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 ☒ 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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit files). Yes ☒ 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.

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 Exchange Act ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒.

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date. ~~38,960,995~~39,762,431 shares of Common Stock, par value $0.0001 per share, were outstanding as of ~~November 1, 2019.~~October 30, 2020.

This Quarterly Report on Form 10-Q, or this Quarterly Report, contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Any statements about our expectations, beliefs, plans, objectives, assumptions, future events or performance are not historical facts and may be forward looking. These forward-looking statements include, but are not limited to, statements about:

These statements are often, but not always, made through the use of words or phrases such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend” and similar words or phrases. Accordingly, these statements involve estimates, assumptions and uncertainties that could cause actual results to differ materially from those expressed in them. Discussions containing these forward-looking statements may be found throughout this Quarterly Report, ~~on Form 10-Q,~~ including, in Part I, the section entitled “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These forward-looking statements involve risks and uncertainties, including the risks discussed in Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, ~~2018~~2019 and in Part II, Item 1A, “Risk Factors” of our Quarterly Report on Form 10-Q for the Quarter ended March 31, 2020 that could cause our actual results to differ materially from those in the forward-looking statements. Such risks should be considered in evaluating our prospects and future financial performance. We undertake no obligation to update the forward-looking statements or to reflect events or circumstances after the date of this document.

	September 30, 2019			December 31, 2018			September 30, 2020			December 31, 2019
ASSETS
Current assets:
Cash and cash equivalents	$	58,904		$	108,419		$	90,082		$	60,037
Marketable securities		51,535			57,002			18,942			51,607
Accounts receivable, net		27,182			20,773			27,137			28,896
Inventory, net		3,123			2,625			3,144			3,170
Prepaid expenses, current		9,990			12,397			8,025			13,259
Deferred rent		39			—			198			154
Restricted cash, current								8,850			8,850
Other current assets		322			1,787			3,426			323
Total current assets		151,095			203,003			159,804			166,296
Lease right-of-use assets, net		20,194			—			16,957			18,522
Property and equipment, net		3,204			3,963			2,659			3,304
Intangible assets, net		41,447			44,408			76,144			40,461
Restricted cash		13,173			4,319
Restricted cash, long-term								3,311			4,323
Prepaid expenses and other, long-term		2,931			3,429			2,820			1,999
Total assets	$	232,044		$	259,122		$	261,695		$	234,905
LIABILITIES AND STOCKHOLDERS' EQUITY
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY
Current liabilities:
Accounts payable	$	9,056		$	20,684		$	12,528		$	19,183
Accrued expenses		76,771			46,431
Lease liabilities		2,516			—
Accrued expenses, current								63,471			69,030
Accrued in-licensed rights, current								31,017			—
Post-marketing commitment liability, current								2,496			—
Lease liabilities, current								2,971			2,624
Current portion of long-term debt								5,714			—
Total current liabilities		88,343			67,115			118,197			90,837
Deferred rent		—			5,815
Accrued expenses, long-term								25,493			—
Lease liabilities, long-term		23,336			—			20,365			22,643
Post-marketing commitment liability		9,000			—
Post-marketing commitment liability, long-term								6,379			9,000
Long-term debt		94,185			151,886			91,714			94,962
Total liabilities		214,864			224,816			262,148			217,442

Stockholders' equity:
Common stock - $.0001 par value per share; 100,000,000 shares authorized; 38,943,774 shares issued and outstanding at September 30, 2019 and 38,325,037 issued and outstanding at December 31, 2018		4			4
Commitments and contingencies (Note 13)
Stockholders' (deficit) equity:
Common stock - $.0001 par value per share; 100,000,000 shares authorized; 39,720,931 shares issued and outstanding at September 30, 2020 and 39,203,304 issued and outstanding at December 31, 2019								4			4
Additional paid-in capital		1,283,498			1,236,355			1,322,180			1,295,033
Receivable from exercise of stock options		—			—
Accumulated other comprehensive income (loss)		115			(12	)
Accumulated other comprehensive income								—			62
Accumulated deficit		(1,266,437	)		(1,202,041	)		(1,322,637	)		(1,277,636	)
Total stockholders' equity		17,180			34,306
Total liabilities and stockholders' equity	$	232,044		$	259,122
Total stockholders' (deficit) equity								(453	)		17,463
Total liabilities and stockholders' (deficit) equity							$	261,695		$	234,905

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

	For the Three Months Ended September 30,						For the Nine Months Ended September 30,						For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2019			2018			2019			2018			2020			2019			2020			2019
Revenue:
Product revenue, net	$	53,482		$	52,629		$	152,913		$	139,412		$	49,333		$	53,482		$	146,713		$	152,913
License revenue		2,750			10,000			56,250			40,500			—			2,750			22,700			56,250
Royalty revenue		120			—			175			—			1,421			120			3,140			175
Total revenue		56,352			62,629			209,338			179,912			50,754			56,352			172,553			209,338
Operating costs and expenses:
Cost of sales		9,371			9,048			26,673			24,262			9,943			9,371			28,434			26,673
Selling, general and administrative		31,402			28,502			110,435			105,239			29,598			31,402			89,882			110,435
Research and development		30,027			36,360			102,610			126,529			23,344			30,027			73,490			102,610
Total operating costs and expenses		70,800			73,910			239,718			256,030			62,885			70,800			191,806			239,718
Loss from operations		(14,448	)		(11,281	)		(30,380	)		(76,118	)		(12,131	)		(14,448	)		(19,253	)		(30,380	)
Other income (expenses):
Interest income		569			590			2,349			1,093			22			569			474			2,349
Interest expense		(3,052	)		(3,499	)		(11,943	)		(7,165	)		(3,627	)		(3,052	)		(10,479	)		(11,943	)
Legal verdict expense		—			—			(16,350	)		—			(15,855	)		—			(16,041	)		(16,350	)
Loss on debt extinguishment		—			—			(8,103	)		—			—			—			—			(8,103	)
Other income (expenses):		46			(11	)		31			(690	)
Total other expenses:		(2,437	)		(2,920	)		(34,016	)		(6,762	)
Other income														128			46			298			31
Total other expenses														(19,332	)		(2,437	)		(25,748	)		(34,016	)
Net loss	$	(16,885	)	$	(14,201	)	$	(64,396	)	$	(82,880	)	$	(31,463	)	$	(16,885	)	$	(45,001	)	$	(64,396	)
Net loss applicable to common stockholders	$	(16,885	)	$	(14,201	)	$	(64,396	)	$	(82,880	)	$	(31,463	)	$	(16,885	)	$	(45,001	)	$	(64,396	)
Net loss per share of common stock—basic and diluted	$	(0.44	)	$	(0.37	)	$	(1.67	)	$	(2.19	)
Weighted-average shares of common stock outstanding—basic and diluted		38,893,757			38,043,174			38,675,961			37,855,249
Net loss per share of common stock—basic													$	(0.79	)	$	(0.44	)	$	(1.14	)	$	(1.67	)
Weighted-average shares of common stock outstanding—basic														39,695,444			38,893,757			39,473,691			38,675,961

