Table of Contents

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM10-Q

☒   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 27, 2019October 2, 2020
or
☐   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 000-30235
exel-20201002_g1.jpg
EXELIXIS, INC.
(Exact name of registrant as specified in its charter)

Delaware04-3257395
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification Number)

1851 Harbor Bay Parkway
Alameda,CA94502
(650) (650) 837-7000
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock $.001 Par Value per ShareEXELThe Nasdaq Stock Market LLC
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days).    Yes  ý No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes  ý No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer☒Accelerated filer☐
Non-accelerated filer☐Smaller reporting company☐
Emerging growth company☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Securities Act. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ☐ No ý
As of October 21, 2019,26, 2020, there were 303,846,306310,243,961 shares of the registrant’s common stock outstanding.


Table of Contents
EXELIXIS, INC.
QUARTERLY REPORT ON FORM 10-Q
INDEX
Page
PART I - FINANCIAL INFORMATION
Item 1.
3
Condensed Consolidated Balance Sheets
3
Condensed Consolidated Statements of Income (Loss)
4
Condensed Consolidated Statements of Comprehensive Income (Loss)
4
Condensed Consolidated Statements of Stockholders’ Equity
5
Condensed Consolidated Statements of Cash Flows
7
Notes to Condensed Consolidated Financial Statements
98
Item 2.
2622
Item 3.
3836
Item 4.
3836
PART II - OTHER INFORMATION
Item 1.
3937
Item 1A.
3937
Item 2.
6259
Item 3.
6259
Item 4.
6259
Item 5.
6259
Item 6.
6359
SIGNATURES

2
Table of Contents
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
EXELIXIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
(unaudited)
 September 30,
2019		 December 31, 2018*
ASSETS   
Current assets:   
Cash and cash equivalents$242,317
 $314,775
Short-term investments518,350
 378,559
Trade receivables, net169,788
 162,771
Other receivables13,801
 16,056
Inventory, net13,366
 9,838
Prepaid expenses and other current assets14,490
 15,017
Total current assets972,112
 897,016
Long-term investments486,763
 157,187
Long-term restricted cash and investments1,000
 1,100
Property and equipment, net49,467
 50,897
Operating lease right-of-use assets17,735
 5,867
Deferred tax assets, net186,836
 244,111
Goodwill63,684
 63,684
Other long-term assets7,268
 2,424
Total assets$1,784,865
 $1,422,286
LIABILITIES AND STOCKHOLDERS’ EQUITY   
Current liabilities:   
Accounts payable$8,352
 $10,901
Accrued compensation and benefits31,713
 32,142
Accrued clinical trial liabilities30,330
 18,231
Rebates and fees due to customers16,782
 14,954
Accrued collaboration liabilities7,973
 7,419
Other current liabilities45,919
 21,825
Total current liabilities141,069
 105,472
Long-term portion of lease liabilities23,705
 12,178
Long-term portion of deferred revenue15,399
 15,897
Other long-term liabilities975
 1,286
Total liabilities181,148
 134,833
Commitments

 

Stockholders’ equity:   
Preferred stock, $0.001 par value, 10,000,000 shares authorized and no shares issued—
 —
Common stock, $0.001 par value; 400,000,000 shares authorized; issued and outstanding: 303,776,032 and 299,876,080 at September 30, 2019 and December 31, 2018, respectively304
 300
Additional paid-in capital2,228,839
 2,168,217
Accumulated other comprehensive income (loss)2,668
 (701)
Accumulated deficit(628,094) (880,363)
Total stockholders’ equity1,603,717
 1,287,453
Total liabilities and stockholders’ equity$1,784,865
 $1,422,286

*The Condensed Consolidated Balance Sheet as of December 31, 2018 has been derived from the audited financial statements as of that date.
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.

EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(in thousands, except per share amounts)
(unaudited)
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Revenues:       
Net product revenues$191,768
 $162,946
 $565,024
 $443,054
Collaboration revenue79,935
 62,451
 162,441
 182,170
Total revenues271,703
 225,397
 727,465
 625,224
Operating expenses:       
Cost of goods sold7,537
 7,360
 22,577
 18,996
Research and development97,295
 44,741
 242,516
 124,986
Selling, general and administrative51,265
 48,120
 170,218
 153,989
Total operating expenses156,097
 100,221
 435,311
 297,971
Income from operations115,606
 125,176
 292,154
 327,253
Other income (expense), net:       
Interest income7,191
 3,507
 20,253
 8,099
Other, net(140) 271
 688
 368
Total other income (expense), net:7,051
 3,778
 20,941
 8,467
Income before income taxes122,657
 128,954
 313,095
 335,720
Provision for income taxes(25,205) (2,324) (60,826) (5,739)
Net income$97,452
 $126,630
 $252,269
 $329,981
Net income per share, basic$0.32
 $0.42
 $0.84
 $1.11
Net income per share, diluted$0.31
 $0.41
 $0.80
 $1.05
Shares used in computing net income per share, basic303,268
 298,416
 301,999
 297,700
Shares used in computing net income per share, diluted315,453
 312,346
 315,046
 313,200
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(in thousands)
(unaudited)
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Net income$97,452
 $126,630
 $252,269
 $329,981
Other comprehensive income (loss):       
Net unrealized gains or losses on available-for-sale securities, net of tax impact of $129, $0, $936 and $0, respectively (1)
461
 218
 3,369
 (166)
Total other comprehensive income (loss)461
 218
 3,369
 (166)
Comprehensive income$97,913
 $126,848
 $255,638
 $329,815
____________________
(1)Reclassification adjustments to net income resulting from realized gains or losses on the sale of securities and the related tax impact were nominal or zero during the periods presented.
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.

EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share data)
(unaudited)
 Three Months Ended September 30, 2019
 Common Stock Additional
Paid-in
Capital		 Accumulated
Other
Comprehensive
Income		 Accumulated
Deficit		 Total
Stockholders’
Equity
 Shares Amount    
Balance at June 30, 2019302,784,854
 $303
 $2,211,668
 $2,207
 $(725,546) $1,488,632
Net income—
 —
 —
 —
 97,452
 97,452
Other comprehensive income—
 —
 —
 461
 —
 461
Issuance of common stock under equity incentive and stock purchase plans991,178
 1
 4,032
 —
 —
 4,033
Stock-based compensation—
 —
 13,139
 —
 —
 13,139
Balance at September 30, 2019303,776,032
 $304
 $2,228,839
 $2,668
 $(628,094) $1,603,717

 Three Months Ended September 30, 2018
 Common Stock Additional
Paid-in
Capital		 Accumulated
Other
Comprehensive
Loss		 Accumulated
Deficit		 Total
Stockholders’
Equity
 Shares Amount    
Balance at June 30, 2018297,892,180
 $298
 $2,142,717
 $(731) $(1,367,082) $775,202
Net income—
 —
 —
 —
 126,630
 126,630
Other comprehensive income—
 —
 —
 218
 —
 218
Issuance of common stock under equity incentive and stock purchase plans989,704
 1
 4,173
 —
 —
 4,174
Stock-based compensation—
 —
 9,742
 —
 —
 9,742
Balance at September 30, 2018298,881,884
 $299
 $2,156,632
 $(513) $(1,240,452) $915,966
Continued on next page
 September 30, 2020December 31, 2019
ASSETS
Current assets:
Cash and cash equivalents$334,046 $266,501 
Short-term investments853,835 585,742 
Trade receivables, net166,138 119,073 
Inventory19,319 12,886 
Prepaid expenses and other current assets34,470 26,988 
Total current assets1,407,808 1,011,190 
Long-term investments358,079 536,385 
Property and equipment, net56,385 48,892 
Deferred tax assets, net155,678 172,374 
Goodwill63,684 63,684 
Other long-term assets69,409 53,145 
Total assets$2,111,043 $1,885,670 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable$47,927 $11,581 
Accrued compensation and benefits40,782 37,364 
Accrued clinical trial liabilities47,074 38,777 
Rebates and fees due to customers19,129 18,719 
Accrued collaboration liabilities11,102 11,856 
Other current liabilities35,329 24,449 
Total current liabilities201,343 142,746 
Long-term portion of deferred revenues9,322 6,596 
Long-term portion of operating lease liabilities47,626 48,011 
Other long-term liabilities721 2,347 
Total liabilities259,012 199,700 
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value, 10,000 shares authorized and 0 shares issued0 0 
Common stock, $0.001 par value; 400,000 shares authorized; issued and outstanding: 309,402 and 304,831 at September 30, 2020 and December 31, 2019, respectively309 305 
Additional paid-in capital2,321,441 2,241,947 
Accumulated other comprehensive income6,239 3,069 
Accumulated deficit(475,958)(559,351)
Total stockholders’ equity1,852,031 1,685,970 
Total liabilities and stockholders’ equity$2,111,043 $1,885,670 
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.

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EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)
(in thousands, except per share amounts)
(unaudited)
 Three Months Ended September 30,Nine Months Ended September 30,
 2020201920202019
Revenues:
Net product revenues$168,587 $191,768 $541,197 $565,024 
License revenues33,205 69,137 113,318 132,443 
Collaboration services revenues29,300 10,798 62,971 29,998 
Total revenues231,092 271,703 717,486 727,465 
Operating expenses:
Cost of goods sold8,725 7,537 27,235 22,577 
Research and development176,762 97,295 393,572 242,516 
Selling, general and administrative88,185 51,265 210,916 170,218 
Total operating expenses273,672 156,097 631,723 435,311 
Income (loss) from operations(42,580)115,606 85,763 292,154 
Interest income3,994 7,191 16,376 20,253 
Other income (expense), net565 (140)571 688 
Income (loss) before income taxes(38,021)122,657 102,710 313,095 
Provision for (benefit from) income taxes(5,981)25,205 19,317 60,826 
Net income (loss)$(32,040)$97,452 $83,393 $252,269 
Net income (loss) per share:
Basic$(0.10)$0.32 $0.27 $0.84 
Diluted$(0.10)$0.31 $0.26 $0.80 
Weighted-average common shares outstanding:
Basic309,116 303,268 307,437 301,999 
Diluted309,116 315,453 317,495 315,046 
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(in thousands)
(unaudited)
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Net income (loss)$(32,040)$97,452 $83,393 $252,269 
Other comprehensive income (loss):
Net unrealized gains (losses) on available-for-sale debt securities, net of tax impact of $453, $(129), $(893) and $(936), respectively(1,601)461 3,170 3,369 
Comprehensive income (loss)$(33,641)$97,913 $86,563 $255,638 
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
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EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
(unaudited)
Three Months Ended September 30, 2020
Common StockAdditional
Paid-in
Capital		Accumulated Other Comprehensive IncomeAccumulated
Deficit		Total
Stockholders’
Equity
SharesAmount
Balance at June 30, 2020308,886 $309 $2,269,093 $7,840 $(443,918)$1,833,324 
Net loss— — — — (32,040)(32,040)
Other comprehensive loss— — — (1,601)— (1,601)
Issuance of common stock under equity incentive and stock purchase plans516 — 1,872 — — 1,872 
Stock transactions associated with taxes withheld on equity awards— — (5,179)— — (5,179)
Stock-based compensation— — 55,655 — — 55,655 
Balance at September 30, 2020309,402 $309 $2,321,441 $6,239 $(475,958)$1,852,031 
Three Months Ended September 30, 2019
Common StockAdditional
Paid-in
Capital		Accumulated Other Comprehensive IncomeAccumulated
Deficit		Total
Stockholders’
Equity
SharesAmount
Balance at June 30, 2019302,785 $303 $2,211,668 $2,207 $(725,546)$1,488,632 
Net income— — — — 97,452 97,452 
Other comprehensive income— — — 461 — 461 
Issuance of common stock under equity incentive and stock purchase plans991 1 4,967 — — 4,968 
Stock transactions associated with taxes withheld on equity awards— — (935)— — (935)
Stock-based compensation— — 13,139 — — 13,139 
Balance at September 30, 2019303,776 $304 $2,228,839 $2,668 $(628,094)$1,603,717 
Continued on next page
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EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY - continued
(in thousands, except share data)thousands)
(unaudited)
Nine Months Ended September 30, 2020
Common StockAdditional
Paid-in
Capital		Accumulated Other Comprehensive IncomeAccumulated
Deficit		Total
Stockholders’
Equity
SharesAmount
Balance at December 31, 2019304,831 $305 $2,241,947 $3,069 $(559,351)$1,685,970 
Net income— — — — 83,393 83,393 
Other comprehensive income— — — 3,170 — 3,170 
Issuance of common stock under equity incentive and stock purchase plans4,571 4 19,823 — — 19,827 
Stock transactions associated with taxes withheld on equity awards— — (26,120)— — (26,120)
Stock-based compensation— — 85,791 — — 85,791 
Balance at September 30, 2020309,402 $309 $2,321,441 $6,239 $(475,958)$1,852,031 
Nine Months Ended September 30, 2019
Common StockAdditional
Paid-in
Capital		Accumulated Other Comprehensive Income (Loss)Accumulated
Deficit		Total
Stockholders’
Equity
SharesAmount
Balance at December 31, 2018299,876 $300 $2,168,217 $(701)$(880,363)$1,287,453 
Net income— — — — 252,269 252,269 
Other comprehensive income— — — 3,369 — 3,369 
Issuance of common stock under equity incentive and stock purchase plans3,900 4 23,244 — — 23,248 
Stock transactions associated with taxes withheld on equity awards— — (3,369)— — (3,369)
Stock-based compensation— — 40,747 — — 40,747 
Balance at September 30, 2019303,776 $304 $2,228,839 $2,668 $(628,094)$1,603,717 
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
6
 Nine Months Ended September 30, 2019
 Common Stock Additional
Paid-in
Capital		 Accumulated
Other
Comprehensive
Income (Loss)		 Accumulated
Deficit		 Total
Stockholders’
Equity
 Shares Amount    
Balance at December 31, 2018299,876,080
 $300
 $2,168,217
 $(701) $(880,363) $1,287,453
Net income—
 —
 —
 —
 252,269
 252,269
Other comprehensive income—
 —
 —
 3,369
 —
 3,369
Issuance of common stock under equity incentive and stock purchase plans3,899,952
 4
 19,875
 —
 —
 19,879
Stock-based compensation—
 —
 40,747
 —
 —
 40,747
Balance at September 30, 2019303,776,032
 $304
 $2,228,839
 $2,668
 $(628,094) $1,603,717

Table of Contents
 Nine Months Ended September 30, 2018
 Common Stock Additional
Paid-in
Capital		 Accumulated
Other
Comprehensive
Loss		 Accumulated
Deficit		 Total
Stockholders’
Equity
 Shares Amount    
Balance at December 31, 2017296,209,426
 $296
 $2,114,184
 $(347) $(1,829,172) $284,961
Adoption of Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606)
—
 —
 —
 —
 258,505
 258,505
Adoption of ASU No. 2016-02, Leases (Topic 842)
—
 —
 —
 —
 234
 234
Net income—
 —
 —
 —
 329,981
 329,981
Other comprehensive loss—
 —
 —
 (166) —
 (166)
Issuance of common stock under equity incentive and stock purchase plans2,672,458
 3
 14,118
 —
 —
 14,121
Stock-based compensation—
 —
 28,330
 —
 —
 28,330
Balance at September 30, 2018298,881,884
 $299
 $2,156,632
 $(513) $(1,240,452) $915,966

EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
 Nine Months Ended September 30,
 2019 2018
Net income$252,269
 $329,981
Adjustments to reconcile net income to net cash provided by operating activities:   
Depreciation and amortization6,088
 2,876
Stock-based compensation40,747
 28,330
401(k) matching contributions made in common stock4,079
 3,232
Amortization and other changes in right-of-use assets(6,367) 2,732
Deferred income taxes56,339
 —
Gain on other equity investments(730) (209)
Accretion of investments, net and other(3,970) (1,423)
Changes in operating assets and liabilities:   
Trade receivables, net(7,017) (12,707)
Other receivables2,469
 (2,938)
Inventory, net(3,528) (3,776)
Current portion of unbilled collaboration revenue(2,640) (32,673)
Prepaid expenses and other current assets527
 (3,529)
Other long-term assets(6,294) (542)
Accounts payable(2,708) (1,248)
Accrued compensation and benefits(429) 6,210
Accrued clinical trial liabilities12,099
 (891)
Rebates and fees due customers1,828
 4,124
Accrued collaboration liability554
 (577)
Current and long-term deferred revenue3,592
 (1,548)
Long-term portion of lease liabilities6,087
 (974)
Other current and long-term liabilities15,940
 (3,321)
Net cash provided by operating activities368,935
 311,129
Cash flows from investing activities:   
Purchases of property and equipment(5,575) (30,403)
Proceeds from sale of property and equipment—
 308
Purchases of investments(887,698) (368,304)
Proceeds from maturities of investments422,419
 231,204
Proceeds from sale of investments13,078
 11,935
Proceeds from other equity investments730
 209
Net cash used in investing activities(457,046) (155,051)
Cash flows from financing activities:   
Proceeds from exercise of stock options14,811
 10,390
Proceeds from employee stock purchase plan4,145
 3,650
Taxes paid related to net share settlement of equity awards(3,369) (3,205)
Principal payments on financing lease obligation(34) —
Net cash provided by financing activities15,553
 10,835
Net (decrease) increase in cash, cash equivalents and restricted cash(72,558) 166,913
Cash, cash equivalents and restricted cash at beginning of period315,875
 188,314
Cash, cash equivalents and restricted cash at end of period$243,317
 $355,227
Continued on next page
 Nine Months Ended September 30,
 20202019
Net income$83,393 $252,269 
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation6,731 6,088 
Stock-based compensation85,791 40,747 
Non-cash lease expense3,607 1,803 
Deferred taxes15,803 56,339 
Other, net1,609 (621)
Changes in operating assets and liabilities:
Trade receivables, net(47,074)(7,017)
Inventory(13,466)(3,528)
Prepaid expenses and other assets(15,868)(14,108)
Deferred revenue4,012 3,592 
Accounts payable and other liabilities51,151 33,371 
Net cash provided by operating activities175,689 368,935 
Cash flows from investing activities:
Purchases of property, equipment and other(16,055)(5,575)
Purchases of investments(866,975)(887,698)
Proceeds from maturities and sales of investments781,324 436,227 
Net cash used in investing activities(101,706)(457,046)
Cash flows from financing activities:
Proceeds from issuance of common stock under equity incentive and stock purchase plans19,682 18,956 
Taxes paid related to net share settlement of equity awards(26,120)(3,369)
Other, net0 (34)
Net cash (used in) provided by financing activities(6,438)15,553 
Net increase (decrease) in cash, cash equivalents and restricted cash67,545 (72,558)
Cash, cash equivalents and restricted cash at beginning of period268,137 315,875 
Cash, cash equivalents and restricted cash at end of period$335,682 $243,317 
Supplemental cash flow disclosures:
Right-of-use assets obtained in exchange for lease obligations$1,824 $12,944 
Unpaid liabilities incurred for purchases of property and equipment$843 $159 
Unpaid liabilities incurred to acquire investments$0 $8,961 

EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - continued
(in thousands)
(unaudited)
 Nine Months Ended September 30,
 2019 2018
Supplemental cash flow disclosure:   
Right-of-use assets obtained in exchange for lease obligations (1)
$12,944
 $17,180
Unpaid liabilities incurred to acquire Property and equipment$159
 $1,281
Unpaid liabilities incurred to acquire investments$8,961
 $—
____________________
(1)Amounts for the nine months ended September 30, 2019 include receipt of a tenant incentive payment and an amendment to our existing lease for office and research space. Amounts for the nine months ended September 30, 2018 include the transition adjustment for the adoption of Topic 842.

The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.

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EXELIXIS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Organization
Exelixis, Inc. (Exelixis, we, our or us) is an oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Our drug discovery and development capabilities and commercialization platform are the foundations upon which we intend to bring to market novel, effective and tolerable therapies to provide cancer patients with additional treatment options.
Since we were founded in 1994, 4 products resulting from our discovery efforts have progressed through clinical development, received regulatory approval and have launched commercially.established a commercial presence in various geographies around the world. NaN are derived from cabozantinib, our flagship molecule, an inhibitor of multiple tyrosine kinases including MET, AXL, VEGF receptors and RET. TheseOur cabozantinib products are: CABOMETYX® (cabozantinib) tablets approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma (HCC);carcinoma; and COMETRIQ® (cabozantinib) capsules approved for progressive, metastatic medullary thyroid cancer. For these types of cancer, cabozantinib has become or is becoming a standard of care. Beyond these approved indications, cabozantinib is currently the focus of a broad clinical development program and is being investigated both alone and in combination with other therapies in a wide variety of cancers.
The other 2 products resulting from our discovery efforts are: COTELLIC® (cobimetinib), an inhibitor of MEK, approved as part of amultiple combination regimenregimens to treat a specific formforms of advanced melanoma and marketed under a collaboration with Genentech, Inc. (a member of the Roche Group) (Genentech); and MINNEBRO® (esaxerenone), an oral, non-steroidal, selective blocker of the mineralocorticoid receptor, (MR), approved for the treatment of hypertension in Japan and licensed to Daiichi Sankyo Company, Limited (Daiichi Sankyo).
We also remain committed to building our product pipeline by discovering and developing new therapies for cancer patients. Using our in-house drug discovery expertise, specifically in medicinal chemistry, tumor biology and pharmacology, we are advancing small molecule drug candidates toward and through preclinical development. In addition, we have augmented our internal drug discovery activities with multiple partnerships, including several that enable us to discover and advance various biologics, such as bispecific antibodies and antibody-drug conjugates (ADCs), and we continue to engage in business development initiatives aimed at identifying and in-licensing promising, early-stage oncology assets, which we can further develop utilizing our established clinical development infrastructure.
Basis of ConsolidationPresentation
The accompanying Condensed Consolidated Financial Statements include the accounts of Exelixis and those of our wholly-owned subsidiaries. These entities’ functional currency is the U.S. dollar. All intercompany balances and transactions have been eliminated.
Basis of Presentation
The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In our opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial statements for the periods presented have been included.
We have adopted a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31st. Fiscal year 2019, which is a 53-week fiscal year, will end on January 3, 2020 and fiscal year 2018, which was a 52-week fiscal year, ended on December 28, 2018. For convenience, references in this report as of and for the fiscal periods ended September 27, 2019, June 28, 2019, September 28, 2018 and June 29, 2018, and as of and for the fiscal years ending January 3, 2020, and ended December 28, 2018 and December 29, 2017, are indicated as being as of and for the periods ended September 30, 2019, June 30, 2019, September 30, 2018 and June 30, 2018 and the years ending December 31, 2019, and ended December 31, 2018 and December 31, 2017, respectively. Similarly, references in this report to the first day of the fiscal year ended January 3, 2020 are indicated as being as of January 1, 2019 and the first day of the fiscal quarter ended September 27, 2019 are indicated as being as of July 1, 2019.
Operating results for the three and nine months ended September 30, 20192020 are not necessarily indicative of the results that may be expected for the year ending December 31, 20192020 or for any future period. The accompanying Condensed Consolidated Financial Statements and Notes thereto should be read in conjunction with our Consolidated Financial Statements and Notes thereto for the year ended December 31, 2018,2019, included in our Annual Report on Form 10-K filed with the SEC on February 22, 2019.25, 2020.
We have adopted a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31st. Fiscal year 2020, which is a 52-week fiscal year, will end on January 1, 2021 and fiscal year 2019, which was a 53-week fiscal year, ended on January 3, 2020. For convenience, references in this report as of and for the fiscal periods ended October 2, 2020 and September 27, 2019, and as of and for the fiscal years ending January 1, 2021, and ended January 3, 2020, are indicated as being as of and for the fiscal periods ended September 30, 2020 and September 30, 2019 and the years ending
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December 31, 2020 and ended December 31, 2019, respectively. Similarly, references in this report to the first day of the fiscal year ending January 1, 2021 are indicated as being as of January 1, 2020.
Reclassifications
Certain prior period amounts in the accompanying Condensed Consolidated Financial Statements have been reclassified to conform to the current period presentation. Such reclassifications did not impact previously reported total revenues, income from operations, net income, total assets, total liabilities or total stockholders’ equity.
Segment Information
We operate in 1 business segment that focuses on the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Our Chief Executive Officer, as the chief operating decision-maker, manages and allocates resources to our operations on a total consolidated basis. Consistent with this decision-making process, our Chief Executive Officer uses consolidated, single-segment financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets.

All of our long-lived assets are located in the U.S. See “Note 2. Revenues” for enterprise-wide disclosures about product sales, revenues from major customers and revenues by geographic region.
Use of Estimates
The preparation of the accompanying Condensed Consolidated Financial Statements conforms to accounting principles generally accepted in the U.S., which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenues and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates including, but not limited to: those related to revenue recognition, including determining the nature and timing of satisfaction of performance obligations, and determining the standalone selling price of performance obligations, and variable consideration such as rebates, chargebacks, sales returns, sales allowances, and milestone payments included in collaboration arrangements; the amounts of revenues and expenses under our profit and loss sharing agreement; the recoverability of inventory; the amounts of operating lease right-of-use assets and lease liabilities; the amounts of deferred tax assets and liabilities including the related valuation allowance; the accrual for certain liabilities including accrued clinical trial liabilities; and valuations of equity awards used to determine stock-based compensation, including certain awards with vesting subject to market or performance conditions. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates.
In March 2020, we received the Preliminary Calculation of our Branded Prescription Drug Fee for 2020, and in August 2020, the Final Calculation of our Branded Prescription Drug Fee for 2020 from the Internal Revenue Service for the 2018 sales year, which resulted in an increase in our estimate of such fees for the 2018 and 2019 sales years. Accordingly, we recorded an adjustment to increase selling, general and administrative expenses and our accrual for these fees by $5.1 million during the nine months ended September 30, 2020. This adjustment resulted in a $0.02 decrease in basic and diluted earnings per share for the nine months ended September 30, 2020.
Recently Adopted Accounting Pronouncements
On JulyJanuary 1, 2019,2020, we adopted ASU No. 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (ASU 2018-15). ASU 2018-15 requires a customer in a hosting arrangement that is a service contract to follow the guidance in Accounting Standards Codification (ASC) Subtopic 350-40 to determine which implementation costs to capitalize as an asset related to the service contract and which costs to expense and requires us to expense the capitalized implementation costs over the term of the hosting arrangement, which includes reasonably certain renewals. ASU 2018-15 was adopted using the prospective transition method in the accompanying Condensed Consolidated Financial Statements. The adoption of ASU 2018-15 did not have a material impact on our Condensed Consolidated Financial Statements.
On January 1, 2019, we adopted ASU 2018-02, Update (ASU) No. 201Income Statement—Reporting Comprehensive Income (Topic 220) (ASU 2018-02). There was no financial impact from the adoption of ASU 2018-02 and we did not make an election to reclassify the income tax effects of the Tax Cuts and Jobs Act of 2017 from Accumulated other comprehensive income (loss) to Accumulated deficit. In connection with the adoption of ASU 2018-02, we have adopted the individual unit of account approach for releasing income tax effects from Accumulated other comprehensive income (loss).
On January 1, 2019, we also adopted ASU 2017-08, Receivables—Nonrefundable Fees and Other Costs (Subtopic 310-20) (ASU 2017-08). ASU 2017-08 shortens the amortization period for certain callable debt securities held at a premium. Specifically, ASU 2017-08 requires the premium to be amortized to the earliest call date. ASU 2017-08 does not require an accounting change for securities held at a discount; the discount continues to be amortized to maturity. The financial impact from the adoption of ASU 2017-08 was nominal.
Recent Accounting Pronouncements Not Yet Adopted
In November 2018, the Financial Accounting Standards Board (FASB) issued ASU No. 2018-18,8-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (ASU 2018-18). ASU 2018-18 clarifies that certain transactions between collaborative arrangement participants should be accounted for as revenuepart of revenues under Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers (Topic 606) when the counterparty is a customer for a distinct good or service (i.e. a unit of account). For units of account that are in the scope of Topic 606, all of the guidance in Topic 606 should be applied, including the guidance on recognition, measurement, presentation and disclosure. ASU 2018-18 also adds a reference in ASC Topic 808, Collaborative Arrangements (Topic 808) to the unit of account guidance in Topic 606 and requires that it be applied only to assess whether transactions in a collaborative arrangement are in the scope of Topic 606. ASU 2018-18 will precludeprecludes entities from presenting amounts related to transactions with a counterparty in a collaborative arrangement that is not a customer astogether with revenue from contracts with customers. ASU 2018-18If a portion of a distinct bundle of goods or services within an arrangement is effective for us for all interimnot with a customer, then the unit of account is not within the scope of Topic 606, and annual reporting periods beginning after December 15, 2019. Earlythe recognition and measurement of that unit of account shall be based on analogy to authoritative accounting literature or, if there is no appropriate analogy, a reasonable, rational, and consistently applied accounting policy election. Upon adoption is permitted. We are in the process of assessing the impact of ASU 2018-18, onwe have presented revenues from performance obligations associated with our collaboration arrangements that are within the scope of Topic 606 (license revenues) separately from revenues from performance obligations that are not subject to Topic 606 (collaboration services revenues). The adoption of ASU 2018-18 was applied retrospectively, and prior periods have been restated to conform to the presentation prescribed by ASU 2018-18. The adoption of ASU 2018-18 did not impact total revenues for the prior period presented in the accompanying Condensed Consolidated Financial Statements.Statements of Income.

InOn January 2017, the FASB issued1, 2020, we adopted ASU No. 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (ASU 2017-04). ASU 2017-04 eliminated Step 2 from thesimplifies goodwill impairment testing by eliminating the second
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step of the impairment test. Instead, under the amendments in ASU 2017-04, an entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognizeThe amended guidance requires an impairment charge to be recognized for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax deductible goodwill on the carrying amount of thea reporting unit when measuring the goodwillexceeds its fair value under a one-step impairment loss, if applicable. ASU 2017-04 is effective for all interim and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. We do not expect thetest. The adoption of ASU 2017-04 to have a materialdid not impact on ourthe accompanying Condensed Consolidated Financial Statements.
In June 2016, the FASB issuedOn January 1, 2020, we adopted ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) (ASU 2016-13). ASU 2016-13 implements an impairment model, known as the current expected credit loss model, that is based on expected losses rather than incurred losses. Under the new guidance, an entitywe will recognize our estimate of current expected credit losses as an allowance its estimate ofon financial assets measured at amortized cost, including accounts receivable, unbilled collaboration revenues, and investments classified as available for sale. Current expected credit losses. 2016-13 is effective for all interimlosses were immaterial as of the date of adoption, and annual reporting periods beginning after December 15, 2019. Early adoption is permitted. We do not expect the adoption of ASU 2016-13 todid not have a materialsignificant impact on ourthe accompanying Condensed Consolidated Financial Statements.
Investment Impairment
Quarterly, we assess each of our investments in debt securities available-for-sale whose fair value is below its cost basis to determine if the investment’s impairment is due to credit-related factors or noncredit-related factors. Factors considered in determining whether an impairment is credit-related include the extent to which the investment’s fair value is less than its cost basis, declines in published credit ratings, issuer default on interest or principal payments, and declines in the financial condition and near-term prospects of the issuer. If we determine a credit-related impairment exists, we will measure the credit loss based on a discounted cash flows model. Credit-related impairments on debt securities available-for-sale are recognized as an allowance for credit losses with a corresponding adjustment to other income, net in the accompanying Condensed Consolidated Statements of Income. The portion of the impairment that is not credit-related is recorded, net of applicable taxes, as a reduction of other comprehensive income.
We have elected to exclude accrued interest from both the fair value and the amortized cost basis of debt securities available-for-sale for the purposes of identifying and measuring an impairment. We write-off accrued interest as a reduction of interest income when an issuer has defaulted on interest payments due on a security.
Accounts Receivable
Trade receivables, net contain amounts billed to our customers for product sales, and amounts billed to our collaboration partners for development, regulatory and sales-based milestone payments, royalties on the sale of licensed products, profit-sharing arrangements, development cost reimbursements, and payments for product supply services. Our customers are primarily pharmaceutical and biotechnology companies that are located in the U.S., and collaboration partners that are located in Europe and Japan. As of September 30, 2020 and December 31, 2019, 47% and 38%, respectively, of our trade receivables were from our collaboration partner Ipsen Pharma SAS (Ipsen), and 12% and 14% were from affiliates of McKesson Corporation. We record trade receivables net of allowances for credit losses and chargebacks, and cash discounts for prompt payment. We apply an aging method to estimate credit losses and consider our historical loss information, adjusted to account for current conditions, and reasonable and supportable forecasts of future economic conditions affecting our customers.
Goodwill
We recorded goodwill amounts as the excess purchase price over tangible assets, liabilities and intangible assets acquired based on their estimated fair value. We review the carrying amount of goodwill for impairment annually and whenever events or changes in circumstance indicate that the carrying value may not be recoverable. We perform our annual assessment of the recoverability of our goodwill as of the first day of our fourth quarter. The assessment of recoverability may first consider qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. We perform a quantitative assessment if the qualitative assessment results in a more likely than not determination or if a qualitative assessment is not performed. The quantitative assessment determines whether the carrying amount of a reporting unit exceeds its fair value, in which case an impairment charge is recognized for the amount by which the carrying amount of a reporting unit exceeds its fair value, limited to the goodwill balance. We operate in 1 business segment, which is also considered to be our sole reporting unit and therefore, goodwill is tested for impairment at the enterprise level. We did 0t recognize any impairment charges in any of the periods presented.
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Collaboration Agreements
We assess whether our collaboration agreements are subject to ASC Topic 808, Collaborative Arrangements (Topic 808) based on whether they involve joint operating activities and whether both parties have active participation in the arrangement and are exposed to significant risks and rewards. To the extent that the arrangement falls within the scope of Topic 808, we apply by analogy the unit of account guidance under Topic 606 to identify distinct performance obligations, and then determine whether a customer relationship exists for each distinct performance obligation. If we determine a performance obligation within the arrangement is with a customer, we apply the guidance in Topic 606. If a portion of a distinct bundle of goods or services within an arrangement is not with a customer, then the unit of account is not within the scope of Topic 606, and the recognition and measurement of that unit of account shall be based on analogy to authoritative accounting literature or, if there is no appropriate analogy, a reasonable, rational, and consistently applied accounting policy election.
We enter into collaboration arrangements, under which we license certain rights to our intellectual property to third parties. The terms of these arrangements typically include payments to us for one or more of the following: nonrefundable up-front license fees; development, regulatory and sales-based milestone payments; product supply services; development cost reimbursements; profit-sharing arrangements; and royalties on net sales of licensed products. As part of the accounting for these arrangements, we develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include forecasted revenues, clinical development timelines and costs, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success.
Up-front License Fees: If the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from nonrefundable up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license, which generally occurs at or near the inception of the contract. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenues from nonrefundable up-front fees. We evaluate the measure of progress at the end of each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
Regulatory and Development Milestone Payments: At the inception of each arrangement that includes development milestone payments, we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until uncertainty associated with the approvals has been resolved. The transaction price is then allocated to each performance obligation, on a relative standalone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, we re-evaluate the probability of achieving such development and regulatory milestones and any related variable consideration constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis.
Product Supply Services: Arrangements that include a promise for the future supply of drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. We assess if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations.
Development Cost Reimbursements: Our collaboration arrangements may include promises of future clinical development and drug safety services, as well as participation on certain joint committees. When such services are provided to a customer, and they are distinct from the licenses provided to our collaboration partners, these promises are accounted for as a separate performance obligation which we estimate using internal development costs incurred and projections through the term of the arrangements. We record revenues for these services as the performance obligations are satisfied over time based on measure of progress. However, if we conclude that our collaboration partner is not a customer for those collaborative research and development activities, we present such payments as a reduction of research and development expenses.
Profit-sharing Arrangements: Under the terms of our collaboration agreement with Genentech for cobimetinib, we are entitled to a share of U.S. profits and losses received in connection with the commercialization of cobimetinib. We
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account for this arrangement in accordance with Topic 606. We have determined that we are an agent under the agreement and therefore revenues are recorded net of costs incurred. We record revenues for the variable consideration associated with the profits and losses under the collaboration agreement when it is probable that a significant reversal in the amount of cumulative revenues recognized will not occur.
Royalty and Sales-based Milestone Payments: For arrangements that include royalties and sales-based milestone payments, including milestone payments earned for the first commercial sale of a product, the license is deemed to be the predominant item to which such payments relate and we recognize revenues at the later of when the related sales occur or when the performance obligation to which the royalty has been allocated has been satisfied.
Recent Accounting Pronouncements Not Yet Adopted
In December 2019, the Financial Accounting Standards Board issued ASU 2019-12, Income Taxes (Topic 740)-Simplifying the Accounting for Income Taxes (ASU 2019-12). ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions to the general principles in ASC Topic 740, Income Taxes and clarifying and amending existing guidance. ASU 2019-12 will be effective for us in the first quarter of 2021 with early adoption permitted. We are currently assessing the impact of ASU 2019-12 on our financial statements.
NOTE 2. REVENUES
Revenues by disaggregated category were as followsconsisted of the following (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Product revenues:
Gross product revenues$220,401 $239,916 $702,865 $704,084 
Discounts and allowances(51,814)(48,148)(161,668)(139,060)
Net product revenues168,587 191,768 541,197 565,024 
Collaboration revenues:
License revenues33,205 69,137 113,318 132,443 
Collaboration services revenues29,300 10,798 62,971 29,998 
Total collaboration revenues62,505 79,935 176,289 162,441 
Total revenues$231,092 $271,703 $717,486 $727,465 
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Product revenues:       
Gross product revenues$239,916
 $193,356
 $704,084
 $525,438
Discounts and allowances(48,148) (30,410) (139,060) (82,384)
Net product revenues191,768
 162,946
 565,024
 443,054
Collaboration revenues:       
License revenues (1)
68,035
 51,323
 128,937
 152,261
Research and development services revenues (2)
12,988
 10,560
 35,814
 27,464
Other collaboration revenues (3)
(1,088) 568
 (2,310) 2,445
Total collaboration revenues79,935
 62,451
 162,441
 182,170
Total revenues$271,703
 $225,397
 $727,465
 $625,224
____________________
(1)License revenues included the recognition of the portion of milestones allocated to the transfer of intellectual property licenses for which it had become probable in the current period that the milestone would be achieved and a significant revenue reversal would not occur, as well as royalty revenues from Ipsen Pharma SAS (Ipsen), Genentech and Daiichi Sankyo.
(2)Research and development services revenues included the recognition of deferred revenue for the portion of upfront and milestone payments that have been allocated to research and development services performance obligations, as well as development cost reimbursements earned on our collaboration agreements.
(3)Other collaboration revenues included the profit on the U.S. commercialization of COTELLIC from Genentech and revenues on product supply services provided to Ipsen and Takeda Pharmaceutical Company Ltd. (Takeda), which were offset by the 3% royalty we are required to pay GlaxoSmithKline (GSK) on the net sales by Ipsen of any product incorporating cabozantinib.
Net product revenues and license revenues are recorded in accordance with Topic 606. License revenues include the recognition of the portion of milestones payments allocated to the transfer of intellectual property licenses for which it had become probable in the current period that the milestone would be achieved and Researcha significant reversal of revenues would not occur, as well as royalty revenues and developmentour share of profits under our collaboration agreement with Genentech. Collaboration services revenues were recorded in accordance with Topic 606808 and by analogy to Topic 606. Collaboration services revenues include the recognition of deferred revenues for all periods presented. Net product revenuesthe portion of upfront and License revenues relatedmilestone payments allocated to goods and intellectual property licenses transferred at a point in time and Researchour research and development services revenues related to services performed over time. Otherperformance obligations, development cost reimbursements earned under our collaboration revenues, which included the profit on the U.S. commercialization of COTELLIC and net losses onagreements, product supply services, were recorded in accordance with Topic 808 for all periods presented.

