Exelixis (EXEL) has been on a downward spiral lately with significant selling pressure. After declining 11.7% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is ...

Exelixis, Inc. (EXEL) reported earnings of 33 cents per share in the fourth quarter of 2023, which beat the Zacks Consensus Estimate of 31 cents. The company posted a net loss of 3 cents per share in the fourth quarter of 2022.Including stock-based compensation expenses, earnings per share were 27 cents against a loss of 9 cents in the year-ago quarter due to an increase in revenues and lower expenses.Net revenues were $479.6 million, marginally missing the Zacks Consensus Estimate of $481 million. Revenues ...

For the quarter ended December 2023, Exelixis (EXEL) reported revenue of $479.65 million, up 13.2% over the same period last year. EPS came in at $0.33, compared to -$0.03 in the year-ago quarter.The reported revenue represents a surprise of -0.33% over the Zacks Consensus Estimate of $481.23 million. With the consensus EPS estimate being $0.31, the EPS surprise was +6.45%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street ...

Exelixis (EXEL) came out with quarterly earnings of $0.33 per share, beating the Zacks Consensus Estimate of $0.31 per share. This compares to loss of $0.03 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 6.45%. A quarter ago, it was expected that this drug developer would post earnings of $0.17 per share when it actually produced earnings of $0.10, delivering a surprise of -41.18%.Over the last four quarters, the company has ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 29, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 000-30235 EXELIXIS, INC. (Exact name of registrant as specified in its charter) Delaware 04-3257395 (State or other jurisdiction ...

It doesn't matter your age or experience: taking full advantage of the stock market and investing with confidence are common goals for all investors. Luckily, Zacks Premium offers several different ways to do both.The research service features daily updates of the Zacks Rank and Zacks Industry Rank, full access to the Zacks #1 Rank List, Equity Research reports, and Premium stock screens, all of which will help you become a smarter, more confident investor.Zacks Premium includes access to the Zacks Style Sc ...

Financial Performance - Total revenues for Q3 2023 were $471.9 million, a 15% increase year-over-year[60] - Net product revenues reached $426.5 million[115] - GAAP net income was $1 million, a significant decrease compared to $73.2 million in Q3 2022[9, 124] - Non-GAAP net income was $32.1 million[9] - Ending cash and investments totaled $1915.1 million, a 9% decrease year-over-year[60] Cabozantinib Franchise - Cabozantinib franchise net product revenues were approximately $426 million in the U S and $586 million globally in Q3 2023[113] - Ipsen's royalty to Exelixis from ex-US and ex-Japan cabozantinib franchise net product revenues was $34.8 million in Q3 2023[63] - Ipsen ex-US and ex-Japan cabozantinib franchise net product revenues reached $145.4 million[215] - CABOMETYX maintained its position as the 1 prescribed TKI in RCC[127] Research and Development - GAAP R&D expenses were $332.6 million, a 67% increase compared to Q3 2022[116, 124] - Non-GAAP R&D expenses were $320.1 million[116] - License revenues include cabozantinib royalties to Exelixis of $37.8 million[132]

I'll turn now to XB002, our antibody drug conjugate which targets tissue factor and incorporates a modified aura statin as the payload. We've initiated expansion in multiple cohorts at two different doses which will allow us to determine the best dose to take forward into registrational studies and combinations while also fulfilling project optimists. Combinations with nivolumab and with bevacizumab are also underway and data here will serve to inform a broader clinical development program. Finally, I'm ver ...