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

2019

2018

2019

2018

Net loss

$
(16,885
)

$
(14,201
)

$
(64,396
)

$
(82,880
)
Other comprehensive loss

Unrealized gain (loss) on available-for-sale securities

15

(2
)

115

(3
)
Reclassifications of (gain) loss on available-for-sale securities

(10
)

—

12

—

Comprehensive loss

$
(16,880
)

$
(14,203
)

$
(64,269
)

$
(82,883
)

	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2020			2019			2020			2019
Net loss	$	(31,463	)	$	(16,885	)	$	(45,001	)	$	(64,396	)
Other comprehensive (loss) income:
Unrealized (loss) gain on available-for-sale securities, net of tax of $0		(1	)		15			(65	)		115
Reclassifications of gain (loss) on available-for-sale securities, included in “Other income”, net of tax of $0		—			(10	)		3			12
Comprehensive loss	$	(31,464	)	$	(16,880	)	$	(45,063	)	$	(64,269	)

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

For the Three Months Ended September 30, 2019

Receivables

Accumulated

Additional

from

Other

Common Stock

Paid-in

Exercises

Comprehensive

Accumulated

Shares

Amount

Capital

of Options

Income (Loss)

Deficit

Total

Balance at June 30, 2019

38,738,707

$
4

$
1,271,209

$
—

$
110

$
(1,249,552
)

$
21,771

Stock-based compensation

—

—

12,213

—

—

—

12,213

Shares issued or restricted stock units vested under employee stock plans

205,067

—

76

—

—

—

76

Unrealized gain on available-for-sale securities

—

—

—

—

5

—

5

Net loss

—

—

—

—

—

(16,885
)

(16,885
)
Balance at September 30, 2019

38,943,774

$
4

$
1,283,498

$
—

$
115

$
(1,266,437
)

$
17,180

For the Three Months Ended September 30, 2020
							Accumulated
					Additional		Other
	Common Stock				Paid-in		Comprehensive			Accumulated
	Shares		Amount		Capital		Income (Loss)			Deficit			Total
Balance at June 30, 2020		39,626,917	$	4	$	1,314,572	$	1		$	(1,291,174	)	$	23,403
Stock-based compensation		—		—		7,565		—			—			7,565
Shares issued or restricted stock units vested under employee stock plans		94,014		—		43		—			—			43
Unrealized loss on available- for-sale securities		—		—		—		(1	)		—			(1	)
Net loss		—		—		—		—			(31,463	)		(31,463	)
Balance at September 30, 2020		39,720,931	$	4	$	1,322,180	$	—		$	(1,322,637	)	$	(453	)

For the Three Months Ended September 30, 2018

Receivables

Accumulated

Additional

from

Other

Common Stock

Paid-in

Exercises

Comprehensive

Accumulated

Shares

Amount

Capital

of Options

Income (Loss)

Deficit

Total

Balance at June 30, 2018

37,890,220

$
4

$
1,195,600

$
(159
)

$
(1
)

$
(1,157,145
)

$
38,299

Stock-based compensation

—

—

20,807

—

—

—

20,807

Shares issued or restricted stock units vested under employee stock plans

234,902

—

851

159

—

—

1,010

Unrealized loss on available-for-sale securities

—

—

—

—

(2
)

—

(2
)
Net loss

—

—

—

—

—

(14,201
)

(14,201
)
Balance at September 30, 2018

38,125,122

$
4

$
1,217,258

$
—

$
(3
)

$
(1,171,346
)

$
45,913

For the Three Months Ended September 30, 2019
							Accumulated
					Additional		Other
	Common Stock				Paid-in		Comprehensive			Accumulated
	Shares		Amount		Capital		Income (Loss)			Deficit			Total
Balance at June 30, 2019		38,738,707	$	4	$	1,271,209	$	110		$	(1,249,552	)	$	21,771
Stock-based compensation		—		—		12,213		—			—			12,213
Shares issued or restricted stock units vested under employee stock plans		205,067		—		76		—			—			76
Reclassification of loss on available-for-sale securities		—		—		—		(10	)		—			(10	)
Unrealized gain on available-for-sale securities		—		—		—		15			—			15
Net loss		—		—		—		—			(16,885	)		(16,885	)
Balance at September 30, 2019		38,943,774	$	4	$	1,283,498	$	115		$	(1,266,437	)	$	17,180

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

For the Nine Months Ended September 30, 2019

Receivables

Accumulated

Additional

from

Other

Common Stock

Paid-in

Exercises

Comprehensive

Accumulated

Shares

Amount

Capital

of Options

Income (Loss)

Deficit

Total

Balance at December 31, 2018

38,325,037

$
4

$
1,236,355

$
—

$
(12
)

$
(1,202,041
)

$
34,306

Stock-based compensation

—

—

45,791

—

—

—

45,791

Shares issued or restricted stock units vested under employee stock plans

618,737

—

1,352

—

—

—

1,352

Unrealized gain on available-for-sale securities

—

—

—

—

127

—

127

Net loss

—

—

—

—

—

(64,396
)

(64,396
)
Balance at September 30, 2019

38,943,774

$
4

$
1,283,498

$
—

$
115

$
(1,266,437
)

$
17,180

For the Nine Months Ended September 30, 2020
							Accumulated
					Additional		Other
	Common Stock				Paid-in		Comprehensive			Accumulated
	Shares		Amount		Capital		Income (Loss)			Deficit			Total
Balance at December 31, 2019		39,203,304	$	4	$	1,295,033	$	62		$	(1,277,636	)	$	17,463
Stock-based compensation		—		—		27,102		—			—			27,102
Shares issued or restricted stock units vested under employee stock plans		517,627		—		45		—			—			45
Reclassification of gain on available-for-sale securities		—		—		—		3			—			3
Unrealized loss on available- for-sale securities		—		—		—		(65	)		—			(65	)
Net loss		—		—		—		—			(45,001	)		(45,001	)
Balance at September 30, 2020		39,720,931	$	4	$	1,322,180	$	—		$	(1,322,637	)	$	(453	)

For the Nine Months Ended September 30, 2018

Receivables

Accumulated

Additional

from

Other

Common Stock

Paid-in

Exercises

Comprehensive

Accumulated

Shares

Amount

Capital

of Options

Income (Loss)

Deficit

Total

Balance at December 31, 2017

37,594,851

$
4

$
1,142,213

$
(449
)

$
—

$
(1,088,466
)

$
53,302

Stock-based compensation

—

—

68,343

—

—

—

68,343

Shares issued or restricted stock units vested under employee stock plans

530,271

—

6,702

449

—

—

7,151

Unrealized loss on available-for-sale securities

—

—

—

—

(3
)

—

(3
)
Net loss

—

—

—

—

—

(82,880
)

