé un bénéfice par action dilué GAAP de 0,40 dollar et un bénéfice par action dilué non-GAAP de 0,47 dollar. Suite à une performance commerciale forte, Exelixis a augmenté ses prévisions pour 2024 concernant les revenus totaux à 2,150-2,200 milliards de dollars. L'entreprise a obtenu un jugement favorable concernant les litiges de brevet de cabozantinib et a élargi son programme de développement de zanzalintinib grâce à une nouvelle collaboration avec Merck.
Exelixis (EXEL) berichtete über starke Finanzresultate im 3. Quartal 2024 mit Gesamtumsätzen von 539,5 Millionen Dollar, einschließlich Netto-Produktumsätzen von 478,1 Millionen Dollar aus seiner Cabozantinib-Franchise. Das Unternehmen erzielte einen GAAP-diluted EPS von 0,40 Dollar und einen non-GAAP-diluted EPS von 0,47 Dollar. Nach einer starken kommerziellen Leistung erhöhte Exelixis seine Prognose für die Gesamtumsätze im Jahr 2024 auf 2,150-2,200 Milliarden Dollar. Das Unternehmen erhielt ein günstiges Urteil im Patentstreit über Cabozantinib und erweiterte sein Entwicklungsprogramm für Zanzalintinib durch eine neue Zusammenarbeit mit Merck.
- Total revenues increased to $539.5M from $471.9M YoY
- Net product revenues grew to $478.1M from $426.5M YoY
- Increased 2024 revenue guidance to $2.150-$2.200B
- Favorable patent litigation ruling protecting cabozantinib until 2030
- GAAP net income improved to $118.0M from $1.0M YoY
- $51.7M non-cash asset impairment charge for unused facilities
- Higher tax provision of $36.8M compared to $4.8M YoY
Insights
Strong Q3 2024 results show significant growth with
Notable improvements in operational efficiency are evident with R&D expenses decreasing by
The expansion of zanzalintinib's development program through the Merck collaboration is strategically significant, adding two new phase 3 RCC trials and leveraging combinations with KEYTRUDA and WELIREG. The positive CABINET trial results in NET, published in NEJM, create a compelling case for label expansion, with both FDA and EMA submissions underway.
The pipeline is advancing meaningfully with three novel agents in phase 1: XB010 (ADC targeting 5T4), XL495 (PKMYT1 inhibitor) and XL309. The STELLAR-303 trial completion in colorectal cancer and planned STELLAR-311 in NET demonstrate aggressive expansion of the development portfolio. These developments position Exelixis to potentially address multiple new cancer indications.
- 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 5:00 PM Eastern Time -
“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 Michael M. Morrissey, Ph.D., President and CEO, Exelixis. “We are increasing 2024 full year guidance for total and net product
Dr. Morrissey continued: “Importantly, the zanzalintinib development program, which is now the subject of six ongoing or planned phase 3 pivotal trials, including two new renal cell carcinoma studies as part of our collaboration with Merck, headlines our emerging pipeline of novel agents with the potential to improve standards of care for patients with cancer. At the same time, we are accelerating our early-stage clinical pipeline with XL309, XB010 and XL495 in phase 1 development. I want to thank everyone at Exelixis for their hard work and dedication as we continue driving value for shareholders and innovating on behalf of the patients we serve.”