revenues, net of product supply costs, and the royalties we paid to GlaxoSmithKline (GSK) on sales of products containing cabozantinib by our collaboration partners.
Net product revenues disaggregated by product were as follows (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
CABOMETYX$159,555 $187,410 $522,381 $552,315 
COMETRIQ9,032 4,358 18,816 12,709 
Net product revenues$168,587 $191,768 $541,197 $565,024 
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
CABOMETYX$187,410
 $158,262
 $552,315
 $428,317
COMETRIQ4,358
 4,684
 12,709
 14,737
Net product revenues$191,768
 $162,946
 $565,024
 $443,054
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TotalThe percentage of total revenues disaggregated by significant customer who individually accounted for 10% or more of our total revenues were as follows (dollars in thousands):follows:
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Ipsen16 %28 %16 %17 %
Affiliates of CVS Health Corporation14 %13 %15 %15 %
Affiliates of McKesson Corporation12 %12 %13 %12 %
Affiliates of AmerisourceBergen Corporation11 %9 %11 %10 %
Affiliates of Optum Specialty Pharmacy10 %7 %11 %8 %
Takeda Pharmaceutical Company Limited (Takeda)10 %0 %7 %2 %
 Three Months Ended September 30,
 2019 2018
 Dollars Percent of Total Dollars Percent of Total
Ipsen$76,016
 28% $57,186
 25%
Caremark L.L.C.35,703
 13% 30,707
 14%
Affiliates of McKesson Corporation31,901
 12% 26,597
 12%
Affiliates of AmerisourceBergen Corporation25,235
 9% 17,232
 8%
Others, individually less than 10% of Total revenues for all periods presented102,848
 38% 93,675

41%
Total revenues$271,703
 100% $225,397
 100%

 Nine Months Ended September 30,
 2019 2018
 Dollars Percent of Total Dollars Percent of Total
Ipsen$120,133
 17% $145,038
 23%
Caremark L.L.C.105,638
 15% 83,516
 13%
Affiliates of McKesson Corporation88,496
 12% 71,249
 11%
Affiliates of AmerisourceBergen Corporation70,503
 10% 49,995
 8%
Others, individually less than 10% of Total revenues for all periods presented342,695

46%
275,426

45%
Total revenues$727,465
 100% $625,224
 100%

Total revenues disaggregatedRevenues by geographic region were as follows (in thousands):
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
U.S.$194,484
 $166,270
 $572,957
 $453,342
Europe76,017
 57,186
 120,134
 145,038
Japan1,202
 1,941
 34,374
 26,844
Total revenues$271,703
 $225,397
 $727,465
 $625,224

Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
U.S.$171,552 $194,484 $549,379 $572,957 
Europe36,006 76,017 117,959 120,134 
Japan23,534 1,202 50,148 34,374 
Total revenues$231,092 $271,703 $717,486 $727,465 
Net product revenues are attributed to geographic region based on the ship-to location. CollaborationLicense and collaboration services revenues are attributed to geographic region based on the location of our collaboration partners’ headquarters.

Product Sales Discounts and Allowances
The activities and ending reserve balances for each significant category of discounts and allowances, (whichwhich constitute variable consideration)consideration, were as follows (in thousands):
 Chargebacks and Discounts for Prompt Payment Other Customer Credits/Fees and Co-pay Assistance Rebates Total
Balance at December 31, 2018$2,322
 $3,038
 $11,916
 $17,276
Provision related to sales made in:       
Current period92,769
 11,190
 35,422
 139,381
Prior periods(130) (106) (85) (321)
Payments and customer credits issued(92,317) (11,466) (33,127) (136,910)
Balance at September 30, 2019$2,644
 $2,656
 $14,126
 $19,426

Chargebacks and Discounts for Prompt PaymentOther Customer Credits/Fees and Co-pay AssistanceRebatesTotal
Balance at December 31, 2019$7,514 $3,497 $15,222 $26,233 
Provision related to sales made in:
Current period108,166 11,718 41,351 161,235 
Prior periods33 (352)752 433 
Payments and customer credits issued(107,118)(11,513)(41,546)(160,177)
Balance at September 30, 2020$8,595 $3,350 $15,779 $27,724 
ChargebacksThe allowance for chargebacks and discounts for prompt payment areis recorded as a reduction of trade receivables, net and the remaining reserve balancesreserves are classifiedrecorded as Other current liabilitiesrebates and fees due to customers in the accompanying Condensed Consolidated Balance Sheets.
Contract Assets and Liabilities
We receive payments from our licenseescollaboration partners based on billing schedules established in each contract. Amounts are recorded as accounts receivable when our right to consideration is unconditional. We may also recognize revenuerevenues in advance of the contractual billing schedule and such amounts are recorded, net of any allowance for credit losses, as unbilled collaboration revenuea contract asset when recognized. Unbilled collaboration revenue was 0Contract assets, which are presented in prepaid expenses and other current assets in the accompanying Condensed Consolidated Balance Sheets, were $0 and $1.1 million as of both September 30, 20192020 and December 31, 2018. Upfront2019, respectively. We may be required to defer recognition of revenues for upfront and milestone payments may require deferral of revenue recognition to a future period until we perform our obligations under these arrangements, and such amounts are recorded as deferred revenuerevenues upon receipt or when due. Deferred revenue was $15.4Contract liabilities were $10.6 million and $15.9$6.6 million as of September 30, 2020 and
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December 31, 2019, respectively. The current portion of the contract liabilities totaling $1.3 million and $0 as of September 30, 2020 and December 31, 2018, respectively. The amount2019, respectively, are presented in other current liabilities and the remainder of the contract liabilities are presented in long-term portion of deferred revenues recognizedas of those dates in the accompanying Condensed Consolidated Balance Sheets. For those contracts that have multiple performance obligations, contract assets and liabilities are reported on a net basis at the contract level.
Significant changes in contract assets during the nine months ended September 30, 2020 include the impact of a $20.0 million development milestone from Ipsen we determined was probable of achievement, which was offset by the impact of a $10.0 million milestone from Takeda which was recognized as revenues during the year ended December 31, 2019 and 2018was achieved, invoiced and collected in the first quarter of 2020.
During the nine months ended September 30, 2020 and 2019, we recognized $6.8 million and $2.7 million, respectively, in revenues that were included in the beginning deferred revenuerevenues balance as of December 31, 2018 and December 31, 2017 was $2.7 million and $6.1 million, respectivelyfor those periods.
During the three and nine months ended September 30, 2019,2020, we recognized $67.7$33.1 million and $129.0$115.3 million, respectively, in revenues under Topic 606 for performance obligations satisfied in previous periods as compared to $48.2$67.7 million and $151.8$129.0 million during the samecomparable periods in 2018.2019. Such revenues primarily related to milestone and royalty payments allocated to ourthe license performance obligations offor our collaborations with Ipsen, Takeda, Daiichi Sankyo and Daiichi Sankyo.Genentech.
As of September 30, 2020, $88.9 million of the combined transaction prices for our Ipsen and Takeda collaborations were allocated to performance obligations that had not yet been satisfied. See “Note 3. Collaboration Agreements - Cabozantinib Commercial Collaborations - Performance Obligations and Transaction Prices for our Ipsen and Takeda Collaborations” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2019 for information about the expected timing to satisfy these performance obligations.
NOTE 3. COLLABORATION AGREEMENTS
We have established multiple collaborations with leading pharmaceutical companies for the commercialization and further development of cabozantinib. Additionally, consistent with our business strategy prior to the commercialization of cabozantinib, as well aswe entered into other collaborations with leading pharmaceutical companies for other compounds and programs in our portfolio. Under these collaborations, we are generally entitled to receive milestone and royalty payments, and for certain collaborations receive payments for product supply services, development cost reimbursements, and/or profit-sharing payments. See “Note 2. Revenues” for additional information on revenues recognized under our collaboration agreements.
We have also established multiple collaborations with smaller, discovery-focused biotechnology companies to expand our product pipeline. Additionally, in line with our business strategy priorUnder these collaborations, we may be required to the commercialization of our first product, COMETRIQ, we entered into othermake milestone and royalty payments, and for certain collaborations with leading pharmaceutical companies including Genentech, Daiichi Sankyo and Bristol-Myers Squibb Companymake payments for other compounds and programs in our portfolio. development cost reimbursements and/or option exercise fees.
See “Note 3. Collaboration Agreements” to our Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 20182019, or as further described below, for a description of each of our collaboration agreements.
Under these collaborations, we are generally entitled to receive milestone and royalty payments, and for certain collaborations, payments for product supply services, development cost reimbursements, and/or profit-sharing payments. See “Note 2. Revenues” for information on collaboration revenues recognized during the three and nine months ended September 30, 2019 and 2018.
CommercialCabozantinib Collaborations
Ipsen Collaboration
In February 2016, we entered into a collaboration and license agreement with Ipsen for the commercialization and further development of cabozantinib. Pursuant toUnder the terms of the collaboration agreement, as amended, Ipsen received exclusive commercialization rights for current and potential future cabozantinib indications outside of the U.S., Canada and Japan. The collaboration agreement was subsequently amended on three occasions, including in December 2016 to include

commercialization rights in Canada. We have also agreed to collaborate with Ipsen on the development of cabozantinib for current and potential future indications. Collaboration revenuesThe parties’ efforts are governed through a joint steering committee and appropriate subcommittees established to guide and oversee the collaboration’s operation and strategic direction; provided, however, that we retain final decision-making authority with respect to cabozantinib’s ongoing development. During the second quarter of 2020, Ipsen opted into and is now co-funding the development costs for CONTACT-01 and CONTACT-02, two phase 3 pivotal trials of cabozantinib in combination with atezolizumab in patients with previously treated, metastatic non-small cell lung cancer and metastatic castration-resistant prostate cancer, respectively, and the four remaining cohorts of COSMIC-021 it had not previously opted into. COSMIC-021 is a broad phase 1b study evaluating the safety and tolerability of cabozantinib in combination with atezolizumab in patients with locally advanced or metastatic solid tumors.
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Revenues under the collaboration agreement with Ipsen were as follows (in thousands):
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Ipsen collaboration revenues$76,016
 $57,186
 $120,133
 $145,038

Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
License revenues$19,910 $66,409 $71,456 $95,318 
Collaboration services revenues16,096 9,607 46,503 24,815 
Total$36,006 $76,016 $117,959 $120,133 
At September 30, 2020, we are eligible to receive additional regulatory and development milestone payments from Ipsen totaling an aggregate of $59.0 million, as well as sales-based milestones, including milestone payments earned for the first commercial sale of a product, of up to $469.9 million. We excluded these milestones from the transaction price as of September 30, 2020 because we determined such payments to be fully constrained under Topic 606 due to the fact that it was not probable that a significant reversal of cumulative revenue would not occur, given the inherent uncertainty of success with these milestones. We will re-evaluate the transaction price at each reporting period and as uncertain events are resolved or other changes in circumstances occur.
As of September 30, 2019, $47.12020, $42.6 million of the transactiontransaction price was allocated to our research and development services performance obligation hadthat has not yet been satisfied. As of September 30, 2019, the net contract liability for the collaboration agreement with Ipsen was $7.2 million which was included in the Long-term portion of deferred revenue in the accompanying Condensed Consolidated Balance Sheets.
Takeda Collaboration
In January 2017, we entered into a collaboration and license agreement with Takeda. Pursuant toUnder this collaboration agreement, as amended, Takeda has exclusive commercialization rights for current and potential future cabozantinib indications in Japan, and the parties have agreed to collaborate on the clinical development of cabozantinib in Japan. The operation and strategic direction of the parties’ collaboration agreement was subsequently amended in March 2018is governed through a joint executive committee and April 2019.appropriate subcommittees.
The second amendment to the collaboration agreement with Takeda, which was executed on April 29, 2019 and became effective on May 7, 2019 (the Amendment), among other things, reduced the amount of reimbursements we will receive from Takeda for costs associated with our required global pharmacovigilance activities and limits those reimbursements to $1.0 million per year. It also increased the total potential development, regulatory and first-sale milestone payments to be paid to us by Takeda for second-line RCC, first-line RCC and second-line HCC by $12.0 million to $102.0 million, including an increase from $10.0 million to $16.0 million for the milestone we received for the April 2019 submission of a regulatory application for cabozantinib as a treatment for patients with advanced RCC to the Japanese Ministry of Health, Labour and Welfare (MHLW). We continue to be eligible to receive additional development, regulatory and first-sale milestone payments for other potential future indications. The Amendment also increased the amount of Takeda’s total potential commercial milestones by $6.0 million to $89.0 million. We continue to be eligible to receive royalties on net sales of cabozantinib in Japan.
Collaboration revenuesRevenues under the collaboration agreement with Takeda were as follows (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
License revenues$9,780 $0 $32,726 $9,056 
Collaboration services revenues13,204 1,187 16,468 5,189 
Total$22,984 $1,187 $49,194 $14,245 
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Takeda collaboration revenues$1,187
 $1,940
 $14,245
 $6,843
Milestone revenues for the three and nine months ended September 30, 2020 included $9.2 million in revenues recognized in connection with a $10.0 million milestone we expect to achieve upon Takeda’s and Ono Pharmaceutical Co., Ltd.’s supplemental application to the Japanese Ministry of Health, Labour and Welfare for Manufacturing and Marketing Approval of CABOMETYX in combination with Opdivo for the treatment of patients with unresectable, advanced or metastatic RCC. At September 30, 2020, we have not yet received this milestone payment.
During the third quarter of 2020, Takeda opted into and is now co-funding the development costs for CONTACT-01, CONTACT-02 and certain cohorts of COSMIC-021. Concurrently, we entered into the third amendment to the collaboration agreement with Takeda (the Amendment), which modified certain cost sharing obligations related to the Japan-specific development costs associated with CONTACT-01 and CONTACT-02. We determined the Amendment represented a contract modification that was treated as a termination of an existing contract and the creation of a new contract under Topic 606. As a result, we allocated the remaining transaction price to the performance obligations identified in the contract. The two remaining performance obligations are the research and development services associated with committed studies described in “Note 3. Collaboration Agreements” of the Notes to Consolidated Financial Statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and the research and development services associated with CONTACT-01, CONTACT-02, and certain cohorts of COSMIC-021 studies. In allocating the transaction price for the modified contract we estimated the standalone selling price for the performance obligations. We utilized development costs incurred for these obligations in process and the projections of costs through the term of the arrangement. Revenue is recognized when, or as, we satisfy our performance obligations by transferring the promised services to Takeda. Revenue is being recognized using the cost proportional performance method, based on costs incurred to perform the research and development services, since the level of costs incurred over time is thought to best reflect the transfer of services to Takeda.
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We are eligible to receive additional regulatory and development milestone payments, without contractual limit, for additional potential future indications. We are further eligible to receive sales-based milestones, including milestone payments earned for the first commercial sale of a product, of up to $124.0 million. We excluded these milestones from the transaction price as of September 30, 2020 because we determined such payments to be fully constrained under Topic 606 due to the fact that it was not probable that a significant reversal of cumulative revenue would not occur, given the inherent uncertainty of success with these milestones. We will re-evaluate the transaction price at each reporting period and as uncertain events are resolved or other changes in circumstances occur.
As of September 30, 2019, $18.72020, $46.3 million of the transactiontransaction price was allocated to our research and development services performance obligation hadobligations that has not yet been satisfied. As of September 30, 2019, the net contract liability for the collaboration agreement with Takeda was $8.2 million which was included in the Long-term portion of deferred revenue in the accompanying Condensed Consolidated Balance Sheets.
Genentech Collaboration
In December 2006, we out-licensed the development and commercialization of cobimetinib to Genentech pursuant to a worldwide collaboration agreement. Under the terms of the collaboration agreement, we developed cobimetinib through the determination of the maximum tolerated dose in a phase 1 clinical trial, and Genentech had the option to co-develop cobimetinib, an option that Genentech exercised, and in March 2009, we granted to Genentech an exclusive worldwide revenue-bearing license to cobimetinib, at which point Genentech became responsible for completing the phase 1 clinical trial and the subsequent clinical development.

In November 2015, the U.S. Food and Drug Administration (FDA) approved cobimetinib, under the brand name COTELLIC, in combination with Genentech’s Zelboraf (vemurafenib) as a treatment for patients with BRAF V600E or V600K mutation-positive advanced melanoma. COTELLIC in combination with Zelboraf has also been approved in the European Union and multiple additional countries for use in the same indication. Profits on U.S. commercialization and Royalty revenues on ex-U.S. sales were as follows (in thousands):
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Profits on U.S. commercialization$1,102
 $1,935
 $3,507
 $6,004
Royalty revenues on ex-U.S. sales$1,614
 $1,390
 $4,426
 $4,285

Daiichi Sankyo
In March 2006, we entered into a collaboration agreement with Daiichi Sankyo pursuant to which we granted to Daiichi Sankyo an exclusive, worldwide license to certain intellectual property primarily relating to compounds that modulate MR, including esaxerenone, an oral, non-steroidal, selective MR antagonist. Daiichi Sankyo was responsible for all further preclinical and clinical development, regulatory, manufacturing and commercialization activities for the compounds.
In January 2019, the Japanese MHLW approved esaxerenone, under the brand name MINNEBRO, as a treatment for patients with hypertension and in May 2019, Daiichi Sankyo had its first commercial sale of MINNEBRO. As a result of the launch, we received a $20.0 million milestone payment from Daiichi Sankyo in June 2019. We are eligible for low double-digit royalties on sales of MINNEBRO. In addition, pursuant to a license agreement we entered into with Ligand Pharmaceuticals, Inc. (Ligand), we are required to pay a royalty of 0.5% to Ligand on net sales of MINNEBRO.
Collaboration revenues under the collaboration agreement with Daiichi Sankyo were as follows (in thousands):
 Nine Months Ended September 30,
 2019 2018
Daiichi Sankyo collaboration revenues$20,130
 $20,000

Such collaboration revenues were nominal or zero for the three months ended September 30, 2019 and 2018.
Iconic Therapeutics, Inc. (Iconic) Collaboration
In May 2019, we entered into an exclusive option and license agreement with Iconic. Under the terms of the agreement, we gained an exclusive option to license ICON-2, Iconic’s lead oncology antibody-drug conjugate program, in exchange for an upfront payment to Iconic of $7.5 million and a commitment for preclinical development funding. As of September 30, 2019, we accrued $6.6 million for the preclinical development funding commitment. Both the upfront payment and the accrual for the preclinical development funding commitment were included in Research and development expenses in the accompanying Condensed Consolidated Statements of Income.
If we exercise the option, we would be required to make an option exercise fee payment of $20.0 million to Iconic, we would assume responsibilities for all subsequent clinical development and commercialization activities, and Iconic would become eligible for up to $190.6 million in potential development, regulatory and first-sale milestone payments, $262.5 million in potential commercial milestone payments, as well as royalties on potential sales.
Aurigene Discovery Technologies Limited (Aurigene) Collaboration
In July 2019, we entered into an exclusive collaboration, option and license agreement with Aurigene, and India-based biotechnology company focused on oncology and inflammatory disorders, to in-license as many as 6 programs. Under the terms of the agreement, we made an upfront payment of $10.0 million for exclusive options to license 3 preexisting programs. In addition, we and Aurigene selected 3 additional Aurigene-led drug discovery programs on mutually agreed upon targets, in exchange for additional option payments totaling $7.5 million. We are also responsible for up to $32.6 million in research funding for the discovery and preclinical development work on these programs. As of September 30, 2019, we accrued $1.3 million for the discovery and preclinical development funding commitment.
For each option we decide to exercise, we would be required to pay an exercise fee of either $10.0 million or $12.0 million, depending on the program, and would assume responsibilities for all subsequent clinical development,

commercialization and global manufacturing of that program. Aurigene would then become eligible for up to $148.8 million per program in potential development and regulatory milestone payments, $280.0 million per program in potential commercial milestone payments, as well as royalties on potential sales. Under the terms of the agreement, Aurigene retains limited development and commercial rights for India and Russia.
GSK
In October 2002, we established a product development and commercialization collaboration agreement with GSK. Under the terms of the collaboration agreement, GSK had the right to choose cabozantinib for further development and commercialization, but notified us in October 2008 that it had waived its right to select the compound for such activities. Although the collaboration agreement was terminated in December 2014, we continue to beWe are required to pay a 3% royalty to GSK on the net sales of any product incorporating cabozantinib by us and our collaboration partners. Royalties accruing toearned by GSK in connection with the sales of cabozantinib are included in Costcost of goods sold for sales by us and as a reduction of Collaborationcollaboration services revenues for sales by Ipsen.our collaboration partners. Such royalties accruingwere $7.9 million and $23.7 million during the three and nine months ended September 30, 2020, respectively, as compared to GSK$8.0 million and $23.1 million during the comparable periods in 2019.
Genentech Collaboration
In December 2006, we out-licensed the development and commercialization of cobimetinib to Genentech under a worldwide collaboration agreement. In November 2015, the U.S. Food and Drug Administration (FDA) approved cobimetinib, under the brand name COTELLIC, in combination with Genentech’s ZELBORAF® (vemurafenib) for the treatment of patients with BRAF V600E or V600K mutation-positive advanced melanoma. COTELLIC in combination with ZELBORAF has also been approved in the European Union and multiple additional countries for use in the same indication. In July 2020, the FDA also approved COTELLIC for use in combination with ZELBORAF and TECENTRIQ® (atezolizumab) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma in previously untreated patients. License revenues under the collaboration agreement with Genentech were as follows (in thousands):
 Three Months Ended September 30,Nine Months Ended September 30,
 2020201920202019
Profits on U.S. commercialization$1,595 $1,102 $4,378 $3,507 
Royalty revenues on ex-U.S. sales$1,370 $1,614 $3,804 $4,426 
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Royalties accruing to GSK$7,964
 $6,268
 $23,079
 $17,021
In-Licensing Collaborations
Redwood Bioscience, Inc., R.P. Scherer Technologies, LLC, Catalent Pharma Solution LLC Collaboration
In September 2020, we entered into a collaboration and license agreement with Catalent, Inc.’s wholly owned subsidiaries Redwood Bioscience, Inc., R.P. Scherer Technologies, LLC and Catalent Pharma Solutions, Inc., (individually and collectively referred to as Catalent). Under the terms of the agreement, we made an upfront payment of $10.0 million in exchange to nominate and have the exclusive option to license four targets using Catalent’s ADC platform over a three-year period. In addition, we have a right to extend the target selection term to five years and nominate up to two additional targets for an additional payment of $4.0 million. We will also contribute research funding to Catalent for discovery and preclinical development work. For each option we decide to exercise, we will pay an exercise fee of $2.0 million, and would assume responsibilities for all subsequent clinical development, commercialization and global manufacturing of that program. Catalent would then become eligible to receive up to $44.0 million per compound in potential development milestone payments, $60.0 million per product in potential commercial milestone payments, as well as royalties on potential sales.
NBE Therapeutics AG (NBE) Collaboration
In September 2020, we entered into a collaboration and license agreement with NBE. Under the terms of the agreement, we made an upfront payment of $25.0 million in exchange for exclusive options to nominate four targets using NBE’s ADC platform over a two-year period. In addition, within the first eighteen months of the agreement, we also have a right to extend the target selection term to three years for an additional payment of $2.0 million. We will also contribute research funding to NBE for discovery and preclinical development work. For each option we decide to exercise, we will be
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required to pay an exercise fee of $10.0 million, and would assume responsibilities for all subsequent clinical development, commercialization and global manufacturing of that program. NBE would then become eligible to receive up to $90.0 million per program in potential development milestone payments, $135.0 million per program in potential commercial milestone payments, as well as royalties on potential sales.
NOTE 4. CASH AND INVESTMENTS
Cash, Cash Equivalents and Restricted Cash Equivalents
A reconciliation of Cash,cash, cash equivalents, and restricted cash equivalents reported within ourin the accompanying Condensed Consolidated Balance Sheets to the amount reported within the accompanying Condensed Consolidated Statements of Cash Flows was as follows (in thousands):
 September 30, 2019 December 31, 2018 September 30, 2018 December 31, 2017
Cash and cash equivalents$242,317
 $314,775
 $353,623
 $183,164
Restricted cash included in short-term restricted cash and investments—
 —
 504
 504
Restricted cash included in long-term restricted cash and investments1,000
 1,100
 1,100
 4,646
Cash, cash equivalents, and restricted cash as reported within the accompanying Condensed Consolidated Statements of Cash Flows$243,317
 $315,875
 $355,227
 $188,314

 September 30, 2020December 31, 2019
Cash and cash equivalents$334,046 $266,501 
Restricted cash equivalents included in long-term investments1,636 1,636 
Cash, cash equivalents, and restricted cash equivalents as reported in the accompanying Condensed Consolidated Statements of Cash Flows$335,682 $268,137 
Restricted cash includesequivalents consisted of certificates of deposit with original maturities of 90 days or less used to collateralize letters of credit and, in prior periods, a purchasing card program.

credit. The long-term classification of restricted cash equivalents is based upon the remaining term of the underlying restriction.
Cash and Investments
Cash and investments by security type were as followsconsisted of the following (in thousands):
September 30, 2020
Amortized CostGross Unrealized GainsGross Unrealized LossesFair Value
Debt securities available-for-sale:
Commercial paper$466,141 $225 $0 $466,366 
Corporate bonds629,309 7,526 (20)636,815 
U.S. Treasury and government-sponsored enterprises213,449 354 (10)213,793 
Municipal bonds20,326 105 0 20,431 
Total debt securities available-for-sale1,329,225 8,210 (30)1,337,405 
Cash55,979 0 0 55,979 
Money market funds96,992 0 0 96,992 
Certificates of deposit55,583 1 0 55,584 
Total cash and investments$1,537,779 $8,211 $(30)$1,545,960 
December 31, 2019
Amortized CostGross Unrealized GainsGross Unrealized LossesFair Value
Debt securities available-for-sale:
Commercial paper$389,573 $0 $0 $389,573 
Corporate bonds752,295 3,934 (3)756,226 
U.S. Treasury and government-sponsored enterprises166,483 187 (5)166,665 
Total debt securities available-for-sale1,308,351 4,121 (8)1,312,464 
Cash40,964 0 0 40,964 
Money market funds2,467 0 0 2,467 
Certificates of deposit32,728 5 0 32,733 
Total cash and investments$1,384,510 $4,126 $(8)$1,388,628 
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 September 30, 2019
 
Amortized
Cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 Fair Value
Investments available-for-sale:       
Money market funds$26,641
 $—
 $—
 $26,641
Commercial paper332,239
 —
 —
 332,239
Corporate bonds703,325
 3,549
 (67) 706,807
U.S. Treasury and government sponsored enterprises152,531
 143
 (24) 152,650
Total investments available-for-sale1,214,736
 3,692
 (91) 1,218,337
Cash and restricted cash901
 —
 —
 901
Certificates of deposit29,189
 3
 —
 29,192
Total cash and investments$1,244,826
 $3,695
 $(91) $1,248,430
Interest receivable was $4.5 million and $6.2 million as of September 30, 2020 and December 31, 2019, respectively, and is included in prepaid expenses and other current assets in the accompanying Condensed Consolidated Balance Sheets.

 December 31, 2018
 
Amortized
Cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 Fair Value
Investments available-for-sale:       
Money market funds$47,744
 $—
 $—
 $47,744
Commercial paper381,134
 —
 (1) 381,133
Corporate bonds344,741
 180
 (857) 344,064
U.S. Treasury and government sponsored enterprises55,224
 2
 (25) 55,201
Total investments available-for-sale828,843
 182
 (883) 828,142
Cash and restricted cash6,883
 —
 —
 6,883
Certificates of deposit16,596
 —
 —
 16,596
Total cash and investments$852,322
 $182
 $(883) $851,621

GainsRealized gains and losses on the sales of investments available-for-sale were nominalinsignificant during the three and nine months ended September 30, 20192020 and 2018.2019.
We manage credit risk associated with our investment portfolio through our investment policy, which limits purchases to high-quality issuers and limits the amount of our portfolio that can be invested in a single issuer. The fair value and gross unrealized losses on investmentsdebt securities available-for-sale in an unrealized loss position were as follows (in thousands):
September 30, 2020
Fair ValueGross Unrealized Losses
Corporate bonds$29,627 $(20)
U.S. Treasury and government-sponsored enterprises70,465 (10)
Total$100,092 $(30)
September 30, 2019
In an Unrealized Loss Position Less than 12 Months In an Unrealized Loss Position 12 Months or Greater TotalDecember 31, 2019
Fair Value Gross
Unrealized
Losses		 Fair Value Gross
Unrealized
Losses		 Fair Value Gross
Unrealized
Losses		Fair ValueGross Unrealized Losses
Corporate bonds$73,064
 $(66) $4,398
 $(1) $77,462
 $(67)Corporate bonds$14,529 $(3)
U.S. Treasury and government sponsored enterprises46,744
 (24) —
 —
 46,744
 (24)
U.S. Treasury and government-sponsored enterprisesU.S. Treasury and government-sponsored enterprises2,848 (5)
Total$119,808
 $(90) $4,398
 $(1) $124,206
 $(91)Total$17,377 $(8)


 December 31, 2018
 In an Unrealized Loss Position Less than 12 Months In an Unrealized Loss Position 12 Months or Greater Total
 Fair Value Gross
Unrealized
Losses		 Fair Value Gross
Unrealized
Losses		 Fair Value Gross
Unrealized
Losses
Corporate bonds$236,162
 $(606) $39,627
 $(251) $275,789
 $(857)
U.S. Treasury and government sponsored enterprises28,105
 (16) 9,182
 (9) 37,287
 (25)
Commercial paper7,091
 (1) —
 —
 7,091
 (1)
Total$271,358
 $(623) $48,809
 $(260) $320,167
 $(883)

All securities presented have been in an unrealized loss position less than 12 months. There were 4316 and 1999 investments in an unrealized loss position as of September 30, 20192020 and December 31, 2018,2019, respectively. During the three and nine months ended September 30, 20192020 and 20182019, we did 0t record any other-than-temporaryan allowance for credit losses or other impairment charges on our available-for-saleinvestment securities. Based upon our quarterly impairment review, we determined that the unrealized losses were not attributed to credit risk but were primarily associated with changes in interest rates.rates and market liquidity. Based on the scheduled maturities of our investments, and our determinationwe determined that it was more likely than not that we will hold these investments for a period of time sufficient for a recovery of our cost basis, we concluded that the unrealized losses in our investment securities were not other-than-temporary.basis.
The fair value of investmentsdebt securities available-for-sale by contractual maturity werewas as follows (in thousands):
 September 30,
2019		 December 31, 2018
Maturing in one year or less$743,768
 $674,455
Maturing after one year through five years474,569
 153,687
Total investments available-for-sale$1,218,337
 $828,142

 September 30, 2020December 31, 2019
Maturing in one year or less$993,211 $789,913 
Maturing after one year through five years344,194 522,551 
Total debt securities available-for-sale$1,337,405 $1,312,464 
Related Party Transactions
 BlackRock, Inc. (BlackRock), a global provider of investment, advisory and risk management solutions, reported that as of December 31, 2018, the most recent date for which they reported ownership data, their beneficial ownership was more than 10% of our outstanding common stock. BlackRock manages a portion of our cash and investments portfolio. As of September 30, 2019 and December 31, 2018, respectively, the fair value of cash and investments managed by BlackRock was $470.8 million and $298.5 million, which included $1.9 million and $3.0 million invested in the BlackRock Liquidity Money Market Fund. As of September 30, 2019, we also had a $9.0 million payable to BlackRock for unsettled trades that was included in Other current liabilities in the accompanying Condensed Consolidated Balance Sheets. We incurred $0.2 million in fees for BlackRock advisory services performed during the nine months ended September 30, 2019.
NOTE 5. INVENTORY
Inventory consisted of the following (in thousands):
 September 30,
2019		 December 31, 2018
Raw materials$1,906
 $1,922
Work in process11,035
 6,170
Finished goods7,311
 3,836
Total$20,252
 $11,928
    
Balance Sheet classification:   
Current portion included in Inventory$13,366
 $9,838
Long-term portion included in Other long-term assets6,886
 2,090
Total$20,252
 $11,928


Write-downs related to excess and expiring inventory are charged to Cost of goods sold or the cost of supplied product included in Collaboration revenues. Such write-downs were $0.4 million and $0.8 million for the nine months ended September 30, 2019 and 2018, respectively.
Inventory not expected to be used in production or sold in the next 12 months is classified as Other long-term assets in the accompanying Condensed Consolidated Balance Sheets. As of both September 30, 2019 and December 31, 2018, the long-term portion of inventory consisted of portions of our raw materials and finished goods, and as of September 30, 2019, also a portion of our work in process.
NOTE 6. PROPERTY AND EQUIPMENT
Property and equipment consisted of the following (in thousands): 
 September 30,
2019		 December 31,
2018
Leasehold improvements$33,769
 $33,941
Computer equipment and software17,017
 15,022
Furniture and fixtures13,053
 12,709
Laboratory equipment8,408
 5,668
Construction in progress617
 866
 72,864
 68,206
Less: accumulated depreciation and amortization(23,397) (17,309)
Property and equipment, net$49,467
 $50,897