(82,880
)
Balance at September 30, 2018

38,125,122

$
4

$
1,217,258

$
—

$
(3
)

$
(1,171,346
)

$
45,913

For the Nine Months Ended September 30, 2019
							Accumulated
					Additional		Other
	Common Stock				Paid-in		Comprehensive			Accumulated
	Shares		Amount		Capital		Income (Loss)			Deficit			Total
Balance at December 31, 2018		38,325,037	$	4	$	1,236,355	$	(12	)	$	(1,202,041	)	$	34,306
Stock-based compensation		—		—		45,791		—			—			45,791
Shares issued or restricted stock units vested under employee stock plans		618,737		—		1,352		—			—			1,352
Reclassification of gain on available-for-sale securities		—		—		—		12			—			12
Unrealized gain on available-for-sale securities		—		—		—		115			—			115
Net loss		—		—		—		—			(64,396	)		(64,396	)
Balance at September 30, 2019		38,943,774	$	4	$	1,283,498	$	115		$	(1,266,437	)	$	17,180

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

.	For the Nine Months Ended September 30,
							For the Nine Months Ended September 30,
	2019			2018			2020			2019
Operating activities:
Net loss	$	(64,396	)	$	(82,880	)	$	(45,001	)	$	(64,396	)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation and amortization		6,178			5,279			7,085			6,178
Stock-based compensation		45,791			68,343			27,102			45,791
Disposal of property and equipment		54			—			—			54
Loss on debt extinguishment		8,047			—			—			8,047
Debt modification fees		—			289
Changes in operating assets and liabilities:
Accounts receivable, net		(6,409	)		(10,080	)		1,759			(6,409	)
Inventory		(498	)		(803	)
Inventory, net								26			(498	)
Prepaid expenses and other		2,905			244			4,413			2,905
Other current assets		1,465			(11,495	)		(3,103	)		1,465
Accounts payable		(11,628	)		(11,388	)		(6,655	)		(11,628	)
Accrued expenses		30,340			10,869
Accrued expenses and other								20,951			30,340
Deferred rent		(39	)		470			(44	)		(39	)
Post-marketing commitment liability		9,000			—			(125	)		9,000
Net cash provided by (used in) operating activities		20,810			(31,152	)
Net cash provided by operating activities								6,408			20,810
Investing activities:
Purchase of property and equipment		—			(550	)		(23	)		—
Purchase of available-for-sale securities		(127,072	)		(71,112	)		(24,430	)		(127,072	)
Sale of available-for-sale securities		28,135			—			—			28,135
Maturity of available-for-sale securities		104,532			11,457			57,033			104,532
Net cash provided by (used in) investing activities		5,595			(60,205	)
Purchase of intangible assets								(10,000	)		—
Net cash provided by investing activities								22,580			5,595
Financing activities:
Net proceeds from shares issued under employee stock plans		1,352			7,151			45			1,352
Proceeds from long-term debt		25,000			75,000
Proceeds from debt								8,444			25,000
Payment of debt		(80,000	)		—			(8,444	)		(80,000	)
Payment of debt extinguishment costs		(7,793	)		—			—			(7,793	)
Payment of debt issuance costs		(5,625	)		(4,192	)		—			(5,625	)
Net cash (used in) provided by financing activities		(67,066	)		77,959
Net decrease in cash, cash equivalents and restricted cash		(40,661	)		(13,398	)
Net cash provided by (used in) financing activities								45			(67,066	)
Net increase (decrease) in cash, cash equivalents and restricted cash								29,033			(40,661	)
Cash, cash equivalents and restricted cash, beginning of period		112,738			86,015			73,210			112,738
Cash, cash equivalents and restricted cash, end of period	$	72,077		$	72,617		$	102,243		$	72,077

Supplemental disclosures of non-cash investing and financing activities:
Property and equipment purchases in accounts payable	$	—		$	59
Receivables related to stock option exercises	$	—		$	—
Intangibles in accrued expenses							$	30,000		$	—

Supplemental disclosure of cash flow information:
Interest paid	$	9,464		$	5,134		$	7,021		$	9,464
Income taxes paid							$	183		$	—

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

Puma Biotechnology, Inc., or the Company, is a biopharmaceutical company based in Los Angeles, California with a focus on the development and commercialization of innovative products to enhance cancer care. The Company ~~has in-licensed~~in-licenses from Pfizer, Inc., or Pfizer, the global development and commercialization rights to PB272 (neratinib, ~~(oral))~~oral), PB272 (neratinib, ~~(intravenous))~~intravenous) and ~~PB357.~~PB357, as well as certain related compounds. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors HER1, HER2 and HER4. Currently, the Company is primarily focused on the ~~U.S.~~development and commercialization ~~of NERLYNX (neratinib), its first U.S. Food and Drug Administration, or FDA, approved product, and on the further development~~ of the oral version of neratinib, ~~for additional indications in~~and its most advanced drug candidates are directed at the treatment of HER2-positive breast ~~cancer.~~ cancer and HER2 mutated cancers. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including other tumor types that over-express or have a mutation in HER2 or EGFR, such as breast cancer, cervical cancer, lung cancer or other solid tumors.

The Company has 2 subsidiaries, Puma Biotechnology Ltd., a United Kingdom company, and Puma Biotechnology, B.V., a Netherlands company. These subsidiaries were established for the purpose of legal representation in the United Kingdom and the European Union.

The Company is focused on developing and commercializing neratinib for the treatment of patients with human epidermal growth factor receptor type 2, or HER2-positive, breast cancer, HER2 mutated breast cancer and non-small cell lung cancer, and other solid tumors that have an activating mutation in HER2. The Company has reported a net loss of approximately $16.9 million and $64.4 million for the three and nine months ended September 30, 2019, and cash flows from operations of approximately $20.8 million for the nine months ended September 30, 2019.incurred significant operating losses since its inception. The Company believes that it will continue to incur net losses and may incur negative net cash flows from operating activities through the drug development process and global commercialization.

~~The Company has incurred significant operating losses since its inception. On July 17,~~ In 2017, the Company received U.S. Food and Drug Administration, or FDA, approval for its first product, NERLYNX® (neratinib), formerly known as PB272 (neratinib, ~~(oral))~~oral), for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. Following FDA approval in July 2017, NERLYNX became available by prescription in the United States, and the Company commenced commercialization.

~~The Company in-licenses~~ ~~PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357, as well as certain related compounds,~~ ~~from Pfizer Inc.,~~In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or ~~Pfizer. The Company is required to make substantial payments to Pfizer upon~~metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the ~~achievement of certain milestones and has contractual obligations for clinical trial contracts.~~metastatic setting.

