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Exelixis Announces Second Quarter 2024 Financial Results and Provides Corporate Update

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Exelixis (Nasdaq: EXEL) announced its Q2 2024 financial results, reporting total revenues of $637.2 million, up from $469.8 million in Q2 2023. Net product revenues from the cabozantinib franchise reached $437.6 million, with a GAAP diluted EPS of $0.77 and non-GAAP diluted EPS of $0.84.

The FDA accepted a supplemental new drug application (sNDA) for cabozantinib in advanced neuroendocrine tumors (NET), targeting a review date of April 3, 2025. Exelixis also announced a $150 million milestone payment from Ipsen and completed a $450 million stock repurchase program. An additional $500 million stock repurchase program is planned through the end of 2025.

Operating expenses showed a decrease in R&D and SG&A, leading to a GAAP net income of $226.1 million compared to $81.2 million in Q2 2023. Exelixis also highlighted updated clinical developments including the completion of the phase 3 CONTACT-02 study in metastatic castration-resistant prostate cancer.

Exelixis (Nasdaq: EXEL) ha annunciato i risultati finanziari per il secondo trimestre del 2024, riportando ricavi totali di 637,2 milioni di dollari, rispetto ai 469,8 milioni di dollari nel secondo trimestre del 2023. I ricavi netti dei prodotti della franchigia cabozantinib hanno raggiunto i 437,6 milioni di dollari, con un utile per azione (EPS) diluito GAAP di 0,77 dollari e un EPS diluito non GAAP di 0,84 dollari.

La FDA ha accettato una domanda supplementare per un nuovo farmaco (sNDA) per cabozantinib nel trattamento dei tumori neuroendocrini avanzati (NET), con una data di revisione prevista per il 3 aprile 2025. Exelixis ha anche annunciato un pagamento di traguardo di 150 milioni di dollari da Ipsen e ha completato un programma di riacquisto di azioni da 450 milioni di dollari. Un ulteriore programma di riacquisto di azioni da 500 milioni di dollari è previsto fino alla fine del 2025.

Le spese operative hanno mostrato una diminuzione nelle spese di ricerca e sviluppo e nelle spese generali e amministrative, portando a un reddito netto GAAP di 226,1 milioni di dollari rispetto agli 81,2 milioni di dollari del secondo trimestre del 2023. Exelixis ha anche messo in evidenza gli sviluppi clinici aggiornati, compresa la conclusione dello studio di fase 3 CONTACT-02 nel cancro della prostata resistente alla castrazione in stadio metastatico.

Exelixis (Nasdaq: EXEL) anunció sus resultados financieros del segundo trimestre de 2024, reportando ingresos totales de 637,2 millones de dólares, en comparación con 469,8 millones de dólares en el segundo trimestre de 2023. Los ingresos netos por productos de la franquicia cabozantinib alcanzaron los 437,6 millones de dólares, con una ganancia por acción (EPS) diluida GAAP de 0,77 dólares y una EPS diluida no GAAP de 0,84 dólares.

La FDA aceptó una solicitud suplementaria de nuevo medicamento (sNDA) para cabozantinib en tumores neuroendocrinos avanzados (NET), con una fecha de revisión programada para el 3 de abril de 2025. Exelixis también anunció un pago de hito de 150 millones de dólares de Ipsen y completó un programa de recompra de acciones de 450 millones de dólares. Se planea un programa adicional de recompra de acciones de 500 millones de dólares hasta finales de 2025.

Los gastos operativos mostraron una disminución en I+D y SG&A, lo que resultó en un ingreso neto GAAP de 226,1 millones de dólares en comparación con 81,2 millones de dólares en el segundo trimestre de 2023. Exelixis también destacó desarrollos clínicos actualizados, incluida la finalización del estudio de fase 3 CONTACT-02 en cáncer de próstata resistente a la castración metastásico.

Exelixis (Nasdaq: EXEL)는 2024년 2분기 재무 결과를 발표하며 총 수익이 6억 3,720만 달러에 달하고, 이는 2023년 2분기의 4억 6,980만 달러에서 증가한 수치입니다. 카보잔티닙 프랜차이즈의 순 제품 수익은 4억 3,760만 달러에 달하며, GAAP 기준 희석 주당 순이익(EPS)은 0.77 달러, 비 GAAP 기준 희석 EPS는 0.84 달러입니다.