Depreciation expense was $2.1 million and $6.1 million for the three and nine months ended September 30, 2019, respectively, as compared to $1.7 million and $2.9 million and for the comparable periods in 2018.
NOTE 5. FAIR VALUE MEASUREMENTS
Fair value reflects the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value hierarchy has the following three levels:
•Level 1 - quoted prices (unadjusted) in active markets for identical assets and liabilities;
•Level 2 - inputs other than level 1 that are observable either directly or indirectly, such as quoted prices in active markets for similar instruments or on industry models using data inputs, such as interest rates and prices that can be directly observed or corroborated in active markets;
•Level 3 - unobservable inputs that are supported by little or no market activity that are significant to the fair value measurement
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The classifications within the fair value hierarchy of our financial assets that were measured and recorded at fair value on a recurring basis were as follows (in thousands):
September 30, 2020
Level 1Level 2Total
Commercial paper$0 $466,366 $466,366 
Corporate bonds0 636,815 636,815 
U.S. Treasury and government-sponsored enterprises0 213,793 213,793 
Municipal bonds0 20,431 20,431 
Total debt securities available-for-sale0 1,337,405 1,337,405 
Money market funds96,992 0 96,992 
Certificates of deposit0 55,584 55,584 
Total financial assets carried at fair value$96,992 $1,392,989 $1,489,981 
December 31, 2019
Level 1Level 2Total
Commercial paper$0 $389,573 $389,573 
Corporate bonds0 756,226 756,226 
U.S. Treasury and government-sponsored enterprises0 166,665 166,665 
Total debt securities available-for-sale0 1,312,464 1,312,464 
Money market funds2,467 0 2,467 
Certificates of deposit0 32,733 32,733 
Total financial assets carried at fair value$2,467 $1,345,197 $1,347,664 
When available, we value investments based on quoted prices for those financial instruments, which is a Level 1 input. Our remaining investments are valued using third-party pricing sources, which use observable market prices, interest rates and yield curves observable at commonly quoted intervals for similar assets as observable inputs for pricing, which is a Level 2 input.
The carrying amount of our remaining financial assets and liabilities, which include cash, receivables and payables, approximate their fair values due to their short-term nature.
NOTE 6. INVENTORY
Inventory consisted of the following (in thousands):
 September 30, 2020December 31, 2019
Raw materials$5,298 $2,709 
Work in process17,911 9,447 
Finished goods4,535 4,367 
Total$27,744 $16,523 
Balance Sheet classification:
Current portion included in inventory$19,319 $12,886 
Long-term portion included in other long-term assets8,425 3,637 
Total$27,744 $16,523 
Write-downs related to excess and expiring inventory were $2.2 million and $0.4 million for the nine months ended September 30, 2020 and 2019, respectively.
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NOTE 7. STOCK-BASED COMPENSATION
We allocated the stock-based compensation expense for our equity incentive plans and our 2000 Employee Stock Purchase Plan (ESPP) as follows (in thousands):
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Research and development$4,301
 $3,169
 $13,745
 $9,102
Selling, general and administrative8,838
 6,573
 27,002
 19,228
Total stock-based compensation$13,139
 $9,742
 $40,747
 $28,330

Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Research and development$18,936 $4,301 $30,134 $13,745 
Selling, general and administrative36,719 8,838 55,657 27,002 
Total stock-based compensation$55,655 $13,139 $85,791 $40,747 
We have several equity incentive plans under which we have granted stock options and restricted stock units (RSUs) to employees and directors. At As of September 30, 20192020, 6,024,995 shares16,900,406 shares were available for grant under the Exelixis, Inc. 2017 Equity Incentive Plan (as amended and restated, the 2017 Plan). The share reserve is reduced by 1 share for each share issued pursuant to a stock option or stock appreciation award and 1.5 shares for full value awards granted in the form of restricted stock units (RSUs). On May 20, 2020, at our equity incentive plans.2020 Annual Meeting of Stockholders, our stockholders approved the amendment and restatement of the 2017 Plan. The amendment and restatement increased the share reserve under the 2017 Plan by 21,000,000 shares, subject to adjustment for certain changes in our capitalization, which became effective immediately upon stockholder approval. 
We used a Monte Carlo simulation pricing model to valueDuring the nine months ended September 30, 2020, we granted 1,189,888 stock options that include marketwith a weighted average exercise price of $21.84 per share and a weighted average grant date fair value of $9.61 per share. As of September 30, 2020, there were 16,219,326 stock options outstanding and $28.4 million unrecognized compensation expense.
During the nine months ended September 30, 2020, we granted 2,813,888 service-based RSUs with a weighted average grant date fair value of $23.56 per share. As of September 30, 2020, there were 6,554,909 RSUs outstanding and $111.9 million unrecognized compensation expense.
Stock options and RSUs granted to employees during the nine months ended September 30, 2020 have vesting conditions and contractual lives of a Black-Scholes Merton option pricing modelsimilar nature to valuethose described in “Note 8. Employee Benefit Plans” of the Notes to Consolidated Financial Statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019.
During the year ended December 31, 2018, in connection with our long-term incentive compensation program, we granted 308,365 performance-based stock options (PSOs) to our President and Chief Executive Officer. In addition to the standard service-based vesting conditions included in our other stock options, and ESPP purchases. The weighted average grant-date fair valuethese PSOs contain a market vesting condition such that they may not be exercised until, at any time after the grant date, the closing market price of our Common Stock is equal to or greater than 125% of the per share of stock options and ESPP purchases were as follows:
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Stock options$7.71
 $8.67
 $8.57
 $9.13
ESPP$5.39
 $6.19
 $4.93
 $6.96


The grant-date fair value of stock option grants and ESPP purchases was estimated using the following assumptions:
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Stock options:       
Risk-free interest rate1.57% 2.91% 1.82% 2.83%
Dividend yield—% —% —% —%
Volatility48% 55% 48% 55%
Expected life4.0 years
 4.4 years
 4.4 years
 4.4 years
ESPP:       
Risk-free interest rate2.09% 2.11% 2.34% 1.74%
Dividend yield—% —% —% —%
Volatility43% 51% 52% 52%
Expected life6 months
 6 months
 6 months
 6 months

We considered our implied volatility and our historical volatility in developing our estimates of expected volatility. The assumptions for the expected life of stock options were based on historical exercise patterns and post-vesting termination behavior. The risk-free interest rate is based on U.S. Treasury rates with the same or similar term as the underlying award. Our dividend rate is based on historical experience and our investors’ current expectations.
The fair value of RSUs was based on the closing price of the underlying common stockPSOs over a period of at least 30 consecutive calendar days. This market vesting condition was achieved during the three months ended June 30, 2020. The stock-based compensation expense for the PSOs is being recognized on an accelerated basis over the service period of the award, which commenced on the date of grant.
Activity for stock options The achievement of the market vesting condition did not impact the compensation expense recognized during the nine months endedSeptember 30, 2019 was as follows (dollars in thousands, except per share amounts):
 Shares 
Weighted
Average
Exercise Price Per Share
 
Weighted
Average
Remaining Contractual
Term
 
Aggregate
Intrinsic
Value
Options outstanding at December 31, 201822,674,062
 $8.71
    
Granted1,042,286
 $20.81
    
Exercised(3,042,201) $4.94
    
Forfeited(160,241) $16.76
    
Expired(35,045) $23.41
    
Options outstanding at September 30, 201920,478,861
 $9.80
 3.4 years $186,407
Exercisable at September 30, 201915,860,131
 $7.02
 2.8 years $181,542

period.
As of September 30, 20192020, there were , there was $38.0 million8,186,977 ofperformance-based restricted stock units (PSUs) outstanding with $129.7 million in related unrecognized compensation expense relatedexpense. Expense recognition for PSUs commences when it is determined that achievement of the performance target is probable. Of the outstanding PSUs, 188,624 relate to our unvested stock options. Theawards for which we achieved the performance target during 2019 or had determined during 2019 that it was probable that we would achieve the performance target during 2020. During 2020, we determined that it had become probable that we would achieve additional performance targets for 2,947,563 additional PSUs granted during 2018 and 2019. Total stock-based compensation expense for the unvested stock options will be recognized over a weighted-average period of 2.3 years.

Activity for RSUsPSUs was $41.2 million and $43.2 million during the three and nine months endedSeptember 30, 2019 was as follows (dollars2020, respectively. For more information about our PSUs, see “Note 8. Employee Benefit Plans” of the Notes to Consolidated Financial Statements included in thousands, except per share amounts):
 Shares 
Weighted
Average
Grant Date
Fair Value Per Share
 
Weighted
Average
Remaining
Contractual
Term
 
Aggregate
Intrinsic
Value
RSUs outstanding at December 31, 20184,857,334
 $18.42
    
Awarded5,635,362
 $19.54
    
Vested and released(484,731) $12.33
    
Forfeited(258,142) $18.47
    
RSUs outstanding at September 30, 20199,749,823
 $19.37
 2.2 years $175,448

our Annual Report on Form 10-K for the fiscal year ended December 31, 2019.
As of In September 30, 2019, there was $166.0 million of unrecognized compensation expense related to our unvested RSUs, including those RSUs granted in September 2018 and September 2019 that will vest upon the achievement of specific performance targets (PSUs) described below. The compensation expense for the unvested RSUs will be recognized over a weighted-average period of 2.8 years.
During 2019,2020, in connection with our long-term incentive compensation program, we awarded 1,926,605 RSUs1,951,830 PSUs (the target amount) that will vest upon the achievement of acertain performance targettargets related to aclinical trial positive top-line results and product approvalapprovals by the FDA (the 20192020 PSUs); employees. Employees may earn 150% of the target amount, or an additional 963,136 shares relativeup to the target amount, if the performance target is achieved before December 31, 2020 and may earn the full 200% of the target amount or up to an additional 1,926,6053,903,660 shares, relative todepending on the target amount, if we receive a second product approval. During 2018 we awarded 693,131 RSUs that will vest uponvolume and the timing of achievement of certain product revenue, late-stage clinical development and pipeline expansion theperformance targets (the 2018 PSUs).targets. The 20182020 PSUs and 2019 PSUs
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were designed to drive the performance of our management team and employees toward the achievement of key corporate objectives and will be forfeited if the performance targets are not met by December 31, 2021.2024.
Expense recognition for PSUs commences when it is determined that attainment of the performance target is probable. During the quarter ended June 30, 2019, we achieved one of the two product revenue related performance targets for 114,843 of the 2018 PSUs and determined that it was probable that we would achieve the second product revenue related performance target for 172,272 additional 2018 PSUs. During the quarter ended September 30, 2019, the second product revenue related performance target of the 2018 PSUs was achieved. Those 2018 PSUs will vest over various dates through February 2021. We recognized $0.9 million and $3.5 million in compensation expense related to those 2018 PSUs during the three and nine months ended September 30, 2019, respectively; the remaining unrecognized compensation expense for those 2018 PSUs was $1.7 million as of September 30, 2019. The total unrecognized compensation expense for both the 2019 PSUs and the remaining 2018 PSUs for which we have not yet determined that attainment of the performance target is probable was $82.4 million as of September 30, 2019.
NOTE 8. INCOME TAXES
Our effective income tax rate was 20.5%15.7% and 19.4%18.8% during the three and nine months ended September 30, 2019,2020, respectively, as compared to 1.8%20.5% and 1.7% during19.4% for the three and nine months ended September 30, 2018, respectively.comparable periods in 2019. The Provision for income taxes relating to our pre-tax incomeeffective tax rate for the three and nine months ended September 30, 2018 was largely2020 differed from U.S. federal statutory tax rate of 21% primarily due to excess tax benefits related to the exercise of certain stock options and federal tax credits, offset by a valuation allowance against our net operating loss carryforwards and other deferred tax assets. At December 31, 2018, we released substantially all of our valuation allowance against our deferred tax assets, after we determined that it was more likely than not that these deferred tax assets would be realized.
the non-deductible executive compensation during the periods. The effective tax rate for the three and nine months ended September 30, 2019 differed from the U.S. federal statutory rate of 21% primarily due to excess tax benefits related to the exercise of certain stock options and federal tax credits during thosethe periods.

NOTE 9. NET INCOME (LOSS) PER SHARE
TheNet income (loss) per share - basic and diluted, net income per share were computed as follows (in thousands, except per share amounts):
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Numerator:       
Net income$97,452
 $126,630
 $252,269
 $329,981
Denominator:       
Weighted-average shares of common stock outstanding used in computing basic net income per share303,268
 298,416
 301,999
 297,700
Dilutive securities12,185
 13,930
 13,047
 15,500
Weighted-average shares of common stock outstanding and dilutive securities used in computing diluted net income per share315,453
 312,346
 315,046
 313,200
        
Net income per share, basic$0.32
 $0.42
 $0.84
 $1.11
Net income per share, diluted$0.31
 $0.41
 $0.80
 $1.05

Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Numerator:
Net income (loss)$(32,040)$97,452 $83,393 $252,269 
Denominator:
Weighted-average common shares outstanding — basic309,116 303,268 307,437 301,999 
Dilutive securities0 12,185 10,058 13,047 
Weighted-average common shares outstanding — diluted309,116 315,453 317,495 315,046 
Net income (loss) per share — basic$(0.10)$0.32 $0.27 $0.84 
Net income (loss) per share — diluted$(0.10)$0.31 $0.26 $0.80 
Dilutive securities include outstandingincluded stock options, unvested RSUs, PSUs, PSOs and ESPP contributions. Potential
Certain potential common shares were excluded from our calculation of weighted-average common stock not included in the computation ofshares outstanding - diluted because either they would have had an anti-dilutive effect on net income per share becauseor they were related to do so would be anti-dilutive,shares from PSUs for which the contingent vesting condition had not been achieved. The weighted-average potential common shares excluded from our calculation were as follows (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Anti-dilutive securities and contingently issuable shares excluded27,033 6,153 10,224 5,740 
NOTE 10. COMMITMENTS AND CONTINGENCIES
In September 2019, we received a notice letter regarding an Abbreviated New Drug Application (ANDA) submitted to the FDA by MSN Pharmaceuticals, Inc. (MSN), requesting approval to market a generic version of CABOMETYX tablets. MSN’s initial notice letter included a Paragraph IV certification with respect to our U.S. Patent Nos. 8,877,776, 9,724,342, 10,034,873 and 10,039,757, which are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations, also referred to as the Orange Book. MSN’s initial notice letter did not provide a Paragraph IV certification against U.S. Patent No. 7,579,473, the composition of matter patent, or U.S. Patent No. 8,497,284, a method of use patent. On October 29, 2019, we filed a complaint in the United States District Court for the District of Delaware for patent infringement against MSN asserting U.S. Patent No. 8,877,776 arising from MSN’s ANDA filing with the FDA. On November 20, 2019, MSN filed its response to the complaint, alleging that U.S. Patent No. 8,877,776 is invalid and not infringed. On May 5, 2020, we received notice from MSN that it had amended its ANDA to assert additional Paragraph IV certifications. The ANDA now requests approval to market a generic version of CABOMETYX tablets prior to expiration of the two previously-unasserted CABOMETYX patents: U.S. Patent No. 7,579,473 and U.S. Patent No. 8,497,284. On May 11, 2020, we
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Potentially dilutive securities6,153
 5,687
 5,740
 2,938
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filed a complaint in the United States District Court for the District of Delaware for patent infringement against MSN asserting U.S. Patent No. 7,579,473 and U.S. Patent No. 8,497,284 arising from MSN’s amended ANDA filing with the FDA. On May 22, 2020, MSN filed its response to the complaint, alleging that each of U.S. Patent No. 7,579,473 and U.S. Patent No. 8,497,284 is invalid and not infringed. Neither of our complaints alleges infringement of U.S. Patent Nos. 9,724,342, 10,034,873 and 10,039,757. In our complaints, we are seeking, among other relief, an order that the effective date of any FDA approval of the ANDA would be a date no earlier than the expiration of all of U.S. Patent No. 7,579,473, U.S. Patent No. 8,497,284 and U.S. Patent No. 8,877,776, the latest of which expires on October 8, 2030, and equitable relief enjoining MSN from infringing these patents. These two lawsuits against MSN have been consolidated, and a bench trial has been scheduled for May 2022. The sale of a generic version of CABOMETYX earlier than its patent expiration could significantly decrease our revenues and thereby materially harm our business, financial condition and results of operations. It is not possible at this time to determine the likelihood of an unfavorable outcome or estimate of the amount or range of any potential loss.
We may also from time to time become a party or subject to various other legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business. Some of these proceedings have involved, and may involve in the future, claims that are subject to substantial uncertainties and unascertainable damages.
NOTE 10. FAIR VALUE MEASUREMENTS
The classifications within the fair value hierarchy of our financial assets that were measured and recorded at fair value on a recurring basis were as follows (in thousands):
 September 30, 2019
 Level 1 Level 2 Total
Money market funds$26,641
 $—
 $26,641
Commercial paper—
 332,239
 332,239
Corporate bonds—
 706,807
 706,807
U.S. Treasury and government sponsored enterprises—
 152,650
 152,650
Total investments available-for-sale26,641
 1,191,696
 1,218,337
Certificates of deposit—
 29,192
 29,192
Total financial assets carried at fair value$26,641
 $1,220,888
 $1,247,529
 December 31, 2018
 Level 1 Level 2 Total
Money market funds$47,744
 $—
 $47,744
Commercial paper—
 381,133
 381,133
Corporate bonds—
 344,064
 344,064
U.S. Treasury and government sponsored enterprises—
 55,201
 55,201
Total investments available-for-sale47,744
 780,398
 828,142
Certificates of deposit—
 16,596
 16,596
Total financial assets carried at fair value$47,744
 $796,994
 $844,738


We did not have any financial liabilities measured and recorded at fair value on a recurring basis as of September 30, 2019 or December 31, 2018. We did not have any financial assets or liabilities classified as Level 3 in the fair value hierarchy as of September 30, 2019 or December 31, 2018. There were no transfers of financial assets or liabilities between Levels 1, 2 and 3 during the three and nine months ended September 30, 2019 or 2018.
When available, we value investments based on quoted prices for those financial instruments, which is a Level 1 input. Our remaining investments are valued using third-party pricing sources, which use observable market prices, interest rates and yield curves observable at commonly quoted intervals for similar assets as observable inputs for pricing, which is a Level 2 input.
See “Note 11. Leases” for a description of the determination of the amount of operating lease liabilities. Our remaining financial assets and liabilities include cash and restricted cash, Trade receivables, net, Other receivables, Accounts payable, Accrued compensation and benefits, Accrued clinical trial liabilities, Accrued collaboration liabilities and Rebates and fees due to customers. Those financial assets and liabilities are carried at cost, which approximates their fair values.
NOTE 11. LEASES
In May 2017, we entered into a Lease Agreement (the Lease) for our corporate headquarters located at 1851, 1801 and 1751 Harbor Bay Parkway, Alameda, California (the Initial Premises). The Lease was subsequently amended in October 2017, June 2018 and April 2019, resulting in the addition of the building located at 1601 Harbor Bay Parkway and increasing the leased space to an aggregate of 169,606 square feet (the Current Premises) as of September 30, 2019. We have made certain tenant improvements to the space leased on the Initial Premises, for which we received $8.2 million in reimbursements in January 2019. The Lease’s initial term is through January 31, 2028. Rent payments began February 1, 2018, following the conclusion of a partial twelve-month rent abatement period. We have 2 five-year options to extend the Lease and a one-time option to terminate the Lease without cause on the last day of the 8th year of the initial term (the Early Termination Right); none of these optional periods have been considered in the determination of the right-of-use asset or the lease liability for the Lease as we did not consider it reasonably certain that we would exercise any such options. The Lease further provides that we are obligated to pay the landlord certain variable costs, including taxes and operating expenses.
The April 2019 amendment to the Lease (the Third Lease Amendment) provides, among other things, for the (i) expansion of the Initial Premises by 37,544 square feet of office facilities located at 1601 Harbor Bay Parkway, Alameda, California (the 1601 Expansion Space) and (ii) surrender of 2,703 square feet of office facilities located at 1751 Harbor Bay Parkway, Alameda, California (the 1751 Space). The term for the 1601 Expansion Space will run coterminous with the term of the Lease for the existing space. We have been provided an allowance of $1.7 million for tenant improvements to the 1601 Expansion Space. As of September 30, 2019, we have surrendered the 1751 Space and we have taken possession of the 1601 Expansion Space, and accordingly we have adjusted our right-of-use asset and lease liability, and have begun to recognize lease costs for the Third Lease Amendment.
The balance sheet classification of our lease liabilities were as follows (in thousands):
 September 30,
2019		 December 31, 2018
Operating lease liabilities:   
Current portion included in Other current liabilities$2,695
 $2,738
Long-term portion of lease liabilities23,661
 12,099
Total operating lease liabilities26,356
 14,837
Financing lease liabilities:   
Current portion included in Other current liabilities50
 49
Long-term portion of lease liabilities44
 79
Total financing lease liabilities94
 128
Total lease liabilities$26,450
 $14,965


The components of lease costs for operating leases, which were included in Selling, general and administrative expenses in our Condensed Consolidated Statements of Income, were as follows (in thousands):
 Three Months Ended September 30, Nine Months Ended September 30,
 2019 2018 2019 2018
Operating lease cost$692
 $1,614
 $1,768
 $3,587
Variable lease cost274
 363
 654
 1,366
Total lease costs$966
 $1,977
 $2,422
 $4,953

Cash paid for amounts included in the measurement of lease liabilities for the nine months ended September 30, 2019 was $2.1 million and was included in Net cash provided by operating activities in our Condensed Consolidated Statements of Cash Flows.
As of September 30, 2019, the maturities of our operating lease liabilities were as follows (in thousands): 
Remainder of 2019$745
Years ending December 31, 
20203,625
20213,731
20223,852
20233,959
Thereafter17,444
Total lease payments33,356
Less: 
Present value adjustment(5,258)
Tenant improvement reimbursements (1)
(1,742)
Operating lease liabilities$26,356

____________________
(1)Represents anticipated tenant improvement reimbursements applicable to the portion of the 1601 Expansion Space.
Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, we use our incremental borrowing rate. The weighted average discount rate used to determine the operating lease liability was 4.20%. As of September 30, 2019, the weighted average remaining lease term is 8.3 years.
NOTE 12. SUBSEQUENT EVENTS
Build to Suit Lease
On October 25, 2019, we entered into a build-to-suit Lease Agreement (the Build-to-Suit Lease) with Ernst Development Partners, Inc. (Ernst), for approximately 220,000 square feet of office space located in Alameda, California (the New Premises), adjacent to the Current Premises. The term of the Build-to-Suit Lease is for a period of 242 months (the Term), which will begin on the completion of the building and tenant improvements by Ernst. The Term is currently anticipated to begin on October 25, 2021. The monthly base rent under the Build-to-Suit Lease will equal to a percentage of the total development costs incurred in connection with the development of the New Premises (excluding the cost of the tenant improvements in excess of the allowance provided by Ernst and any development costs we pay) and is currently estimated to be about $726,000, subject to an annual increase of 3% during the Term. The monthly base rent will begin sixty days following commencement of the Term. We will also be responsible for paying operating expenses related to the New Premises.
The Build-to-Suit Lease includes 2 five-year options to extend the term of the Build-to-Suit Lease, exercisable under certain conditions and at a market rate determined in accordance with the Build-to-Suit Lease. We have a one-time option to terminate the Build-to-Suit Lease without cause after the 180th month of the Term, exercisable under certain conditions as described in the Build-to-Suit Lease and subject to a termination payment calculated in accordance with the Build-to-Suit Lease.

See Part II, Item 5 of this Quarterly Report on Form 10-Q for more information about the Build to Suit Lease.
Fourth Amendment to the Lease
In the fourth quarter of 2019, Hillwood Enterprises, L.P. (Hillwood) is expected to purchase the project known as 1750 North Loop Road and 1601, 1701, 1751, 1801 and 1851 Harbor Bay Parkway, Alameda, California from Ascentris 105, LLC (the Purchase), which project includes the Current Premises. Effective upon the Purchase, Hillwood will become the landlord pursuant to the Lease.
On August 30, 2019, we entered into an amendment to the Lease with Hillwood (the Fourth Lease Amendment), pursuant to which each of our rights and obligations are contingent upon the Purchase. Effective upon the Purchase, the Fourth Lease Amendment will provide for, among other things, the (i) expansion of the Current Premises by 59,335 square feet of laboratory facilities located at 1701 Harbor Bay Parkway, Alameda, California, (ii) extension of the Lease term through October 31, 2031 and (iii) elimination of the Early Termination Right.
As of September 30, 2019, we have not yet recorded a right-of-use asset or lease liability for the Fourth Lease Amendment, and the remainder of the disclosures in this note do not reflect the impact of this amendment.
See Part II, Item 5 of this Quarterly Report on Form 10-Q for more information about the Fourth Lease Amendment.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
This Quarterly Report on Form 10-Q contains forward-looking statements. These statements are based on Exelixis, Inc.’s (Exelixis, we, our or us) current expectations, assumptions, estimates and projections about our business and our industry and involve known and unknown risks, uncertainties and other factors that may cause our company’s or our industry’s results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied in, or contemplated by, the forward-looking statements. Our actual results and the timing of events may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include those discussed in “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q, as well as those discussed elsewhere in this report. These and many other factors could affect our future financial and operating results. We undertake no obligation to update any forward-looking statement to reflect events after the date of this report.
This discussion and analysis should be read in conjunction with our condensed consolidated financial statements and accompanying notes included in this report and the consolidated financial statements and accompanying notes thereto included in our Annual Report on Form 10-K for the fiscal year ended December 31, 20182019 filed with the Securities and Exchange Commission (SEC) on February 22, 2019.25, 2020.
Overview
We are an oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Since we were founded in 1994, four products resulting from our discovery efforts have progressed through clinical development, received regulatory approval and have launched commercially.established a commercial presence in various geographies around the world. Two are derived from cabozantinib, our flagship molecule, an inhibitor of multiple tyrosine kinases including MET, AXL, VEGF receptors and RET. TheseOur cabozantinib products are: CABOMETYX® (cabozantinib) tablets approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma (HCC); and COMETRIQ® (cabozantinib) capsules approved for progressive, metastatic medullary thyroid cancer (MTC). For these types of cancer, cabozantinib has become or is becoming a standard of care. The other two products resulting from our discovery efforts are: COTELLIC® (cobimetinib), an inhibitor of MEK, approved as part of amultiple combination regimenregimens to treat a specific formforms of advanced melanoma and marketed under a collaboration with Genentech, Inc. (a member of the Roche Group) (Genentech); and MINNEBRO® (esaxerenone), an oral, non-steroidal, selective blocker of the mineralocorticoid receptor, approved for the treatment of hypertension in Japan and licensed to Daiichi Sankyo Company, Limited (Daiichi Sankyo).
CABOMETYX was first approved by theThe U.S. Food and Drug Administration (FDA) first approved CABOMETYX for previously treated patients with advanced RCC in April 2016, and then in December 2017 the FDA expanded CABOMETYX’s approval to include previously untreated patients with advanced RCC. Additionally, in January 2019, the FDA approved CABOMETYX as afor the treatment forof patients with HCC who have been previously treated with sorafenib. This approval was basedMost recently on results from CELESTIAL,August 24, 2020, we announced a significant milestone for our phase 3 pivotal trial evaluatingprogram combining cabozantinib with immune checkpoint inhibitors (ICIs) with the submission a supplemental New Drug Application (sNDA) for CABOMETYX in combination with Bristol-Myers Squibb Company’s (BMS) Opdivo as a treatment of patients with previously treated HCC, which demonstratedadvanced RCC to the FDA, and on October 19, 2020, we and BMS announced that
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the FDA had accepted our sNDA and BMS’ supplemental Biologics License Application (sBLA), granted Priority Review to both applications and assigned a statistically significant and clinically meaningful improvement in overall survival versus placebo.Prescription Drug User Fee Act (PDUFA) goal date, or target action date, of February 20, 2021.
To develop and commercialize CABOMETYX and COMETRIQ outside the U.S., we have entered into license agreements with Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Ltd.Limited (Takeda). We granted to Ipsen has been grantedthe rights to develop and commercialize cabozantinib outside of the U.S. and Japan, and to Takeda has been grantedthe rights to develop and commercialize cabozantinib in Japan. Both partnersIpsen and Takeda also contribute financially and operationally to the further global development and commercialization of cabozantinib in other potential indications, and we continue to work closely with them on these activities. Utilizing its regulatory expertise and established international oncology marketing network, Ipsen has continued to execute on its commercialization plans for CABOMETYX, having received regulatory approvals and launched in multiple territories outside of the United States,U.S., including in the European Union (EU), and Canada, as a treatment for advanced RCC and for HCC in adults who have previously been treated with sorafenib,sorafenib. In addition, in September 2020, Ipsen and in Canada where CABOMETYX has recently been approved for previously untreated advanced RCC in additionBMS submitted type II variation applications to the earlier approvalEuropean Medicines Agency (EMA) to approve the combination of CABOMETYX and Opdivo as a treatment for advanced RCC, who have received prior VEGF-targeting therapy.with the EMA validating the type II variations and beginning its centralized review process, and both Ipsen and BMS plan to submit applications to approve the combination in other territories beyond the EU. With respect to the Japanese market, Takeda has also made significant progress on bridging studiesachieved important milestones in both RCC2020, including receipt of Manufacturing and HCC and achieved an important regulatory milestone in April 2019 with its application toMarketing Approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for approval to manufacture and sellfirst commercial sales of CABOMETYX as a treatment of patients with curatively unresectable or metastatic RCC. Takeda also submitted an application to the Japanese MHLW for Manufacturing and Marketing Approval of CABOMETYX as a treatment of patients with unresectable HCC who progressed after prior systemic therapy, and most recently in October 2020, Takeda and Ono Pharmaceutical Co., Ltd. (Ono), BMS’ development and commercialization partner in Japan, submitted a supplemental application to the Japanese MHLW for Manufacturing and Marketing Approval of CABOMETYX in combination with Opdivo for the treatment of patients with unresectable, advanced or metastatic RCC in Japan.RCC.
In addition to our regulatory and commercialization efforts in the U.S. and the support provided to our collaboration partners for rest of worldrest-of-world regulatory and commercialization activities, we are also pursuing other indications for cabozantinib that have the potential to increase the number of cancer patients who could benefit from this medicine. We are evaluating cabozantinib, both as a single agent and in combination with other therapies, in a broad development program comprising over 80100 ongoing or planned clinical trials across multiple indications. We, along with our clinical and commercial

collaboration partners, sponsor some of the trials, and independent investigators conduct the remaining trials through our Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP) or our investigator sponsoredinvestigator-sponsored trial program. Informed by the available data from these clinical trials, we continue to advance cabozantinib’s late-stage development program.program with potentially label-enabling trials. One pivotal trial that has resulted from this effort is COSMIC-311, our ongoing phase 3 pivotal trial evaluating cabozantinib versus placebo in patients with radioactive iodine-refractoryradioiodine (RAI)-refractory differentiated thyroid cancer (DTC) who have progressed after up to two VEGF receptor-targeted therapies. We plan to conduct an analysis among the first 100 patients randomized in COSMIC-311 for the co-primary endpoint of objective response rate (ORR), and an interim analysis of progression-free survival (PFS) before the end of 2020.
We are particularly interested in examiningcontinuing to evaluate cabozantinib’s potential in combination with immune checkpoint inhibitors (ICIs)ICIs to determine if suchthese combinations further improve outcomes for patients. Building on preclinical and clinical observations that cabozantinib may promote a more immune-permissive tumor environment potentially resulting in cooperative activity of cabozantinib in combination with these products, we are evaluating cabozantinib in combination with a variety of ICIs. The most advanced of these combination studies include CheckMate 9ER,-9ER, a phase 3 pivotal trial evaluating the combination of cabozantinib in combination withand nivolumab compared to sunitinib in previously untreated advanced or metastatic RCC, for which we and our collaboration partner Bristol-Myers Squibb Company (BMS) hasBMS announced top linepositive top-line results are expected in earlyApril 2020, is reflective of this strategy. The trial met its primary endpoint of PFS at final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis and ORR, and showed that the combination of cabozantinib with nivolumab significantly reduced the risk of disease progression or death compared with sunitinib (hazard ratio [HR]=0.51; 95% confidence interval [CI]: 0.41 to 0.64; p<0.0001) and also significantly improved OS, reducing the risk of death by 40% compared with sunitinib (HR=0.60; 98.89% CI: 0.40 to 0.89; p<0.0010), as well as demonstrated a superior ORR of 56% versus 27% for sunitinib. Data from CheckMate -9ER were presented at Presidential Symposium I at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 in September 2020 and served as the basis for the submission of our sNDA to the FDA for CABOMETYX in combination with Opdivo as a treatment of patients with advanced RCC. We have also collaborated with BMS on CheckMate 040,-040, a multi-cohort phase 1/2 trial evaluating cabozantinib in combination with nivolumab and in combination with both nivolumab and ipilimumab in patients with previously treated or previously untreated advanced HCC, alsofor which initial clinically meaningful results were presented at
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American Society of Clinical Oncology’s (ASCO’s) Gastrointestinal Cancers Symposium in collaboration with BMS. Additionally in May 2019, as part of our clinical collaboration with BMS, we initiatedJanuary 2020, and COSMIC-313, a phase 3 pivotal trial evaluating the triplet combination of cabozantinib, nivolumab and ipilimumab versus the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk RCC,RCC. We expect to complete enrollment for COSMIC-313 in early 2021 and plan to further evaluatereport top-line results of the combination of cabozantinib and nivolumab, with or without ipilimumab,event-driven analyses from the trial in various other tumor types. the 2022 time frame.
In an effort to diversify our exploration of combinations with ICIs, we have also initiated multiple trials evaluating cabozantinib in combination with F. Hoffmann-La Roche Ltd.’s (Roche’s) ICI, atezolizumab, including COSMIC-312, a phase 3 pivotal trial evaluating cabozantinib in combination with the Roche Group’s (Roche’s) ICI, atezolizumab versus sorafenib in previously untreated advanced HCC, for which we announced in August 2020 that enrollment was completed, and COSMIC-021, a broad phase 1b study evaluating the safety and tolerability of cabozantinib in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. COSMIC-021 is divided into two parts: a dose-escalation phase, which was completed in 2018; and an expansion phase, which is ongoing. Findings from the dose-escalation stage of COSMIC-021 demonstrated that the combination was well-tolerated and showed encouraging anti-tumor activity in patients with advanced RCC. The expansion phase of COSMIC-021 comprises 24 total cohorts, with 20 cohorts evaluating the combination of cabozantinib and atezolizumab and four cohorts evaluating cabozantinib or atezolizumab as single-agent therapies. Based on initialcontinuing encouraging results fromefficacy and safety data certain cohorts have been or may be further expanded, including the ongoing expansion cohorts inof patients with castration-resistant prostate cancer (CRPC) and in ICI-pretreated non-small cell lung cancer (NSCLC), who have been previously treated with an ICI and metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with enzalutamide and/or abiraterone acetate and experienced radiographic disease progression in July 2019, we expandedsoft tissue. We anticipate enrolling up to 1,732 patients in the original 30-patienttrial in early 2021, although both the timing and final number of patients are subject to the initiation of additional cohorts or expansion of selected existing cohorts, as well as any further delays resulting from the COVID-19 pandemic. Since its initiation, data from COSMIC-021 have been instrumental in guiding our clinical development strategy for eachcabozantinib in combination with ICIs, including supporting the recent initiation of these disease states to allow enrollment of an additional 50 patients for a total of 80 patients each. Additionally, four new cohorts, consisting of two expansion and two exploratory cohorts, were added to COSMIC-021three phase 3 pivotal trials in July 2019: two new expansion cohortscollaboration with Roche evaluating the combination of cabozantinib and atezolizumab inwith atezolizumab. The first, CONTACT-01, focuses on patients with metastatic CRPCNSCLC who have received prior enzalutamide or abiraterone therapy,been previously treated with or without prior docetaxelan ICI and platinum-containing chemotherapy; the second, CONTACT-02, focuses on patients with mCRPC who have been previously treated with one novel hormonal therapy; and two new exploratory cohorts evaluating single-agent cabozantinib and single-agent atezolizumab inthe third, CONTACT-03, focuses on patients with inoperable, locally advanced or metastatic CRPC,RCC who have progressed during or following treatment with an ICI as the immediate preceding therapy. Encouraging results from interim analyses of the mCRPC and NSCLC cohorts of COSMIC-021 were presented at ASCO’s Genitourinary Cancer Symposium in February 2020 and the 2020 ASCO Virtual Scientific Program in May 2020, respectively, and positive results from two RCC cohorts of COSMIC-021 were presented at the ESMO Virtual Congress 2020 in September 2020. Based on regulatory feedback from the FDA, and if supported by the clinical data, we intend to file with the purpose of determining the individual contribution of each therapy. Depending on the results from COSMIC-021, we may evaluate the combination of cabozantinib and atezolizumabFDA for accelerated approval in various late-stage clinical trials, including in NSCLC and CRPC.an mCRPC indication as early as 2021.
As we continue to work to maximize the clinical and commercial potential of cabozantinib, weWe also remain committed to building our product pipeline by discovering and developing new cancer therapies for cancer patients. In this regard, we reinitiated internalUsing our in-house drug discovery effortsexpertise, specifically in 2017 with the goal of identifying new productmedicinal chemistry, tumor biology and pharmacology, we are advancing small molecule drug candidates to advance into clinical trials.toward and through preclinical development. Notably, these efforts are led by some of the same experienced scientists responsible forthat led the discovery ofefforts to discover cabozantinib, cobimetinib and esaxerenone, which have been approved for commercialization by regulatory authorities. Usingcommercialization. In addition, we have augmented our expertiseinternal drug discovery activities with multiple partnerships, including several that enable us to discover and advance various biologics, such as bispecific antibodies and antibody-drug conjugates (ADCs), and we continue to engage in medicinal chemistry, tumor biologybusiness development initiatives aimed at identifying and pharmacology,in-licensing promising, early-stage oncology assets, which we can further develop utilizing our established clinical development infrastructure. In total, we are advancing drug candidates across approximately 20 ongoing discovery programs toward and through preclinical development. Furthest along in thesedevelopment, with plans for up to four new compounds to reach Investigational New Drug (IND) filing status by the end of the second quarter of 2021.
The first compounds to advance from our recent internal drug discovery efforts isinclude XL092, a next-generation oral tyrosine kinase inhibitor that is currently in a phase 1 clinical trial in patients with advanced solid malignancies.
malignancies for which dose-escalation cohorts evaluating XL092, both as a single agent and in combination with atezolizumab, are currently enrolling. We augment these internal drug discovery activities with business development initiatives aimed at identifying and in-licensing promising, early-stage oncology assets and then further develop them utilizing our establishedpresented data that support the ongoing clinical development infrastructure. of XL092 at the 32nd EORTC-NCI-AACR (ENA) Symposium in October 2020, and we expect that once recommended doses of both single-agent XL092 and XL092 in combination with atezolizumab are established, the trial will begin to enroll expansion cohorts for patients with clear cell and non-clear cell RCC, hormone-receptor positive breast cancer and mCRPC. In addition, we anticipate filing an IND for XL265, a TAM kinase-focused kinase inhibitor, in the first quarter of 2021.
In furtherance of thisour business development strategy, in 2019, we have entered into multiple collaboration and license agreements including with:with Aurigene Discovery Technologies Limited (Aurigene), which is focused on the discovery and development of novel small molecules as therapies for cancer, and Iconic Therapeutics, Inc. (Iconic), which is focused on the
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advancement of a next-generation ADC program targeting tissue factor in solid tumors. In September 2020, we presented preclinical data that support the continued development of ICON-2, Iconic’s ADC comprised of an anti-tissue factor antibody and a proprietary linker-payload developed by Zymeworks Inc., at the World ADC Digital Conference, and in October 2020, we presented preclinical data that support the continued development of AUR102, the lead Aurigene program targeting cyclin-dependent kinase 7 (CDK7), at the 32nd ENA Symposium. Both ICON-2 and AUR102 continue to progress through preclinical development and could result in IND filings in the fourth quarter of 2020. We have also made progress under our other collaborations with Invenra, Inc. (Invenra), which is focused on the discovery and development of multispecific antibodies for the treatment of cancer, and StemSynergy Therapeutics, Inc. (StemSynergy), which is focused on the discovery and development of novel oncology compounds aimed to inhibit tumor growth by targeting Casein Kinase 1α; Invenra,1 alpha. Most recently, in September 2020, we entered into additional collaboration agreements to develop multiple ADCs with Catalent, Inc. (Invenra)’s wholly owned subsidiaries Redwood Bioscience, Inc., which is focused on the discoveryR.P. Scherer Technologies, LLC and development of multispecific antibodies for the treatment of cancer; Iconic Therapeutics,Catalent Pharma Solutions, Inc. (Iconic)(individually and collectively referred to as Catalent), which is focused on the advancement of a next-generation antibody-drug conjugate program targeting tissue factor in solid tumors; and Aurigene Discovery Technologies Limited (Aurigene), which is focused on the discovery and development of novel small molecules as therapies for cancer.with NBE-Therapeutics AG (NBE). To further enhance our early-stage pipeline, we expect to enter into