Financial Data and Key Metrics Changes - The company reported total revenues of approximately $470 million for Q2 2023, which included cabozantinib franchise net product revenues of $409.6 million [116] - GAAP net income for Q2 2023 was approximately $81.2 million or $0.25 per share, while non-GAAP net income was approximately $100.3 million or $0.31 per share [88] - Cash and investments as of June 30, 2023, were approximately $2.1 billion, providing flexibility for investments and shareholder returns [75] Business Line Data and Key Metrics Changes - CABOMETYX net product revenues were $403.3 million, including approximately $21 million in clinical trial sales [73] - CABOMETYX TRx volume grew by 9% year-over-year in Q2 2023 and 4% compared to Q1 2023 [77] - The cabozantinib franchise net product revenues in the US grew 18% year-over-year in Q2 2023 compared to Q2 2022 [83] Market Data and Key Metrics Changes - CABOMETYX maintained a leading TKI market basket share at 39% [77] - The overall survival data for CABOMETYX plus nivolumab showed a median overall survival of 49.5 months, representing a 14-month improvement over the comparator arm [122] - The company is seeing strong demand and new patient starts, reinforcing its leadership position in the RCC marketplace [121] Company Strategy and Development Direction - The company is focused on building a pipeline of clinically and commercially differentiated medicines for cancer patients with high unmet medical needs [68] - Business development activities remain a priority, with ongoing discussions to access new clinical assets [85] - The company plans to present its R&D efforts at an investor event on December 2, 2023, in New York City [69] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of CABOMETYX into the second half of the year, reiterating full-year 2023 financial guidance [149] - The company is excited about the future and the strength of its balance sheet, which allows for continued investment in R&D and business development [12][75] - Management highlighted the importance of emerging data for both Zanzalintinib and XB002, indicating a positive outlook for these assets [154] Other Important Information - The company entered into a settlement and license agreement with Teva to resolve patent litigation, allowing Teva to market a generic version of CABOMETYX in the US starting January 1, 2031 [70][86] - The gross to net deductions for the cabozantinib franchise in Q2 2023 were 27.3%, lower than the previous quarter, primarily due to lower Medicare Part-D and co-pay assistance expenses [117] Q&A Session Summary Question: Can you comment on the rationale for keeping the original guidance and expectations for cabo growth? - Management reiterated confidence in CABOMETYX's growth potential based on strong performance in the first half of the year [149] Question: What are the scenarios for COSMIC-313 with upcoming data? - Management is focused on the data and its implications for supplemental NDA filing, emphasizing the importance of the upcoming results [5] Question: How does the company view the competitive landscape for TKIs in the RCC market? - CABOMETYX continues to lead the TKI market with strong overall survival data, differentiating it from competitors [122] Question: Are there plans to review the current cost base for efficiencies? - Management indicated that cost efficiencies are being evaluated as part of ongoing strategic discussions [10] Question: What is the company's strategy regarding business development? - The company remains committed to business development activities to access new clinical assets while also focusing on internal R&D efforts [49]