FDA는 고급 신경내분비 종양(NET) 치료를 위한 카보잔티닙의 보충 신약 허가 신청(sNDA)을 수락하였으며, 검토 날짜는 2025년 4월 3일로 예정되어 있습니다. Exelixis는 Ipsen으로부터 1억 5천만 달러의 이정표 지급을 발표하였고, 4억 5천만 달러 규모의 자사주 매입 프로그램을 완료하였습니다. 2025년 말까지 5억 달러 규모의 추가 자사주 매입 프로그램이 계획되어 있습니다.

운영 비용은 연구개발(R&D) 및 판매관리비(SG&A)에서 감소를 보여, GAAP 기준 순이익은 2억 2천 610만 달러를 기록하였으며, 이는 2023년 2분기의 8천 120만 달러와 비교됩니다. Exelixis는 전이성 거세 저항성 전립선암에서 3상 CONTACT-02 연구의 완료를 포함하여, 업데이트된 임상 개발 사항도 강조하였습니다.

Exelixis (Nasdaq: EXEL) a annoncé ses résultats financiers pour le deuxième trimestre de 2024, rapportant des revenus totaux de 637,2 millions de dollars, en hausse par rapport à 469,8 millions de dollars au deuxième trimestre de 2023. Les revenus nets des produits de la franchise cabozantinib ont atteint 437,6 millions de dollars, avec un BPA dilué GAAP de 0,77 dollar et un BPA dilué non GAAP de 0,84 dollar.

La FDA a accepté une demande d'autorisation de médicament supplémentaire (sNDA) pour le cabozantinib dans le traitement des tumeurs neuroendocrines avancées (NET), avec une date d'examen prévue pour le 3 avril 2025. Exelixis a également annoncé un paiement d'étape de 150 millions de dollars de la part d'Ipsen et a complété un programme de rachat d'actions de 450 millions de dollars. Un programme de rachat d'actions supplémentaire de 500 millions de dollars est prévu jusqu'à la fin de 2025.

Les dépenses opérationnelles ont montré une diminution des dépenses de R&D et des SG&A, conduisant à un revenu net GAAP de 226,1 millions de dollars par rapport à 81,2 millions de dollars au deuxième trimestre de 2023. Exelixis a également mis en avant les développements cliniques mis à jour, y compris l'achèvement de l'étude de phase 3 CONTACT-02 dans le cancer de la prostate résistant à la castration métastatique.

Exelixis (Nasdaq: EXEL) hat die finanziellen Ergebnisse für das 2. Quartal 2024 bekannt gegeben und berichtet von Gesamterlösen in Höhe von 637,2 Millionen Dollar, im Vergleich zu 469,8 Millionen Dollar im 2. Quartal 2023. Die Netto-Produkteinnahmen aus der Cabozantinib-Franchise betrugen 437,6 Millionen Dollar, mit einem GAAP verwässerten EPS von 0,77 Dollar und einem non-GAAP verwässerten EPS von 0,84 Dollar.

Die FDA hat einen ergänzenden Antrag auf Zulassung eines neuen Medikaments (sNDA) für Cabozantinib bei fortgeschrittenen neuroendokrinen Tumoren (NET) akzeptiert und ein Prüfdatum für den 3. April 2025 festgelegt. Exelixis gab außerdem eine Meilensteinzahlung von 150 Millionen Dollar von Ipsen bekannt und schloss ein Aktienrückkaufprogramm im Wert von 450 Millionen Dollar ab. Ein zusätzliches Aktienrückkaufprogramm über 500 Millionen Dollar ist bis Ende 2025 geplant.

Die Betriebskosten zeigten einen Rückgang in Forschung und Entwicklung sowie in Verwaltungskosten, was zu einem GAAP-Nettoeinkommen von 226,1 Millionen Dollar im Vergleich zu 81,2 Millionen Dollar im 2. Quartal 2023 führte. Exelixis hob auch aktualisierte klinische Entwicklungen hervor, einschließlich des Abschlusses der Phase-3-Studie CONTACT-02 bei metastasiertem kastrationsresistentem Prostatakrebs.

Positive
  • Total revenues increased to $637.2 million, a significant rise from $469.8 million in Q2 2023.
  • Net product revenues from the cabozantinib franchise reached $437.6 million.
  • GAAP diluted EPS rose to $0.77, with non-GAAP diluted EPS at $0.84.
  • FDA accepted the sNDA for cabozantinib in advanced NET with a target action date of April 3, 2025.
  • Earned a $150 million milestone payment from Ipsen.
  • Completed a $450 million stock repurchase program for 2024.
  • Announced a new $500 million stock repurchase program through the end of 2025.
  • R&D expenses decreased to $211.1 million from $232.6 million, and SG&A expenses decreased to $132 million from $141.7 million.
Negative
  • Provision for income taxes increased to $66.7 million from $19.2 million in Q2 2023.
  • Final overall survival in the CONTACT-02 trial did not achieve statistical significance.