Additionally, the Company has entered into exclusive license agreements with Specialised Therapeutics Asia Pte Ltd., or STA, Medison Pharma Ltd., or Medison, CANbridgepharma Limited, or CANbridge, Pint Pharma International SA, or Pint, and, most recently, Knight Therapeutics Inc., or Knight, and Pierre Fabre Medicament SAS, or Pierre Fabre, to pursue regulatory approval and/or commercialize NERLYNX, if approved, in various specified regions outside of the United States. The Company plans to continue to pursue commercialization of NERLYNX in additional countries outside the United States, if approved, and is evaluating various commercialization options in those countries, including developing a direct salesforce, contracting with third parties to provide sales and marketing capabilities, or some combination of these two options. In ~~September~~ 2018, the European Commission, or EC, granted marketing ~~authorisation~~authorization for NERLYNX in the European Union for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant ~~trastuzumab based~~trastuzumab-based therapy.

The Company is required to make substantial payments to Pfizer upon the achievement of certain milestones and has contractual obligations for clinical trial contracts.

The Company has entered into other exclusive sub-license agreements with various parties to pursue regulatory approval, if necessary, and commercialize NERLYNX, if approved, in many regions outside the United States, including Europe (excluding Russia and Ukraine), Canada, China, Southeast Asia, Israel, Mexico, South Korea, and various countries and territories in Central and South America. The Company plans to continue to pursue commercialization of NERLYNX in other countries outside the United States, if approved.

The Company has reported net losses of approximately $31.5 million and $45.0 million for the three and nine months ended September 30, 2020, respectively, and cash flows from operations of approximately $6.4 million for the nine months ended September 30, 2020. The Company’s commercialization, research and development ~~or R&D,~~ or marketing efforts may require funding in addition to the cash and cash equivalents totaling approximately ~~$58.9~~$90.1 million and marketable securities totaling approximately ~~$51.5~~$18.9 million available at September 30, ~~2019.~~2020. The Company believes that its existing cash and cash equivalents and marketable securities as of September 30, ~~2019~~2020 and proceeds that will become available to the Company through product sales and ~~license~~sub-license payments are sufficient to satisfy its operating cash and needs for at least one year after the filing of the Quarterly Report on Form ~~10-Q.~~10-Q in which these financial statements are included. The Company continues to remain dependent on its ability to obtain sufficient funding to sustain operations and continue to successfully commercialize neratinib in the United States. While the Company has been successful in raising capital in the past, there can be no assurance that it will be able to do so in the future. The Company’s ability to obtain funding may be adversely impacted by uncertain market conditions, the Company’s success in commercializing neratinib, unfavorable decisions of regulatory authorities or adverse clinical trial results. The outcome of these matters cannot be predicted at this time. Additionally, the terms of the Company’s loan and security agreement place restrictions on the Company’s ability to operate the business and on the Company’s financial flexibility, and the Company may be unable to achieve the revenue necessary to satisfy the minimum revenue covenants as specified in the agreement.

Since its inception through September 30, ~~2019,~~2020, the Company’s financing has primarily been proceeds from product and license revenue, public offerings of its common stock, private equity placements, and borrowings under its loan and security agreement.

The significant accounting policies followed in the preparation of these unaudited ~~condensed~~ consolidated financial statements are as follows:

The ~~carrying value~~consolidated financial statements include the accounts of ~~financial instruments, such as cash equivalents, accounts receivable~~the Company and ~~accounts payable, approximate their fair value because~~its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

Management has determined that the Company operates in 1 business segment, which is the development and commercialization of ~~their short-term nature. The carrying value of long-term debt approximates its fair value as the principal amounts outstanding are subject~~innovative products to ~~variable interest rates that are based on market rates, which are regularly reset.~~enhance cancer care.

The preparation of consolidated financial statements in conformity with ~~Generally Accepted Accounting Principles,~~U.S. generally accepted accounting principles, or GAAP, requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the balance sheet, and reported amounts of revenues and expenses for the period presented. Accordingly, actual results could differ from those estimates.

Significant estimates include estimates for variable consideration for which reserves were established. These estimates are included in the calculation of net revenues and include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company’s sale of its products.

During the ~~accounts~~period ended September 30, 2020, the Company changed its estimate of the legal verdict expense and the associated legal expense accrual for the Hsu vs. Puma Biotechnology, Inc. class action lawsuit. The previous estimate was based on data and assumptions that were the best available information at the time. During the third and fourth quarters of 2020, the Company obtained additional data, previously unavailable, from the claims report and ~~its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.~~

The Company classifies all investment securities (short-term and long-term) as available-for-sale, as the sale of such securities may be required prior to maturity to implement management’s strategies. These securities are carried at fair value,amended claims report filed with the ~~unrealized gains and losses, reported as~~Court. The new data indicate that the settlement is expected to be larger than previously estimated. As a ~~component~~result, the Company has changed its estimate of ~~accumulated other comprehensive loss in stockholders’ equity until realized. Realized gains and losses from~~ the ~~sale of available-for-sale securities, if any, are determined~~legal accrual on a ~~specific identification basis. A decline~~prospective basis beginning in the ~~market value~~third quarter of any available-for-sale security below cost that is determined to be other than temporary results in the revaluation of its carrying amount to fair value. The impairment is charged to earnings and a new cost basis for the security is established. Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method. Interest income is recognized when earned.2020.

~~The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability~~This change resulted in an increase of ~~the amounts paid is uncertain~~approximately $15.7 million in legal verdict expense and the ~~technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to~~associated accrued expense, or capitalized based upon the asset achieving technological feasibility in accordance with management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates is reached when the requisite regulatory approvals are obtained to make the product available for sale. The Company capitalizes technology licenses upon reaching technological feasibility.

The Company maintains definite-lived intangible assets related to the Company’s license with Pfizer. These assets are amortized over their remaining useful lives, which are estimated based on the shorter of the remaining patent life or the estimated useful life of the underlying product. Intangible assets are amortized using the economic consumption method if anticipated future revenues can be reasonably estimated. The straight-line method is used when future revenues cannot be reasonably estimated. Amortization costs are recorded as part of cost of sales.

The Company assesses its intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the receipt of additional clinical or nonclinical data regarding one of the Company’s drug candidates or a potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or new information regarding potential sales of the drug. If impairment indicators are present or changes in circumstance suggest that impairment may exist, the Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value. The FDA approval of NERLYNX in July 2017 triggered a one-time milestone payment pursuant to the Company’s license agreement with the Pfizer. The Company capitalized the milestone payment as an intangible asset and is amortizing the asset to cost of sales on a straight-line basis through 2030, the estimated useful life of the licensed patent. The Company recorded amortization expense related to its intangible asset of $1.0 million ~~and $3.0 million~~long-term, for the three and nine months ended September 30, ~~2019, respectively. As~~2020. For the three and nine months ended September 30, 2020, the change in estimate has 0 impact on revenue from operations and reduces net income by approximately $15.7 million. The change in accounting estimate increased the net loss per share by approximately $0.40 for each of the three and nine months ended September 30, 2020.