PART I - FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Exelixis, Inc.'s unaudited condensed consolidated financial statements for the periods ended June 30, 2023, are presented Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | June 30, 2023 (in thousands) | December 31, 2022 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $464,480 | $501,195 | | Total current assets | $1,590,527 | $1,618,762 | | Total assets | $3,142,468 | $3,071,489 | | Total current liabilities | $339,617 | $324,359 | | Total liabilities | $614,530 | $583,062 | | Total stockholders' equity | $2,527,938 | $2,488,427 | Condensed Consolidated Statements of Income Highlights (Unaudited) | Income Statement Item | Three Months Ended June 30, 2023 (in thousands) | Three Months Ended June 30, 2022 (in thousands) | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $469,848 | $419,427 | $878,636 | $775,407 | | Income from operations | $77,850 | $83,706 | $106,680 | $166,949 | | Net income | $81,178 | $70,672 | $121,206 | $139,245 | | Diluted EPS | $0.25 | $0.22 | $0.37 | $0.43 | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | Cash Flow Item | Six Months Ended June 30, 2023 (in thousands) | Six Months Ended June 30, 2022 (in thousands) | | :--- | :--- | :--- | | Net cash provided by operating activities | $205,386 | $178,849 | | Net cash used in investing activities | ($123,377) | ($209,681) | | Net cash provided by (used in) financing activities | ($120,206) | $4,627 | | Net decrease in cash and cash equivalents | ($38,197) | ($26,205) | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's Q2 2023 financial performance, revenue growth, expense trends, and pipeline progress Q2 2023 Financial Highlights vs. Q2 2022 | Metric | Q2 2023 (in millions) | Q2 2022 (in millions) | Change | | :--- | :--- | :--- | :--- | | Net product revenues | $409.6 | $347.0 | +18% | | Total revenues | $469.8 | $419.4 | +12% | | R&D expenses | $232.6 | $199.5 | +17% | | SG&A expenses | $141.7 | $122.8 | +15% | | Net income | $81.2 | $70.7 | +15% | | Diluted EPS | $0.25 | $0.22 | +13.6% | - The **18% increase** in net product revenues for Q2 2023 was driven by a **10% increase** in CABOMETYX units sold and a **9% increase** in its average net selling price compared to the same period in 2022[134](index=134&type=chunk) - R&D expenses rose **17% YoY** in Q2 2023, primarily due to increased manufacturing costs for development candidates, higher personnel expenses, and increased clinical trial costs for zanzalintinib and XB002[148](index=148&type=chunk)[149](index=149&type=chunk)[151](index=151&type=chunk) - The company is advancing its pipeline with key programs: zanzalintinib in Phase 3 trials for colorectal cancer (STELLAR-303) and renal cell carcinoma (STELLAR-304), and XB002, a tissue factor-targeting ADC, in a Phase 1 trial (JEWEL-101)[106](index=106&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk) - As of June 30, 2023, the company has repurchased **$127.0 million** of its common stock under a **$550 million** program authorized in March 2023[125](index=125&type=chunk)[73](index=73&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that its market risks as of June 30, 2023, have not changed significantly from those described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 - There have been no significant changes to the company's market risks since the end of fiscal year 2022[182](index=182&type=chunk) [Controls and Procedures](index=50&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of the end of the period covered by this report[183](index=183&type=chunk) - There were no changes in internal control over financial reporting during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[185](index=185&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=51&type=section&id=Item%201.%20Legal%20Proceedings) This section details ongoing patent litigation related to generic versions of CABOMETYX, involving MSN, Teva, and Cipla - **MSN I ANDA Litigation:** A Delaware District Court ruled that MSN's proposed generic product does not infringe U.S. Patent No. 8,877,776 but upheld the validity of U.S. Patent No. 7,759,473. The judgment sets the effective date for any FDA approval of MSN's ANDA to be no earlier than **August 14, 2026**[82](index=82&type=chunk)[189](index=189&type=chunk) - **MSN II ANDA Litigation:** A separate lawsuit against MSN involves different patents (U.S. Patents No. 11,091,439, 11,091,440, 11,098,015, and 11,298,349). A bench trial for this case is scheduled for **October 2023**[86](index=86&type=chunk)[193](index=193&type=chunk) - **Teva ANDA Litigation:** On July 18, 2023, Exelixis entered into a settlement and license agreement with Teva, resolving patent litigation. Teva is granted a license to market its generic version of CABOMETYX in the U.S. beginning on **January 1, 2031**[87](index=87&type=chunk)[194](index=194&type=chunk) - **Cipla ANDA Litigation:** Exelixis filed a complaint against Cipla in March 2023 for patent infringement related to its ANDA for a generic version of CABOMETYX. The case has been administratively closed after the parties filed a stipulation to stay all proceedings[90](index=90&type=chunk)[195](index=195&type=chunk) [Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) This section outlines key risks, including drug pricing scrutiny, regulatory uncertainties, manufacturing reliance, and legal compliance - **Drug Pricing Scrutiny:** The Inflation Reduction Act of 2022 introduces measures like the Medicare Drug Price Negotiation Program and inflation rebates, which could reduce revenues, present challenges for payor negotiations, and increase government discount liabilities[198](index=198&type=chunk)[200](index=200&type=chunk) - **Regulatory Process Risks:** The FDA's Project Optimus initiative, aimed at reforming dose optimization in oncology drug development, may require additional studies, causing delays and increased costs for product candidates[203](index=203&type=chunk) - **Manufacturing and Supply Chain Risks:** The company's reliance on third-party contract manufacturers for production and distribution exposes it to risks of delays, quality issues, and non-compliance with regulations like the Drug Supply Chain Security Act (DSCSA)[208](index=208&type=chunk)[209](index=209&type=chunk) - **Legal Compliance Risks:** Patient assistance programs and donations to charitable foundations are under enhanced government scrutiny, posing risks of investigations, fines, and reputational harm if found non-compliant with regulations[210](index=210&type=chunk)[211](index=211&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=61&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company details its stock repurchase activity for the quarter ended June 30, 2023, under its authorized $550 million program Stock Repurchase Activity (Q2 2023) | Period | Total Shares Purchased (in thousands) | Average Price Paid per Share | Approximate Dollar Value of Shares That May Yet Be Purchased (in thousands) | | :--- | :--- | :--- | :--- | | April 29 - May 26, 2023 | 2,382 | $19.32 | $503,980 | | May 27 - June 30, 2023 | 4,226 | $19.16 | $423,016 | | **Total** | **6,608** | | **$423,016** | - In March 2023, the Board of Directors authorized a stock repurchase program of up to **$550 million**. As of June 30, 2023, approximately **$423.0 million** remained available for future repurchases[213](index=213&type=chunk) [Defaults Upon Senior Securities](index=61&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that this item is not applicable - Not applicable [Mine Safety Disclosures](index=61&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports that this item is not applicable - Not applicable [Other Information](index=61&type=section&id=Item%205.%20Other%20Information) The company discloses that an executive officer entered into a pre-arranged Rule 10b5-1 stock trading plan during the quarter - Dana T. Aftab, Executive Vice President, Discovery and Translational Research, and Chief Scientific Officer, entered into a pre-arranged Rule 10b5-1 stock trading plan on May 25, 2023, for the sale of up to **199,256 shares** of common stock[218](index=218&type=chunk) - No other directors or Section 16 officers adopted or terminated any Rule 10b5-1 trading arrangement during the three months ended June 30, 2023[219](index=219&type=chunk) [Exhibits](index=62&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including officer certifications and XBRL data files - The report includes several exhibits, such as the Restated Certificate of Incorporation, Amended and Restated Bylaws, officer certifications required by the Exchange Act, and Inline XBRL documents[220](index=220&type=chunk)