Small pharma Announces U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for CABOMETYX®

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ALAMEDA, Calif., (BUSINESS WIRE) -- Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2021 and provided an update on progress toward achieving key corporate objectives, as well as commercial, clinical and pipeline development milestones.

“In the second quarter of 2021, Exelixis delivered a 59 percent year over year increase in CABOMETYX®net product revenue growth and record total revenues, based on the broad adoption of the CABOMETYX and OPDIVO® combination regimen as a preferred treatment in first-line renal cell carcinoma,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “Following this strong commercial performance, we are raising our net product and total revenue guidance for 2021. In parallel, we also made significant progress across our development activities, with the filing of a supplemental New Drug Application for cabozantinib in differentiated thyroid cancer based on the COSMIC-311 study, and announcements of top-line results from both the COSMIC-312 trial in first-line advanced hepatocellular carcinoma and the expanded Cohort 6 of the COSMIC-021 trial in patients with advanced prostate cancer. In addition, on the pipeline front, we broadened the development program of XL092 with a new clinical collaboration with Bristol Myers Squibb and initiated the Phase 1 trial for XB002, our first antibody-drug conjugate. I’d like to thank the entire Exelixis team for a very strong first half of 2021 and look forward to providing further updates on our progress in the second half of the year.”

 

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Second Quarter 2021 Financial Results

Total revenues for the quarter ended June 30, 2021 were $385.2 million, compared to $259.5 million for the comparable period in 2020.

Total revenues for the quarter ended June 30, 2021 included net product revenues of $284.2 million, compared to $178.7 million for the comparable period in 2020. The increase in net product revenues was primarily related to an increase in sales volume that was driven by strong uptake for the combination therapy of CABOMETYX (cabozantinib) and OPDIVO (nivolumab) following approval by the U.S. Food and Drug Administration (FDA) in January 2021.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $100.9 million for the quarter ended June 30, 2021, compared to $80.7 million for the comparable period in 2020. The increase in collaboration revenues was primarily related to increases in development cost reimbursements earned, 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 (Takeda), which was partially offset by a decrease in the recognition of milestone-related revenues.

Research and development expenses for the quarter ended June 30, 2021 were $148.8 million, compared to $114.9 million for the comparable period in 2020. The increase in research and development expenses was primarily related to increases in license and other collaboration costs, personnel expenses and stock-based compensation expense, which was partially offset by decreases in clinical trial costs.

 

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Selling, general and administrative expenses for the quarter ended June 30, 2021 were $98.5 million, compared to $59.8 million for the comparable period in 2020. The increase in selling, general and administrative expenses was primarily related to increases in personnel expenses, marketing costs, corporate giving and stock-based compensation expense.

Provision for income taxes for the quarter ended June 30, 2021 was $28.8 million, compared to $13.9 million for the comparable period in 2020, primarily due to an increase in pre-tax income.

GAAP net income for the quarter ended June 30, 2021 was $96.1 million, or $0.31 per share, basic and $0.30 per share, diluted, compared to GAAP net income of $66.8 million, or $0.22 per share, basic and $0.21 per share, diluted, for the comparable period in 2020.

 

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Non-GAAP net income for the quarter ended June 30, 2021 was $117.9 million, or $0.38 per share, basic and $0.37 per share, diluted, compared to non-GAAP net income of $79.4 million, or $0.26 per share, basic and $0.25 per share, diluted, for the comparable period in 2020. Non-GAAP net income excludes stock-based compensation, adjusted for the related income tax effect.

Cash, cash equivalents, restricted cash equivalents and investments were $1.7 billion at June 30, 2021, compared to $1.5 billion at December 31, 2020.

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.

 

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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.

 

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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.

2021 Financial Guidance

Exelixis is providing the following updated financial guidance for fiscal year 2021:

Total revenues (1)		$1,300 million - $1,400 million
Net product revenues (1)		$1,050 million - $1,150 million
Cost of goods sold		Approximately 5% - 6% of net product revenue
Research and development expenses (1)(2)		$650 million - $700 million
Selling, general and administrative expenses (1)(3)		$375 million - $425 million
Effective tax rate		20% - 22%
Cash and investments (4)(5)		$1.7 billion - $1.8 billion

(1)		Guidance updated on August 5, 2021 from previously provided guidance on May 6, 2021.
(2)		Includes $45 million of non-cash stock-based compensation expense.
(3)		Includes $60 million of non-cash stock-based compensation expense.
(4)		This cash and investments guidance does not include any potential new business development activity.
(5)		Cash and investments is composed of cash, cash equivalents, restricted cash equivalents and

 

[Cottonmouth]

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Pharma spamming whore.
Who even reply you except me?
As my reward, you should let me whip your CB.

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[Cottonmouth]

You @glockman clone asian turtle son of whore can write in your @ginmother fake holy and @glockman fake act poor act rich act cute so fake class way but your same no class narrow hearted character shows people can only write what you endorsed even when it’s harmless. Your @glockman clone was attacking me on Hokkien heritage series too then and now you diss my pharma series more than once. Who do you think you are? You think I am doing this for you people? or you think this is YouTube I need to care how many viewers how many comments I get? I am doing this for myself to read and post here daily to enhance my knowledge to become expert be it Hokkien expert or vaccine or cancer or pharma expert. Any incidental benefit to others is considered my charity. Understand bastard?

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Tell dirty vicious lies of a woman is your proud Chinese son of whore way to win while act poor thing victim of ceca

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