Press Release
Press Release
Exelixis Announces Preliminary Fourth Quarter and Full Year 2020 Financial Results, Provides 2021 Financial Guidance, and Outlines Key Priorities and Anticipated Milestones For 2021
– Cabozantinib Franchise Preliminary Net Product Revenue of
– Full Year 2021 Net Product Revenue Guidance of
– Corporate priorities for 2021 include potentially filing supplemental New Drug Applications for cabozantinib in three additional indications –
– Presentation and webcast at 2021
Preliminary Fourth Quarter and Full Year 2020 Financial Results & 2021 Financial Guidance
|
Fourth Quarter 2020 |
Full Year 2020 |
Full Year 2021 Guidance |
Total revenues |
|
|
|
Net product revenues |
|
|
|
Cost of goods sold |
4.5% |
4.9% |
~ 5-6% of net product revenues |
Research and development expenses |
|
|
|
Selling, general and administrative expenses |
|
|
|
Effective tax rate |
n/a(7) |
n/a(7) |
20% - 22% |
Cash and investments at year-end(8) |
~ |
|
(1) |
Includes |
|
(2) |
Includes |
|
(3) |
Includes |
|
(4) |
Includes |
|
(5) |
Includes |
|
(6) |
Includes |
|
(7) |
Preliminary results not yet available. |
|
(8) |
This cash and investments guidance does not include any potential new business development activity. |
The preliminary 2020 financial information presented in this press release has not been audited and is subject to change. The complete Exelixis Fourth Quarter and Full Year 2020 Financial Results are planned for release after market on
“2020 was a year of focused execution for
Ahead of the company’s presentation at the
CABOMETYX and OPDIVO Combination for First-line Advanced RCC Represents Large and Growing Commercial Opportunity
-
In
August 2020 ,Exelixis announced the submission of an sNDA to the FDA for CABOMETYX in combination with Bristol Myers Squibb’s (BMS) OPDIVO for patients with advanced RCC. InOctober 2020 ,Exelixis and BMS announced that the FDA had accepted each company’s regulatory application, granted Priority Review, and assigned a PDUFA goal date, or target action date, ofFebruary 20, 2021 .Exelixis is ready to commercially launch this combination regimen inthe United States , where an estimated 15,000 patients with advanced RCC are eligible for first-line treatment every year and with immune checkpoint inhibitor (ICI) combination therapy consisting of approximately 80% of that market. Based on the efficacy, safety and longer duration of therapy as observed in the CheckMate -9ER trial,Exelixis estimates that a doubling of CABOMETYX revenues in RCC alone may be achievable, with a potential$1.5 billion annualized run rate exiting 2022.
Potential sNDA Submissions for Cabozantinib in 2021
-
Relapsed radioiodine-refractory differentiated thyroid cancer (DTC):
Exelixis expects to file an sNDA for the approval of cabozantinib monotherapy in patients with radioactive iodine-refractory DTC previously treated with a vascular endothelial growth factor receptor-targeted therapy. The sNDA will be based on the positive results from the phase 3 pivotal COSMIC-311 trial, which met its co-primary endpoint of progression-free survival (PFS) inDecember 2020 . -
Advanced hepatocellular carcinoma (HCC):
Exelixis expects to report top-line data from COSMIC-312, a global phase 3 pivotal trial evaluating cabozantinib in combination with atezolizumab (TECENTRIQ®), F. Hoffmann-La Roche Ltd.’s (Roche) anti-PD-L1 ICI, versus sorafenib in previously untreated advanced HCC, for the co-primary endpoints of PFS and overall survival (OS) in the first half of 2021. If the data are supportive, the company anticipates filing an sNDA in 2021, and its partner Ipsen Pharma SAS would also seek to file marketing applications with regulatory agencies in its respective territories based on the results.Exelixis completed enrollment inAugust 2020 for this global phase 3 pivotal trial. Separately, patient enrollment remains open inChina in order to enroll a sufficient number of patients to potentially enable local registration. -
Metastatic castration-resistant prostate cancer (CRPC): Should the data continue to be supportive,
Exelixis anticipates filing an sNDA in 2021 seeking accelerated approval of cabozantinib in combination with atezolizumab, for the treatment of metastatic CRPC. A confirmatory phase 3 pivotal trial of this regimen in this patient population (CONTACT-02) was initiated inJune 2020 under the clinical trial collaboration betweenExelixis and Roche.