Basic net loss per share of common stock is computed by dividing net loss available to common stockholders by the weighted-average number of shares of common stock outstanding during the periods presented, as required by Accounting Standards Codification, or ASC, 260, Earnings per Share. For purposes of calculating diluted net loss per share of common stock, the denominator includes both the weighted-average number of shares of common stock outstanding and the number of dilutive common stock equivalents, such as stock options, restricted stock units, or RSUs, and warrants. A common stock equivalent is not included in the denominator when calculating diluted earnings per common share if the effect of such common stock equivalent would be anti-dilutive and a net loss is reported. For the three and nine months ended September 30, 2020, potentially dilutive securities excluded from the calculations were 5,179,581 shares issuable upon exercise of options, 2,116,250 shares issuable upon exercise of a warrant, and 2,237,615 shares underlying RSUs that were subject to vesting and were antidilutive. For the three and nine months ended September 30, 2019, estimated future amortization expense related to the Company’s intangible asset was approximately $0.9 million for the remainder of 2019, approximately $3.9 million for each year starting 2020 through 2029, and approximately $1.0 million for 2030.

Royalties incurred in connection with the Company’s license agreement with Pfizer, as disclosed in Note 13 Commitments and Contingencies, are expensed to cost of sales as revenue from product sales is recognized.

In February 2016, the FASB issued an accounting standards update which requires lessees to recognize most leases on the balance sheet with a corresponding right-of-use asset. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arisingpotentially dilutive securities excluded from the ~~lease. Right-of-use assets~~calculations were 5,076,766 shares issuable upon exercise of options, 2,116,250 shares issuable upon exercise of a warrant, and ~~lease liabilities are recognized at~~1,635,242 shares underlying RSUs that were subject to vesting and were antidilutive. The 2,116,250 shares underlying the lease commencement date based on the estimated present value of fixed lease payments over the lease term. Leases will be classified as financing or operating which will drive the expense recognition pattern. For lessees, the income statement presentation and expense recognition pattern for financing and operating leases is similar to the current model for capital and operating leases, respectively. The Company has elected to exclude short-term leases. The update also requires additional disclosures that will better enable users of financial statements to assess the amount, timing, and uncertainty of cash flows arising from leases. The Company adopted this guidance as of January 1, 2019, the required effective date, using the effective date transition method. As permitted under the effective date transition method, financial information and disclosure for periods prior to the date of initial applicationwarrant will not ~~be updated. An adjustment to opening retained earnings was not required in conjunction with~~have an impact on our ~~adoption. For additional information, see Note 6~~—~~Leases. We have elected not to reassess whether expired or existing contracts contain leases, nor did we reassess~~diluted net income (loss) per share until the ~~classification~~average market price of ~~existing leases as of the adoption date.~~

~~The Company leases office space and copy machines, all of which are operating leases. Most leases include the option to renew and~~our common stock exceeds the exercise price of $16 per share. Refer to Note 11 for further details about the renewals options is at the Company’s sole discretion. Options to extend or terminate a lease are considered in the lease term to the extent that the option is reasonably certain of exercise. The leases do not include the options to purchase the leased property. The depreciable life of assets and leasehold improvements are limited by the expected lease term. Covenants imposed by the leases include letters of credit required to be obtained by the lessee.warrant.

The incremental borrowing rate presents the rate of interest that the Company would expect to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. When determinable, the Company uses the rate implicit in the lease to determine the present value of lease payments. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The Company’s average incremental borrowing rate, or IBR, ~~for existing leases on the transition date (January 1, 2019) was calculated as 10.9%.~~

The Company values its inventories at the lower of cost and estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated net realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within the cost of sales. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as a cost of sales in the consolidated statements of operations and comprehensive loss.

The Company capitalizes inventory costs associated with the Company’s products after regulatory approval, if any, when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. The Company previously expensed $4.5 million of product prior to receipt of marketing approval, which was recorded as R&D expense at the time it was incurred. Inventory that can be used in either the production of clinical or commercial product is recorded as R&D expense when selected for use in a clinical trial. Starter kits, provided to patients prior to insurance approval, are expensed by the Company to selling, general and administrative costs in the consolidated statements of operations and comprehensive loss as incurred.

~~As of September 30, 2019, the Company’s inventory balance consisted primarily of raw materials purchased subsequent to FDA approval of NERLYNX.~~

~~The Company adopted~~Under ASC Topic 606, - Revenue from Contracts with Customers, or ASC 606, ~~on January 1, 2017. This standard applies to all contracts with customers, except for contracts that are within~~ the ~~scope of other standards, such as leases, insurance, collaboration arrangements, and financial instruments. Under ASC 606,~~Company recognizes revenue when its customer obtains control of the promised goods or services, ~~an entity recognizes revenue~~ in an amount that reflects the consideration which the entity expects to be entitled in exchange for those goods or services. The Company had no contracts with customers until ~~after~~ the FDA approved NERLYNX inon July 17, 2017. Subsequent to receiving FDA approval, the Company entered into a limited number of arrangements with specialty pharmacies and specialty distributors in the United States to distribute NERLYNX. These arrangements are the Company’s initial contracts with customers. The Company has determined that these sales channels with customers are similar.

To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identifies the contract(s) with a customer, (ii) identifies the performance obligations in the contract, (iii) determines the transaction price, (iv) allocates the transaction price to the performance obligations in the contract, and (v) recognizes revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product revenue, see ~~Product Revenue, Net~~ ~~(below).~~

The Company sells NERLYNX to a limited number of specialty pharmacies and specialty distributors in the United States. These customers subsequently resell the Company’s products to patients and certain medical centers or hospitals. In addition to distribution agreements with these customers, the Company enters into arrangements with health care providers and payors that provide for government mandated and/or privately negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s products.

The Company recognizes revenue on product sales when the specialty pharmacy or specialty distributor, as applicable, obtains control of the Company's product, which occurs at a point in time (upon delivery). Product revenue is recorded net of applicable reserves for variable consideration, including discounts and allowances. The Company’s payment terms range between 10 and 68 ~~days.~~

Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods and are recorded in cost of sales.

If taxes should be collected from ~~these~~ customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred if the expected amortization period of the asset that the Company would have recognized is one year or less. However, 0 such costs were incurred during the ~~three~~nine months ended September 30, ~~2019.~~

Product revenue from customers who individually accounted for 10% or more of the Company’s total revenue for the three months ended September 30, 2019 consisted of the following, shown as a percentage of total revenue:

The Company also recognizes license revenue under certain of the Company’s license agreements that are within the scope of ASC Topic 606. The terms of these agreements may contain multiple performance obligations, which may include licenses2020 and ~~research and development activities. The Company evaluates these agreements under ASC Topic 606 to determine the distinct performance obligations.~~ Non-refundable, upfront fees that are not contingent on any future performance and require no consequential continuing involvement by the Company, are recognized as license revenue when the license term commences and the licensed data, technology or product is delivered. The Company defers recognition of non-refundable upfront license fees if the performance obligations are not satisfied.

Prior to recognizing license revenue, the Company makes estimates of the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved.