Insights

Exelixis has delivered a strong Q2 2024 performance, with total revenues of $637.2 million, up 35.6% year-over-year. The company's flagship product, CABOMETYX, continues to drive growth with U.S. net product revenues of $433.3 million. The significant increase in collaboration revenues to $199.6 million is noteworthy, primarily due to milestone-related revenues and higher royalties.

The company's profitability has improved substantially, with GAAP net income of $226.1 million ($0.77 per diluted share), compared to $81.2 million ($0.25 per diluted share) in Q2 2023. The non-GAAP EPS of $0.84 demonstrates strong operational efficiency.

Exelixis' financial guidance for 2024 remains robust, with total revenues projected between $1.975 billion and $2.075 billion. The company's strong cash position and ongoing share repurchase programs indicate confidence in its financial stability and commitment to shareholder returns.

The FDA's acceptance of Exelixis' sNDA for cabozantinib in advanced neuroendocrine tumors (NET) is a significant milestone. With a PDUFA date of April 3, 2025, this could potentially expand cabozantinib's indications, addressing a high unmet medical need in NET patients.

The completion of the final overall survival analysis for the CONTACT-02 trial in metastatic castration-resistant prostate cancer (mCRPC) is crucial. While it didn't achieve statistical significance, the continued favorable trend and the previously reported significant progression-free survival benefit could still support an sNDA submission this year.

The initiation of the XB010 phase 1 trial and the planned STELLAR-311 phase 3 trial for zanzalintinib in NET demonstrate Exelixis' commitment to expanding its oncology pipeline. However, the discontinuation of XB002 development highlights the challenges in drug development and the importance of portfolio prioritization.

Exelixis' market position in oncology continues to strengthen, driven by the expanding indications for cabozantinib. The potential entry into the NET market could open up new revenue streams, especially given the orphan drug designation for pancreatic NET.

The collaboration with Ipsen is proving fruitful, as evidenced by the $150 million milestone payment. This partnership enhances Exelixis' global reach and revenue potential. The opt-in by Ipsen for the CABINET trial further validates the potential of cabozantinib in NET.

The company's focus on next-generation medicines, including antibody-drug conjugates like XB010, aligns with current trends in oncology drug development. However, the competitive landscape in areas like tissue factor-targeting ADCs necessitates careful portfolio management, as seen with the XB002 discontinuation.

Exelixis' continued share repurchase programs, totaling $1 billion since March 2023, signal confidence in its long-term prospects and commitment to shareholder value, which could positively influence investor sentiment.

- Total Revenues of $637.2 million, Cabozantinib Franchise U.S. Net Product Revenues of $437.6 million -

- GAAP Diluted EPS of $0.77, Non-GAAP Diluted EPS of $0.84 -

- U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application (sNDA) for Cabozantinib in Advanced Neuroendocrine Tumors (NET) -

- Earned $150 million Cabozantinib Sales-Based Milestone from Ipsen -

- Completed $450 million Stock Repurchase Program for 2024 -

- Announced Additional Stock Repurchase Program for up to $500 million through the End of 2025 -

- Conference Call and Webcast Today at 5:00 PM Eastern Time -

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial, clinical and pipeline development milestones.

“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 U.S. and globally, with Ipsen’s success prompting a $150 million milestone payment to Exelixis based on sales over the past four quarters. On the regulatory front, the FDA accepted the sNDA for cabozantinib in advanced NET, granted standard review and assigned a target action date of April 3, 2025. We’re actively preparing for launch and excited at the prospect of bringing this new treatment option to previously treated advanced NET patients with high unmet medical need. At the same time, we are prioritizing our clinical pipeline with plans to initiate a new phase 3 pivotal trial for zanzalintinib in NET, advance phase 1 efforts for XL309 and XB010, and discontinue development of XB002. I’d like to thank the entire Exelixis team for their hard work and contributions toward achieving these important milestones for cabozantinib and advancing our broad, differentiated pipeline of oncology therapeutics to help the patients we serve.”

Second Quarter 2024 Financial Results

Total revenues for the quarter ended June 30, 2024 were $637.2 million, as compared to $469.8 million for the comparable period in 2023.