additional, external collaborative relationships around assets and technologies that complement our internal drug discovery and development efforts.
COVID-19 Update
As of the date of this Quarterly Report, the COVID-19 pandemic continues to have a modest impact on our business operations, in particular on our clinical trial, drug discovery and commercial activities. We have and continue to undertake considerable efforts to mitigate the various problems presented by this crisis, including as described below:
Clinical Trials. To varying degrees and at different rates across our clinical trials being conducted in regions impacted by COVID-19, we have experienced declines in screening and enrollment activity, delays in new site activations, and restrictions on the access to treatment sites that is necessary to monitor clinical study progress and administration. However, beginning with the second quarter of 2020, we experienced an increase in screening and enrollment activity, and overall, we and our collaboration partners, including principal investigators and personnel at clinical trial sites, have been successful in preventing material delays to our ongoing and planned clinical trials. We have done this through ongoing assessment of the pandemic’s impact and, wherever possible, taking proactive steps in compliance with guidance issued by the FDA, EMA and other regulatory agencies to support the safety of our patients and their access to treatment, as well as to maintain the high quality of our clinical trials. We recognize, however, that we may have to make further operational adjustments to our ongoing and planned clinical trials and that patient enrollment, and new clinical trial site initiations may be further slowed due to the COVID-19 pandemic, especially if it is further prolonged or grows in severity.
Drug Discovery and Preclinical Development. We have partially resumed internal drug discovery in our laboratories following a temporary suspension of these activities while we observed the shelter in place orders issued by the State of California and Alameda County. While this temporary suspension did not result in any significant changes to the timelines for our late-stage discovery work, we did experience modest delays in the advancement of certain of our early-stage programs. We also experienced some modest delays with respect to the portion of drug discovery work outsourced to third-party contractors in regions first impacted by COVID-19. However, those service providers have resumed discovery work and are meeting their contractual obligations in accordance with planned timelines. Prior to the COVID-19 pandemic, we largely outsourced preclinical development work to third-party contractors, and that work has continued without substantial delay or interference resulting from the COVID-19 pandemic. While we continue to utilize our resources effectively to move new product candidates toward the clinic, we may ultimately be unable to achieve our drug discovery and preclinical development objectives within the previously disclosed timelines due to the COVID-19 pandemic, especially if it is further prolonged or grows in severity.
Commercial Activities. Although our field employees have limited their in-person promotional activities, they remain engaged with healthcare professionals and are available to them as an informational resource. Nevertheless, with healthcare professionals acutely focused on the COVID-19 pandemic and patient access to healthcare professionals limited due to shelter in place orders, we experienced a decrease in prescriptions for CABOMETYX during the second and third quarters of 2020, which we believe was, at least in part, attributable to the COVID-19 pandemic with respect to the second quarter of 2020. We also observed fluctuations in CABOMETYX ordering, and we believe that this effect could continue depending on developments related to the COVID-19 pandemic. Overall, despite the challenges posed by the pandemic, our commercial business has only experienced a modest impact. We believe this is the case largely because of the gravity of the cancer conditions that our products are indicated to treat and the fact that CABOMETYX has been available as an orally administrable cancer treatment in the U.S. since 2016, thereby establishing a safety and efficacy profile that is well known to healthcare
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professionals. It remains possible, however, that over a longer period, changes to our standard sales and marketing practices resulting from the COVID-19 pandemic, including the shift from in-person to primarily telephonic and virtual interactions with healthcare professionals, along with obstacles to patient access to healthcare professionals, could diminish sales of our marketed products.
Supply Chain. We have not experienced production delays or seen any significant impact to our clinical or commercial supply chain as a result of the COVID-19 pandemic. In addition, we continue to maintain substantial safety stock inventories for our commercial drug substance and drug products, which should be sufficient to maintain robust long-term supply. We continue to work closely with our third-party contract manufacturers, suppliers, comparator drug sourcing vendors and collaboration partners to safeguard both the timely production and delivery of our products. If the COVID-19 pandemic is further prolonged or becomes more severe, however, we are prepared to modify our manufacturing and supply chain operations as appropriate in response.
General Business Operations. We have taken numerous temporary precautions to help mitigate the risk of transmission of the virus, including reducing the number of our employees working on-site at our Alameda headquarters under enhanced safety and social distancing protocols. Although having most of our employees continue to work remotely has required that we devise new ways of working and collaborating, to date we have not experienced any material reduction in productivity or interruptions in our general business operations. If the COVID-19 pandemic is further prolonged or becomes more severe, however, we may find it more challenging to maintain that level of productivity, to grow the company as we have anticipated, and to execute on our long-term business plans.
The circumstances surrounding the COVID-19 pandemic are volatile and subject to rapid change. Despite our mitigation efforts, we may experience delays or an inability to execute on our clinical and preclinical development plans, reduced revenues or other adverse impacts to our business, which are described in more detail in “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q. We recognize that this pandemic will continue to present unique challenges for us throughout 2020, and potentially in future years should the adverse effects of the COVID-19 pandemic continue indefinitely.
Third Quarter 20192020 Business Updates and Financial Highlights
During the third quarter of 2019,2020, we continued to execute on our business objectives, generating significant revenuerevenues from operations and enabling us to continue to seek to maximize the clinical and commercial potential of our products and expand our product pipeline. Significant business updates and financial highlights for the quarter and subsequent to quarter-end include:
Business Updates
•In July 2019,2020, we announced the initiation of CONTACT-03, a global phase 3 pivotal trial evaluating cabozantinib in combination with atezolizumab in patients with inoperable, locally advanced or metastatic RCC who progressed during or following treatment with an amendmentICI as the immediate preceding therapy. The co-primary endpoints of the trial are PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 as assessed by independent review and OS, and the secondary endpoints include PFS, ORR and duration of response as assessed by the investigators.
•In July 2020, the FDA approved the sBLA submitted by Genentech for atezolizumab plus cobimetinib and vemurafenib for the treatment of BRAF V600 mutation-positive advanced melanoma in previously untreated patients. The approval is based on positive results from IMspire150, a phase 3 pivotal trial that demonstrated that adding atezolizumab to cobimetinib and vemurafenib helped to reduce the protocolrisk of disease worsening or death, compared to placebo plus cobimetinib and vemurafenib. This is the second FDA approval for a regimen including cobimetinib, which we discovered and is now being developed by Genentech as part of a worldwide collaboration agreement between the two companies.
•In August 2020, we announced the completion of patient enrollment in COSMIC-312, a global phase 3 pivotal trial evaluating cabozantinib in combination with atezolizumab versus sorafenib as a treatment of patients with previously untreated advanced HCC, providing the requisite patient population to conduct the event-driven analyses of the trial’s endpoints. Separately, patient enrollment remains open in China in order to enroll a sufficient number of patients to enable local registration, if supported by the clinical data. The co-primary endpoints of the trial are PFS and OS. Based on current event rates, we anticipate announcing top-line results in the first half of 2021.
•In August 2020, we announced the completion of patient enrollment in EXAMINER, the phase 4 trial evaluating the safety and efficacy of the 60 mg tablet formulation of cabozantinib compared with the 140 mg capsule
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formulation, which is marketed as COMETRIQ, for the treatment of patients with progressive, metastatic MTC. EXAMINER is a post-marketing requirement from the FDA and the European Commission. The trial was designed to enroll up to 250 patients, and top-line results from the trial are anticipated later in 2020.
•In September 2020, we announced a collaboration and license agreement with Catalent to develop multiple ADCs using Catalent’s proprietary SMARTag® site-specific bioconjugation technology.
•In September 2020, we announced a collaboration and license agreement with NBE to discover and develop multiple ADCs for oncology applications by leveraging NBE’s unique expertise and proprietary platforms in ADC discovery, including NBE’s SMAC-Technology™ (a site-specific conjugation technology) and novel payloads.
•In September 2020, we and Iconic announced preclinical data that support the continued development of ICON-2 for the treatment of diverse solid tumors. The data, which demonstrate the superior tolerability and exposure of ICON-2 compared with a monomethyl auristatin E anti-tissue factor ADC, were presented at the World ADC Digital Conference.
•In September 2020, clinical data from CheckMate -9ER, a phase 3 pivotal trial evaluating the combination of cabozantinib and nivolumab compared to sunitinib in previously untreated advanced or metastatic RCC, were presented as part of Presidential Symposium I at the ESMO Virtual Congress 2020. In addition, clinical data from the clear cell RCC and non-clear cell RCC cohorts of COSMIC-021, thea phase 1b trial of cabozantinib in combination with atezolizumab in patients with locally advanced or metastatic solid tumors, to expand patient enrollment in certain existing CRPCwere presented as part of the GU Proffered Paper Session and NSCLC cohortsas part of a poster presentation, respectively, at the ESMO Virtual Congress.
•In September 2020, we announced that our collaboration partners Ipsen and to add new expansionBMS each submitted and exploratory cohorts in CRPC (an aggregate of 24 total cohorts, with 20 expansion cohorts evaluatingreceived validation from the EMA for their type II variation applications for the combination of cabozantinibCABOMETYX and atezolizumab and four exploratory cohorts evaluating cabozantinib or atezolizumabOpdivo as single-agent therapies).a treatment for advanced RCC.
•In July 2019,October 2020, we announced an exclusive collaboration, optiondata that support the ongoing clinical development of XL092. The data, which suggest XL092 has a desirable therapeutic profile that pairs the potential for significant anti-tumor activity with a much shorter clinical pharmacokinetic half-life than cabozantinib, as well as a potential synergistic effect in combination with ICIs, were presented at the 32nd ENA Symposium. Later in October 2020, we announced enrollment of the first patient into the dose-escalation cohort of the combination arm of the phase 1 trial evaluating the safety, tolerability, pharmacokinetics and license agreementpreliminary anti-tumor activity of XL092 alone and in combination with Aurigene, and India-based biotechnology company focused on oncology and inflammatory disorders, to in-license as many as six programs.atezolizumab in patients with advanced solid tumors.
•In October 2019, Ipsen received regulatory approval from Health Canada2020, we and Aurigene announced preclinical data that support the continued development of AUR102. The data, which demonstrate that AUR102 effectively engages CDK7 and inhibits a key mediator of the cell cycle and transcription, were presented at the 32nd ENA Symposium.
•In October 2020, we and BMS announced that the FDA had accepted our sNDA and BMS’ sBLA, respectively, for CABOMETYX for the first-line treatment of adultsin combination with advanced RCC.
In October 2019, we expanded our collaboration with Invenra focused on the discovery and development of multispecific antibodiesOpdivo for the treatment of cancerpatients with advanced RCC, granted Priority Review to include the developmentboth applications and assigned a PDUFA goal date of novel binders against six additional targets which we can use to generate multispecific antibodies based on Invenra’s B-Body™ technology platform, or with other platforms and formats at our option.February 20, 2021.
•In October 2019, we filed2020, our collaboration partner Takeda, along with Ono, submitted a patent infringement lawsuit against MSN Pharmaceuticals, Inc. (MSN), following receipt of a Paragraph IV certification notice letter from MSN that it had filed an Abbreviated New Drug Application (ANDA) withsupplemental application to the FDA requesting approval to market a generic versionJapanese MHLW for Manufacturing and Marketing Approval of CABOMETYX tablets, following expirationin combination with Opdivo for the treatment of the CABOMETYX composition of matter patent, U.S. Patent No. 7,579,473, which expires on August 14, 2026. We are seeking, among other relief, an order that the effective date of any FDA approval of the ANDA would be a date no earlier than the expiration of U.S. Patent No. 8,877,776 on October 8, 2030 and equitable relief enjoining MSN from infringing this patent. For a more detailed discussion of this litigation matter, see “Legal Proceedings” in Part II, Item 1 of this Quarterly Report on Form 10-Q.patients with unresectable, advanced or metastatic RCC.
Financial Highlights
•
Net product revenues for the third quarter of 2019 increased to $191.8 million, compared to $162.9 million for the third quarter of 2018.Net product revenues for the third quarter of 2020 were $168.6 million, compared to $191.8 million for the third quarter of 2019.
•Total revenues for the third quarter of 2020 were $231.1 million, compared to $271.7 million for the third quarter of 2019.
•Research and development expenses for the third quarter of 2020 were $176.8 million, compared to $97.3 million for the third quarter of 2019.
•Selling, general and administrative expenses for the third quarter of 2020 were $88.2 million, compared to $51.3 million for the third quarter of 2019.
•Provision for (benefit from) income taxes for the third quarter of 2020 was $(6.0) million, compared to $25.2 million for the third quarter of 2019.
•Net loss for the third quarter of 2020 was $(32.0) million, or $(0.10) per share, basic and diluted, compared to net income of $97.5 million, or $0.32 per share, basic and $0.31 per share diluted, for the third quarter of 2019.
•Cash and investments were $1.5 billion as of September 30, 2020, compared to $1.4 billion as of December 31, 2019.
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•
Total revenues for the third quarter of 2019 increased to $271.7 million, compared to $225.4 million for the third quarter of 2018.
•
Research and development expenses for the third quarter of 2019 increased to $97.3 million, compared to $44.7 million for the third quarter of 2018.
•
Selling, general and administrative expenses for the third quarter of 2019 increased to $51.3 million, compared to $48.1 million for the third quarter of 2018.
•
Provision for income taxes for the third quarter of 2019 increased to $25.2 million, compared to $2.3 million for the third quarter of 2018.
•
Net income for the third quarter of 2019 was $97.5 million, or $0.32 per share, basic and $0.31 per share, diluted, compared to $126.6 million, or $0.42 per share, basic and $0.41 per share diluted, for the third quarter of 2018.
•
Cash and investments increased to $1.2 billion at September 30, 2019, compared to $851.6 million at December 31, 2018.
See “Results of Operations” below for a discussion of the detailed components and analysis of the amounts above.

Challenges and Risks
WeIn addition to the challenges and risks imposed by the COVID-19 pandemic and described under “—COVID-19 Update” above, we will also continue to face challenges and risks that may impact our ability to execute on our remaining 20192020 business objectives.objectives, and some of these risks to our business have been or may be exacerbated by the COVID-19 pandemic. In particular, for the foreseeable future, we expect our ability to maintain or increase unrestrictedgenerate sufficient cash flow to fund our business operations and growth will depend upon the continued commercial success of CABOMETYX, both alone or in combination with other therapies, as a treatment for advanced RCCthe highly competitive indications for which it is approved, and previously treated HCC, and potentiallypossibly for other indications for which cabozantinib has been or is currently being evaluated in late-stagepotentially label-enabling clinical trials, if warranted by the data generated from suchthese trials. TheHowever, we cannot be certain that the clinical trials we and our collaboration partners are currently conducting, or may conduct in the future, will demonstrate adequate safety and efficacy in these additional indications to receive regulatory approval in the major commercial success ofmarkets where CABOMETYX is approved. Even if we and our collaboration partners receive the required regulatory approvals to market cabozantinib for additional indications, we and our collaboration partners may not be able to commercialize CABOMETYX effectively and successfully in its approved indications is subject to a variety of factors, most importantly, the drug’s perceived benefit/risk profile as compared to the benefit/risk profiles of other competitive treatments available or in development for these conditions.additional indications. In addition, CABOMETYX will only continue to be commercially successful if private third-party and government payers continue to provide coverage and reimbursement. However, as is the case for all innovative pharmaceutical therapies, obtaining and maintaining coverage and reimbursement for CABOMETYX is becoming increasingly difficult, both within the U.S. and in foreign markets, because of growing concerns over healthcare cost containment and corresponding policy initiatives and activities aimed at limiting access to, and restricting the prices of, pharmaceuticals.
Achievement of our remaining 20192020 business objectives and the continued success of CABOMETYX will also depend on the success of our development and commercialization strategies to navigate increased competition, including that from, but not limited to, ICIs, as well as the use of combination therapytherapies that combine an ICI with another targeted agent to treat cancer. In the longer term, we may eventually face competition from potential manufacturers of generic versions of our marketed products, including the proposed generic version of CABOMETYX tablets that is the subject of the ANDAan Abbreviated New Drug Application (ANDA) submitted to the FDA by MSN Pharmaceuticals, Inc. (MSN), which if approved, following the expiration of our composition of matter patent in 2026, could result in significant decreases in the revenue derived from the U.S. sales of CABOMETYX and thereby materially harm our business and financial condition. Separately, our research and development objectives may be impeded by the challenges of scaling our organization to meet the demands of expanded drug development, unanticipated delays in clinical testing and the inherent risks and uncertainties associated with internal drug discovery operations.operations, all of which may be increased as a result of the COVID-19 pandemic. In connection with efforts to expand our product pipeline, we may be unsuccessful in discovering new drug candidates or identifying appropriate candidates for in-licensing or acquisition.
Some of these challenges and risks are specific to our business, and others are common to companies in the biotechnology, biopharmaceutical and pharmaceutical industryindustries with development and commercial operations. Moreover, as described under “—COVID-19 Update” above, these risks have been or may be exacerbated by the COVID-19 pandemic. For a more detailed discussion of challenges and risks we face, including those relating to the COVID-19 pandemic, see “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q.
Fiscal Year Convention
We have adopted a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31st. Fiscal year 2019,2020, which is a 53-week52-week fiscal year, will end on January 3, 20201, 2021 and fiscal year 2018,2019, which was a 52-week53-week fiscal year, ended on December 28, 2018.January 3, 2020. For convenience, references in this report as of and for the fiscal periodsthree months ended October 2, 2020 and September 27, 2019, and September 28, 2018, and as of and for the fiscal years ending January 3, 2020,1, 2021, and ended December 28, 2018,January 3, 2020, are indicated as being as of and for the periodsthree months ended September 30, 20192020 and September 30, 20182019 and the years ending December 31, 2019,2020 and ended December 31, 2018,2019, respectively.
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Results of Operations
Revenues
Revenues by category were as follows (dollars in thousands):
 Three Months Ended September 30, Percentage Change -
Q3 2019 v. Q3 2018		 Nine Months Ended September 30,  Percentage Change - Year to Date 2019 v. 2018
 2019 2018  2019 2018 
Net product revenues$191,768
 $162,946
 18% $565,024
 $443,054
 28 %
Collaboration revenues79,935
 62,451
 28% 162,441
 182,170
 (11)%
Total revenues$271,703
 $225,397
 21% $727,465
 $625,224
 16 %

 Three Months Ended September 30,Percent ChangeNine Months Ended September 30,Percent Change
 2020201920202019
Net product revenues$168,587 $191,768 (12 %)$541,197 $565,024 (4 %)
License revenues33,205 69,137 (52 %)113,318 132,443 (14 %)
Collaboration services revenues29,300 10,798 171 %62,971 29,998 110 %
Total revenues$231,092 $271,703 (15 %)$717,486 $727,465 (1 %)
Net Product Revenues
Gross product revenues, Discountsdiscounts and allowances, and Netnet product revenues were as follows (dollars in thousands):
Three Months Ended September 30, Percentage Change -
Q3 2019 v. Q3 2018		 Nine Months Ended September 30,  Percentage Change - Year to Date 2019 v. 2018 Three Months Ended September 30,Percent ChangeNine Months Ended September 30,Percent Change
2019 2018 2019 2018  2020201920202019
Gross product revenues$239,916
 $193,356
 24% $704,084
 $525,438
 34%Gross product revenues$220,401 $239,916 (8 %)$702,865 $704,084 0 %
Discounts and allowances(48,148) (30,410) 58% (139,060) (82,384) 69%Discounts and allowances(51,814)(48,148)8 %(161,668)(139,060)16 %
Net product revenues$191,768
 $162,946
 18% $565,024
 $443,054
 28%Net product revenues$168,587 $191,768 (12 %)$541,197 $565,024 (4 %)
Net product revenues by product were as follows (dollars in thousands):
 Three Months Ended September 30,Percent ChangeNine Months Ended September 30,Percent Change
 2020201920202019
CABOMETYX$159,555 $187,410 (15 %)$522,381 $552,315 (5 %)
COMETRIQ9,032 4,358 107 %18,816 12,709 48 %
Net product revenues$168,587 $191,768 (12 %)$541,197 $565,024 (4 %)
 Three Months Ended September 30, Percentage Change -
Q3 2019 v. Q3 2018		 Nine Months Ended September 30,  Percentage Change - Year to Date 2019 v. 2018
 2019 2018  2019 2018 
CABOMETYX$187,410
 $158,262
 18 % $552,315
 $428,317
 29 %
COMETRIQ4,358
 4,684
 (7)% 12,709
 14,737
 (14)%
Net product revenues$191,768
 $162,946
 18 % $565,024
 $443,054
 28 %
The increasesdecreases in product revenues for CABOMETYX for the three and nine months ended September 30, 2019,2020, as compared to the comparable periods in 2018,2019, were primarily due to a 12% and 21% increase, respectively,decrease in the number of units of CABOMETYX sold and increases in the average selling price of the product. The increases in CABOMETYX sales volumes reflects the continued growth of CABOMETYXdriven by decreases in advanced RCC following FDA approvals in April 2016 of CABOMETYX for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapyprescriptions and in December 2017 for previously untreated patients with advanced RCC, as well as the U.S. launch of CABOMETYX for the treatment of patients with HCC who have been previously treated with sorafenib, following FDA approval in January 2019.lower customer inventory. The decreasesincreases in product revenues for COMETRIQ for the three and nine months ended September 30, 2019,2020, as compared to the comparable periods in 2018,2019, were primarily due to a 8% and 18% decline, respectively,increases in the number of units of COMETRIQ sold. COMETRIQ sales volumes have continuedsold, due to a comparator purchase of the product for use in a clinical trial.
We expect our net product revenues to modestly decrease since the launch of CABOMETYX in April 2016.2020, as compared to fiscal 2019.
We recognize product revenues net of discounts and allowances that are described in “Note 1. Organization and Summary of Significant Accounting Policies” to our “Notes to Consolidated Financial Statements” included in our Annual Report on Form 10-K for the year ended December 31, 2018.2019. The increases8% increase in discounts and allowances for the three months ended September 30, 2020, as compared to the comparable period in 2019, was primarily the result of an increase in the dollar amount of chargebacks related to Public Health Service hospitals, and to a lesser extent, an increase in Medicaid utilization and the dollar amount of the related Medicaid rebates. The 16% increase in discounts and allowances for the nine months ended September 30, 2019,2020, as compared to the comparable periodsperiod in 2018, were2019, was primarily the result of the overall increases in product sales volume and increasesan increase in Public Health Service hospital utilization and the dollar amount of the related chargebacks, and, to a lesser extent, increases to the dollar amount of chargebacks associated with Veterans Affairs hospitals, as well as increases to other government and commercial rebates. chargebacks.
We expect our discounts and allowances as a percentage of gross product revenues to increase during the remainder of 20192020.
License Revenues
License revenues include the recognition of the portion of milestone payments allocated to the transfer of intellectual property licenses for which it had become probable in the related period that the milestone would be achieved
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and a significant reversal of revenues would not occur, as well as royalty revenues and the profit on the U.S. commercialization of COTELLIC from Genentech.
Milestone revenues, which are allocated between license revenues and collaboration services revenues, were $13.5 million and $57.1 million for the three and nine months ended September 30, 2020, respectively, as compared to 2018 as the number of patients participating in government programs increases, and as the discounts and rebates paid to government payers increase.

Collaboration Revenues
Collaboration revenues were as follows (dollars in thousands):
 Three Months Ended September 30, Percentage Change -
Q3 2019 v. Q3 2018		 Nine Months Ended September 30,  Percentage Change - Year to Date 2019 v. 2018
 2019 2018  2019 2018 
Collaboration revenues:    

      
License revenues (1)
$68,035
 $51,323
 33% $128,937
 $152,261
 (15)%
Research and development services revenues (2)
12,988
 10,560
 23% 35,814
 27,464
 30 %
Other collaboration revenues(3)
(1,088) 568
 n/m
 (2,310) 2,445
 n/m
Total collaboration revenues$79,935
 $62,451
 28% $162,441
 $182,170
 (11)%
____________________
(1)License revenues included the recognition of the portion of milestones allocated to the transfer of intellectual property licenses for which it had become probable in the current period that the milestone would be achieved and a significant revenue reversal would not occur, as well as royalty revenues from Ipsen, Genentech and Daiichi Sankyo.
(2)Research and development services revenues included the recognition of deferred revenue for the portion of upfront and milestone payments that have been allocated to research and development services performance obligations, as well as development cost reimbursements earned on our collaboration agreements.
(3)Other collaboration revenues included the profit on the U.S. commercialization of COTELLIC from Genentech and revenues on product supply services provided to Ipsen and Takeda, which were offset by the 3% royalty we are required to pay GlaxoSmithKline (GSK) on the net sales by Ipsen of any product incorporating cabozantinib.
Milestone revenues were $50.6 million and $81.1 million respectively,for the comparable periods in 2019. Milestone revenues by period included the following:
•Milestone revenues for the three and nine months ended September 30, 2020 included $9.2 million in revenues recognized in connection with a $10.0 million milestone we expect to achieve upon Takeda’s and Ono’s submission of a supplemental application to the Japanese MHLW for Manufacturing and Marketing Approval of CABOMETYX in combination with Opdivo for the treatment of patients with unresectable, advanced or metastatic RCC.
•Milestone revenues for the nine months ended September 30, 2020 included $25.3 million in revenues recognized in connection with $31.0 million in milestones we achieved upon Takeda’s first commercial sale of CABOMETYX for the treatment of patients with curatively unresectable or metastatic RCC in Japan and $18.9 million in revenues recognized in connection with a $20.0 million development milestone from Ipsen we determined was probable of achievement. The milestone was achieved on October 1, 2020.
•Milestone revenues for the three and nine months ended September 30, 2019 as compared to $42.6included recognition of a $50.0 million and $134.8commercial milestone from Ipsen that we earned in the third quarter of 2019 upon Ipsen’s achievement of $250.0 million in net sales of cabozantinib in its territories over four consecutive quarters.
•Milestone revenues for the comparable periodsnine months ended September 30, 2019 also included recognition of a $20.0 million milestone from Daiichi Sankyo Company, Limited (Daiichi Sankyo) for the launch of MINNEBRO tablets for the treatment of patients with hypertension in 2018. MilestoneJapan and $9.7 million in revenues by period includedrecognized in connection with a $16.0 million milestone from Takeda for the following:
•
Milestone revenues for the three and nine months endedSeptember 30, 2019 included recognitionsubmission in April 2019 of a regulatory application for cabozantinib for the treatment of a $50.0 million commercial milestone from Ipsen that we earned in the third quarter of 2019 upon Ipsen’s achievement of $250.0 million in net sales of cabozantinib in its territories over four consecutive quarters.
•
Milestone revenues for the nine months endedSeptember 30, 2019 also included recognition of a $20.0 million milestone from Daiichi Sankyo for the launch of MINNEBRO tablets as a treatment for patients with hypertension in Japan and $9.7 million in revenues recognized in connection with a $16.0 million milestone from Takeda for the submission in April 2019 of a regulatory application for cabozantinib as a treatment for patients with advanced RCC to the Japanese MHLW.
•
Milestone revenues for the three and nine months endedSeptember 30, 2018 included $36.9 million in revenue related to a $40.0 million milestone from Ipsen for the approval by the European Commission (EC) of cabozantinib for previously-treated HCC and $5.0 million in revenue for a milestone from Ipsen on the approval by Health Canada of cabozantinib for the treatment of adults with advanced RCC.
•
Milestone revenues for the nine months endedSeptember 30, 2018 also included: i) recognition of $46.2 million in revenue of a $50.0 million milestone from Ipsen for the approval of cabozantinib for the first-line treatment of adults with intermediate- or poor-risk advanced RCC by the EC, of which $0.2 million was recognized in the third quarter of 2018; ii) recognition of a $25.0 million commercial milestone from Ipsen that we earned in the second quarter of 2018 upon Ipsen’s achievement of $100.0 million in net sales of cabozantinib in its territories over four consecutive quarters; and iii) recognition of a $20.0 million milestone upon Daiichi Sankyo’s submission to the Japanese MHLW of a regulatory application for esaxerenone as a treatment for patients with hypertension.
Due to uncertainties surrounding the timing and achievement of regulatory and development milestones, it is difficult to predict future milestone revenues and such milestones can vary significantly from period to period.
Royalties increased primarily as a result of increases in royalties earned on Ipsen’s net sales of cabozantinib by Ipsen outside of the U.S. and JapanJapan. Ipsen royalties were $16.4$19.9 million and $45.3$54.1 million for the three and nine months ended September 30, 2019,2020, respectively, as compared to $10.3$16.4 million and $20.0$45.3 million for the comparable periods in 2018.2019. Ipsen’s net sales of cabozantinib have continued to grow since their first commercial sale of the product in the fourth quarter of 2016, primarily due to increased demand of CABOMETYX, which, as of September 30,

2019, 2020, is approved and commercially available in 48 and 3355 countries outside of the U.S., respectively. We were entitled Royalties also increased due to receive a tiered royaltythe commercial launch of 2% to 12% onCABOMETYX for the initial $150.0 milliontreatment of net sales; this amount was reachedpatients with curatively unresectable or metastatic RCC in Japan by Takeda during the second quarter of 2018. As2020.
Our share of June 30, 2018 and going forward, we are entitled to receive a tiered royalty of 22% to 26% on annual net sales (with separate tiers for Canada); these 22% to 26% royalty tiers reset each calendar year. In Canada, we are entitled to receive a tiered royalty of 22%profits on the first CAD$30.0 millionU.S. commercialization of annual net sales and a tiered royalty thereafter of 22% to 26% on annual net sales; these 22% to 26% royalty tiers for Canada will also reset each calendar year. In May 2019, we also began to earn low double-digit royalties on the sale of MINNEBRO by Daiichi Sankyo in Japan.
Development cost reimbursements in connection withCOTELLIC under our collaboration arrangementsagreement with Ipsen and Takeda were $12.0Genentech was $1.6 million and $32.5$4.4 million for the three and nine months ended September 30, 2019,2020, respectively, as compared to $6.9$1.1 million and $17.7$3.5 million for the comparable periods in 2018. The increases were primarily the result of reimbursements from Ipsen and Takeda for their share of the increase in spending on the CheckMate 9ER study.
Profits on the U.S. commercialization of COTELLIC and2019. We also earned royalties on ex-U.S. net sales of COTELLIC under our collaboration agreement withby Genentech were $2.7of $1.4 million and $7.9$3.8 million for the three and nine months ended September 30, 2019, respectively, as2020, compared to $3.3$1.6 million and $10.3$4.4 million for the comparable periods in 2018. Sales2019.
We expect our license revenues to modestly decrease in 2020, as compared to fiscal 2019, as a result of COTELLICa decrease in milestones expected to be achieved during the U.S.year.
Collaboration Services Revenues
Collaboration services revenues include the recognition of deferred revenue for the portion of upfront and milestone payments that have declined following Genentech’s decisionbeen allocated to scale backresearch and development services performance obligations, development cost reimbursements earned under our collaboration agreements, product supply revenues, net of product supply costs, and the personal promotionroyalties we paid to GlaxoSmithKline (GSK) on sales by Ipsen of COTELLIC commencing in January 2018.products containing cabozantinib.
ForDevelopment cost reimbursements were $26.3 million and $60.3 million for the three and nine months ended September 30, 2019, collaboration2020, respectively, as compared to $12.0 million and $32.5 million for the comparable periods in 2019. The increases in development cost reimbursements were primarily a result of the reimbursements from Ipsen and Takeda associated with their decision to opt in and co-fund CONTACT-02 and additional cohorts of COSMIC-021 studies in 2020 and their respective share of the increase in spending on the COSMIC-312, COSMIC-021 and CONTACT-02 studies.
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Collaboration services revenues were reduced by $8.0$2.9 million and $23.1$7.6 million respectively, for the 3% royalty we are required to pay GSK on the net sales by Ipsen and Takeda of any product incorporating cabozantinib asfor the three and nine months ended September 30, 2020, respectively, compared to $6.3$2.2 million and $17.0$6.2 million for the comparable periods in 2018.2019. As royalty generating sales of cabozantinib by Ipsen have increased as described above, our royalty payments to GSK have also increased. In addition, pursuant
We expect collaboration services revenues to increase in 2020, as compared to fiscal 2019, as a license agreement we entered into with Ligand Pharmaceuticals, Inc. (Ligand), we are required to pay a royaltyresult of 0.5% to Ligand on net sales of MINNEBRO.higher development cost reimbursements earned under our collaboration agreements.
Cost of Goods Sold
The Costcost of goods sold and our gross margin were as follows (dollars in thousands):
Three Months Ended September 30, Percentage Change -
Q3 2019 v. Q3 2018		 Nine Months Ended September 30,  Percentage Change - Year to Date 2019 v. 2018 Three Months Ended September 30,Percent ChangeNine Months Ended September 30,Percent Change
2019 2018 2019 2018  2020201920202019
Cost of goods sold$7,537
 $7,360
 2% $22,577
 $18,996
 19%Cost of goods sold$8,725 $7,537 16 %$27,235 $22,577 21 %
Gross margin96% 95% 