If there are multiple distinct performance obligations, the Company allocates the transaction price to each distinct performance obligation based on its relative standalone selling price. The standalone selling price is generally determined based on the prices charged to customers or using expected cost plus margin. License revenue is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure.

During the first quarter of 2019, the Company entered into a license agreement, or the Knight Agreement, with Knight. Pursuant to the Knight Agreement, the Company granted to Knight, under certain of the Company’s intellectual property rights relating to neratinib, an exclusive, sublicensable (under certain circumstances) license (i) to commercialize any product containing neratinib and certain related compounds in Canada, (ii) to seek and maintain regulatory approvals for the licensed products in Canada and (iii) to manufacture the licensed products anywhere in the world solely for the development and commercialization of the licensed products in Canada for human use, subject to the terms of the Knight Agreement and the related supply agreement. ~~During the first quarter of 2019, a non-refundable, upfront license fee was received and recognized as license revenue in accordance with ASC Topic 606.~~ ~~The Company satisfied the necessary performance obligations to recognize this license revenue under the terms of the arrangement.~~ This license agreement met the contract existence criteria and contained distinct, identifiable performance obligations for which the stand-alone selling prices were readily determinable and allocable. As a separate promise under the terms of the license agreement, the Company is obligated to supply Knight with the licensed product in accordance with the supply agreement entered in connection with the license agreement. The Company is also obligated to participate in a Joint Steering Committee, which was identified as a separate performance obligation. To determine the stand-alone selling price, the Company estimated the transaction prices, including any variable consideration, at contract inception and determined the fair value of such obligations based on similar arrangements. When determining the transaction prices, the Company assumed that the goods or services will be transferred to the customer based on the terms of the existing contract, and did not take into consideration the possibility of a contract being canceled, renewed, or modified. The Company noted there was no additional variable consideration, significant financing components, non-cash consideration, or consideration payable to the customer in this agreement. ~~This license agreement also includes potential future milestone and royalty payments due to the Company upon successful completion of certain separate, distinct performance obligations.~~ Pursuant to the Knight Agreement, the Company will potentially receive upfront, regulatory and commercial milestone payments totaling up to $7.2 million. In addition, the Company is entitled to receive double-digit royalties calculated as a percentage of net sales of the licensed products in Canada.~~At this time, the Company cannot estimate when these milestone-related performance obligations might be achieved.~~

During the first quarter of 2019, the Company entered into a license agreement, or the Pierre Fabre Agreement, with Pierre Fabre Medicament SAS, or Pierre Fabre. The Pierre Fabre Agreement granted intellectual property rights and set forth the parties’ respective obligations with respect to development, commercialization and supply of the licensed product in ~~European countries excluding Russia and Ukraine, along with countries in North Africa and francophone countries of West Africa.~~ ~~During the first quarter of 2019, a non-refundable, upfront license fee of $51.0 million was recognized as license revenue in accordance with ASC Topic 606.~~ ~~The Company satisfied the necessary performance obligations to recognize this license revenue under the terms of the arrangement.~~ The Pierre Fabre Agreement met the contract existence criteria and contained distinct, identifiable performance obligations for which the stand-alone selling prices were readily determinable and allocable. As a separate promise under the terms of the Pierre Fabre Agreement, the Company is obligated to supply Pierre Fabre with the licensed product in accordance with the related supply agreement. The Company is also obligated to participate in a Joint Steering Committee and Transition Plan, which were identified as separate performance obligations. To determine the respective stand-alone selling prices, the Company estimated the transaction prices, including any variable consideration, at contract inception and determined the fair value of such obligations based on similar arrangements. When determining the transaction prices, the Company assumed that the goods or services will be transferred to the customer based on the terms of the existing contract, and did not take into consideration the possibility of a contract being canceled, renewed, or modified. The Company noted there was approximately $9.0 million of additional variable consideration in this agreement related to a post-marketing commitment liability, while there were no significant financing components, non-cash consideration, or consideration payable to the customer. ~~The Pierre Fabre Agreement also includes potential future milestone and royalty payments due to the Company upon successful completion of certain separate, distinct performance obligations.~~ ~~Pursuant to the Pierre Fabre Agreement, the Company will potentially receive additional regulatory and commercial milestone payments totaling up to $345 million.~~ ~~In addition, the Company will receive double-digit royalties on NERLYNX sales throughout the territory covered by the~~ ~~Pierre Fabre Agreement~~. ~~At this time, the Company cannot estimate when these milestone-related performance obligations might be achieved.~~

During the first quarter of 2018, the Company entered into a license agreement, or the Pint Agreement, with Pint. The Pint Agreement granted intellectual property rights and set forth the respective obligations with respect to development, commercialization and supply of NERLYNX in Mexico and 21 countries and territories in Central and South America. The Pint Agreement includes potential future milestone and royalty payments due to the Company upon successful completion of certain performance obligations, such as achieving regulatory approvals. Pursuant to the Pint Agreement, the Company received an upfront payment of $10.0 million during the third quarter of 2018 and will potentially receive additional regulatory and commercial milestone payments totaling up to approximately $24.5 million, as well as double-digit royalties on NERLYNX sales throughout the territory covered by the Pint Agreement. During the third quarter of 2019, the Company achieved a certain development-based milestone, which satisfied a performance obligation necessary to recognize the associated license revenue. The payment associated with this license revenue is expected to be received from Pint during the third quarter of 2020. At this time, the Company cannot estimate when the remaining milestone-related performance obligations might be achieved.

~~Royalty revenue consists of consideration earned related~~ ~~to international sales of NERLYNX made by the Company’s~~ ~~licensees~~ ~~in their respective territories. The Company recognizes royalty revenue when the performance obligations have been satisfied.~~2019.

Revenue from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the related sales, and are classified as reductions of accounts receivable, net when the right of offset exists in accordance with ASU 2013-1, Balance Sheet (Topic 210): Clarifying the Scope of Disclosures about Offsetting Assets and Liabilities,or as a current liability. These estimates take into consideration a range of possible outcomes that are probability-weighted in accordance with the expected value method in ASC ~~Topic~~ 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts.

The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined a ~~material~~significant reversal of revenue would not be probable to occur in a future period for the estimates detailed below as of September 30, ~~2019~~2020 and, therefore, the transaction price was not reduced further during the quarter ended September 30, ~~2019.~~2020. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.

The Company generally provides customers with discounts, which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of ~~product~~ revenue in the period the related product revenue is recognized. The reserve for discounts is established in the same period that the related ~~product~~ revenue is recognized, together with reductions to ~~trade receivables,~~accounts receivable, net on the consolidated balance sheets. In addition, the Company compensates its customers for sales order management, data, and distribution services. The Company has determined such services received to date are not distinct from the Company’s sale of products to its customers and, therefore, these payments have been recorded as a reduction of ~~product~~ revenue within the ~~statement~~statements of ~~operations and comprehensive loss through September 30, 2019.~~operations.