Total revenues for the quarter ended June 30, 2024 included net product revenues of $437.6 million, as compared to $409.6 million for the comparable period in 2023. The increase in net product revenues was primarily due to an increase in sales volume and average net selling price.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $199.6 million for the quarter ended June 30, 2024, as compared to $60.2 million for the comparable period in 2023. The increase in collaboration revenues was primarily related to an increase in milestone-related revenues recognized in the quarter and higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis’ collaboration partners, Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited, partially offset by a decrease in development cost reimbursements earned.

Research and development expenses for the quarter ended June 30, 2024 were $211.1 million, as compared to $232.6 million for the comparable period in 2023. The decrease in research and development expenses was primarily related to decreases in license and other collaboration costs and clinical trial costs, partially offset by an increase in manufacturing costs to support our development candidates.

Selling, general and administrative expenses for the quarter ended June 30, 2024 were $132.0 million, as compared to $141.7 million for the comparable period in 2023. The decrease in selling, general and administrative expenses was primarily related to a decrease in legal and advisory fees related to the proxy contest in the prior year.

Provision for income taxes for the quarter ended June 30, 2024 was $66.7 million, as compared to $19.2 million for the comparable period in 2023.

GAAP net income for the quarter ended June 30, 2024 was $226.1 million, or $0.78 per share, basic and $0.77 per share, diluted, as compared to GAAP net income of $81.2 million, or $0.25 per share, basic and diluted, for the comparable period in 2023. GAAP net income per share for the quarter ended June 30, 2024 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended June 30, 2024, as compared to the comparable period in 2023, as a result of the stock repurchase programs.

Non-GAAP net income for the quarter ended June 30, 2024 was $245.6 million, or $0.85 per share, basic and $0.84 per share, diluted, as compared to non-GAAP net income of $100.3 million, or $0.31 per share, basic and diluted, for the comparable period in 2023.

Non-GAAP Financial Measures

To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation expense, adjusted for the related income tax effect for all periods presented.

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

 

$1.975 billion - $2.075 billion

Net product revenues (2)

 

$1.650 billion - $1.750 billion

Cost of goods sold

 

4% - 5% of net product revenues

Research and development expenses (3)

 

$925 million - $975 million

Selling, general and administrative expenses (4)

 

$450 million - $500 million

Effective tax rate

 

20% - 22%

____________________

(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 U.S. wholesale acquisition cost increase of 2.2% for both CABOMETYX and COMETRIQ effective on January 1, 2024.

(3) Includes $40 million of non-cash stock-based compensation expense.

(4) Includes $60 million of non-cash stock-based compensation expense.

Cabozantinib and Pipeline Highlights

Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $437.6 million during the second quarter of 2024, with net product revenues of $433.3 million from CABOMETYX® (cabozantinib) and $4.2 million from COMETRIQ® (cabozantinib). Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter ended June 30, 2024, Exelixis earned $41.2 million in royalty revenues.

Achievement of Cabozantinib Sales-Based Milestone from Ipsen. Today, Exelixis announced it earned and recognized in license revenues a $150 million commercial milestone from Ipsen during the second quarter of 2024 based on Ipsen achieving $600 million in cumulative net sales of cabozantinib in its related license territory over four consecutive quarters. Exelixis expects to receive the milestone payment during the third quarter of 2024.

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 U.S. and Japan. As part of the agreement, Exelixis is eligible to receive a reimbursement of a portion of costs related to the trial, as well as milestone payments for potential future regulatory action by the European Medicines Agency. The decision to expand the existing agreement was based on detailed results from the CABINET trial, which were first presented at the ESMO Congress 2023.

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; 95% confidence interval: 0.50–0.84; p=0.0007) in the predefined PFS intent-to-treat population (i.e., the first 400 randomized patients). While final OS continued to favor the combination of cabozantinib and atezolizumab, it did not achieve statistical significance. The safety profile of the combination regimen was reflective of the known safety profiles for each single agent and was consistent with the known tolerability profile of approved immune checkpoint inhibitor-tyrosine kinase inhibitor combinations in advanced solid tumors. Exelixis intends to submit an sNDA to the FDA this year and to present these final data at a future medical meeting.