 96% 96%  Gross margin95 %96 %95 %96 %
Cost of goods sold is related to our product revenues and consists primarily of a 3% royalty payable to GSK on U.S. net sales of any product incorporating cabozantinib, as well as the cost of inventory sold, indirect labor costs, write-downs related to expiring and excess inventory, and other third-party logistics costs. The increases in Costcost of goods sold for the three and nine months ended September 30, 2019,2020, as compared to the comparable periods in 2018,2019, were primarily the result of the increases in product sales volume described above.write-downs of excess and expiring inventory and certain period costs. We do not expect our gross margin to change significantly during the remainder of 2019.2020.
Research and Development Expenses
Research and development expenses were as follows (dollars in thousands):
 Three Months Ended September 30, Percentage Change -
Q3 2019 v. Q3 2018		 Nine Months Ended September 30,  Percentage Change - Year to Date 2019 v. 2018
 2019 2018  2019 2018 
Research and development expenses$97,295
 $44,741
 117% $242,516
 $124,986
 94%
 Three Months Ended September 30,Percent ChangeNine Months Ended September 30,Percent Change
 2020201920202019
Research and development expenses$176,762 $97,295 82 %$393,572 $242,516 62 %
Research and development expenses consist primarily of clinical trial costs, personnel expenses, license and other collaboration costs, stock-based compensation, and consulting and outside services, stock-based compensation and the allocation of general corporate costs.

services.
The increases in Researchresearch and development expenses for the three and nine months ended September 30, 2019,2020, as compared to the comparable periods in 2018,2019, were primarily related to increases in clinical trial costs, licenselicensing and other collaboration costs, stock-based compensation and personnel expenses, partially offset by the allocationimpact of general corporate costs and stock-based compensation.increased development cost reimbursements. Clinical trial costs, which includesinclude services performed by third-party contract research organizations and other vendors who support our clinical trials, and comparator drug purchases, increased $20.8$34.2 million and $54.1$93.6 million for the three and nine months ended September 30, 2019,2020, respectively, as compared to the comparable periods in 2018.2019. The increases in clinical trial costs were primarily due to costs associated with the expanding clinical trial program for cabozantinib, that nowwhich includes four phase 3 pivotal studies (CheckMate 9ER, COSMIC-311,CONTACT-02, COSMIC-313, COSMIC-312, and COSMIC-313), as well as the multi-cohort phase 1b study (COSMIC-021). LicenseCOSMIC-021. Licensing and other collaboration costs increased $20.5$24.9 million and $30.4$19.6 million for the three and nine months ended September 30, 2019,2020, respectively, as compared to the comparable periods in 2018,2019, primarily as a resultdue to increases in upfront license fee payments from recent business development activities with two additional collaboration and license agreements focused on the discovery and development of the collaboration agreements we entered into with Aurigene in July 2019 and Iconic in May 2019. Personnel expensesADCs. Stock-based compensation increased $3.8$14.6 million and $13.0 million and the allocation of general corporate costs increased $1.3 million and $4.5$16.4 million for the three and nine months ended September 30, 2019,2020, respectively, as compared to the comparable periods in 2018,2019, primarily due to increasesthe determination that a performance target for the PSUs granted in headcount to support our expanded discovery and development efforts. Stock-based compensation2019 became probable of achievement. Personnel expenses increased $1.1$7.8 million and $4.6$22.6 million for the three and nine months ended September 30, 2019,2020, respectively, as compared to the comparable periods in 2018,2019, primarily due to the increases in headcount to support our expanding discovery and development efforts.
Research and development expenses for the three and nine months ended September 30, 2020 were reduced by $6.3 million and $11.3 million, respectively, as well asa result of development cost reimbursements in connection with our collaboration arrangement with Roche; there were no such reimbursements during the expense recognition for restricted stock units that were grantedcomparable periods in September 2018 that either have vested or will vest upon the achievement2019.
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Table of specific performance targets (the 2018 PSUs).Contents
We do not track fully-burdened Researchresearch and development expenses on a project-by-project basis. We group our Researchresearch and development expenses into three categories: Development, Drug discovery1) development; 2) drug discovery; and Other.3) other. Our development group leads the development and implementation of our clinical and regulatory strategies and prioritizes disease indications in which our compounds are being or may be studied in clinical trials. Our drug discovery group utilizes a variety of technologies, including in-licensed technologies, to enable the rapid discovery, optimization and extensive characterization of lead compounds such that we are able to select development candidates with the best potential for further evaluation and advancement into clinical development.
Research and development expenses by category were as follows (in thousands):
Three Months Ended September 30, Nine Months Ended September 30,Three Months Ended September 30,Nine Months Ended September 30,
2019 2018 2019 20182020201920202019
Research and development expenses:       Research and development expenses:
Development:       Development:
Clinical trial costs$38,055
 $17,242
 $94,612
 $40,482
Clinical trial costs$72,232 $38,055 $188,182 $94,612 
Personnel expenses14,964
 12,316
 44,077
 34,182
Personnel expenses21,388 14,964 62,286 44,077 
Consulting and outside services4,084
 1,943
 10,884
 6,969
Consulting and outside services4,852 4,084 11,907 10,884 
Other development costs3,754
 2,925
 11,824
 10,257
Other development costs5,836 3,754 15,771 11,824 
Total development60,857
 34,426
 161,397
 91,890
Total development104,308 60,857 278,146 161,397 
Drug discovery:       Drug discovery:
License and other collaboration costs20,910
 367
 38,390
 7,708
License and other collaboration costs45,761 20,910 58,013 38,390 
Other drug discovery (1)
6,896
 3,706
 17,870
 9,646
Other drug discovery (1)
7,703 6,896 20,844 17,870 
Total drug discovery27,806
 4,073
 56,260
 17,354
Total drug discovery53,464 27,806 78,857 56,260 
Other (2)
8,632
 6,242
 24,859
 15,742
Other (2)
18,990 8,632 36,569 24,859 
Total research and development expenses$97,295
 $44,741
 $242,516
 $124,986
Total research and development expenses$176,762 $97,295 $393,572 $242,516 
____________________
(1)Primarily includes personnel expenses, consulting and outside services and laboratory supplies.
(2)Includes stock-based compensation and the allocation of general corporate costs to research and development.
(1)    Primarily includes personnel expenses, consulting and outside services and laboratory supplies.
(2)    Includes stock-based compensation, the allocation of general corporate costs to research and development, and development cost reimbursements in connection with our December 2019 collaboration arrangement with Roche.
In addition to reviewing the three categories of Researchresearch and development expenses described above, we principally consider qualitative factors in making decisions regarding our research and development programs. SuchThese factors include enrollment in clinical trials for our drug candidates, preliminary data from and final results offrom clinical trials, the potential indications for our drug candidates, the clinical and commercial potential for our drug candidates, and competitive dynamics. We also make our research and development decisions in the context of our overall business strategy.
We are focusing our development efforts primarily on cabozantinib to maximize the therapeutic and commercial potential of this compound and, as a result, we expect that a significant portion of our near-term research and development expenses to primarily

will relate to the continuing clinical development program of cabozantinib. We expect to continue to incur significant development costs for cabozantinib, in future periods as we evaluate its potential in a broad development program comprisingwhich includes over 80100 ongoing or planned clinical trials across multiple indications. Notable company-sponsored studies ofresulting from this program include: CheckMate 9ER and CheckMate 040, each in collaboration with BMS; company-sponsored COSMIC-021 and COSMIC-312, for which Roche is providing atezolizumab free of charge; company-sponsored COSMIC-313, for which BMS is providing nivolumab and ipilimumab free of charge; CONTACT-02 for which Roche is sharing in the development costs including the provision of atezolizumab free of charge; and company-sponsored COSMIC-311. In addition, post-marketing commitments in connection with the approval of COMETRIQ in progressive, metastatic MTC dictate that we conduct an additional study in that indication.
We are also remain committed to building our product pipeline by discovering and developing new cancer therapies for cancer patients. In this regard, we are conductingconduct internal drug discovery activities with the goal of identifying new product candidates to advance into clinical trials. We augment theseIn addition, we have augmented our internal drug discovery activities with multiple partnerships, including several that enable us to discover and advance various biologics, such as bispecific antibodies and ADCs, and we continue to engage in business development initiatives aimed at identifying and in-licensing promising, early-stage oncology assets, and thenwhich we can further develop them utilizing our established clinical development infrastructure.
We expect our Researchresearch and development expenses to continueincrease in 2020, as compared to increase as we expand thefiscal 2019, driven by our ongoing clinical evaluation of cabozantinib and business development program and our product pipeline.activities.
The length of time required for clinical development of a particular product candidate and our development costs for that product candidate may be impacted by the scope and timing of enrollment in clinical trials for the product
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candidate, our decisions to develop a product candidate for additional indications and whether we pursue development of the product candidate or a particular indication with a collaborator or independently. For example, cabozantinib is being developed in multiple indications, and we do not yet know for how many of those indications we will ultimately pursue regulatory approval. In this regard, our decisions to pursue regulatory approval of cabozantinib for additional indications depend on several variables outside of our control, including the strength of the data generated in our prior, ongoing and potential future clinical trials. Furthermore, the scope and number of clinical trials required to obtain regulatory approval for each pursued indication is subject to the input of the applicable regulatory authorities, and we have not yet sought such input for all potential indications that we may elect to pursue. Even after having given such input, applicable regulatory authorities may subsequently require additional clinical studies prior to granting regulatory approval based on new data generated by us or other companies, or for other reasons outside of our control. As a condition to any regulatory approval, we may also be subject to post-marketing development commitments, including additional clinical trial requirements. As a result of the uncertainties discussed above, we are unable to determine the duration of, or completetotal costs associated with the development of cabozantinib or any of our other research and development projects.
In any event, ourOur potential therapeutic products are subject to a lengthy and uncertain regulatory process that may not result in our receipt of the necessary regulatory approvals. Failure to receive the necessary regulatory approvals would prevent us from commercializing the product candidates affected, including cabozantinib in any additional indications. In addition, clinical trials of our potential product candidates may fail to demonstrate safety and efficacy, which could prevent or significantly delay regulatory approval. A discussion of the risks and uncertainties with respect to our research and development activities, including completing the development of our product candidates, and the consequences to our business, financial position and growth prospects can be found in “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were as follows (dollars in thousands):
 Three Months Ended September 30, Percentage Change -
Q3 2019 v. Q3 2018		 Nine Months Ended September 30,  Percentage Change - Year to Date 2019 v. 2018
 2019 2018  2019 2018 
Selling, general and administrative expenses$51,265
 $48,120
 7% $170,218
 $153,989
 11%
Three Months Ended September 30,Percent ChangeNine Months Ended September 30,Percent Change
2020201920202019
Selling, general and administrative expenses$88,185 $51,265 72 %$210,916 $170,218 24 %
Selling, general and administrative expenses consist primarily of personnel expenses, consulting and outside services, stock-based compensation, marketing costs, and marketingcertain other administrative costs.
The increases in Selling,selling, general and administrative expenses for the three and nine months ended September 30, 2019,2020, as compared to the comparable periods in 2018,2019, were primarily related to the increases in stock-based compensation and personnel expenses; the increase for the three months ended September 30, 2020 was also related to an increase in marketing costs.

personnel expenses and consulting and outside services, and were partially offset by a decrease in corporate giving. Stock-based compensation increased $2.3$27.9 million and $7.8$28.7 million for the three and nine months ended September 30, 2019,2020, respectively, as compared to the comparable periods in 2018,2019, primarily due to increases in administrative headcount to support the company’s commercial and research and development organizations as well as the expense recognitiondetermination that a performance target for the 2018 PSUs.PSUs granted in 2019 became probable of achievement. Personnel expenses increased $2.6$3.2 million and $7.2$10.3 million for the three and nine months ended September 30, 2019,2020, respectively, as compared to the comparable periods in 2018,2019, primarily due to increases in headcount. Consultingadministrative headcount to support our commercial and outside servicesresearch development organizations. Marketing costs increased $0.3$3.9 million for the three months ended September 30, 2020, as compared to the comparable period in 2019, in preparation for the launch of CABOMETYX in combination with Opdivo for the treatment of patients with advanced RCC.
We expect our selling, general and $5.1 millionadministrative expenses to increase in 2020, as compared to fiscal 2019, driven by our continued commercial investment in CABOMETYX, the growth of the broader organization and higher stock-based compensation expense.
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Non-operating Income
Non-operating income were as follows (dollars in thousands):
Three Months Ended September 30,Percent ChangeNine Months Ended September 30,Percent Change
2020201920202019
Interest income$3,994 $7,191 (44 %)$16,376 $20,253 (19 %)
Other income (expense), net565 (140)(504 %)571 688 (17 %)
Non-operating income$4,559 $7,051 (35 %)$16,947 $20,941 (19 %)
The decreases in non-operating income for the three and nine months ended September 30, 2020, as compared to the comparable periods in 2019, were primarily the result of the decreases in interest income due to lower interest rates.
Provision for (Benefit from) Income Taxes
The provision for (benefit from) income taxes and effective income tax rates were as follows (dollars in thousands):
Three Months Ended September 30,Percent ChangeNine Months Ended September 30,Percent Change
2020201920202019
Provision for (benefit from) income taxes$(5,981)$25,205 (124 %)$19,317 $60,826 (68 %)
Effective income tax rate15.7 %20.5 %18.8 %19.4 %
We recorded an income tax benefit for the three months ended September 30, 2020 as a result of a current period pre-tax loss, as compared to the comparable period in 2019 in which we reported pre-tax income. The decrease in provision for income taxes for the nine months ended September 30, 2020 as compared to the comparable period in 2019, was due the decrease in pre-tax income during the period. The effective tax rate for the three and nine months ended September 30, 2020 differed from the U.S. federal statutory rate of 21% primarily due to excess tax benefits related to the exercise of certain stock options and federal tax credits, offset by non-deductible executive compensation during the periods. The effective tax rate for the three and nine months ended September 30, 2019 respectively, as compared todiffered from the comparable periods in 2018,U.S. federal statutory rate of 21% primarily due to increases in marketing activities in support of the CABOMETYX launch in HCC and continued support of the product in an increasingly competitive RCC market. Corporate giving, consisting predominantly of donations to independent patient support foundations, decreased $2.1 million and $6.9 million for the three and nine months ended September 30, 2019, respectively, as comparedexcess tax benefits related to the comparable periods in 2018.
We expect our Selling, generalexercise of certain stock options and administrative expenses to increase modestly to support our overall organizational growth.
Other Income (Expense), Net
Other income (expense), net, was as follows (dollars in thousands): 
 Three Months Ended September 30, Percentage Change -
Q3 2019 v. Q3 2018		 Nine Months Ended September 30,  Percentage Change - Year to Date 2019 v. 2018
 2019 2018  2019 2018 
Interest income$7,191
 $3,507
 105% $20,253
 $8,099
 150%
Other, net(140) 271
 n/m
 688
 368
 87%
Total other income (expense), net$7,051
 $3,778
 87% $20,941
 $8,467
 147%
The increases in Interest income for the three and nine months ended September 30, 2019, as compared to the comparable periods in 2018, were the result of both an increase in our investment balances and an increase in the yield earned on those investments.
Provision for Income Taxes
The Provision for income taxes was as follows (dollars in thousands): 
 Three Months Ended September 30, Percentage Change -
Q3 2019 v. Q3 2018		 Nine Months Ended September 30,  Percentage Change - Year to Date 2019 v. 2018
 2019 2018  2019 2018 
Provision for income taxes$25,205
 $2,324
 985% $60,826
 $5,739
 960%
Our effective incomefederal tax rates were 20.5% and 19.4%credits during the three and nine months ended September 30, 2019, respectively, as compared to 1.8% and 1.7% for the comparable periods in 2018. The Provision for income taxes relating to our pre-tax income for the three and nine months ended September 30, 2018 was largely offset by a valuation allowance against our net operating loss carryforwards and other deferred tax assets. At December 31, 2018, we released substantially all of the remaining valuation allowance against our deferred tax assets, after we determined that it was more likely than not that these deferred tax assets would be realized.periods.
Liquidity and Capital Resources
As of September 30, 2019,2020, we had $1.2$1.5 billion in cash and investments.investments, compared to $1.4 billion as of December 31, 2019. We anticipate that the aggregate of our current cash and cash equivalents, short-term investments available for operations, product revenues and collaboration revenues will enable us to maintain our operations for a period of at least 12 months following the filing date of this report. The sufficiency of our cash resources depends on numerous assumptions, including assumptions related to product sales and operating expenses, as well as the other factors set forth in “Risk Factors” under the headings “Risks Related to our Capital Requirements, Accounting and Financial Results,” in Part II, Item 1A of this Quarterly Report on Form 10-Q. Our

assumptions may prove to be wrong or other factors may adversely affect our sources of cash and, as a result, we may not have the cash resources to fund our operations as currently planned, which would have a material adverse effect on our business.
We expect to continue to spend significant amounts to fund the continued development and commercialization of cabozantinib. In addition, we intend to continue to expand our product pipeline through our internal drug discovery efforts and the execution of strategic transactions that align with our oncology drug expertise. Financing these activities could materially impact our liquidity and capital resources and may require us to incur debt or raise additional funds through the issuance of equity. Furthermore, even ifthough we believe we have sufficient funds for our current and future operating plans, we may choose to incur debt or raise additional funds through the issuance of equity due to market conditions or strategic considerations. The COVID-19 pandemic has caused volatility in the U.S. and global financial markets and a downturn in the U.S. and global economy, which could adversely impact our rates of return for our invested cash resources, the availability and cost of credit, as well as our ability to raise additional funds in the capital markets. Among other things, our inability to access additional funds could in the future inhibit our ability to engage in larger-scale strategic transactions or investments.
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Sources and Uses of Cash
The following table summarizes our cashCash flow activities were as follows (in thousands):
Nine Months Ended September 30, Nine Months Ended September 30,
2019 2018 20202019
Net cash provided by operating activities$368,935
 $311,129
Net cash provided by operating activities$175,689 $368,935 
Net cash used in investing activities$(457,046) $(155,051)Net cash used in investing activities$(101,706)$(457,046)
Net cash provided by financing activities$15,553
 $10,835
Net cash (used in) provided by financing activitiesNet cash (used in) provided by financing activities$(6,438)$15,553 
Operating Activities
Our operating activities provided cash of $368.9 million for nine months ended September 30, 2019, compared to $311.1 million of for the comparable period in 2018.
Cash flows provided by operating activities represent the cash receipts and disbursements related to all of our activities other than investing and financing activities. Cash provided by operating activities is derived by adjusting our net income for: non-cash operating items such as deferred income taxes, share-basedstock-based compensation, charges, depreciation, and amortization, and 401(k) matching contributions made in common stock;non-cash lease expense and changes in operating assets and liabilities which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in our Condensed Consolidated Statements of Income.Income (Loss), the most significant of which may include the timing of milestones payments from our collaboration partners.
The most significant factors that contributed to the increasedecrease in cash provided by operating activities for the nine months ended September 30, 2019,2020, as compared to the comparable period in 2018, was $96.0 million in milestone payments received from Ipsen, Takeda and Daiichi Sankyo, including $60.0 million in payments for milestones that had previously been recognized and2019, were included in Trade receivables, net as of December 31, 2018, and an increase in cash received on sales of our products. Those increases were partially offset by an increase in cash paid for operating expenses, a $53.0 million decrease in milestone payments received, and other net changes in operating assets and liabilities described above.
Investing Activities
Cash used in investing activities for the nine months ended September 30, 2019, as compared to2020 consisted of investment purchases of $867.0 million and purchases of property, equipment and other of $16.1 million, less cash provided by the comparable period in 2018.
Investing Activities
Our investing activities used cashmaturities and sales of $457.0 million for the nine months ended September 30, 2019, as compared to $155.1 million during the comparable period in 2018.investments of $781.3 million.
Cash used in investing activities for the nine months ended September 30, 2019 was primarily due toconsisted of investment purchases of $887.7 million and Propertyproperty and equipment purchases of $5.6 million, less cash provided by the maturitymaturities and salesales of investments of $422.4 million and $13.1 million, respectively.$436.2 million.
Financing Activities
Cash used in investingfinancing activities for the nine months ended September 30, 2018 was primarily due2020 consisted of $26.1 million of withholding taxes paid related to investment purchasesnet share settlements of $368.3equity awards, partially offset by $19.7 million in proceeds from the issuance of common stock under our equity incentive and Property and equipment purchases of $30.4 million, less cash provided by the maturity and sale of investments of $231.2 million and $11.9 million, respectively.
Financing Activities
Cash provided by financing activities was $15.6 million for the nine months ended September 30, 2019, as compared to $10.8 million during the comparable period in 2018.

stock purchase plans.
Cash provided by financing activities for the nine months ended September 30, 2019 was primarily a resultconsisted of $19.0 million in proceeds from the issuance of common stock under our equity incentive and stock purchase plans, partially offset by $3.4 million of withholding taxes paid related to net share settlements.settlements of equity awards.
Cash provided by financing activities for the nine months ended September 30, 2018 was primarily a result of $14.0 million in proceeds from the issuance of common stock under our equity incentive plans, partially offset by $3.2 million of taxes paid related to net share settlements.
Contractual Obligations
Except as follows, thereThere were no material changes outside of the ordinary course of business in our contractual obligations as of September 30, 20192020 from those as of December 31, 2018.
In April 2019, we entered into an amendment to the existing Lease Agreement dated May 2, 2017, as amended (the Lease) relating to our corporate headquarters located in Alameda, California, and in August 2019 we entered into an agreement that will further amend the Lease upon consummation of a third-party transaction. See “Note 11. Leases”disclosed in our “Notes to Condensed Consolidated Financial Statements” contained in Part I, Item 1 of this QuarterlyAnnual Report on Form 10-Q10-K for more information about these amendments to the Lease.year ended December 31, 2019.
Off-Balance Sheet Arrangements
As of September 30, 2019,2020, we did not have any material off-balance-sheet arrangements, as defined by applicable SEC regulations.
Critical Accounting Policies and Estimates
The preparation of our Condensed Consolidated Financial Statements conforms to accounting principles generally accepted in the U.S. which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenues and expenses, and related disclosures. An accounting policy is considered to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at
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the time the estimate is made, and if different estimates that reasonably could have been used, or changes in the accounting estimates that are reasonably likely to occur periodically, could materially impact our Condensed Consolidated Financial Statements. On an ongoing basis, management evaluates its estimates including, but not limited to: those related to revenue recognition, including determining the nature and timing of satisfaction of performance obligations and determining the standalone selling price of performance obligations, and variable consideration such as rebates, chargebacks, sales returns and sales allowances and milestone paymentsas well as milestones included in collaboration arrangements; the amounts of revenues and expenses under our profit and loss sharing agreement; the recoverability of inventory; the amounts of operating lease right-of-use assets and lease liabilities; the amounts of deferred tax assets and liabilities including the related valuation allowance; the accrual for certain liabilities including accrued clinical trial liabilities; and valuations of equity awards used to determine stock-based compensation, including certain awards with vesting subject to market or performance conditions. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Our senior management has discussed the development, selection and disclosure of these estimates with the Audit Committee of our Board of Directors. Actual results could differ materially from those estimates.
We believe our critical accounting policies relating to revenue recognition, inventory, clinical trial accruals, stock option valuationstock-based compensation and income taxes reflect the more significant estimates and assumptions used in the preparation of our Condensed Consolidated Financial Statements.
There have been no significant changes in our critical accounting policies and estimates during the nine months ended September 30, 2019,2020, as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 20182019 filed with the SEC on February 22, 2019.25, 2020.
Recent Accounting Pronouncements
For a description of the expected impact of recent accounting pronouncements, see “Note 1. Organization and Summary of Significant Accounting Policies” in the “Notes to Condensed Consolidated Financial Statements” contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.

Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our market risks at as of September 30, 20192020 have not changed significantly from those described in Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2018.2019.
Item 4. Controls and Procedures.
Evaluation of disclosure controls and procedures. Based on the evaluation of our disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) of the Securities Exchange Act of 1934, as amended, or the Exchange Act) required by Rules 13a-15(b) or 15d-15(b) of the Exchange Act, our Chief Executive Officer and Chief Financial Officer have concluded that as of the end of the period covered by this report, our disclosure controls and procedures were effective at the reasonable assurance level.
Limitations on the effectiveness of controls. A control system, no matter how well conceivedwell-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within an organization have been detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our principal executive officer and principal financial officer have concluded, based on their evaluation as of the end of the period covered by this report, that our disclosure controls and procedures were effective to provide reasonable assurance that the objectives of our disclosure control system were met.
Changes in internal control over financial reporting. There were no changes in our internal control over financial reporting that occurred during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
In OctoberSeptember 2019, we received a notice letter regarding an ANDA submitted to the FDA by MSN, requesting approval to market a generic version of CABOMETYX tablets. TheMSN’s initial notice letter included a Paragraph IV certification with respect to our U.S. Patent Nos. 8,877,776, 9,724,342, 10,034,873 and 10,039,757, which are listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations,,also referred to as the Orange Book. MSN’s initial notice letter doesdid not provide a Paragraph IV certification against U.S. Patent No. 7,579,473, the CABOMETYX composition of matter patent, or U.S. Patent No. 7,579,473, which expires on August 14, 2026, and therefore this patent is not presently at issue.8,497,284, a method of use patent. On October 29, 2019,, we filed a complaint for patent infringement against MSN asserting U.S. Patent No. 8,877,776 in the United States District Court for the District of Delaware (the Delaware District Federal Court)for patent infringement against MSN asserting U.S. Patent No. 8,877,776 arising from MSN’s ANDA filing with the FDA. Based onOn November 20, 2019, MSN filed its response to the informationcomplaint, alleging that U.S. Patent No. 8,877,776 is invalid and not infringed. On May 5, 2020, we have received notice from MSN that it had amended its ANDA to date,assert additional Paragraph IV certifications. The ANDA now requests approval to market a generic version of CABOMETYX tablets prior to expiration of the two previously-unasserted CABOMETYX patents: U.S. Patent No. 7,579,473 and U.S. Patent No. 8,497,284. On May 11, 2020, we filed a complaint in the United States District Court for the District of Delaware for patent infringement against MSN asserting U.S. Patent No. 7,579,473 and U.S. Patent No. 8,497,284 arising from MSN’s amended ANDA filing with the FDA. On May 22, 2020, MSN filed its response to the complaint, alleging that each of U.S. Patent No. 7,579,473 and U.S. Patent No. 8,497,284 is invalid and not infringed. Neither of our complaint does not allegecomplaints alleges infringement of U.S. Patent Nos. 9,724,342, 10,034,873 and 10,039,757. WeIn our complaints, we are seeking, among other relief, an order that the effective date of any FDA approval of the ANDA would be a date no earlier than the expiration of all of U.S. Patent No. 7,579,473, U.S. Patent No. 8,497,284 and U.S. Patent No. 8,877,776, the latest of which expires on October 8, 2030, and equitable relief enjoining MSN from infringing this patent.these patents. These two lawsuits against MSN have been consolidated, and a bench trial has been scheduled for May 2022.
We may also from time to time become a party or subject to various other legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business. Some of these proceedings have involved, and may involve in the future, claims that are subject to substantial uncertainties and unascertainable damages.
Item 1A. Risk Factors
In addition to the factorsrisks discussed elsewhere in this report, and our other reports filed with the SEC, the following are important factors that could cause actual results or events to differ materially from those contained in any forward-looking statements made by us or on our behalf. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not currently known to us or that we deem immaterial also may impair our business operations. If any of the following risks or such other risks actually occur, our business could be harmed.
Risks Related to Our Business and Industry
Our ability to grow our company is critically dependent upon the commercial success of CABOMETYX in its approved indications and the further clinical development, regulatory approval and commercial success of cabozantinib in additional indications.
Our mission is to maximize the clinical and commercial potential of cabozantinib, and to position us for future growth through our discovery efforts and expansion of our development pipeline. We anticipate that for the foreseeable future, our ability to maintain or meaningfully increase unrestricted cash flow to fund our business operations and growth will depend upon the continued commercial success of CABOMETYX, both alone or in combination with other therapies, as a treatment for advanced RCCthe highly competitive indications for which it is approved, and previously treated HCC, and potentiallypossibly for other indications for which cabozantinib has been or is currently being evaluated in late-stagepotentially label-enabling clinical trials, if warranted by the data generated from suchthese trials. TheIn this regard, part of our strategy is to pursue additional indications for cabozantinib to increase the number of cancer patients who could benefit from this medicine. However, we cannot be certain that the clinical trials we and our collaboration partners are currently conducting, or may conduct in the future, will demonstrate adequate safety and efficacy in these additional indications to receive regulatory approval in the major commercial success ofmarkets where CABOMETYX is approved. Even if we and our collaboration partners receive the required regulatory approvals to market cabozantinib for additional indications, we and our collaboration partners may not be able to commercialize CABOMETYX effectively and successfully in its approved indications is subject to a variety of factors, most importantly, the drug’s perceived benefit/risk profile as compared to the benefit/risk profiles of other treatments available or in development for these conditions.additional indications. If revenue from CABOMETYX decreases or remains flat, or if we are unable to expand the labeled indications in major commercial markets where CABOMETYX is approved, or if we fail to achieve anticipated product royalties and collaboration milestones, whether as a result of the COVID-19 pandemic or otherwise, we may need to reduce our operating expenses, access other sources of
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cash or otherwise modify our business plans, which could have a material adverse impact on our business, financial condition and results of operations. Furthermore,
If the COVID-19 pandemic is further prolonged or becomes more severe, our business operations and corresponding financial results could suffer, which could have a material adverse impact on our financial condition and prospects for growth.
Our business could be materially and adversely impacted by the ongoing COVID-19 pandemic, a disease caused by a novel coronavirus, SARS-CoV-2, which has spread globally. To date, the COVID-19 pandemic has had a modest impact on our business operations, in particular on our clinical trial, drug discovery and commercial activities. For example, to varying degrees and at different rates across our clinical trials being conducted in regions impacted by COVID-19, we experienced declines in screening and enrollment activity, delays in new site activations, and restrictions on access to treatment sites that is necessary to monitor clinical study progress and initiation. However, as the COVID-19 pandemic continues to surge in various parts of the world, the impact on our clinical development operations could grow more severe. We anticipate that a further prolonged, or more severe, global public health crisis could limit our ability to identify and work with clinical investigators at clinical trial sites globally to enroll, initiate and maintain treatment per protocol of patients for our ongoing COSMIC-311, COSMIC-312, COSMIC-313, COSMIC-021, CONTACT-01, CONTACT-02 and CONTACT-03 clinical trials. Disruptions to medical and administrative operations at clinical trial sites and the implementation of crisis management initiatives have and may continue to reduce personnel and other resources necessary to conduct our clinical trials, which could delay our clinical trial plans or require certain trials to be temporarily suspended. Moreover, quarantines and travel restrictions have impeded and may continue to impede patient movement or interrupt healthcare services, which we anticipate over time, could also interfere with and potentially negatively impact clinical trial results. In addition, new and increased costs connected with our efforts to mitigate the adverse impacts resulting from the COVID-19 pandemic on our clinical trials could cause the expenses we incur in administering those clinical trials to increase considerably. Specifically, with respect to our clinical trials evaluating cabozantinib in combination with therapies that must be administered via professional intravenous infusion, such as COSMIC-312, COSMIC-313, COSMIC-021, CONTACT-01, CONTACT-02 and CONTACT-03, limited patient movement or interrupted healthcare services at medical institutions have delayed in some instances and may continue to delay or prevent on-site infusion of the therapies being evaluated in combination with cabozantinib. If a sizable portion of patients in our combination studies are unable or unwilling to receive all components of the combination therapy being tested in accordance with the applicable clinical trial protocol, it could cause those studies to be delayed, suspended or prevented from producing statistically significant results.Depending upon the duration and severity of the COVID-19 pandemic, we could also experience delays in the commencement of new clinical trials of cabozantinib, or our earlier-stage investigative product candidates. The COVID-19 pandemic could also impede internal clinical operations and delay our planning and preparation timelines for new clinical trials, as well as adversely affect our ability to obtain regulatory approval for clinical protocols and increase the operating expenses connected with these new clinical trials.
In addition, the COVID-19 pandemic caused us to suspend internal drug discovery work in our laboratories temporarily while we observed the shelter in place orders issued by the State of California and Alameda County. We also experienced some modest delays with respect to the portion of drug discovery work outsourced to third-party contractors in regions first impacted by COVID-19. While both internal drug discovery work in our laboratories and outsourced drug discovery activities have since partially resumed, we may be unable to maximize the potential of these programs due to reduced staffing and the imposition of increased safety protocols, and should the COVID-19 pandemic grow in severity, we may have to further scale back or suspend activities in the future. For example, as a consequenceresult of spikes or surges in infection, positivity or hospitalization rates, we may choose or be required to suspend work in our laboratories, which will once again impede our internal drug discovery efforts. Prior to the COVID-19 pandemic, we largely outsourced preclinical development work, as well as certain drug discovery activities, to third-party contractors, and although to date that work has continued without substantial delay or interference, the COVID-19 pandemic could impede these third parties from providing timely deliverables to us in the future. As a result, should the COVID-19 pandemic be further prolonged or grow in severity, we may ultimately be unable to achieve our drug discovery and preclinical development objectives within the previously disclosed timelines, which could have a material adverse impact on our prospects for growth.
While we believe that our commercial business has, to date, only experienced a modest impact related to the COVID-19 pandemic, it remains possible that over a longer period, changes to our standard sales and marketing practices, including the shift from in-person to primarily telephonic and virtual interactions with healthcare professionals, could negatively impact the flow of important information regarding our medicines, which along with obstacles to patient access to healthcare professionals, could diminish sales of our collaboration agreementsmarketed products.
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Although as of the date of this Quarterly Report, we continue to maintain substantial safety stock inventories for our drug substance and drug products and have not experienced production delays or seen significant impairment to our supply chain as a result of the COVID-19 pandemic, our third-party contract manufacturers and suppliers could experience operational delays due to facility closures and other hardships as a result of the COVID-19 pandemic, which could impact our supply chain by potentially causing delays to or disruptions in the supply of our commercial or clinical products or product candidates. These delays or disruptions could be further exacerbated if the COVID-19 pandemic begins to impact essential distribution systems, which could substantially increase delivery times and costs, or otherwise adversely affect our ability to provide our products to customers and clinical trial sites and generate product revenues.
As of the date of this Quarterly Report, we have taken temporary precautions to help mitigate the risk of transmission of the virus, including: reducing the number of our employees working on-site at our Alameda headquarters under enhanced safety and social distancing protocols; suspending all non-essential business travel for our employees; and limiting the circumstances under which our field employees may engage in in-person promotional activities with healthcare professionals. Over a longer period, all of these measures could negatively affect our business operations and prospects in both foreseeable and unforeseeable ways. For instance, requiring employees to work remotely while we adhered to shelter in place orders limited our internal drug discovery activities, and although we have begun to allow our employees to return to our Alameda headquarters under enhanced safety and social distancing protocols, if we are forced to, or determine that we should, resume shelter in place restrictions for an extended period of time, this could eventually cause delays and otherwise negatively impact the effectiveness of these programs and impede our ability to execute on our long-term business plans. Further, extended periods of remote work could impede the focused attention of management or reduce the productivity of teams that would otherwise be working closely together. The COVID-19 pandemic has also caused volatility in the U.S. and global financial markets and a downturn in the U.S. and global economy, which could adversely impact our rates of return for our invested cash resources, the availability and cost of credit, as well as our ability to raise additional funds in the capital markets. Among other things, our inability to access additional funds could in the future inhibit our ability to engage in larger scale strategic transactions or investments.
While we expect the COVID-19 pandemic to continue to have varying degrees of adverse impact on our business operations and, potentially in the future, our financial results, the extent of such adverse impact arising from the COVID-19 pandemic to our business and our financial results, as well as to the value of and market for our common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These effects could materially and adversely affect our business, financial condition, results of operations and growth prospects, as further explained in the risks and uncertainties described elsewhere in this ‘‘Risk Factors’’ section. In addition, to the extent the ongoing COVID-19 pandemic adversely impacts our business and financial results, it may also have the effect of exacerbating many of these other risks and uncertainties inherent to our business.
We rely on Ipsen and Takeda wefor the commercial success of CABOMETYX in its approved indications outside of the U.S., and are unable to control the amount or timing of resources expended by these collaboration partners in the commercialization of CABOMETYX in its approved indications outside of the U.S.
We rely heavily upon theirthe regulatory, commercial, medical affairs, market access and other expertise and resources of our collaboration partners, Ipsen and Takeda, for commercialization of CABOMETYX in their respective territories outside of the U.S. We cannot control the amount and timing of resources that our collaboratorscollaboration partners dedicate to the commercialization of CABOMETYX, or to its marketing and distribution, and our ability to generate revenues from the commercialization of CABOMETYX by our collaboratorscollaboration partners depends on their ability to obtain and maintain regulatory approvals for, achieve market acceptance of, and to otherwise effectively market, CABOMETYX in its approved indications in their respective territories. Further, the operations of our collaboration partners, and ultimately their foreign sales of CABOMETYX, by our collaborators could be adversely affected by the degree and effectiveness of their respective corporate responses to the COVID-19 pandemic, as well as by the imposition of governmental price or other controls, political and economic instability, trade restrictions or barriers and changes in tariffs, including as a result of the pending withdrawal of the United Kingdom (UK) from the EU (commonly referred to as “Brexit”) and the uncertainty surrounding the date and the terms of the withdrawal, escalating global trade and political tensions, or otherwise. If our collaboratorscollaboration partners are unable to, or do notunwilling to invest the resources necessary to successfully commercialize CABOMETYX successfully in the EU,