Consistent with industry practice, the Company offers the specialty pharmacies and specialty distributors that are its customers limited product return rights for damaged and expiring product, provided it is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of product revenue, net in the period the related product revenue is recognized, as well as a reduction to ~~trade receivables,~~accounts receivable, net on the consolidated balance sheets. The Company currently estimates product returns using ~~available industry data and~~ its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company has ~~experienced~~ an insignificant amount of returns to date and believes that returns of its products will continue to be minimal.

Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to its customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. The reserve for chargebacks is established in the same period ~~that~~ the related ~~product~~ revenue is recognized, resulting in a reduction of product revenue, net and a reduction to accounts receivable, net on the ~~establishment of a current liability.~~consolidated balance sheets. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by customers, and the Company generally issues ~~payments~~credits for such amounts within a few weeks of the customer’s notification to the Company of the resale. ~~Reserves for chargebacks~~Chargebacks consist of ~~payments~~credits the Company expects to issue for units that remain in the distribution channel at each reporting period-end that the Company expects will be sold to qualified healthcare providers and chargebacks that customers have claimed, but for which the Company has not yet issued a payment.

The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related ~~product~~ revenue is recognized, resulting in a reduction of product revenue, net and the establishment of a current liability, which is included in accrued expenses ~~and other current liabilities~~ on the consolidated balance sheets. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimates of future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel at the end of each reporting period.

The Company contracts with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates and records such estimates in the same period the related ~~product~~ revenue is recognized, resulting in a reduction of product revenue, net and the establishment of a current ~~liability.~~liability, which is included in accrued expenses on the consolidated balance sheets.

Other incentives the Company offers include voluntary patient assistance programs, such as the co-pay assistance program, which are intended to provide financial assistance to qualified ~~commercially-insured~~commercially insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included as a component of accrued expenses ~~and other current liabilities~~ on the consolidated balance sheets.

The Company also recognizes license revenue under certain of the Company’s sub-license agreements that are within the scope of ASC 606. The terms of these agreements may contain multiple performance obligations, which may include licenses and research and development activities. The Company evaluates these agreements under ASC 606 to determine the distinct performance obligations. Non-refundable, upfront fees that are not contingent on any future performance and require no consequential continuing involvement by the Company, are recognized as revenue when the license term commences and the licensed data, technology or product is delivered. The Company defers recognition of non-refundable upfront license fees if the performance obligations are not satisfied.

Prior to recognizing revenue, the Company makes estimates of the transaction price, including variable consideration that is subject to a ~~Recurring Basis:~~

~~ASC, 820,~~ ~~Fair Value Measurement, or ASC 820, provides~~constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a ~~single definition~~significant reversal in the amount of ~~fair value~~cumulative revenue recognized will not occur and ~~a common framework for measuring fair value as well as new disclosure requirements for fair value measurements used in financial statements. Under ASC 820, fair value~~when the uncertainty associated with the variable consideration is subsequently resolved.

If there are multiple distinct performance obligations, the Company allocates the transaction price to each distinct performance obligation based on its relative standalone selling price. The standalone selling price is generally determined based on the prices charged to customers or using expected cost-plus margin. Revenue is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure.

Since 2018, the Company has entered into sub-license agreements with certain sub-licensees in territories outside of the United States. These sub-licensing agreements grant certain intellectual property rights and set forth various respective obligations with respect to actions such as development, pursuit and maintenance of regulatory approvals, commercialization and supply of NERLYNX in the sub-licensees’ respective territories.

License fees under the sub-license agreements include one-time upfront payments when each sub-license agreement was executed and potential additional one-time milestone payments due to the Company upon successful completion of certain performance obligations, such as achieving regulatory approvals or sales target thresholds, and potential double-digit royalties on sales of the ~~exit price~~licensed product, calculated as a percentage of net sales of the licensed product throughout each sub-licensee’s respective territory. For the nine-month period ended September 30, 2020, pursuant to the sub-license agreements, the Company recognized as license revenue, upfront payments totaling $0.5 million and development-based milestone payments totaling $22.2 million. For the three months ended September 30, 2020, the Company recognized 0 license revenue. The beginning balance of accounts receivable, net on the Company’s consolidated balance sheet for license revenue from the sub-license agreements for the three and nine months ended September 30, 2020 was $2.7 million and $2.5 million, respectively. As of September 30, 2020, $2.5 million in license revenue from the sub-license agreements is included in accounts receivable, net on the consolidated balance sheet. As of September 30, 2020, the total potential milestone payments that would be received by a company to sell an asset or paid by a company to transfer a liability in an orderly transaction between market participants, exclusive of any transaction costs. Fair value measurements are determined by either the principal market or the most advantageous market. The principal market is the market with the greatest level of activity and volume for the asset or liability. Absent a principal market to measure fair value, the Company uses the most advantageous market, which is the market from which the Company would receive the highest selling price for the asset or pay the lowest price to settle the liability, after considering transaction costs. However, when using the most advantageous market, transaction costs are only considered to determine which market is the most advantageous and these costs are then excluded when applying a fair value measurement. ASC 820 creates a three-level hierarchy to prioritize the inputs used in the valuation techniques to derive fair values. The basis for fair value measurements for each level within the hierarchy is described below, with Level 1 having the highest priority and Level 3 having the lowest.

Following are the major categories of assets measured at fair value on a recurring basis as of September 30, 2019 and December 31, 2018, using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3) (in thousands):

September 30, 2019

Level 1

Level 2

Level 3

Total

Cash equivalents

$
40,935

$
—

$
—

$
40,935

Commercial paper

—

—

—

—

Corporate bonds

—

41,501

—

41,501

U.S. government securities

10,034

—

—

10,034

Totals

$
50,969

$
41,501

$
—

$
92,470

December 31, 2018

Level 1

Level 2

Level 3

Total

Cash equivalents

$
83,329

$
2,987

$
—

$
86,316

Commercial paper

—

35,941

—

35,941

Corporate bonds

—

18,077

—

18,077

U.S. government securities

2,984

—

—

2,984

Totals

$
86,313

$
57,005

$
—

$
143,318

The Company’s investments in commercial paper, corporate bonds and U.S. government securities are exposed to price fluctuations. The fair value measurements for commercial paper, corporate bonds and U.S. government securities are based upon the quoted prices of similar items in active markets multiplied by the number of securities owned.