Third Quarter 2024 Financial Results
Total revenues for the quarter ended September 30, 2024 were
Total revenues for the quarter ended September 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 September 30, 2024 were
Selling, general and administrative expenses for the quarter ended September 30, 2024 were
Impairment of long-lived assets for the quarter ended September 30, 2024 of
Provision for income taxes for the quarter ended September 30, 2024 was
GAAP net income for the quarter ended September 30, 2024 was
Non-GAAP net income for the quarter ended September 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):
|
Current Guidance
|
Previous Guidance
|
Total revenues |
|
|
Net product revenues(2) |
|
|
Cost of goods sold |
~ |
|
Research and development expenses |
|
|
Selling, general and administrative expenses(5) |
|
|
Effective tax rate |
|
|
____________________ |
||
(1) |
2024 financial guidance excludes expenses related to the restructuring plan announced in January 2024 and impairment of long-lived assets announced in October 2024. |
|
(2) |
Exelixis’ 2024 net product revenues guidance range includes the impact of a |
|
(3) |
Includes |
|
(4) |
Includes |
|
(5) |
Includes |
Corporate Highlights
Favorable Ruling in Second Cabozantinib Abbreviated New Drug Application (ANDA) Litigation Against MSN Pharmaceuticals, Inc. (MSN). In October, the
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, Exelixis and Merck (known as MSD outside of the
Stock Repurchase Program. In August, Exelixis announced that the company’s Board of Directors authorized the repurchase of up to
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 European Medicines Agency (EMA). 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 pancreatic NET (pNET) and extra-pancreatic NET (epNET) from regulatory authorities outside of the
FDA Accepted Supplemental New Drug Application (sNDA) for Cabozantinib for Patients with Advanced NET. In August, Exelixis announced that the FDA accepted its sNDA for cabozantinib for patients with previously treated advanced pNET and for patients with previously treated advanced 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 sNDA was based on results from the CABINET trial.
Final Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced NET Presented at the 2024 European Society for Medical Oncology (ESMO) Congress and Published in The New England Journal of Medicine (NEJM). In September, detailed final results from CABINET were presented at the 2024 ESMO Congress and published in NEJM. The results demonstrated continued improvement with cabozantinib in the primary endpoint of progression-free survival by blinded independent central review, and additional analyses suggest benefits with cabozantinib across all clinical subgroups examined, including primary tumor site, grade and prior systemic anti-cancer therapy.
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 ESMO Congress. In September, the final analysis of OS from the phase 3 CONTACT-02 pivotal study was presented at the 2024 ESMO Congress. The results of the final OS analysis showed a trend that favored the combination of cabozantinib and atezolizumab but was not statistically significant. The trend in OS benefit was consistently observed in key subgroups, including in patients with liver metastases, a subgroup of mCRPC patients with the poorest prognosis in need of new treatment options, which Exelixis anticipates will grow in the coming years. CONTACT-02 evaluated cabozantinib in combination with atezolizumab compared with a second novel hormonal therapy (NHT) in patients with measurable, extra-pelvic mCRPC who have progressed after treatment with one prior NHT. Exelixis intends to submit an sNDA to the FDA for cabozantinib in combination with atezolizumab for mCRPC in the fourth quarter of 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, Exelixis announced that enrollment was 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 CRC 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 in 2025. Additionally, Exelixis announced plans to initiate STELLAR-311, a new phase 3 pivotal trial evaluating zanzalintinib compared with everolimus as a first oral therapy in patients with advanced NET, regardless of site of origin, in the first half of 2025.
Initiation of Phase 1 Clinical Trial Evaluating XB010 in Patients with Advanced Solid Tumors. In August, 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 global phase 1 study is evaluating 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.
Initiation of Phase 1 Clinical Trial Evaluating XL495 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 XL495 in patients with advanced solid tumors. XL495 is a novel, potent, small molecule inhibitor of PKMYT1. The dose-escalation stage of this phase 1 study is designed to determine the maximum tolerated dose of XL495. The expansion cohorts are designed to further assess the tolerability and activity of XL495 both as monotherapy and in combination with select cytotoxic agents in tumor-specific indications.
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 September 27, 2024 and September 29, 2023, are indicated as being as of and for the periods ended September 30, 2024 and September 30, 2023.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the third 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, October 29, 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 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
Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are registered trademarks of Exelixis, Inc.
KETRUDA® and WELIREG® are registered trademarks of Merck Sharp & Dohme LLC,
a subsidiary of Merck & Co., Inc.,
EXELIXIS, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (in thousands, except per share amounts) (unaudited) |
||||||||||||||
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|||||||||||
|
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 |
EXELIXIS, INC. RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (in thousands, except per share amounts) (unaudited) |
|||||||||||||||
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||||||
|
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/
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.
FAQ
What were Exelixis (EXEL) Q3 2024 earnings per share?
What is Exelixis (EXEL) new revenue guidance for 2024?