Japan and other international territories where it has been approved, this could reduce the amount of revenue we are due to receive under these collaboration agreements, thus resulting in harm to our business and operations.
CABOMETYX has been approved for the treatment
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Table of advanced RCC and previously treated HCC in the U.S., the EU and other territories. With these approvals, our ability to grow our company remains contingent upon, among other things, further success in the clinical development, regulatory approval and market acceptance of cabozantinib, the active pharmaceutical ingredient in CABOMETYX, in potential additional indications. We cannot be certain that the clinical trials we and our collaboration partners are currently conducting, or may conduct in the future, will demonstrate adequate safety and efficacy in these additional indications to receive regulatory approval. Even if we and our partners receive the required regulatory approvals to market cabozantinib for any additional indications or in additional territories, we and our partners may not be able to effectively commercialize CABOMETYX in these additional indications or territories.Contents
Our ability to grow revenues from sales of CABOMETYX will depend upon the degree of market acceptance among physicians, patients, health carehealthcare payers, and the medical community.
Our ability to increase or maintain revenues from sales of CABOMETYX for its approved indications is, and if approved for additional indications will be, highly dependent upon the extent of market acceptance of CABOMETYX among physicians, patients, government health carehealthcare payers such as Medicare and Medicaid, commercial health carehealthcare plans and the medical community. Market acceptance for CABOMETYX could depend on numerous factors, including the effectiveness and safety profile, or the perceived effectiveness and safety profile, of CABOMETYX compared to competing products, the strength of CABOMETYX sales and marketing efforts, the impact to healthcare systems and our ability to successfully communicate product information to healthcare professionals resulting from the COVID-19 pandemic, and changes in pricing and reimbursement for CABOMETYX. If CABOMETYX does not continue to be prescribed broadly for the treatment of its approved RCC and HCC indications, we may not be able to growour product revenues. The degree of market acceptance of CABOMETYX will depend upon a number of factors, including:
the effectiveness,revenues could flatten or perceived effectiveness, of CABOMETYX in comparison to competing products;
the safety of CABOMETYX, including the existence of serious side effects of CABOMETYX and their severity in comparison to those of competing products;
CABOMETYX’s relative convenience and ease of administration;
potential unexpected results connected with analysis of data from future or ongoing clinical trials of cabozantinib;
the timing of CABOMETYX label expansions for additional indications, if any, relative to competitive treatments;
the price of CABOMETYX relative to competitive therapies;
price increases taken by us and the impact on the net sales price of CABOMETYX as a result of any new laws, regulations or other government initiatives affecting pharmaceutical pricing;
the strength of CABOMETYX sales efforts, marketing, market access and product distribution support;
our ability to obtain and maintain coverage and reimbursement for CABOMETYX from commercial and government payers; and
our ability to enforce our intellectual property rights with respect to CABOMETYX, including against potential generic competition.
Further, in the event that any of these or other factors cause market acceptance of CABOMETYX to decrease, this could negatively impact our revenues, which could have a material adverse impact on our business, financial condition and results of operations.
Our competitors may develop products and technologies that impair the relative value of our marketed products and any future product candidates.
The pharmaceutical,biotechnology, biopharmaceutical and biotechnologypharmaceutical industries are competitive highly diversified and are characterized by rapidconstant technological change and diverse offerings of products, particularly in the area of novel oncology therapies. Many of the organizations competing with usour competitors have greater capital resources, larger research and development staff and facilities, more experience in obtainingdeeper regulatory approvalsexpertise and more extensive product manufacturing and commercial capabilities than we do, which may allowafford them to have a competitive advantage. Further, our competitors may be more effective at using their technologies to developin-licensing and developing new commercial products. As a result, our competitors may be able to more easily develop products that wouldcould render our products, and those of our collaborators,collaboration partners, obsolete and noncompetitive. There may also be drug candidates that we are not aware of at an earlier stage of development that may compete with our marketed products and product candidates. We face, and will continue to face, intense competition from biotechnology, biopharmaceutical and pharmaceutical companies, as well as academic research institutions, clinical reference laboratories and government

agencies that are pursuing scientific and clinical research activities similar to ours. Delays in the development of cabozantinib for the treatment of additional tumor types, for example, could allow our competitors to bring products to market before us.
Furthermore, the specific indications for which CABOMETYX is currently or may be approved, based on the results from clinical trials currently evaluating cabozantinib, are highly competitive. Several novel therapies and combinations of therapies have been approved, are in advanced stages of clinical development or are under expedited regulatory review in these indications, and these other therapies are currently competing or are expected to compete with CABOMETYX. We believe our future success will depend upon our ability to maintain a competitive position with respect to technological advances and the shifting landscape of therapeutic strategy following the advent of ICIs. While we have adapted our cabozantinib development strategy to address the factuse of therapies that the approach to treating cancer withcombine ICIs in combination with other therapeutictargeted agents has become highly prevalent in indications for which our products areCABOMETYX is approved, we cannot ensure that our ongoing or planned clinical trials will show efficacy in comparison to competing products or product combinations. Moreover, the complexities of such a development strategy have required and mayare likely to continue to require collaboration with some of our competitors.
We also may face competition from manufacturers of generic versions of our marketed products, and both Congress and the FDA are seeking to promote generic competition, including through proposals focused on drug patenting, importation and provision of drug to generic applicants for testing. Such generic competition often results in very significant decreases in the overall sales or prices at which branded products can be sold. Please also see the risk factor entitled, “If competitors use litigation and regulatory means to obtain approval for generic versions of our marketed products, our business will suffer.”
If we are unable to maintain or scale adequateincrease our internal sales, marketing, market access and product distribution capabilities for our products, or enter into or maintain agreements with third parties to do so, we may be unable to maximize product revenues, which could have a material adverse impact on our business, financial condition and results of operations.
Maintaining our sales, marketing, market access and product distribution capabilities requires significant resources, and there are numerous risks involved with managingmaintaining and continuously improving such a commercial organization, including our potential inability to successfully recruit, train, retain and incentivize adequate numbers of qualified and effective sales and marketing personnel. We are competing for talent with numerous commercial- and pre-commercial-stageprecommercial-stage, oncology-focused biotechnology companies seeking to build out and maintain their commercial organizations, as well as other large pharmaceutical and biotechnology organizations that have extensive, well-funded and more experienced sales and marketing operations, and we may be unable to maintain or adequately scale our commercial organization as a result of such competition. If we cannot maintain effective sales, marketing, market access and product distribution capabilities, we may be unable to maximize the commercial potential of CABOMETYX and COMETRIQ in their approved indications. Also, to the extent that the commercial opportunities for CABOMETYX grow over time, we may not properly judgescale the requisite size and experience of our current commercialization teams or the level of distribution necessary to market and sell CABOMETYX successfully in multiplean expanded number of indications. If we are unable to maintain or scale our organizationcommercial function appropriately, or should we have to maintain primarily telephonic and virtual interactions in lieu of in-person meetings with healthcare professionals for an extended period of time as a result of the COVID-19 pandemic, we may not be able to maximize product revenues, which could have a material adverse impact on our business, financial condition and results of operations.
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If we are unable to enter into or maintain agreements with third parties to store, distribute and commercialize our products, we may be unable to maximize product revenues, which could have a material adverse impact on our business, financial condition and results of operations.
Our ability to successfully commercialize our products successfully will depend, in part, on the extent to which we are able to adequately distribute theadequacy of our distribution of those products to eligible patients. We currently rely on third-party providers for storage and distribution of our commercial supplies of both CABOMETYX and COMETRIQ in the U.S. Furthermore, we rely on our collaboration partners for ongoing and further commercialization and distribution of CABOMETYX and COMETRIQ in their respective territories outside of the U.S., as well as for access and distribution activities for the approved products under named patient use programs (or similar programs) with the effect of introducing earlier patient access to CABOMETYX and COMETRIQ..
Our current and anticipated future dependence upon the activities, support, and legal and regulatory compliance of third parties may adversely affect our ability to supply CABOMETYX and COMETRIQ to the marketplace on a timely and competitive basis. TheseThe services provided by these third parties may not provide services inbe effective or timely, which risks may be increased as a result of the time requiredCOVID-19 pandemic. In such cases, we may be unable to meet our commercial timelines and objectives or to meet regulatory requirements. We may not be able to maintain, improve or renew our arrangements with these third parties or enter into new, alternative arrangements with other service providers, on acceptable terms or at all. Third parties could terminate or decline to renew our arrangements based on their own business priorities. If we are unable to contract successfully for theseeffective third-party services related to the distribution of CABOMETYX and COMETRIQ on acceptable terms, our commercialization efforts and those of our collaboration partners may be delayed or otherwise adversely affected, which could have a material adverse impact on our business, financial condition and results of operations.

If we are unable to obtain or maintain coverage and reimbursement for our products from third-party payers, our business will suffer.
Our ability to commercialize our products successfully is highly dependent on the extent to which health insurance coverage and reimbursement is, and will be, available from third-party payers, including governmental payers, such as Medicare and Medicaid, and private health insurers. Third-party payers continue to scrutinize and manage access to pharmaceutical products and services and may limit reimbursement for newly approved products and indications. Patients are generally not capable of paying for CABOMETYX or COMETRIQ themselves and rely on third-party payers to pay for, or subsidize, the costs of their medications, among other medical costs. Accordingly, market acceptance of CABOMETYX and COMETRIQ is dependent on the extent to which coverage and reimbursement is available from third-party payers. If third-party payers do not provide coverage or reimbursement for CABOMETYX or COMETRIQ, our revenues and results of operations will suffer. In addition, even if third-party payers provide some coverage or reimbursement for CABOMETYX or COMETRIQ, the availability of such coverage or reimbursement for prescription drugs under private health insurance and managed care plans, which often varies based on the type of contract or plan purchased, may not be sufficient for patients to afford CABOMETYX or COMETRIQ. Third-party payers continue to scrutinize and manage access to pharmaceutical products and services and press manufacturers for discounts and rebates. Payers may also limit reimbursement for newly approved products and indications.
We are subject to certain healthcare laws, regulations and enforcement; our failure to comply with those laws could have a material adverse impact on our business, financial condition and results of operations.
We are subject to certainfederal and state healthcare laws and regulations, which laws and enforcementregulations are enforced by the federal government and the states in which we conduct our business. Should our compliance controls prove ineffective at preventing or mitigating the risk and impact of improper business conduct or inaccurate reporting, we could be subject to enforcement of the laws that may affect our ability to operate include,following, including, without limitation:
•the federal Anti-Kickback Statute, (AKS), which governs our business activities, including our marketing practices, medical educational programs, pricing policies, and relationships with healthcare providers or other entities. The AKS has been broadly interpreted to apply to manufacturer arrangements with prescribers, purchasers and formulary managers, among others. Among other things, this statute prohibits persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either entities;
•the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs. Remuneration is not defined in the AKS and has been broadly interpreted to include anything of value, including for example, gifts, discounts, coupons, the furnishing of supplies or equipment, credit arrangements, payments of cash, waivers of payments, ownership interests, value-added services to customers, and providing anything at less than its fair market value;
the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations, which prohibit, among other things, the introduction or delivery for introduction into interstate commerce of any drug that is adulterated or misbranded;
•federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
•federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
•the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information on covered entities and business associates that access such information on behalf of a covered entity;
•state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and securitylaws;
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•the Open Payments program of the Patient Protection and Affordable Care Act, as amended by the Healthcare and Education Reconciliation Act (PPACA), which was created under the Physician Payments Sunshine Act and its implementing regulations and requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to report annually to the government information related to certain payments and other

transfers of value to physicians (as defined by such law) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members;
•state and local laws and regulations that require drug manufacturers to file reports relating to marketing activities, payments and other remuneration and items of value provided to healthcare professionals and entities, as well as state and local laws requiring the registration of pharmaceutical sales representatives; and
•state and federal pharmaceutical price and price reporting laws and regulations that require us to provide notice of price increases or the introduction of new high-cost products, and/or file complex ancillary reports concerning prices and pricing and discount practices.
In addition, we may be subject to the Foreign Corrupt Practices Act, a U.S. law which regulates certain financial relationships with foreign government officials (which could include, for example, certain medical professionals)professionals employed by national healthcare programs) and its foreign equivalents;
equivalents, as well as federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and
state pharmaceutical price and price reporting laws and regulations that require us to provide notice of price increases and/or file complex ancillary reports concerning prices and pricing and discount practices. Laws and regulations in this area, and associated compliance obligations, may increase general and administrative costs, cause volatility in our revenues due to speculative buying practices by purchasers, or diminish our revenues as a result of the imposition of caps on pricing and price increases.laws.
These federal and state healthcare fraud and abuse laws FDA rules and regulations as well as false claims laws, including the civil False Claims Act, govern certaindrug marketing practices, including off-label promotion. If our operations are found, or even alleged, to be in violation of any of the laws described above or any other governmental regulations that apply to us, we, or our officers or employees, may be subject to significant penalties, including administrative civil and criminal penalties, damages, fines, regulatory penalties, the curtailment or restructuring of our operations, exclusion from participation in Medicare, Medicaid and other federal and state healthcare programs, imprisonment, reputational harm, additional reporting requirements and oversight, if we become subject to a corporate integrity agreement or similar agreement, any of which would adversely affect our ability to sell our products and operate our business and also adversely affect our financial results. Of particular concern are suits filed under the civil False Claims Act, known as “qui tam” actions, which can be brought by any individual on behalf of the government. TheseUnder the False Claims Act, these individuals, commonly known as relators or “whistleblowers,” may potentially then share in amounts paid by the entity to the government in fines or settlement. The filing of qui tam actions has caused a number of pharmaceutical, medical device and other healthcare companies to have to defend civil False Claims Act actions. When an entity is determined to have violated the civil False Claims Act, or settles a lawsuit brought pursuant to the False Claims Act to avoid further prosecution, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may beaction is brought against us, our business may be impaired.impaired, even if we are ultimately successful in our defense.
Current healthcare laws and regulations in the U.S. and future legislative or regulatory reforms to the U.S. healthcare system may affect our ability to commercialize our marketed products profitably.
TheFederal and state governments in the U.S. and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the U.S. healthcare system in ways that could affect our ability to continue to commercialize CABOMETYX and COMETRIQ profitably. AmongSimilarly, among policy makers and payers, in the U.S. and elsewhere, there is significant interest in promoting such changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/orand expanding patient access. InThe life sciences industry and specifically the U.S.,market for the pharmaceutical industrysale, insurance coverage and distribution of pharmaceuticals has been a particular focus of these efforts and has beenwould likely be significantly affected by any major legislative or regulatory initiatives.
Specifically, we mayWe face related uncertainties as a result of executive, legislative and administrative efforts to repeal, substantially modify or invalidate some or all of the provisions of the PPACA. OnNotably, in December 14, 2018, a Texas U.S. District Court Judge ruled that the PPACA is unconstitutional in its entirety because the penalty enforcing the “individual mandate” was repealed by Congress as part of the Tax Cuts and Jobs Act of 2017. The decision has been appealed toThen, in December 2019, the U.S. Court of Appeals for the Fifth5th Circuit upheld this District Court ruling that the individual mandate was unconstitutional and remanded the Trump administration filed its brief in supportcase back to the District Court to determine whether the remaining provisions of the decisionPPACA are invalid as well. While the U.S. Supreme Court has agreed to review an appeal of the Texas District Court judge on May 1, 2019. While the Texas District Court Judge, as well as the Trump Administration and the Centers for Medicare and Medicaid Services, have stated that the ruling will have no immediate effect pending the appeal,5th Circuit’s decision in November 2020, it is unclear how this decision, future decisions, subsequent appeals and other efforts to repeal and replace the PPACA will impact the PPACA. ThereAdditionally, the 2020 federal spending package permanently repealed, effective January 1, 2020, the PPACA-mandated “Cadillac” tax on high-cost employer-sponsored health coverage and medical device taxes, and, effective January 1, 2021, also eliminates the health insurer tax. Although such efforts have not significantly impacted our business to date, there is no assurance that the PPACA, as currently enactedrepeal, modification or as amendedinvalidation of some or all of the provisions of the PPACA in the future, will not have a material adverse impact on our business, financial
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condition and results of operations, and we cannot predict how future federal or state legislative or administrative changes relating to healthcare reform will affect our business. The Trump Administration has also indicated an intention to regulate prescription drug pricing, and recent Congressional hearings and proposed legislation have brought increased public attention to the costs of prescription drugs. These actions and the uncertainty about the future of the

PPACA, healthcare laws or future legislation on drug pricing at the federal level may put downward pressure on pharmaceutical pricing and increase our regulatory burdens and operating costs.
ThereIn addition, there are pending federal and state Congressionalstate-level legislative proposals that would significantly expand government-provided health insurance coverage, ranging from establishing a single-payer, national health insurance system to more limited buy-in“buy-in” options that would be available to individuals above a certain age. Federal legislation has also been proposed that would authorize states to permit individuals to “buy in” to their state Medicaid programs. Several states are also considering or have already enacted legislation that would allow individuals to “buy in” to the state’s Medicaid program or that would otherwise establish a “publicexisting public health option,”insurance programs, each of which could have a significant impact on the healthcare industry. At this stage,It is also possible that additional governmental actions will be taken to address the ongoing COVID-19 pandemic, and that such actions would have a significant impact on these public health insurance programs. While we cannot predict how future legislation (or enacted legislation that has yet to be implemented) will affect our business. However,business, such proposals could have the potential to impact access to and sales of our products.
In August 2017, President Trump signed the FDA Reauthorization Act of 2017, which reauthorized the FDA user fee programs for prescription drugs, generic drugs, medical devices, and biosimilars, under which applicants for such products partially pay for the FDA’s pre-market review of their product candidates and pay other specified fees, including yearly program fees in the case of most New Drug Application (NDA)-approved prescription drugs. The legislation includes, inter alia, measures to expedite the development and approval of generic products, where generic competition is lacking even in the absence of exclusivities or listed patents. The FDA has also released a Drug Competition Action Plan, which proposes actions to broaden access to generic drugs and lower consumers’ health care costs by, among other things, improving the efficiency of the generic drug approval process and supporting the development of complex generic drugs, and the FDA has taken steps to implement this plan. Moreover, both Congress and the FDA are considering various legislative and regulatory proposals focused on drug competition, including legislation focused on drug patenting, importation, and provision of drug to generic applicants for testing. While we cannot currently predict the specific outcome or impact on our business of such regulatory actions or legislation, they do have the potential to facilitate the development and future approval of generic versions of our products, or otherwise limit or reduce the term for our market exclusivity, which could result in significant decreases in the revenue derived from sales of our marketed products and thereby materially harm our business and financial condition.
As a result of the overall trend towards managed healthcare in the U.S.,these developments and trends, third-party payers are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs. Insurers also continue to pursue means of contracting for pharmaceutical “value” or “outcomes.” These entities could refuse, limit or limitcondition coverage for CABOMETYX and COMETRIQ,our products, such as by using tiered reimbursement or pressing for new forms of value-based contracting, including, for example, the movement by insurers towards “value-based” contracting, any of which wouldcould adversely affect demandproduct sales. Furthermore, the expansion of the 340B Drug Discount Program has increased the number of purchasers who claim eligibility for CABOMETYX and COMETRIQ. They may also refuse to provide coverage for uses of CABOMETYX and COMETRIQ for medical indications other than those for which the FDA has granted market approval. As a result, significant uncertainty exists as to whether and how much third-party payers will cover newly approveddiscounts on branded drugs, which in turn will put pressure on the pricing of drugs.including our marketed products. Due to the current volatility in the current economicregulatory and market dynamics, we are unable to predict the impact of any unforeseen or unknown legislative, regulatory, third-party payer or policy actions, which may includeincluding potential cost containment and healthcare reform measures. These policy actionsIf enacted, any such measures could have a material adverse impact on our business, financial condition and results of operations.
Pricing for and patient access to, pharmaceutical products in the U.S. has come under increasing attention and scrutiny by federal and state governments, legislative bodies and enforcement agencies. These activities may result in actions that have the effect of reducing our revenue or harming our business or reputation.
There have been several recent U.S. Congressional inquiries, hearings and proposed and enacted federal legislation and rules, as well as Executive Orders, designed to, among other things: reduce or limit the prices of drugs and make them more accessible and affordable for patients;patients (including, for example, by tying the prices that Medicare reimburses for physician-administered drugs to the prices of drugs in other countries); reform the structure and financing of public health insuranceMedicare Part D pharmaceutical benefits, most importantly, Medicare and Medicaid, including through increasing manufacturer contributions to offset Medicare beneficiary costs; facilitate value-based arrangements between manufacturers and payers; bring more transparency to drug pricing rationale and methodologies; and expedite the development and approval of genericrevise rebate payments for prescription drugs and biosimilars. It is entirely unclear what, if any, legislative, regulatory and/or administrative measures that impact the biopharmaceutical industry will eventually be implemented; however, both Congress,under Medicaid and the Trump Administration have indicated that they will continuemethodologies to seek reforms in this area.calculate average manufacturer price and best price; and facilitate the importation of certain lower-cost drugs from other countries. While we cannot know the final form of any such reforms,legislative, regulatory and/or administrative measures, some of the pending legislative proposals or executive rulemaking, such as those incorporating International Pricing Index or Most-Favored-Nation models, if enacted, would likely have a significant and far-reaching impact on the biopharmaceutical industry and therefore also likely have a material adverse impact on our business, financial condition and results of operations.

In connection with its evaluation of proposals concerning the pricing of, and access to, pharmaceutical products, many companies in our industry have received governmental requests for documents and information relating to drug pricing and patient support programs. Requests take various forms, including through a Congressional inquiry (e.g., from the U.S. Senate Finance Committee) or a subpoena from the U.S. Department of Justice. We could receive a similar request, which would require us to incur significant expense and result in distraction for our management team.divert the attention of management. Additionally, to the extent there are findings, or even allegations, of improper conduct on the part of the company, these findings could further harm our business, reputation and/or prospects. It is possible that these inquiries could result in: negative publicity or other negative actions that could harm our reputation; changes in our product pricing and distribution strategies; reduced demand for our approved products; and/or reduced reimbursement of our approved products, including by federal health care programs such as Medicare and Medicaid as well as state health care programs.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access andpricing or reimbursement at the state government level, limitations on discounts to patients, marketing cost disclosure and transparency measures, and, in some cases, policies to encourage importation from other countries (subject to federal approval) and bulk purchasing, including the National Medicaid Pooling Initiative. With respect to drug pricing transparency, forFor example, in October 2017, Jerry Brown, the Governor of California at the time, signedadopted SB-17, which requires, among other provisions, pharmaceutical manufacturers to provide advance notice of price increases above a defined threshold to certain purchasers and related reports to the government. SB-17 is currently subjectSuch obligations to challenge, but in the meantime, manufacturers must comply with its requirements. It is possible that laws such as SB-17 will encourage federal and state healthcare programs to reduce the amount of reimbursements they provide for prescription drugs, and any reduction in reimbursement from these government healthcare programs may result in a similar reduction in payments from private payers. We also believe that pricing transparency requirements, such as the requirement for us, in certain circumstances, to provide lengthy notices of price increases to purchasers may influence customer ordering patterns for CABOMETYX and COMETRIQ, and that this,which in turn may increase the volatility of our revenues as a reflection of changes in inventory volumes. Furthermore, adoption of these drug pricing transparency regulations, and our associated compliance obligations, may increase general and administrative costs and/or diminish our revenues as a result of the imposition of caps on pricing and price increases. Therefore, the implementation of these cost-containment measures or other healthcare reforms may result in fluctuations in our results of operations and limit our ability to generate product revenue or commercialize our currentproducts.
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Lengthy regulatory pricing and reimbursement procedures and cost control initiatives imposed by governments outside the U.S. could delay the marketing of and/or result in downward pressure on the price of our approved products and/or those for which we may receive regulatory approvalresulting in a decrease in revenue.
Outside the future.
Further, in some foreign countries,U.S., particularly in the EU, the pricing and reimbursement of prescription pharmaceuticals is generally subject to governmental control under the respective national health system.control. In these EU countries, pricing and reimbursement negotiations with governmental authorities or payers can take six to 12 months or longer after the initial marketing authorization is granted for a product, or after the marketing authorization for a new indication is granted. This can substantially delay broad availability of the product. To obtain reimbursement and/or pricing approval in some countries, our collaboration partner Ipsen may also be required to conduct a study that seeks to establish the cost effectiveness of CABOMETYX compared with other available established therapies. The conduct of such a study could also result in delays in the commercialization of CABOMETYX. Additionally, cost-control initiatives, increasingly based on affordability, could decrease the price we and our collaboration partner, Ipsen might establish for CABOMETYX, which would result in lower license revenues to us.
A significant and prolonged economic downturn, whether globally or just within the U.S., could have a substantial impact on our revenues and financial condition.
Our revenues are substantially dependent on the net pricing that we ultimately realize in payment for our marketed products, and commercial third-party payers do not receive the same degree of discounts and allowances that we provide to government payers. In the event of a significant and prolonged economic downturn, the number of patients enrolled in commercial health insurance programs is likely to decrease, particularly in the U.S. where workforce reductions could cause widespread loss of the private health insurance coverage typically provided by employers, and a commensurate shift of eligible individuals to government insurance programs or to the circumstance of lacking health insurance coverage altogether. The effects of the COVID-19 pandemic, among other catalysts, have already caused a downturn in the U.S. and global economy and significant levels of unemployment, and the duration and severity of this economic downturn are not yet known. Depending on the duration and severity of the COVID-19 pandemic, as well as other factors, we could experience a substantial decrease in revenues as a result of the increase in gross-to-net discounting applied to the price of our products due to a substantial shift from private health insurance coverage to government insurance coverage, and also a significant increase in demand for our patient assistance and/or free drug program, all or any of which would adversely affect our product revenues.
Enhanced governmental and private scrutiny over, or investigations or litigation involving, pharmaceutical manufacturer donations to patient assistance programs offered by charitable foundations may require us to modify our programs and could negatively impact our business practices, harm our reputation, divert the attention of management and increase our expenses.
To help patients afford our products, we have a patient assistance program and also occasionally make donations to independent charitable foundations that help financially needy patients. These types of programs designed to assist patients with affording pharmaceuticals have become the subject of scrutiny. In recent years, some pharmaceutical manufacturers were named in class action lawsuits challenging the legality of their patient assistance programs and support of independent charitable patient support foundations under a variety of federal and state laws. Notably, certain of these manufacturers have entered into significant monetary or other settlements with the federal government, including entering into Corporate Integrity Agreements, to resolve allegations that they paid kickbacks through independent charitable foundations. Our patient assistance program and support of independent charitable foundations could become the target of similar litigation. Though not affecting CABOMETYX, at least one insurer also has directed its network pharmacies to no longer accept manufacturer co-payment coupons for certain specialty drugs the insurer identified. In addition, certain state and federal enforcement authorities and members of Congress have initiated inquiries about co-pay assistance programs. Some state legislatures have also been considering proposals that would restrict or ban co-pay coupons.

In addition, there has been regulatory review, Congressional interest and enhanced government scrutiny of donations by pharmaceutical companies to patient assistance programs operated by charitable foundations.scrutiny. The U.S. Department of Health and Human Services Office of Inspector General has established specific guidelines permitting pharmaceutical manufacturers to make donations to charitable organizations whothat provide co-pay assistance to Medicare patients, provided that manufacturers meet certain specified compliance requirements. In the event we make such organizationsdonations but are bona fide charities, are entirely independent of and not controlled by the manufacturer, provide aid to applicants on a first-come basis according to consistent financial criteria, and do not link aid to use of a donor’s product. If we are deemedfound not to have complied with these guidelines and other laws or regulations inrespecting the operation of these programs, we could be subject to significant damages, fines, penalties or other criminal, civil or administrative sanctions or enforcement actions. Further, numerous organizations,We also rely on a third-party hub provider and exercise oversight to monitor patient assistance program activities. Hub providers are generally hired by manufacturers to assist patients with insurance coverage, financial assistance and treatment support after the patients receive a prescription from their healthcare professional. For manufacturers of specialty pharmaceuticals (including our marketed products), the ability to have a single point of contact for their therapies helps ensure efficient medication distribution to patients. Accordingly, our hub activities are also subject to scrutiny and may create risk for us if not conducted appropriately. A variety of entities, including independent charitable foundations and pharmaceutical manufacturers, but not including our company, have received subpoenas from the U.S. Department of Justice and other enforcement authorities seeking information related to their patient assistance programs and support, and, as noted above, certain of these organizations have entered into,support. Should we receive a subpoena or have otherwise agreed to, significant civil settlements with applicable enforcement authorities. Additionally, in March 2019, the Senate Finance Committee launched an inquiry into alleged ties between pharmaceutical manufacturers and patient assistance charitable foundations. It is possible that future legislation may propose establishing requirements that affect pharmaceutical manufacturers and such charitable organizations. We cannot ensure that our compliance controls, policies and procedures will be sufficient to protect against acts of our employees, business partners or vendors that may violate the laws or regulations of the jurisdictions in which we operate. Regardlessother process, regardless of whether we are ultimately found to have complied with the law, aregulations governing patient assistance programs, this type of government investigation could negatively impact our business practices, harm our reputation, divert the attention of management and increase our expenses.
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We are subject to laws and government regulations relating to privacy, and data protection that have required us to modify certain of our policies and procedures with respect to the collection and processing of personal data, and future laws and regulations may cause us to incur additional expenses or otherwise limit our ability to collect and process personal data. Failure to maintain compliance with these regulations could jeopardize certain business transactions and create additional liabilities for us.
The legislative and regulatory landscape for privacy and data protection continues to evolve globally and in the U.S. continues to evolve, and there has been an increasing focus on privacy and data protection, including state security breach notification laws, state health information privacy laws and federal and state consumer protection laws governing the collection, use and disclosure of personal information. For example, in June 2018, Jerry Brown, the Governor of California at the time, signed into law the California Consumer Privacy Act of 2018 (CCPA), which was subsequently amended, and which goes went into operation on January 1, 2020 and will giveaffords California residents expanded privacy rights and protections, and will provide forincluding civil penalties for violations and statutory damages under a private right of action for data security breaches. There are similarSimilar legislative proposals are being advanced in other states and Congress is also considering federal privacy legislation. In addition, most healthcare providers who are expected to prescribe our products, and from whom we obtain patient health information, are subject to privacy and security requirements under HIPAA. Although we are not directly subject to HIPAA, we could be subject to criminal penalties if we knowingly encourage, assist or otherwise facilitate a HIPAA-covered entity (or its business associate) to use or disclose individually identifiable health information in a manner not authorized or permitted by HIPAA. Other countries also have, or are developing, laws governing the collection, use and transmission of personal information. For example, the EU General Data Protection Regulation 2016/679 (GDPR), which became enforceable on May 25, 2018, regulates the processing of personal data of individuals within the EU, even if, under certain circumstances, that processing occurs outside the EU, and also restricts transfers of such data to countries outside of the EU, including the United States. Switzerland is updating the Swiss Data Protection Act, and updates to data protection laws in other countries may occur in due course. In connection with these new laws, in particular the CCPA and GDPR,U.S. Should we have modified or are reviewing certain of our policies and procedures with respect to the collection and processing of personal data. We will continue to review all future privacy and other regulations implemented pursuant to the CCPA, GDPR and other applicable laws to assess whether additional procedural safeguards are warranted, which may cause us to incur additional expenses or otherwise limit our ability to collect and process personal data. Failurefail to provide adequate privacy or data security protections or maintain compliance with these laws and regulations, could jeopardize certain domestic and cross-border business transactions and create additional liabilities for us, including the imposition ofCCPA and GDPR, we could be subject to sanctions or other penalties, litigation or an increase in our cost of doing business.
If competitors use litigationLegislation and regulatory meansaction designed to obtainfacilitate the development, approval forand adoption of generic versionsdrugs in the U.S., and the entrance of generic competitors, could limit the commercial potential of our marketed products, which could have a material adverse impact on our business, will suffer.financial condition and results of operations.
Under the FDCA, the FDA can approve an ANDA for a generic version of a branded drug without the applicant undertaking the human clinical testing necessary to obtain approval to market a new drug. The FDA can also approve an NDAa New Drug Application (NDA) under section 505(b)(2) of the FDCA that relies in whole or in part on the agency’s findings of safety and/or

effectiveness for a previously approved drug. Both the ANDA and 505(b)(2) processes are discussed in more detail under “Item 1. Business-Government Regulation-The Hatch-Waxman Act”Business—Government Regulation—FDA Review and Approval” in our Annual Report on Form 10-K for the year ended December 31, 20182019 filed with the SEC on February 22, 2019.25, 2020. In either case, if an ANDA or 505(b)(2) applicant submits an application referencing one of our marketed products prior to the expiry of one or more our Orange Book-listed patents for the applicable product, we may engage in litigationlitigate with the potential generic competitor to protect our patent rights, which will require us to incur significant expense andwould result in distraction for oursubstantial costs and divert the attention of management, team, and could also have an adverse impact on our stock price. If oneFor example, we received Paragraph IV certification notice letters from MSN concerning the ANDA that it had filed with the FDA seeking approval to market a generic version of CABOMETYX tablets. It is possible that MSN or moreother companies, receivefollowing FDA approval of an ANDA or 505(b)(2) NDA, it is possible that such company or companies could introduce generic versions of our marketed products before our patents expire if they do not infringe our patents or if it is determined that our patents are invalid or unenforceable. In particular,unenforceable, and we expect that generic cabozantinib products would be offered at a significantly lower price compared to our marketed cabozantinib products. RegardlessTherefore, regardless of the regulatory approach, whether through the ANDA or 505(b)(2) pathways or otherwise, the introduction of a generic version of any ofcabozantinib could significantly decrease our marketed products could result in significant decreases in the revenue derived from sales of our marketed productsrevenues and thereby materially harm our business, financial condition and financial condition.results of operations.
The U.S. federal government has also taken numerous legislative and regulatory actions to expedite the development and approval of generic drugs and biosimilars. In October 2019, we received a notice letter regarding an ANDA submitted toAugust 2017, President Trump signed the FDA by MSN, requestingReauthorization Act of 2017, which reauthorized the FDA user fee programs for prescription drugs, generic drugs, medical devices, and biosimilars, under which applicants for such products partially pay for the FDA’s pre-market review of their product candidates and pay other specified fees. The legislation also includes, inter alia, measures to expedite the development and approval to market aof generic version of CABOMETYX tablets. The notice letter included a Paragraph IV certification with respect to our U.S. Patent Nos. 8,877,776, 9,724,342, 10,034,873 and 10,039,757, which are listedproducts, where generic competition is lacking even in the Orange Book. MSN’s notice letter does not provideabsence of exclusivities or listed patents. In addition, the FDA has also released a Paragraph IV certification againstDrug Competition Action Plan, which proposes actions to broaden access to generic drugs and lower consumers’ healthcare costs by, among other things, improving the CABOMETYX compositionefficiency of matter patent, U.S. Patent No. 7,579,473, which expiresthe generic drug approval process and supporting the development of complex generic drugs, and the FDA has taken steps to implement this plan. Moreover, both Congress and the FDA are considering various legislative and regulatory proposals focused on August 16, 2026. On October 29,drug competition, including legislation focused on drug patenting and provision of drug to generic applicants for testing. For example, the Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act of 2019, we filed a complaint for patent infringement against MSN asserting U.S. Patent No. 8,877,776signed into law as part of the 2019 year-end federal spending package, purports to promote competition in the Delaware District Federal Court arising from MSN’s ANDA filing withmarket for drugs and biological products by facilitating the FDA. Basedtimely entry of lower-cost generic and biosimilar versions of those drugs and biological products, including by allowing generic manufacturers access to branded drug samples. While the FDA has yet to issue guidance on the information weprovisions of CREATES, its provisions do have receivedthe potential to date, our complaint does not allege infringement of U.S. Patent Nos. 9,724,342, 10,034,873facilitate the development and 10,039,757. We are seeking, among other relief, an order that the effective date of any FDAfuture approval of the ANDA would be a date no earlier than the expiration of U.S. Patent No. 8,877,776 on October 8, 2030 and equitable relief enjoining MSN from infringing this patent. We cannot assure you that the lawsuit will prevent the introduction of a generic version of CABOMETYX for any particular length of time, or at all. If MSN’s ANDA is approved, and a generic version of CABOMETYX is introduced following the expirationversions of our composition of matter patent in 2026, our sales of CABOMETYX would be adversely affected. In addition, we cannot predict what additional ANDAsproducts, introducing generic competition that could be filed by MSN or other potential generic competitors requesting approval to market generic forms of cabozantinib, including against the cabozantinib composition of matter patent that MSN has not challenged, which would require us to incur significant additional expense and result in distraction for our management team, and if approved, result in significant decreases in the revenue derived from sales of our marketed products and thereby materially harmhave a material adverse impact on our business, financial condition and financial condition.results of operations.
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Clinical testing of cabozantinib for new indications, or of new potential product candidates, is a lengthy, costly, complex and uncertain process and may fail to demonstrate safety and efficacy.
Clinical trials are inherently risky and may reveal that cabozantinib, despite its approval for certain indications, or a new potential product candidate, is ineffective or has an unacceptable safety profile with respect to an intended use. Such results may significantly decrease the likelihood of regulatory approval inof that product for a particular indication. Moreover, the results of preliminary studies do not necessarily predict clinical or commercial success, and later stagelate-stage or other potentially label-enabling clinical trials may fail to confirm the results observed in earlier stageearly-stage trials or preliminary studies. Although we have established timelines for manufacturing and clinical development of cabozantinib and our other product candidates based on existing knowledge of our compounds in development and industry metrics, we may not be able to meet those timelines.
We may experience numerous unforeseen events, during or as a result of clinical testing,investigations, that could delay or prevent commercialization of cabozantinib (or of other product candidates) in new indications, and in some cases, as described in the risk factor titled, “If the COVID-19 pandemic is further prolonged or ofbecomes more severe, our other product candidates, including:business operations and corresponding financial results could suffer, which could have a material adverse impact on our financial condition and prospects for growth,” the COVID-19 pandemic has already increased and may further increase the potential for such developments to occur. These may include:
•lack of acceptable efficacy or a tolerable safety profile;
•negative or inconclusive clinical trial results that require us to conduct further testing or to abandon projects that we had expected to be promising;projects;
•discovery or commercialization by our competitors of other compounds or therapies that show significantly improved safety or efficacy compared to cabozantinib or our other product candidates;
•our inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs;sites;
•lower-than-anticipated patient registration or enrollment in our clinical testing, resulting in the delay or cancellation of clinical testing;
•failure by our collaboratorscollaboration partners to provide us with an adequate and timely supply of product that complies with the applicable quality and regulatory requirements for a combination trial;