Additional Cabozantinib Clinical Updates
-
COSMIC-313:
Exelixis expanded the enrollment target to 840 patients to provide additional power to assess the secondary endpoint of OS for COSMIC-313, the phase 3 pivotal trial evaluating the triplet combination of cabozantinib, nivolumab and ipilimumab (YERVOY®) versus the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk RCC and expects to complete the expanded enrollment in early 2021. Top-line results of the event-driven analyses from the study are expected in 2022. If the data are supportive, the company would seek to file an sNDA with the FDA. -
CONTACT trials: In 2020, as part of a clinical trial collaboration between
Exelixis and Roche, three phase 3 global pivotal trials were initiated evaluating the combination of cabozantinib and atezolizumab: CONTACT-01 in patients with metastatic non-small cell lung cancer who have been previously treated with an ICI and platinum-containing chemotherapy; CONTACT-02 in patients with metastatic CRPC who have been previously treated with one novel hormonal therapy; and CONTACT-03, in patients with inoperable, locally advanced or metastatic RCC who progressed during or following treatment with an ICI.
Anticipated Progress for XL092 and
-
XL092:
Exelixis is currently enrolling patients into the dose escalation cohorts of the phase 1b clinical trial of XL092 in combination with atezolizumab, and expects to initiate enrollment in the clear cell and non-clear cell RCC, hormone-receptor positive breast cancer and metastatic CRPC expansion cohorts shortly. The company also plans to initiate additional expansion cohorts in other tumor types, as well as potential additional studies, evaluating XL092 in combination with other oncology therapies, including ICIs. As data from these cohorts mature and are supportive, XL092 could enter pivotal trials over the course of 2021. -
XL102: Following the FDA’s acceptance of its IND,
Exelixis expects to initiate a phase 1 trial of XL102 (formerly known as AUR102), alone or in combination therapy for the treatment of inoperable, locally advanced or metastatic solid tumors.Exelixis in-licensed XL102 fromAurigene Discovery Technologies Limited inDecember 2020 . -
XB002:
Exelixis anticipates beginning a phase 1 trial of XB002 (formerly known as ICON-2), in patients with inoperable, locally advanced or metastatic solid tumors.Exelixis in-licensed XB002 fromIconic Therapeutics, Inc. inDecember 2020 and plans to file an IND once the drug product release assays are finalized. -
Additional INDs planned: Subject to preclinical data,
Exelixis has the potential to file up to two additional INDs.
Presentation and Webcast
To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 90 days.
About
Founded in 1994,
Forward-Looking Statements and Preliminary Financial Results
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ anticipation of the FDA’s approval and commercial launch of CABOMETYX for patients with advanced RCC as a first-line treatment in combination with Opdivo; Exelixis’ 2021 financial guidance; the therapeutic and commercial potential of CABOMETYX and Exelixis’ belief that it is well-positioned to deliver significant revenue growth throughout 2021 and beyond; Exelixis’ intention to pursue additional regulatory approvals and clinical development activities that create the potential for a multi-billion dollar franchise; Exelixis’ clinical development plans for XL092 and belief that it may ultimately become a source of long-term revenue; Exelixis’ belief that it is well on its way to becoming a multi-product oncology company; Exelixis’ corporate priorities and anticipated key milestones for 2021, including the potential filing of sNDAs for CABOMETYX in three additional indications, expanded clinical development activities for XL092, and multiple INDs for preclinical assets; Exelixis’ estimate for CABOMETYX revenues in RCC exiting 2022; Exelixis’ expectations for, and the related anticipated timelines for, completing enrollment in, conducting analyses of and obtaining top-line results from its ongoing potential label-enabling clinical studies evaluating cabozantinib, and if supported by the data, pursuing potential regulatory approvals; Exelixis’ clinical development plans for XL102 and XB002; Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery; and other statements that are not historical facts. 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, risks and uncertainties associated with: the continuing COVID-19 pandemic and its impact on Exelixis’ clinical trial, drug discovery and commercial activities; the degree of market acceptance of CABOMETYX and other
In addition, this press release includes Exelixis’ preliminary financial results for the quarter and fiscal year ended
MINNEBRO is a Japanese trademark.
OPDIVO® and YERVOY® are registered trademarks of Bristol-Myers Squibb Company.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210110005056/en/
Investor Contacts:
EVP, Public Affairs & Investor Relations
650-837-8194
shubbard@exelixis.com
Chief Financial Officer
650-837-7240
csenner@exelixis.com
Media Contact:
For
415-994-0040
hal@torchcommunications.com
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