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 USA. In May, Exelixis entered into a Settlement and License Agreement (Agreement) with Cipla Ltd. and Cipla USA, Inc. (individually and collectively referred to as Cipla) resolving two patent litigations brought by Exelixis in response to Cipla’s Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of CABOMETYX tablets (20 mg / 40 mg / 60 mg) prior to the expiration of the applicable patents. Pursuant to the terms of the Agreement, Exelixis will grant Cipla a license to market generic versions of CABOMETYX in the United States beginning on January 1, 2031, if approved by the FDA and subject to conditions and exceptions common to agreements of this type. The U.S. District Court for the District of Delaware dismissed the case without prejudice in July 2024 per the parties’ joint request, effectively terminating all ongoing Hatch-Waxman litigation between Exelixis and Cipla regarding CABOMETYX patents

Completion of the $450 million 2024 Stock Repurchase Program. As of June 30, 2024, Exelixis completed the repurchase of 20.3 million shares of the company’s common stock for a total of $450 million, fulfilling its commitment under the stock repurchase program announced in January 2024. With the completion of this 2024 stock repurchase program, the company has returned $1 billion to shareholders since the initial $550 million stock repurchase program was authorized in March 2023.

Announcement of Additional Stock Repurchase Program for up to $500 million through the End of 2025. Today, Exelixis announced that the company’s Board of Directors has authorized the repurchase of up to an additional $500 million of the company’s common stock through the end of 2025. The newly authorized stock repurchase program is the third such program undertaken by Exelixis since March 2023. Stock repurchases under the newly authorized program may be made from time to time through a variety of methods, which may include open market purchases, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The timing and amount of any stock repurchases under the stock repurchase program will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of Exelixis’ common stock and general market conditions.

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 $150 million milestone payment from Ipsen; Exelixis’ plans to present updated results from CABINET, including final results for the primary efficacy endpoint of PFS, at the ESMO Congress 2024 in September; Exelixis’ expectation to receive reimbursement payments from Ipsen relating to CABINET, as well as milestone payments for potential future regulatory actions by the European Medicines Agency; Exelixis’ plans to submit an sNDA for the combination of cabozantinib and atezolizumab in mCRPC to the FDA this year based on the results of CONTACT-02, and to present final data from CONTACT-02 at a future medical meeting; Exelixis’ expectation that preliminary results from STELLAR-303 will readout in 2025; Exelixis’ plans to initiate STELLAR-311 in the first half of 2025; Exelixis’ plans to disclose data from JEWEL-101 at a later date; Exelixis’ future obligations under the Agreement settling the company’s patent litigation with Cipla; Exelixis’ plans to repurchase up to an additional $500 million of its common stock before the end of 2025; and Exelixis’ scientific pursuit to create transformational treatments that give more patients hope for the future. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the degree of market acceptance of CABOMETYX and other Exelixis products in the indications for which they are approved and in the territories where they are approved, and Exelixis’ and its partners’ ability to obtain or maintain coverage and reimbursement for these products; the effectiveness of CABOMETYX and other Exelixis products in comparison to competing products; the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; Exelixis’ ability to maintain and scale adequate sales, marketing, market access and product distribution capabilities for its products or to enter into and maintain agreements with third parties to do so; the availability of data at the referenced times; the potential failure of cabozantinib, zanzalintinib and other Exelixis product candidates, both alone and in combination with other therapies, to demonstrate safety and/or efficacy in clinical testing; uncertainties inherent in the drug discovery and product development process; Exelixis’ dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals for partnered compounds in new indications, their adherence to their obligations under relevant collaboration agreements and the level of their investment in the resources necessary to complete clinical trials or successfully commercialize partnered compounds in the territories where they are approved; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis’ continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib and other Exelixis product candidates; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of its products and product candidates; Exelixis’ ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of Exelixis’ marketed products; changes in economic and business conditions; and other factors detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ other future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

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.

 

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

What were Exelixis' revenues for Q2 2024?

Exelixis reported total revenues of $637.2 million for Q2 2024.

How did Exelixis' cabozantinib franchise perform in Q2 2024?

The cabozantinib franchise generated net product revenues of $437.6 million in Q2 2024.

What was Exelixis' GAAP diluted EPS for Q2 2024?

Exelixis' GAAP diluted EPS for Q2 2024 was $0.77.

When is the FDA's target action date for cabozantinib's sNDA in advanced NET?

The FDA has set a target action date of April 3, 2025, for cabozantinib's sNDA in advanced NET.

How much is Exelixis' new stock repurchase program?

Exelixis announced a new stock repurchase program for up to $500 million through the end of 2025.

What milestone payment did Exelixis earn from Ipsen?

Exelixis earned a $150 million milestone payment from Ipsen.

Exelixis Inc

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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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