•failure of our third-party contract research organizations or investigators to satisfy their contractual obligations, including deviating from any trial protocols; and
•withholding of authorization from regulators or institutional review boards to commence or conduct clinical trials of cabozantinib or another product candidate, or delays, suspensions or terminations of clinical research for various reasons, including noncompliance with regulatory requirements or a determination by these regulators and institutional review boards that participating patients are being exposed to unacceptable health risks.
If we were to have significantthere are further delays in or termination of the clinical testing of cabozantinib or our other product candidates as a result ofdue to any of the events described above or otherwise, including as a result of the COVID-19 pandemic, our expenses could increase and our ability to generate revenues could be impaired, either of which could adversely impact our financial results. Furthermore, we rely on our clinical and commercial collaboration partners to fund a significant portion of theour clinical development of cabozantinib and our product candidates.programs. Should one or all of our collaboration partners decline to support future planned clinical trials, we will be entirely responsible for the financial obligations associated withfinancing the further development of cabozantinib or our other product candidates and, as a result, we may be unable to execute our current business plans, which could have a material adverse impact on our business, financial condition and results of operations.
We may not be able to rapidly or effectively continuepursue the further development of cabozantinib or our other product candidates or meet current or future requirements of the FDA or regulatory authorities in other jurisdictions including those identified based onin accordance with our discussions with the FDAstated timelines or such other regulatory authorities.at all. Our planned clinical trials may not begin on time, or at all, may not be completed on schedule, or at all, may not be sufficient for registration of our product candidates or may not result in an approvable product.
The duration and the cost of clinical trials vary significantly as a result of factors relating to the clinical trial, including, among others:
characteristics of the product candidate under investigation;
the number of patients who ultimately participate in the clinical trial;
the duration of patient follow-up that is appropriate in view of the results or required by regulatory authorities;
follow-up; the number of clinical sites included in the trials; and
the length of time required to enroll suitable patient subjects.eligible patients.
Any delay could limit our ability to generate revenues, cause us to incur additional expense and cause the market price of our common stock to decline significantly. Our partners under our collaboration agreements may experience similar risks with respect to the compounds we have out-licensed to them. If any of the events described above were to occur with such programs or compounds, the likelihood of receipt of milestones and royalties under such collaboration agreements could decrease.
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The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy and uncertain and may not result in regulatory approvals for cabozantinib or our other product candidates, which could have a material adverse impact on our business, financial condition and results of operations.
The activities associated with the research, development and commercialization of cabozantinib and our other product candidates are subject to extensive regulation by the FDA and other regulatory agencies in the U.S. and, as well as by comparable authorities in other countries. The processprocesses of obtaining regulatory approvals in the U.S. and other foreign jurisdictions is expensive and often takes many years, if approval is obtained at all, and they can vary substantially based upon the type, complexity and novelty of the product candidates involved. For example, before an NDA or supplemental New Drug Application (sNDA)sNDA can be submitted to the FDA, or a marketing authorization application to the European Medicines AgencyEMA or any application or submission to regulatory authorities in other jurisdictions, the product candidate must undergo extensive clinical trials, which can take many years and require substantial expenditures.
Any clinical trial may fail to produce results satisfactory to the FDA or regulatory authorities in other jurisdictions. For example, the FDA could determine that the design of a clinical trial is inadequate to produce reliable results. The regulatory process also requires preclinical testing, and data obtained from preclinical and clinical activities are susceptible to varying interpretations. The FDA has substantial discretion in the approval process and may refuse to approve any NDA or sNDA andor decide that our data is insufficient for approval and require additional preclinical, clinical or other studies. For

example, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent regulatory approval of cabozantinib for any individual additional indications.
In addition, we may encounter delays or rejections may be encountered based upon changes in regulatory policy, for product approval during the period of product development and regulatory agency review, which maycould cause delays in the approval or rejection of an application for cabozantinib or for our other product candidates.
Even if the FDA or a comparable authority in another jurisdiction approves cabozantinib for one or more new indications, beyond advanced RCC, previously treated HCC and MTC, or approves one of our other product candidates, such approval may be limited, imposing significant restrictions on the indicated uses, conditions for use, labeling, distribution, advertising, promotion, marketing and/or production of the product and could impose ongoing requirements for post-approval studies, including additional research and developmentclinical trials, all of which may result in significant expense and clinical trials.limit our and our collaboration partners’ ability to commercialize cabozantinib in one or more new indications. For example, in connectionbased on the regulatory feedback from the FDA, and if supported by the clinical data from COSMIC-021, we intend to file with the FDA’sFDA for accelerated approval of COMETRIQ forcabozantinib in an mCRPC indication as early as 2021. We expect that as a condition of any potential approval under the treatment of progressive, metastatic MTC in November 2012, we are subjectFDA's accelerated approval pathway, the FDA will require us to aperform confirmatory post-marketing requirementclinical trials to conduct aconfirm the clinical study comparing a lower dosebenefit, if any, of cabozantinib to the approved dose of 140 mg daily cabozantinib in progressive,combination with Roche’s atezolizumab in patients with locally advanced or metastatic MTC.solid tumors, such as mCRPC. Failure to complete any post-marketing requirements in accordance with the timelines and conditions set forth by the FDA could significantly increase costs or delay, limit or eliminateultimately restrict the commercialization of cabozantinib.cabozantinib in any additional indications. Further, these regulatory agencies maycould also impose various administrative, civil or criminal sanctions for failure to comply successfully with regulatory requirements, including withdrawal of product approval.
In addition, on March 27, 2020, Congress enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in response to the COVID-19 pandemic. Amongst other provisions, the CARES Act made a number of changes to the FDCA aimed at preventing drug shortages. While we are still evaluating these and other CARES Act changes, these changes could impact our business. For example, in light of the COVID-19 pandemic, the FDA has issued a number of guidance documents describing the agency’s expectations for how drug manufacturers should comply with various FDA requirements during the pandemic, including with respect to conducting clinical trials, distributing drug samples, and reporting post-marketing adverse events. In addition, as a result of the COVID-19 pandemic, there has been increasing political and regulatory scrutiny of foreign-sourced drugs and foreign drug supply chains, resulting in proposed legislative and executive actions to incentivize or compel drug manufacturing operations to relocate to the United States. These political and regulatory developments and any further guidance documents issued by FDA that impact the requirements to which we are subject, as well as any equivalent federal or state legislative or regulatory initiatives, or similar measures outside of the United States, could have a material adverse impact on our business, financial condition and results of operations.
We may be unable to expand our development pipeline, which could limit our growth and revenue potential.
Our business is focused on the discovery, development and commercialization of new medicines for difficult-to-treat cancers. In this regard, we are pursuinghave invested in substantial technical, financial and human resources toward internal drug discovery effortsactivities with the goal of identifying new product candidates to advance into clinical trials. InternalNotwithstanding this investment, we temporarily suspended internal drug discovery effortsin our laboratories due to identify new product candidates require substantial technical,the COVID-19 pandemic, among other limitations to our programs described in the risk factor titled, “If the COVID-19 pandemic is further prolonged or becomes more severe, our business operations and corresponding financial results could suffer, which could have a material adverse impact on our financial condition and human resources. These internal prospects for growth.” While we have since partially resumed our drug
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discovery efforts mayoperations, even assuming we successfully return these operations to full capacity in the future, many programs that initially show promise in identifying potential product candidates, yetwill ultimately fail to yield product candidates for clinical development for a number ofmultiple reasons. For example, potential product candidates may, on further study, be shown to have inadequate efficacy, harmful side effects, suboptimal pharmaceutical profiles or other characteristics suggesting that they are unlikely to be commercially viable products.
Apart from our internal drug discovery efforts, our strategy to expand our development pipeline is also dependent on our ability to successfully identify and acquire or in-license relevant product candidates. However, the in-licensing and acquisition of product candidates is a highly competitive area, and many other companies are pursuing the same or similar product candidates to those that we may consider attractive. In particular, larger companies with more well-established and diverse revenue streams may have a competitive advantage over us due to their size, financialcapital resources and more extensive clinical development and commercialization capabilities.capabilities may have a competitive advantage over us. Furthermore, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We may also be unable to in-license or acquire additional relevant product candidates on acceptable terms that would allow us to realize an appropriate return on our investment. If we are unable to develop suitable product candidates through internal discovery efforts or if we are unable to successfully obtain rights to suitable product candidates, our business and prospects for growth could suffer. Even if we succeed in our efforts to obtain rights to suitable product candidates, the competitive business environment may result in higher acquisition or licensing costs, and our investment in these potential products will remain subject to the inherent risks associated with the development and commercialization of new medicines. In certain circumstances, we may also be reliant on the licensor for the continued development of the in-licensed technology and their efforts to safeguard their underlying intellectual property.
With respect to acquisitions, we may not be able to integrate the target company successfully into our existing business, maintain the key business relationships of the target, or retain key personnel of an acquired business. Furthermore, we could assume unknown or contingent liabilities or incur unanticipated expenses. Any acquisitions or investments made by us also could result in our spending significant amounts, issuing dilutive securities, assuming or incurring significant debt obligations and contingent liabilities, incurring large one-time expenses and acquiring intangible assets that could result in significant future amortization expense and significant write-offs, any of which could harm our operating results.financial condition and results of operations. If our internal drug discovery or business development efforts do not result in suitable product candidates, our business and prospects for growth could suffer.
Increasing use of social media could give rise to liability and result in harm to our business.
We and our employees are increasingly utilizing social media tools and our website as a means of communication. For example, we use Facebook and Twitter to communicate with the medical community and the investing public, although we do not intend to disclose material, nonpublic information through these means. Despite our efforts to monitor evolving

social media communication guidelines and comply with applicable laws and regulations,communications, there is risk that the unauthorized use of social media by us or our employees to communicate about our products or business, or any inadvertent disclosure of material, nonpublic information through these means, may cause us to be foundresult in violationviolations of applicable laws and regulations, which may give rise to liability and result in harm to our business. In addition, there is also risk of inappropriate disclosure of sensitive information, which could result in significant legal and financial exposure and reputational damages that could potentially have a material adverse impact on our business, financial condition and results of operations. Furthermore, negative posts or comments about us or our products on social media could seriously damage our reputation, brand image and goodwill.
Risks Related to Our Capital Requirements, Accounting and Financial Results
We mayOur profitability could be unablenegatively impacted by our extensive clinical development, business development and commercialization activities for cabozantinib and pipeline expansion efforts relative to maintain or increase profitability.the revenues we generate.
Although we reported net income of $252.3 million and $690.1$83.4 million for the nine months ended September 30, 20192020 and $321.0 million for the year ended December 31, 2018,2019, respectively, we reported a net loss of $32.0 million for the three months ended September 30, 2020. We may not be able to resume, maintain or increase profitability on a quarterly or annual basis, and we are unable to predict the extent of long-range future profits or losses. The amount of our net profits or losses will depend, in part, on: the level of sales of CABOMETYX and COMETRIQ in the U.S.; achievement of clinical, regulatory and commercial milestones, if any, under our collaboration agreements with Ipsen and Takeda;agreements; the amount of royalties from sales of CABOMETYX and COMETRIQ outside of the U.S. under our collaboration agreements with Ipsen and Takeda;agreements; other collaboration revenues; and the level of our expenses, including for development and commercialization activities for cabozantinib and for any pipeline expansion efforts. We expect to continue to spend significant additionalsubstantial amounts to fund the continued development of cabozantinib for additional indications and the commercialization of our approved products. In addition, we intend to continue to expand our product pipeline through our internal drug discovery efforts and the execution of additional partnerships through business development activities or strategic transactions that align with our oncology drug development, regulatory and commercial expertise, which efforts could involve substantial costs. To offset these costs in the future, we will need to generate
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substantial revenues. If these costs exceed our current expectations, or we fail to achieve anticipated revenue targets, the market value of our common stock may decline.
Our financial outlook may not be realized.
From time to time, in press releases and otherwise, we may publish estimates, forecasts or other forward-looking statements regarding our future financial or operating results, including estimated revenues, expenses and earnings. Any forecast of our future performance reflects various assumptions. These assumptions are subject to significant risks and uncertainties, and as a matter of course, any number of them may prove to be incorrect. Further, the achievement of any forecast depends on numerous assumptions and other factors (including those described in this discussion), many of which are beyond our control. Moreover, the impact of the COVID-19 pandemic on our profitability, especially if it is further prolonged or grows in severity, is difficult to predict. As a result, we cannot be certain that our performance will be consistent with any management estimates or forecasts or that the variation from such estimates or forecasts will not be material and adverse. Current and potential stockholders are cautioned not to base their entire analysis of our business and prospects upon isolated estimates or forecasts, but instead are encouraged to utilize our entire publicly available mix of historical and forward-looking information, as well as other available information regarding us, our products, the competitive landscape for our products, our commercialization, development and regulatory efforts, as well as those of our collaboration partners, and the biotechnology and pharmaceutical industry generally when evaluating our prospective financial or operating results.
If additional capital is not available to us when we need it, we may be unable to expand our product offerings and maintain business growth.
AsCash and investments were $1.5 billion as of September 30, 2019, we had $1,248.4 million in cash and investments as2020, compared to $851.6 million$1.4 billion as of December 31, 2018.2019. Our business operations grew substantially during 20182019 and the first nine months of 2019.2020. In order to maintain business growth during the remainder of 2020, we plan to continue to execute on our U.S. commercialization plans for CABOMETYX, while reinvesting in our product pipeline through the continued development of cabozantinib and our other product candidates, internal discovery activities, and the execution of strategic transactions. Our ability to achieve these business objectives will depend on many factors including but not limited to:
•the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;
•costs associated with maintaining our expanded sales, marketing, market access, medical affairs and product distribution capabilities for CABOMETYX and COMETRIQ;
•the achievement of stated regulatory and commercial milestones and royalties paid under our collaboration agreements with Ipsen and Takeda;
•the commercial success of and revenues generated by products marketed under our collaboration and license agreements;
•future clinical trial results;
•the impact of the COVID-19 pandemic on our ability to conduct critical business operations, including internal drug discovery activities, clinical trials and commercial operations;
•the level of our investments in the expansion of our pipeline through internal drug discovery and business development activities;
our ability to control costs;
•the number and size of clinical trials we conduct and the cost of drug supply for such clinical trials evaluating our products with other therapeutic agents;
•trends and developments in the pricing of oncologic therapeutics in the U.S. and abroad, especially in the EU;
•scientific developments in the market for oncologic therapeutics and the timing of regulatory approvals for competing oncologic therapies; and

•the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights.
Our commitment of cash resources to CABOMETYX and the reinvestment in our product pipeline through the continued development of cabozantinib and increasing internal drug discovery activities, as well as through the execution of strategic transactions, could require us to obtain additional capital. We may seek such additional capital through some or all of the following methods: corporate collaborations; licensing arrangements; and public or private debt or equity financings. Our ability to obtain additional capital may depend on prevailing economic conditions and financial, business and other
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factors beyond our control. Disruptions in the U.S. and global financial markets, including any disruptions resultingthat have resulted and may continue to result from the COVID-19 pandemic and the related downturn in the U.S. and global economy, as well as future potential U.S. federal government shutdowns, the uncertainty surrounding the date and the terms of the pending Brexit, rising interest rate environments, increased or changed tariffs and trade restrictions or otherwise, may adversely impact the availability and cost of credit, as well as our ability to raise moneyadditional funds in the capital markets. Economic and capital markets conditions have been, and continue to be, volatile. Continued instability in these market conditions may limit our ability to access the capital necessary to fund and grow our business. Accordingly, weIn particular, our inability to access additional funds, whether due to the COVID-19 pandemic or otherwise, could in the future inhibit our ability to engage in larger scale strategic transactions or investments. We do not know whether additional capital will be available when needed, or that, if available, we will obtain additional capital on terms favorable to us or our stockholders. If we are unable to raise additional funds when we need them, we may be unable to expand our product offerings and maintain business growth, which could have a material adverse impact on our business, financial condition and results of operations.
Our financial results are impacted by management’s selection of accounting methods, certain assumptions and estimates and future changes in accounting standards.
Our accounting policies and methods are fundamental to how we record and report our financial condition and results of operations. Our management must exercise judgment in selecting and applying many of these accounting policies and methods so they comply with generally accepted accounting principles and reflect management’s judgment of the most appropriate manner to report our financial condition and results of operations. In some cases, management must select the accounting policy or method to apply from two or more alternatives, any of which may be reasonable under the circumstances, yet may result in our reporting materially different results than would have been reported under a different alternative.
Certain accounting policies are critical to the presentation of our financial condition and results of operations. The preparation of our financial statements requires us to make significant estimates, assumptions and judgments that affect the amounts of assets, liabilities, revenues and expenses and related disclosures. We believe our critical accounting policies relating to revenue recognition, clinical trial accruals, inventory, and stock-based compensation and income taxes reflect the more significant estimates and judgments used in the preparation of our Condensed Consolidated Financial Statements. Although we base our estimates and judgments on historical experience, our interpretation of existing accounting literature and on various other assumptions that we believe to be reasonable under the circumstances, if our assumptions prove to be materially incorrect, actual results may differ materially from these estimates.
In addition, future changes in financial accounting standards may cause adverse, unexpected revenue fluctuations and affect our financial position or results of operations. New pronouncements from the Financial Accounting Standards Board (FASB) and varying interpretations of pronouncements have occurred with frequency in the past and are expected to occur again in the future and, as a result, we may be required to make changes in our accounting policies. Those changes could adversely affect our reported revenues and expenses, our other results of operations or our current financial position.
The 2017 comprehensive tax reform bill could have a material adverse impact on our business, financial condition and results of operations.
The Tax Cuts and Jobs Act could be amended or subject to technical correction, which could change the financial impacts that were recorded at December 31, 2018 and September 30, 2019, or are expected to be recorded in future periods. Additionally, further guidance may be forthcoming from the FASB and SEC, as well as regulations, interpretations and rulings from federal and state tax agencies, which could result in additional impacts, possibly with retroactive effect.
Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
We are subject to income tax in the U.S. as well as numerous U.S. states and territories, municipalities, and other local jurisdictions. As a result, our effective tax rate is derived from various factors including the mix of forecast and actual earnings and applicable tax rates in the various places that we operate, the accounting for stock options and share basedstock-based awards, and research and development spending. In preparing our financial statements, we estimate the amount of tax that will become

payable in each jurisdiction. Our effective tax rate, however, may be different than experienced in the past due to numerous factors, including changes in tax laws, such as the passage of the Tax Cuts and Jobs Act, changes in the mix of our earnings from state to state, the results of examinations and audits of our tax filings, or our inability to secure or sustain acceptable agreements with tax authorities. Any of these factors could cause our effective tax rate to fluctuate.
Our ability to use net operating losses and tax credits to offset future taxable income may be subject to limitations.
As of December 31, 2018,2019, we had federal and, subject to the recent California franchise tax law change affecting California state net operating losses mentioned below, state net operating loss carryforwards of approximately $1.1 billion. The$675 million. Portions of the federal and state net operating loss carryforwards will begin to expire, if not utilized, beginning in 20312035 for federal income tax purposes and 20282020 for California state income tax purposes. ThesePortions of these net operating loss carryforwards could expire unused and be unavailable to offset future income tax liabilities. Under the Internal Revenue Code (the Code) and similar state provisions, certain substantial changes in our ownership could result in an annual
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limitation on the amount of net operating loss carryforwards that can be utilized in future years to offset future taxable income. The annual limitation may result in the expiration of a portion of our net operating losses and credit carryforwards before utilization. Based on our review and analysis, we concluded, as of December 31, 2018,2019, that an ownership change, as defined under Section 382, had not occurred. However, if there is an ownership change under Section 382 of the Code in the future, we may not be able to utilize a material portion of our net operating losses. Furthermore, our ability to utilize our net operating losses is conditioned upon our maintaining profitability and generating U.S. federal taxable income.
The transition away from In addition, at the London Interbank Offered Rate (LIBOR) could affect the value of certain short-term investments, as well as our ability to seek additional debt financing.
Actions by governmental entitiesstate level, there may impact certain financial instruments inbe periods during which we have invested or may invest in the future. For example, some of these financial instruments may rely in some fashion upon LIBOR, which is an average interest rate, determined by the ICE Benchmark Administration, that banks charge one another for the use of short-term money. The UK's Financial Conduct Authority, which regulates LIBOR, has announced plansnet operating losses is suspended or otherwise limited. For example, California recently imposed limits on the usability of California state net operating losses to phase out the use of LIBOR by the end of 2021. While only a small percentage of our short-term investments include financial instruments subject to LIBOR,offset taxable income in tax years beginning after 2019 and while we do not currently have any outstanding debt that is subject to LIBOR, there remains uncertainty regarding the future utilization of LIBOR and the nature of any replacement rate, and any potential effects of the transition away from LIBOR on certain instruments in to which we may enter in the future are not known. The transition process may involve, among other things, increased volatility or illiquidity in markets for instruments that currently rely on LIBOR. The transition may also result in reductions in the value of certain instruments or the effectiveness of related transactions such as hedges, increased borrowing costs, uncertainty under applicable documentation, or difficult and costly consent processes.  Any such effects of the transition away from LIBOR, as well as other unforeseen effects, result in expenses, difficulties, complications or delays in connection with future financing efforts, which could have a material adverse impact on our business, financial condition and results of operations.before 2023.
The UK’s pendingUnited Kingdom’s (UK’s) withdrawal from the EU may have a negative effect on global economic conditions, financial markets and our business.
Brexit has created significant uncertainty concerningFollowing the termsratification of the Withdrawal Agreement by the European Parliament and UK withdrawal fromParliament, the UK left the EU and the future relationship between the UK and the EU. On April 11, 2019, the European Council agreed at its Special Meeting to extend the UK’s departure date to October 31, 2019, and then on October 28, 2019, the European Council informally agreed to further extend the departure date to January 31, 2020 though this latest extension allows the UK(commonly referred to withdraw from the EU prior to Januaryas “Brexit”). The Withdrawal Agreement provides for a transition period until December 31, 2020, if a transition agreement is ratified by both the UK Parliament and the European Parliament. However, despite numerous proposals to provide for a more fair and reasonable exit, both the EU and the UK are preparing for a “no deal” scenario induring which the UK will leave the EU as a “third country” without the benefit of any transition arrangements. In addition, the resignation of Theresa May and election of Boris Johnson as UK Prime Minister has further increased this uncertainty, since the UK’s future position on Brexit will depend significantly upon the policies and political decisions of the new administration under the premiership of Prime Minister Johnson.
The “no deal” scenario has been recognized by the policy makersremains in the UK and the EU as likely to cause significantsingle market and economic disruption. The effects of Brexit will depend on whether the UK retains access to EU markets either during a transitional period or more permanently. Brexit could disrupt the single internal market principle, which ensurescustoms union and the free movement of goods, services, people and peoplecapital will continue, in order to ensure frictionless trade and business continuity until a long-term relationship is agreed. At the end of transition, the UK’s relationship with the EU will be determined by the new agreements it has entered into on trade and other areas of cooperation. The new agreements must be reached before the transition period ends. If not, the UK would have to rely on previous international conventions for security cooperation and would trade with the EU on World Trade Organization terms. The exception is Northern Ireland, whose trade in goods with the EU would be covered by the provisions in the Northern Ireland Protocol. As a result of the COVID-19 pandemic, planned negotiating rounds for the UK’s future relationship with the EU have not been progressing at a pace that would facilitate a final agreement on trade and cooperation between the UK and the EU undermine bilateral cooperation in key policy areas and significantly disturb trade relationshipsprior to December 31, 2020. Under the formal withdrawal arrangements between the UK and the EU. In addition, Brexit could leadEU, the parties had until June 30, 2020 to legal

uncertaintyagree to extend the transition period if required, and potentially divergent national laws and regulations asno such extension was agreed prior to such date. Under these circumstances, it is uncertain whether the UK determines whichand EU lawswould agree to replace, amend or adopt.
extend the transition period beyond December 31, 2020. Given the lack of comparable precedent, it is unclear what financial, trade, regulatory and legal implications the withdrawal of the UK from the EU wouldBrexit will have and how such withdrawal wouldit might affect us. For example, we rely on third-party contract manufacturing organization facilities located in the UK, responsible for packaging, labeling, storing and subsequently distributing supplies of our product to the EU. Any tariffs, differing regulatory requirements and other restrictions on the free movement of goods between the UK and the EU that ultimately result from Brexit may have an adverse impact on this part of our supply chain. Trade restrictions, changes to the regulatory approval or drug cost reimbursement systems, and additional administrative costs may impede the ability of our collaboratorcollaboration partner Ipsen to market our products in Europe. Furthermore, the initial announcement of Brexit caused significant volatility in global stock markets and currency exchange rate fluctuations, andfluctuations; therefore, the pending withdrawal of the UK from the EUBrexit transition may alsocontinue to adversely affect European and global economic and market conditions, which may cause third-party payers, including governmental organizations, to closely monitor their costs and reduce their spending budgets, and which could contribute to instability in the global financial and foreign exchange markets. Any of these effects of Brexit could have a material adverse impact on our business, financial condition and results of operations.
Risks Related to Our Relationships with Third Parties
We are dependent upon ourOur clinical and commercial collaborations with major companies make us reliant on those companies for their continued performance, which subjectsubjects us to a number of risks.
We have established clinical and commercial collaborations with leading pharmaceuticalbiotechnology, biopharmaceutical and biotechnologypharmaceutical companies, including, Ipsen, Takeda, Roche and Genentech, BMS and Daiichi Sankyo, and BMS for the development and ultimate commercialization of certain compounds generated from our research and development efforts. Our dependence on our relationships with collaborators for the development and commercialization of compoundsour products, and our dependence on these collaboration partners subjects us to, a number of risks, including:
•our collaboration partners’ decision to terminate our collaboration, or their failure to comply with the terms of our collaboration agreements and related ancillary agreements, either intentionally or as a result of negligent performance;
•our inability to control the amount and timing of resources that our collaborators or potential future collaborators willcollaboration partners devote to the development or commercialization of drug candidates or to their marketing and distribution;our products;
•the possibility that collaboratorsour collaboration partners may stop or delay clinical trials, fail to supply us on a timely basis with the product required for a combination trial (including as a result of the COVID-19 pandemic), or deliver product that fails to meet appropriate quality and regulatory standards and results in a market recall or withdrawal, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulationstandards;
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•disputes that may arise between us and our collaboratorscollaboration partners that result in the delay or termination of the research, development or commercialization of our drug candidates, or that diminish or delay receipt of the economic benefits we are entitled to receive under the collaboration, or that result in costly litigation or arbitration that diverts management’s attention and resources;arbitration;
our inability to control the U.S. commercial resourcing decisions made and resulting costs incurred by Genentech for COTELLIC, which costs we are obligated to share, in part, under our collaboration agreement with Genentech;
•the possibility that our collaboratorscollaboration partners may experience financial difficulties;difficulties, including, without limitation, difficulties arising from the impact of the COVID-19 pandemic which prevent them from fulfilling their obligations under our agreements;
•our collaborators’ lack of success in their effortscollaboration partners’ inability to obtain regulatory approvals in a timely manner, or at all; and
•our collaborators’collaboration partners’ failure to properly maintain or defend our intellectual property rights or their use of our intellectual property rights or proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or expose us to potential litigation;
our collaborators’ failure to comply with the terms of our collaboration agreements and related ancillary agreements;
our collaborators’ failure to comply with applicable healthcare laws, as well as established guidelines, laws and regulations related to Good Manufacturing Practice, Good Clinical Practice, Good Distribution Practice and Good Pharmacovigilance Practice;
business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement;
the possibility that our collaborators could independently move forward with competing drug candidates, developed either independently or in collaboration with others, including our competitors;

our inability to enter into additional collaboration arrangements with third parties in an area or field of exclusivity;
the possibility that future collaborators may require us to relinquish some important rights, such as marketing and distribution rights; and
the possibility that collaborations may be terminated or allowed to expire, which would delay, and may increase the cost of, development of our drug candidates.litigation.
If any of these risks materialize, we may not receive collaboration revenues or otherwise realize anticipated benefits from such collaborations, and our product development efforts and prospects for growth could be delayed or disrupted, all of which could have a material adverse impact on our business, financial condition and results of operations.
Our growth potential is dependent upon companies with which we have entered into in-licensing collaborations and similar business development relationships.
To expand our early-stage product pipeline, we have augmented our internal drug discovery activities with multiple in-licensing collaborations with smaller, discovery-focused biotechnology companies, including Aurigene, Iconic, StemSynergy, Invenra, Catalent and NBE. Our dependence on our relationships with these in-licensing partners subjects us to numerous risks, including:
•our in-licensing partners’ decision to terminate our relationship, or their failure to comply with the terms of our agreements, either intentionally or as a result of negligent performance;
•disputes that may arise between us and our collaboration partners that result in the delay or termination of research activities with respect to the licensed assets;
•the possibility that our in-licensing partners may experience financial difficulties, including, without limitation, difficulties arising from the impact of the COVID-19 pandemic, which prevent them from fulfilling their obligations under our agreements;
•our in-licensing partners’ failure to properly maintain or defend their intellectual property rights or their use of third-party intellectual property rights or proprietary information in such a way as to invite litigation that could jeopardize or invalidate our license to develop these assets; and
•our in-licensing partners’ failure to comply with applicable healthcare laws, as well as established guidelines, laws and regulations related to Good Manufacturing Practice and Good Laboratory Practice.
If any of these risks materialize, we may not be able to expand our product pipeline or otherwise realize a return on the resources we will have invested to develop these early-stage assets, which could have a material adverse impact on our financial condition and prospects for growth.
If third parties upon which we rely to perform clinical trials for cabozantinib in new indications or for new potential product candidates do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize cabozantinib or other product candidates beyond currently approved indications.
We do not have the ability to conduct clinical trials for cabozantinib or for new potential product candidates independently, including our post-marketing commitments in connection with the approval of COMETRIQ in progressive, metastatic MTC, so we rely on independent third parties for the performance of these trials, such as the U.S. federal government (including NCI-CTEP, a department of the National Institutes of Health, with whom we have our CRADA), third-party contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, whether as a result of the COVID-19 pandemic or otherwise, or if the third parties must be replaced or if the quality or accuracy of the data they generate or provide is compromised due to their failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our preclinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for or commercialize cabozantinib or other product candidates beyond currently approved indications. In addition, due to the complexity of our research initiatives, we may be unable to engage with third-party contract research organizations that have the necessary
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experience and sophistication to further our internal drug discovery efforts, which would impede our ability to identify, develop and commercialize our potential product candidates.
We lack internal manufacturing capabilities necessary for us to produce materials required for certain preclinical activities and produce our products for clinical development or for commercial sale and rely on third parties to do so, which subjects us to various risks.
We do not own or operate manufacturing facilities, distribution facilities or resources for chemistry, manufacturing and control development activities, preclinical, clinical or commercial production and distribution offor our products.current products and new product candidates. Instead, we have multiple contractual agreements in place withrely on various third-party contract manufacturing organizations that, on our behalf, manufacture preclinical, clinical and commercial supplies of CABOMETYX and COMETRIQ.our products. As our operations continue to expand through our clinical development and commercial progress,grow in these areas, we arecontinue to appropriately expandingexpand our supply chain by entering into new agreements with additionalthrough secondary third-party contract manufacturers and suppliers. This will continue for the foreseeable future for all of our product candidates, as well as our current and future commercial products.
To establish and manage our supply chain requires a significant financial commitment, the creation of numerous third-party contractual relationships and continued oversight of these third parties to ensurefulfill compliance with applicable regulatory requirements. Although we maintain significant resources to directly and effectively oversee the activities and relationships with the companies in our supply chain, we do not have direct control over their operations.
Our third-party contract manufacturers may not be able to produce material on a timely basis or manufacture material with the required quality standards, or in the quantity required to meet our preclinical, clinical development and commercial needs and applicable regulatory requirements.requirements, including as a result of the COVID-19 pandemic. Although as of the date of this Quarterly Report, we continue to maintain substantial safety stock inventories for our drug substance and drug products and have not experienced production delays or seen significant impairment to our supply chain as a result of the COVID-19 pandemic, our third-party contract manufacturers and suppliers could experience operational delays due to facility closures and other hardships as a result of the COVID-19 pandemic, which could impact our supply chain by potentially causing delays to or disruptions in the supply of our commercial or clinical products or product candidates. If our third-party contract manufacturers and suppliers do not continue to supply us with our products or product candidates in a timely fashion and in compliance with applicable quality and regulatory requirements, or if they otherwise fail or refuse to comply with their obligations to us under our supplymanufacturing and manufacturingsupply arrangements, we may not have adequate remedies for any breach. Furthermore, their failure to supply us could impair or preclude our ability to meet ourmeeting commercial or clinical product supply requirements or our supply needs for clinical trials, including those being conducted in collaboration withus or our partners, which could delay our product development and future commercialization efforts and have a material adverse impact on our business, financial condition and results of operations. ThroughIn addition, through our third-party contract manufacturers and data service providers, we have implemented product serialization designedcontinue to provide serialized commercial products as required to comply with the Drug Supply Chain Security Act (DSCSA), pursuant to which, subject to limited exemptions, all prescription pharmaceutical products manufactured and distributed in the U.S. were required to be serialized as of November 27, 2018.. If our third-party

contract manufacturers or data service providers fail to support our efforts to continue to comply with DSCSA and any future federal or state electronic pedigree requirements, we may face legal penalties or be restricted from selling our products.products
As part of our collaboration agreements with Ipsen and Takeda, we are responsible for the supply of CABOMETYX and COMETRIQ for global development and commercial purposes. Failure to meet our supply obligations under these collaboration agreements could impair our collaborators’partners’ ability to successfully develop and commercialize CABOMETYX and COMETRIQ and generate revenues to which we are entitled under the collaborations.
Our collaborations with outsideIf third-party scientific advisors and collaboratorscontractors we rely on to assist with our drug discovery efforts do not perform as expected, the expansion of our product pipeline may be subject to restriction and change.delayed.
We work with scientific and clinical advisors and collaborators at academic and other institutions, as well as third-party contractors in various locations throughout the world, that assist us in our research and development efforts, including in internal drug discovery and preclinical development strategy. These advisors and collaboratorsthird parties are not our employees and may have other commitments or pursue other opportunitiescontractual obligations that limit their availability to us. Although these third-party scientific advisors and collaboratorscontractors generally agree not to do competing work, if a conflict of interest between their work for us and their work for another entity arises, we may lose their services. There has also been increased scrutiny surrounding the disclosures of payments made to medical researchers from companies in the pharmaceutical industry, and it is possible that the academic and other institutions that employ these medical researchers may prevent us from engaging them as scientific advisors and collaboratorscontractors or otherwise limit our access to these experts, or that the scientific advisors themselves may now be more reluctant to work with industry partners. In anyEven if these scientific advisors and contractors with whom we have engaged intend to meet their contractual obligations, their ability to perform services may be impacted by external factors, as we experienced in the early stages of these circumstances,the COVID-19 pandemic. If we mayexperience additional delays in the receipt of services, lose
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work performed by these scientific advisors and collaboratorscontractors or beare unable to engage them in the first place, and our discovery and development efforts with respect to the matters on which they were working or would work in the future may be significantly delayed or otherwise adversely affected. In addition, although our advisors and collaborators sign agreements not to disclose our confidential information, it is possible that valuable proprietary knowledge may become publicly known through them.
Risks Related to Our Information Technology Data Privacy and Intellectual Property
Data breaches, cyber-attackscyber attacks and other failures in our information technology infrastructure could compromise our intellectual property or other sensitive information, damage our operations and cause significant harm to our business and reputation.
In the ordinary course of our business, we collect, maintain and transmit sensitive data on our networks and systems, including our intellectual property and proprietary or confidential business information (such as research data and personal information) and confidential information with respect to our customers, clinical trial patients and our businesscollaboration partners. We have also outsourced significant elements of our information technology infrastructure to third parties and, as a result, such third parties may or could have access to our confidential information. The secure maintenance of this information is critical to our business and reputation, and while we have enhanced and are continuing to enhance our cyber-securitycybersecurity efforts commensurate with the growth and complexity of our business, our systems and those of third-party service providers may be vulnerable to a cyber-attack.cyber attack. Such vulnerabilities may be further exacerbated by the fact that our workforce is operating remotely as we comply with shelter in place orders and the recent rise in COVID-19 phishing attacks targeting remote workers. In addition, we are heavily dependent on the functioning of our information technology infrastructure to carry out our business processes, such as external and internal communications or access to clinical data and other key business information. Accordingly, both inadvertent disruptions to this infrastructure and cyber-attackscyber attacks could cause us to incur significant remediation or litigation costs, result in product development delays, disrupt keycritical business operations, and divert attention of management andexpend key information technology resources.resources and divert the attention of management.
Numerous companies have been subject to a wide variety of security incidents, cyber-attackscyber attacks (including through use of ransomware) and other attempts to gain unauthorized access or otherwise compromise information technology systems. In fact, although the aggregate impact of cyber-attackscyber attacks on our operations and financial condition has not been material to date, we and our third-party vendors have frequently been the target of threats of this nature and expect them to continue. These threats can come from a variety of sources, ranging in sophistication from an individual hacker to a state-sponsored attack, and such threats can also vary in motive (including corporate espionage). Cyber threats may be generic, or they may be custom-crafted against our information systems. Cyber-attacksattacks continue to become more prevalent and much harder to detect and defend against. Our networkagainst, and storage applications and those of our contract manufacturing organizations, contract research organizations or vendors may be subject to unauthorized access by hackers or breached due to operator error, malfeasance or other system disruptions. Itit is often difficult to anticipate or immediately detect such incidents and the damage caused by such incidents. These data breaches and any unauthorized access or disclosure of our information or intellectual property could compromise our intellectual property and expose our sensitive business information (or sensitive business information of our collaboration partners, which may lead to significant liability for us). A data security breach could also lead to public exposure of personal information of our clinical trial patients, employees or others. Any such event

that leads to unauthorized access, use or disclosure of personal information, including personal information regarding our patients or employees, could harm our reputation and business, compel us to comply with federal and/or state breach notification laws and foreign law equivalents (including the GDPR), subject us to investigations and mandatory corrective action, or otherwise subject us to liability under laws and regulations that protect the privacy and security of personal information, which could disrupt our business, result in increased costs or loss of revenue, and/or result in significant financial exposure. Furthermore, the costs of maintaining or upgrading our cyber-securitycybersecurity systems (including the recruitment and retention of experienced information technology professionals, who are in high demand) at the level necessary to keep up with our expanding operations and prevent against potential attacks are increasing, and despite our best efforts, our network security and data recovery measures and those of our vendors may still not be adequate to protect against such security breaches and disruptions, which could cause material harm to our business, financial condition and results of operations.
If we are unable to adequately protect our intellectual property, third parties may be able to use our technology, which could adversely affect our ability to compete in the market.
Our success will depend in part upon our ability to obtain patents and maintain adequate protection of the intellectual property related to our technologies and products. The patent positions of biopharmaceutical companies, including our patent position, are generally uncertain and involve complex legal and factual questions. We will be able to protect our intellectual property rights from unauthorized use by third parties only to the extent that our technologies are covered by valid and enforceable patents or are effectively maintained as trade secrets. We will continue to apply for patents covering our technologies and products as, where and when we deem lawful and appropriate. However, these applications may be challenged or may fail to result in issued patents. Our issued patents have been and may in the future
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be challenged by third parties as invalid or unenforceable under U.S. or foreign laws, or they may be infringed by third parties, and we are from time to time involved in the defense and enforcement of our patents or other intellectual property rights in a court of law, U.S. Patent and Trademark Office inter partes review or reexamination proceeding, foreign opposition proceeding or related legal and administrative proceeding in the U.S. and elsewhere. The costs of defending our patents or enforcing our proprietary rights in post-issuance administrative proceedings and litigation can be substantial and the outcome can be uncertain. An adverse outcome may allow third parties to use our intellectual property without a license and/or allow third parties to introduce generic and other competing products, any of which would negatively impact our business. Third parties may also attempt to invalidate or design around our patents, or assert that they are invalid or otherwise unenforceable, and seek to introduce generic versions of cabozantinib. For example, in October 2019, we received aParagraph IV certification notice letterletters from MSN concerning the ANDA that it hashad filed an ANDA with the FDA forseeking approval to market a generic version of CABOMETYX tablets, and we subsequently filed a patent infringement lawsuit against MSN on October 29, 2019.tablets. Should MSN or any other third parties receive FDA approval of an ANDA for a generic version of cabozantinib or a 505(b)(2) NDA with respect to cabozantinib, and if our patents covering cabozantinib were held to be invalid (or ifit is possible that such competing generic versions of cabozantinib were found to not infringe our patents), then theycompany or companies could introduce generic versions of cabozantinib or other such 505(b)(2)our marketed products before our patents expire if they do not infringe our patents or if it is determined that our patents are invalid or unenforceable, and the resulting generic competition would negatively affectcould have a material adverse impact on our business, financial condition and results of operations. Please also see the risk factor entitled, “If competitors use litigation and regulatory means to obtain approval for generic versions of our marketed products, our business will suffer.”
In addition, because patent applications can take many years to issue, third parties may have pending applications, unknown to us, which may later result in issued patents that cover the production, manufacture, commercialization or use of our product candidates. Our existing patents and any future patents we obtain may not be sufficiently broad to prevent others from practicing our technologies or from developing competing products. Furthermore, others may independently develop similar or alternative technologies or design around our patents. In addition, our patents may be challenged or invalidated or may fail to provide us with any competitive advantages, if, for example, others were the first to invent or to file patent applications for closely related inventions.
The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the U.S., and many companies have encountered significant problems in protecting and defending such rights in foreign jurisdictions. Many countries, including certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties (for example, the patent owner has failed to “work” the invention in that country or the third party has patented improvements). In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of the patent. Initiatives seeking compulsory licensing of life-saving drugs are also becoming increasingly prevalent in developing countries either through direct legislation or international initiatives. Governments in those developing countries could require that we grant compulsory licenses to allow competitors to manufacture and sell their own versions of our products or product candidates, thereby reducing our product sales.

Moreover, the legal systems of certain countries, particularly certain developing countries, do not favor the aggressive enforcement of patent and other intellectual property protection, which makes it difficult to stop infringement. We rely on trade secret protection for some of our confidential and proprietary information. We have taken security measures to protect our proprietary information and trade secrets, but these measures may not provide adequate protection. While we seek to protect our proprietary information by entering into confidentiality agreements with employees, collaboratorspartners and consultants, we cannot assure youprovide assurance that our proprietary information will not be disclosed, or that we can meaningfully protect our trade secrets. In addition, our competitors may independently develop substantially equivalent proprietary information or may otherwise gain access to our trade secrets.
Litigation or third-party claims of intellectual property infringement could require us to spend substantial time and money and adversely affect our ability to develop and commercialize products.
Our commercial success depends in part upon our ability to avoid infringing patents and proprietary rights of third parties and not to breach any licenses that we have entered into with regard to our technologies and the technologies of third parties. Other parties have filed, and in the future are likely to file, patent applications covering products and technologies that we have developed or intend to develop. If patents covering technologies required by our operations are issued to others, we may have to obtain licenses from third parties, which may not be available on commercially reasonable terms, or at all, and may require us to pay substantial royalties, grant a cross-license to some of our patents to another patent holder or redesign the formulation of a product candidate so that we do not infringe third-party patents, which may be impossible to accomplish or could require substantial time and expense.
In addition, third parties may obtain patents that relate to our technologies and claim that use of such technologies infringes on their patents or otherwise employs their proprietary technology without authorization. Regardless of their merit, such claims could require us to incur substantial costs includingand divert the diversionattention of management and key technical
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personnel in defending ourselves against any such claims or enforcing our own patents. In the event that a successful claim of patent infringement is brought against us, we may be required to pay damages and obtain one or more licenses from these third parties, subjecting us to substantial royalty payment obligations. We may not be able to obtain these licenses on commercially reasonable terms, or at all. Defense of any lawsuit or failure to obtain any of these licenses could adversely affect our ability to develop and commercialize products.
We may be subject to damages resulting from claims that we, our employees or independent contractors have wrongfully used or disclosed alleged trade secrets of their former employers.
Many of our employees and independent contractors were previously employed at universities or other biotechnology, biopharmaceutical or pharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that we or these employees or independent contractors have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers, or used or sought to use patent inventions belonging to their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and divert management’s attention.the attention of management. If we fail in defending such claims, in addition to paying damages, we may lose valuable intellectual property rights or personnel. A loss of key research personnel and/or their work product could hamper or prevent our ability to develop or commercialize certain product candidates, which could severely harmhave a material adverse impact on our business.business, financial condition and results of operations.
Risks Related to Employees and Location
If we are unable to manage our growth, there could be a material adverse impact on our business, financial condition and results of operations, and our prospects may be adversely affected.
We have experienced and expect to continue to experience growth in the number of our employees and in the scope of our operations. This growth places significant demands on our management operational and financial resources, and our current and planned personnel facilities, systems, procedures and controlsoperating practices may not be adequate to support our growth. To effectively manage our growth, we must continue to improve existing, and implement new, facilities, operational and financial systems, and procedures and controls, as well as expand, train and manage our growing employee base, and there can be no assurance that we will effectively manage our growth without experiencing operating inefficiencies or control deficiencies. We expect that we may need to increase our management personnel to oversee our expanding operations, and recruiting and retaining qualified individuals is difficult. If we are unable to manage our growth effectively, including as result of the COVID-19 pandemic or otherwise, or we are unsuccessful in recruiting qualified management personnel, there could be a material adverse impact on our business, financial condition and results of operations, and our prospects may be adversely affected.

operations.
The loss of key personnel or the inability to retain and, where necessary, attract additional personnel could impair our ability to operate and expand our operations.
We are highly dependent upon the principal members of our management, as well as clinical, commercial and scientific staff, the loss of whose services might adversely impact the achievement of our objectives. Also, we may not have sufficient personnel to execute our business plans. Retaining and, where necessary, recruiting qualified clinical, commercial, scientific and scientificpharmaceutical operations personnel will be critical to support activities related to advancing the development program for cabozantinib and our other compounds,product candidates, successfully executing upon our commercialization plan for cabozantinib and our internal proprietary research and development efforts. Competition is intense for experienced clinical, commercial, scientific and pharmaceutical operations personnel, and we may be unable to retain or recruit such personnel with the expertise or experience necessary to allow us to successfully develop and commercialize our products. Similarly, the COVID-19 pandemic could negatively impact the health of key personnel or make it difficult to recruit qualified personnel for critical positions. Further, all of our employees are employed “at will” and, therefore, may leave our employment at any time.
Additionally, in the second quarter of 2018, we moved our corporate headquarters from South San Francisco, California to Alameda, California. This relocation may make it more difficult to retain certain employees, and any resulting loss of talent and need to recruit and train new employees could be disruptive to our business.
Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event.
Our headquarters in Alameda, California is located in the San Francisco Bay Area, and therefore our facilities are vulnerable to damage from earthquakes. We have limitedOur earthquake insurance which may not cover all of the damage we may suffer in the event of an earthquake. We are also vulnerable to damage from other types of disasters, including fires and floods, which have become a significant danger in California during recent years, as well as power loss, communications failures, aircraft disasters (due to the proximity of our headquarters to a major international airport), terrorism and similar events, and any insurance we may maintain may be inadequate to cover our losses. If any disaster were to occur, our ability to operate our
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business at our facilities could be seriously, or potentially completely, impaired. In addition, a disaster could causeimpaired, causing significant delays in our programs and makemaking it difficult for us to recover due to the unique nature of our research activities. Accordingly, an earthquake or other disaster could materiallyhave a material adverse impact on our business, financial condition and adversely harm our ability to conduct business.results of operations.
Facility security breaches may disrupt our operations, subject us to liability and harm our operating results.
Any break-in or trespass at our facilities that results in the misappropriation, theft, sabotage or any other type of security breach with respect to our proprietary and confidential information, including research or clinical data, or that results in damage to our research and development equipment and assets, or that results in physical or psychological harm to any of our employees, could subject us to liability or otherwise have a material adverse impact on our business, financial condition and results of operations.
Risks Related to Environmental and Product Liability
We use hazardous chemicals and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly.
Our research and development processes involve the controlled use of hazardous materials, including chemicals and biological materials. Ourmaterials, and our operations can produce hazardous waste products. We cannot eliminate the risk of accidental contamination or discharge, or any resultant injury from these materials. Federal, statematerials, and local laws and regulations govern the use, manufacture, storage, handling and disposal of hazardous materials. Wewe may face liability under applicable laws for any injury or contamination that results from our use or the use by our collaboration partners or other third parties of these materials, and such liability may exceed our insurance coverage and our total assets. ComplianceIn addition, we may be required to indemnify our collaboration partners against all damages and other liabilities arising out of our development activities or products produced in connection with our collaborations with them. Moreover, our continued compliance with environmental laws and regulations may be expensive, and current or future environmental regulations may impair our research, development and production efforts.
In addition, our collaborators may use hazardous materials in connection with our collaborative efforts. In the event of a lawsuit or investigation, we could be held responsible for any injury caused to persons or property by exposure to, or release of, any hazardous materials used by these parties. Further, we may be required to indemnify our collaborators against all damages and other liabilities arising out of our development activities or products produced in connection with these collaborations.
We face potential product liability exposure far in excess of our limited insurance coverage.
We may be held liable if any product we or our collaboratorscollaboration partners develop or commercialize causes injury or is found otherwise unsuitable during product testing, manufacturing, marketing or sale. Regardless of merit or eventual outcome,

product liability claims could result in decreased demand for our products and product candidates, injury to our reputation, withdrawal of patients from our clinical trials, product recall, substantial monetary awards to third parties and the inability to commercialize any products that we may develop in the future. These claims might be made directly by consumers, health carehealthcare providers, pharmaceutical companies or others selling or testing our products. We have obtained limited product liability insurance coverage for our clinical trials and commercial activities for cabozantinib in the amount of $20.0 million per occurrence and $20.0 million in the aggregate. However, our insurance may not reimburse us or may not be sufficient to reimburse us for expenses or losses we may suffer. Moreover, if insurance coverage becomes more expensive, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. On occasion, juries have awarded large judgments in class action lawsuits for claims based on drugs that had unanticipated side effects. In addition, the pharmaceutical,biotechnology, biopharmaceutical and biotechnologypharmaceutical industries, in general, have been subject to significant medical malpractice litigation. A successful product liability claim or series of claims brought against us could harm our reputation and business and would decrease our cash reserves.
Risks Related to Our Common Stock
We expect that our quarterly results of operations will fluctuate, and this fluctuation could cause our stock price to decline, causing investor losses.
Our quarterly operating results have fluctuated in the past and are likely to fluctuate in the future. A number of factors, many of which we cannot control, could subject our operating results to volatility, including:
the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;
customer ordering patterns for CABOMETYX and COMETRIQ, which may vary significantly from period to period as a result of multiple factors, including pricing information required to be disclosed by us pursuant to drug pricing transparency laws;
the overall level of demand for CABOMETYX and COMETRIQ, including the impact of any competitive products and the duration of therapy for patients receiving CABOMETYX or COMETRIQ;
the achievement of stated regulatory and commercial milestones and royalties paid under our collaboration agreements;
the commercial success of and revenues generated by products marketed under our collaboration and license agreements, including COTELLIC and MINNEBRO;
changes in the amount of deductions from gross sales, including changes to the discount percentage of rebates and chargebacks mandated by the government programs in which we participate, including increases in the government discount percentage resulting from price increases we have taken or may take in the future, or due to different levels of utilization by entities entitled to government rebates and chargebacks and changes in patient demographics;
costs associated with maintaining our sales, marketing, market access, medical affairs and product distribution capabilities for CABOMETYX and COMETRIQ;
the progress and scope of other development and commercialization activities for cabozantinib and our other compounds;
future clinical trial results;
our future investments in the expansion of our pipeline through internal drug discovery and business development activities;
the inability to obtain adequate product supply for any approved drug product or inability to do so at acceptable prices;
recognition of upfront licensing or other fees or revenues;
payments of non-refundable upfront or licensing fees, or payment for cost-sharing expenses, to third parties;
the introduction of new technologies or products by our competitors;
the timing and willingness of collaborators to further develop or, if approved, commercialize our product candidates out-licensed to them;
the termination or non-renewal of existing collaborations or third-party vendor relationships;
regulatory actions with respect to our product candidates and any approved products or our competitors’ products;

disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies, including with respect our current and potential future patent litigations against MSN and potential future generic applicants;
the timing and amount of expenses incurred for clinical development and manufacturing of cabozantinib;
adjustments to expenses accrued in prior periods based on management’s estimates after the actual level of activity relating to such expenses becomes more certain;
the impairment of acquired goodwill and other assets;
significant fluctuations in interest rates or foreign currency exchange rates;
general and industry-specific economic conditions that may affect our or our collaborators’ research and development expenditures; and
other factors described in this “Risk Factors” section.
In addition, in the fourth quarter of 2018, we determined, based on our facts and circumstances, that it was more likely than not that a substantial portion of our deferred tax assets would be realized and, as a result, substantially all of our valuation allowance against deferred tax assets was released. Therefore, beginning in 2019, we record income tax expense at an estimated tax rate that will likely approximate statutory tax rates, adjusted for discrete tax items, which has resulted in a significant reduction in our net income and net income per share.
Due to the possibility of such fluctuations in our revenues and expenses, we believe that quarter-over-quarter comparisons of our operating results are not a good indication of our future performance. As a result, in some future quarters, our operating results may not meet the expectations of securities analysts and investors, which could result in a decline in the price of our common stock.
Our stock price has been and may in the future be highly volatile.
The trading price of our common stock has been highly volatile, and we believe the trading price of our common stock will remain highly volatile and may fluctuate substantially due to factors such as the following, many of which we cannot control:
adverse or inconclusive results or announcements related to our or our collaborators’ clinical trials or delays in those clinical trials;
•the announcement of FDA approval or non-approval, or delays in the FDA review process with respect to cabozantinib, our collaborators’collaboration partners’ product candidates being developed in combination with cabozantinib, or our competitors’ product candidates;
•the commercial successperformance of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;products, including royalties paid under our collaboration and license agreements;
•adverse or inconclusive results or announcements related to our or our collaboration partners’ clinical trials or delays in those clinical trials;
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•the timing of achievement of our clinical, regulatory, partnering, commercial and other milestones such as the commencement of clinical development, the completion of a clinical trial, the filing for regulatory approval or the establishment of collaborative arrangements for cabozantinib or any of our other programs or compounds;product candidates;
•our ability to make future investments in the expansion of our pipeline through internal drug discovery and business development activities;
•our ability to obtain the materials and services, including an adequate product supply for any approved drug product, from our third-party vendors or do so at acceptable prices;
•the timing and amount of expenses incurred for clinical development and manufacturing of cabozantinib;
•actions taken by regulatory agencies, both in the U.S. and abroad, with respect to cabozantinib or our clinical trials for cabozantinib;
•unanticipated regulatory actions taken by the FDA as a result of changing FDA standards and practices concerning the review of product candidates, including approvals at earlier stages of clinical development or with lesser developed data sets and expedited reviews;
•the announcement of new products or clinical trial data by our competitors;
•the announcement of regulatory applications, such as MSN’s ANDA, seeking approval of generic versions of our marketed products;
•quarterly variations in our or our competitors’ results of operations;
developments•changes in our relationships with our collaborators,collaboration partners, including the termination or modification of our agreements;agreements, or other events or conflicts that may affect our collaboration partners’ timing and willingness to develop, or if approved, commercialize our products and product candidates out-licensed to them;
•the announcement of an in-licensed product candidate or strategic acquisition;
conflicts or litigation with our collaborators;
•litigation, including intellectual property infringement and product liability lawsuits, involving us;

•the impairment of acquired goodwill and other assets;
•changes in earnings estimates or recommendations by securities analysts, or financial guidance from our management team, and any failure to achieve the operating results projected by securities analysts;analysts or by our management team;
•the entry into new financing arrangements;
•developments in the biotechnology, biopharmaceutical or pharmaceutical industry;
•sales of large blocks of our common stock or sales of our common stock by our executive officers, directors and significant stockholders;
•additions and departures of key personnel or board members;
•the extent to which coverage and reimbursement is available for both CABOMETYX and COMETRIQ from government and health administration authorities, private health insurers, managed care programs and other third-party payers;
disposition of any of our technologies or compounds;
•significant fluctuations in interest rates or foreign currency exchange rates; and
•general market, economic and political conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.competitors, such as the impact of the COVID-19 pandemic on financial markets.
These and other factors as well as general economic, political and market conditions, may materially adversely affectcould have material adverse impact on the market price of our common stock. In addition, the stock markets in general, and the markets for biotechnology and pharmaceutical stocks in particular, have historically experienced significant volatility that has often been unrelated or disproportionate to the operating performance of particular companies. For example, negative publicity regarding drug pricing and price increases by pharmaceutical companies has negatively impacted, and may continue to negatively impact, the markets for biotechnology and pharmaceutical stocks. Likewise, as a result of the uncertainty of the date and the terms of the pending Brexit and/or significant changes in U.S. social,or global political regulatory and economic conditions, or in laws andincluding the effects of the COVID-19 pandemic, policies governing foreign trade and health carehealthcare spending and delivery, including possible repeal and/or replacement of or adverse judicial rulings against all or portions of PPACA or increases or changes in tariffs and other trade restrictions stemming from Trump administration and foreign government policies, or future potential U.S. federal government shutdowns, the financial markets could continue to experience significant volatility that could also continue to negatively impact the markets for biotechnology and pharmaceutical stocks. These broad market fluctuations have adversely affected, and may in the future adversely affect the trading price of our common stock. Excessive volatility may continue for an extended period of time following the date of this report.
In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted. A securities class action suit against us could result in substantial costs and divert management’sthe attention and resources,of management, which could have a material adverse impact on our business, financial condition and results of operations.
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Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent or deter attempts by our stockholders to replace or remove our current management, which could cause the market price of our common stock to decline.
Provisions in our corporate charter and bylaws may discourage, delay or prevent an acquisition of us, a change in control, or attempts by our stockholders to replace or remove members of our current Board of Directors. Because our Board of Directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team. These provisions include:
•a prohibition on actions by our stockholders by written consent;
the inability of our stockholders to call special meetings of stockholders;
•the ability of our Board of Directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our Board of Directors; and
•advance notice requirements for director nominations and stockholder proposals.
Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds    
Not applicable.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Build to Suit LeaseNot applicable.
On October 25, 2019, we entered into a build-to-suit Lease Agreement (the Build-to-Suit Lease) with Ernst Development Partners, Inc. (Ernst), for approximately 220,000 square feet of office space located in Alameda, California (the New Premises), adjacent to our current corporate headquarters (the Current Premises).
The term of the Build-to-Suit Lease is for a period of 242 months (the Term), which will begin on the completion of the building and tenant improvements by Ernst. The Term is currently anticipated to begin on October 25, 2021. The monthly base rent under the Build-to-Suit Lease will equal to a percentage of the total development costs incurred in connection with the development of the New Premises (excluding the cost of the tenant improvements in excess of the allowance provided by Ernst and any development costs we pay) and is currently estimated to be about $726,000, subject to an annual increase of 3% during the Term. The monthly base rent will begin sixty days following commencement of the Term. We will also be responsible for paying operating expenses related to the New Premises. We have been provided an allowance of $75 per square foot of the New Premises (approximately $16.5 million) for tenant improvements to the New Premises. To the extent that the total development costs of the New Premises exceeds $525 per square foot, we will also pay 50% of such excess costs prior to the commencement of the Term, and may be required to secure such amount and the cost of the tenant improvements in excess of the allowance by providing a letter of credit or depositing such amounts in an account with Ernst’s lender prior to the start of construction.
The Build-to-Suit Lease includes two five-year options to extend the term of the Build-to-Suit Lease, exercisable under certain conditions and at a market rate determined in accordance with the Build-to-Suit Lease. We have a one-time option to terminate the Build-to-Suit Lease without cause after the 180th month of the Term, exercisable under certain conditions as described in the Build-to-Suit Lease and subject to a termination payment calculated in accordance with the Build-to-Suit Lease. In addition, we have a right of first offer to purchase the New Premises, subject to certain procedures and exclusions set forth in the Build-to-Suit Lease.
In connection with the Build-to-Suit Lease, we will deliver to Ernst an irrevocable standby letter of credit for $726,000, which amount will be adjusted to reflect the initial monthly base rent once it is determined, as security for our performance of our obligations under the Build-to-Suit Lease.
Ernst does not yet own the land upon which the New Premises will be built, and the Build-to-Suit Lease is subject to termination if Ernst does not acquire such land. The Build-to-Suit Lease contains customary events of default, representations, warranties and covenants.
 The foregoing summary of the Build-to-Suit Lease does not purport to be complete and is qualified in its entirety by the full text of the Build-to-Suit Lease, which is filed as Exhibit 10.2 to this Quarterly Report on Form 10-Q and incorporated herein by reference.
Fourth Amendment to the Lease
In the fourth quarter of 2019, Hillwood Enterprises, L.P. (Hillwood) is expected to purchase the project known as 1750 North Loop Road and 1601, 1701, 1751, 1801 and 1851 Harbor Bay Parkway, Alameda, California from Ascentris 105, LLC (the Purchase), which project includes the Current Premises. Effective upon the Purchase, Hillwood will become the landlord pursuant to that certain Lease Agreement dated May 2, 2017, as amended (the Lease).

On August 30, 2019, we entered into an amendment to the Lease with Hillwood (the Fourth Lease Amendment), pursuant to which each of our rights and obligations are contingent upon the Purchase. Effective upon the Purchase, the Fourth Lease Amendment will provide for, among other things, the (i) expansion of the Current Premises by 59,335 square feet of laboratory facilities located at 1701 Harbor Bay Parkway, Alameda, California (the 1701 Expansion Space), (ii) extension of the Lease term through October 31, 2031 (the New Term) and (iii) elimination of our early termination right.
Assuming the Purchase occurs, we expect to take possession of the 1701 Expansion Space on or prior to April 30, 2020 and will begin to pay rent on or within fifteen days following delivery of each respective portion of the 1701 Expansion Space. Following receipt of the entire 1701 Expansion Space, and assuming such receipt occurs on April 30, 2020 (the 1701 Expansion Space Commencement Date), the total monthly base rent under the Lease for the entire premises, consisting of the Current Premises and the 1701 Expansion Space (the Entire Premises) will be $391,580 per month, increasing throughout the remainder of the New Term to $574,975 at the end of the New Term. The aggregate contractual base rent for the entire 228,941 square feet of the Entire Premises from the 1701 Expansion Space Commencement Date through the remainder of the New Term of Lease will be approximately $67.0 million. If any portion of the 1701 Expansion Space is delivered prior to the 1701 Expansion Space Commencement Date, our base rent obligations will increase in accordance with the terms of the Lease. In addition, we will pay the New Landlord specified percentages of certain operating expenses and taxes related to the leased facilities incurred by the New Landlord.
The foregoing summary of the Fourth Lease Amendment does not purport to be complete and is qualified in its entirety by reference to the Fourth Lease Amendment, which is filed as Exhibit 10.3 to this Quarterly Report on Form 10-Q and incorporated herein by reference.
Item 6. Exhibits
Exhibit
Number
Exhibit DescriptionIncorporation by Reference
Filed
Herewith
FormFile Number
Exhibit/
Appendix
Reference
Filing Date
3.110-K000-302353.13/10/2010
3.210-K000-302353.23/10/2010
3.38-K000-302353.15/25/2012
3.48-K000-302353.110/15/2014
3.58-K000-302353.210/15/2014
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Exhibit
Number
 Exhibit Description Incorporation by Reference 
Filed
Herewith
Form File Number 
Exhibit/
Appendix
Reference
 Filing Date 
3.1 
Amended and Restated Certificate of Incorporation of Exelixis, Inc.
 10-K 000-30235 3.1 3/10/2010  
3.2 
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Exelixis, Inc.
 10-K 000-30235 3.2 3/10/2010  
3.3 
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Exelixis, Inc.
 8-K 000-30235 3.1 5/25/2012  
3.4 
Certificate of Change of Registered Agent and/or Registered Office of Exelixis, Inc.
 8-K 000-30235 3.1 10/15/2014  
3.5 
Certificate of Ownership and Merger Merging X-Ceptor Therapeutics, Inc. with and into Exelixis, Inc.
 8-K 000-30235 3.2 10/15/2014  
3.6 
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Exelixis, Inc.
 8-K 000-30235 3.1 5/23/2019  
3.7 
Amended and Restated Bylaws of Exelixis, Inc.
 8-K 000-30235 3.2 5/23/2019  
4.1 
Specimen Common Stock Certificate
 
S-1,
as amended
 333-96335 4.1 4/7/2000  
10.1* 
Amendment No. 2 dated August 15, 2019 to the Clinical Trial Collaboration Agreement dated February 24, 2017, by and between Exelixis, Inc. and Bristol-Myers Squibb Company
         X

Exhibit
Number
Exhibit DescriptionIncorporation by Reference
Filed
Herewith
FormFile Number
Exhibit/
Appendix
Reference
Filing Date
3.68-K000-302353.15/23/2019
3.78-K000-302353.12/20/2020
4.1S-1,
as amended		333-963354.14/7/2000
10.1*X
31.1X
31.2X
32.1‡X
101.INSXBRL Instance DocumentThe XBRL instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
101.SCHInline XBRL Taxonomy Extension Schema DocumentX
101.CALInline XBRL Taxonomy Extension Calculation Linkbase DocumentX
101.DEFInline XBRL Taxonomy Extension Definition Linkbase DocumentX
101.LABInline XBRL Taxonomy Extension Labels Linkbase DocumentX
101.PREInline XBRL Taxonomy Extension Presentation Linkbase DocumentX
104Cover Page Interactive Data FileFormatted as Inline XBRL and contained in Exhibit 101.
Exhibit
Number
Exhibit DescriptionIncorporation by Reference
Filed
Herewith
FormFile Number
Exhibit/
Appendix
Reference
Filing Date
10.2
Lease Agreement dated October 25, 2019, between Ernst Development Partners, Inc. and Exelixis, Inc.
X
10.3
Fourth Amendment dated August 30, 2019, to Lease Agreement dated May 2, 2017, between Hillwood Enterprises, L.P. (as successor in interest to Ascentris 105, LLC) and Exelixis, Inc.
X
31.1
Certification of Principal Executive Officer Pursuant to Exchange Act Rules 13a-14(a) and Rule 15d-14(a)
X
31.2
Certification of Principal Financial Officer Pursuant to Exchange Act Rules 13a-14(a) and Rule 15d-14(a)
X
32.1‡
Certifications of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350
X
101.INSXBRL Instance DocumentThe instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
101.SCH
Inline XBRL Taxonomy Extension Schema Document
X
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
X
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
X
101.LAB
Inline XBRL Taxonomy Extension Labels Linkbase Document
X
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
X
104Cover Page Interactive Data FileFormatted as Inline XBRL and contained in Exhibit 101.
*
*Portions of this exhibit have been omitted as being immaterial and would be competitively harmful if publicly disclosed.
‡This certification accompanies this Quarterly Report on Form 10-Q, is not deemed filed with the SEC and is not to be incorporated by reference into any filing of Exelixis, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Quarterly Report on Form 10-Q), irrespective of any general incorporation language contained in such filing.

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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. 
EXELIXIS, INC.
October 30, 2019November 5, 2020By:
/s/    CHRISTOPHER J. SENNER        
DateChristopher J. Senner
Executive Vice President and Chief Financial Officer
(Duly Authorized Officer and Principal Financial and Accounting Officer)

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