~~The following tables summarize the Company’s short-term investments (in thousands):~~

Maturity

Amortized

Unrealized

Estimated

September 30, 2019

(in years)

cost

Gains

Losses

fair value

Cash equivalents

$
40,935

$
—

$
—

$
40,935

Commercial paper

Less than 1

—

—

—

—

Corporate bonds

Less than 1

41,396

105

—

41,501

U.S. government securities

Less than 1

10,024

10

—

10,034

Totals

$
92,355

$
115

$
—

$
92,470

Maturity

Amortized

Unrealized

Estimated

December 31, 2018

(in years)

cost

Gains

Losses

fair value

Cash equivalents

$
86,316

$
—

$
—

$
86,316

Commercial paper

Less than 1

35,941

—

—

$
35,941

Corporate bonds

Less than 1

18,089

—

(12
)

$
18,077

U.S. government securities

Less than 1

2,984

—

—

$
2,984

Totals

$
143,330

$
—

$
(12
)

$
143,318

Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash and cash equivalents and accounts receivable. The Company’s cash and cash equivalents and restricted cash in excess of the Federal Deposit Insurance Corporation and the Securities Investor Protection Corporation insured limits at September 30, 2019, were approximately $75.7 million. The Company does not believe it is exposed to any significant credit risk due to the ~~nature~~Company upon achievement of all respective performance obligations under the ~~financial instruments~~sub-license agreements is approximately $536.3 million. At this time, the Company cannot estimate if or when these milestone-related performance obligations might be achieved.

For sub-license agreements that are within the scope of ASC 606, the Company recognizes revenue when the related sales occur in ~~which~~accordance with the ~~money is held. Pursuant~~sales-based royalty exception under ASC 606-10-55-65. Royalty revenue consists of consideration earned related to international sales of NERLYNX made by the Company’s ~~internal investment policy, investments must be rated A-1/P-1 or better by Standard and Poor’s Rating Service and Moody’s Investors Service at the time of purchase.~~

sub-licensees in their respective territories. The Company ~~sells its products in~~recognizes royalty revenue when the ~~United States primarily through specialty pharmacies~~performance obligations have been satisfied. Royalty revenue was $1.4 million and specialty distributors. Therefore, wholesale distributors and large pharmacy chains account for a large portion of its trade receivables and net product revenue. The Company monitors the creditworthiness of its customers and has internal policies regarding customer credit limits. The Company estimates an allowance for doubtful accounts primarily based on the credit worthiness of its customers, historical payment patterns, aging of receivable balances and general economic conditions.

The Company’s success depends on its ability to successfully commercialize NERLYNX. The Company currently has a single product with limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth. The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, NERLYNX, and expects NERLYNX to constitute the vast majority of product revenue$3.1 million for the ~~foreseeable future. The~~three and nine months ended September 30, 2020, respectively.

Royalties incurred in connection with the Company’s ~~success depends on its ability~~license agreement with Pfizer, as disclosed in Note 13—Commitments and Contingencies, are expensed to ~~effectively commercialize NERLYNX.~~

~~The Company relies exclusively on third parties to formulate and manufacture NERLYNX and its drug candidates. The commercialization~~cost of ~~NERLYNX and any other drug candidates, if approved, could be stopped, delayed or made less profitable if those third parties fail to provide sufficient quantities of~~sales as revenue from product or fail to do so at acceptable quality or price. The Company has no experience in drug formulation or manufacturing and does not intend to establish its own manufacturing facilities. The Company lacks the resources and expertise to formulate or manufacture NERLYNX or its drug candidates. While the drug candidates were being developed by Pfizer, both the drug substance and drug product were manufactured by third-party contractors. The Companysales is using the same third-party contractors to manufacture, supply, store and distribute drug supplies for clinical trials and the commercialization of NERLYNX. If the Company is unable to continue its relationships with one or more of these third-party contractors, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers.recognized.

Research and development expenses, or R&D ~~expenses~~Expenses, are charged to operations as incurred. The major components of R&D ~~costs~~Expenses include clinical manufacturing costs, clinical trial expenses, consulting and other third-party costs, salaries and employee benefits, stock-based compensation expense, supplies and materials, and allocations of various overhead costs. Clinical trial expenses include, but are not limited to, investigator fees, site costs, comparator drug costs, and clinical research organization, or CRO, costs. In the normal course of business, the Company contracts with third parties to perform various clinical trial activities in the ongoing development of potential products. The financial terms of these agreements are subject to negotiation and variations from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients and the completion of portions of the clinical trial or similar conditions. The Company’s accruals for clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical trial sites, cooperative groups and CROs. As actual costs become known, the Company adjusts its accruals in that period.

In instances where the Company enters into agreements with third parties for clinical trials and other consulting activities, upfront amounts are recorded to prepaid expenses and other in the accompanying consolidated balance sheets and expensed as services are performed or as the underlying goods are delivered. If the Company does not expect the services to be rendered or goods to be delivered, any remaining capitalized amounts for non-refundable upfront payments are charged to expense immediately. Amounts due under such arrangements may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables.

Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of R&D ~~costs.~~

ASC Topic 718, Compensation-Stock Compensation, or ASC 718, requires the fair value of all share-based payments to employees and nonemployees, including grants of stock options, to be recognized in the statement of operations over the requisite service period. Under ASC 718, employee and nonemployee option grants are generally valued at the grant date and those valuations do not change once they have been established. The fair value of each option award is estimated on the grant date using the Black-Scholes Option Pricing ~~Method and those valuations do not change once they have been established.~~Method. As allowed by ASC 718, the Company’s estimate of expected volatility is based on its average volatilities using its past six years of publicly traded ~~history. Beginning in 2018, the Company estimated its expected volatility based on its average volatilities using its past six years of publicly traded stock~~ history. The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant valuation. Option forfeitures are ~~calculated~~estimated when the option is granted to reduce the option expense to be recognized over the life of the ~~award~~award. The estimated forfeiture rate considers historical employee turnover rates stratified into employee pools, actual forfeiture experience and ~~updated upon receipt of further information as to the amount of options expected to be forfeited.~~other factors. The option expense is ~~“trued-up”~~adjusted upon the actual forfeiture of a stock option ~~grant.~~grant and the Company periodically revises the estimated forfeiture rate in subsequent periods if actual forfeitures differ from those estimates. Due to its limited history of stock option exercises, the Company uses the simplified method to determine the expected life of the option grants. Compensation expense related to modified stock options is measured based on the fair value for the awards as of the modification date. Any incremental compensation expense arising from the excess of the fair value of the awards on the modification date compared to the fair value of the awards immediately before the modification date is recognized at the modification date or ratably over the requisite service period, as appropriate.

~~Restricted stock units, or~~ RSUs are valued on the grant date and the fair value of the RSUs is equal to the market price of the Company’s common stock on the grant date. The RSU expense is recognized over the requisite service period. When the requisite service period begins prior to the grant date (because the service inception date occurs prior to the grant date), the Company is required to begin recognizing compensation cost before there is a measurement date (i.e., the grant date). The service inception date is the beginning of the requisite service period. If the service inception date precedes the grant date, accrual of compensation cost for periods before the grant date shall be based on the fair value of the award at the reporting date. In the period in which the grant date occurs, cumulative compensation cost shall be adjusted to reflect the cumulative effect of measuring compensation cost based on fair value at the grant date rather than the fair value previously used at the service inception date (or any subsequent reporting date). RSU forfeitures are estimated when the RSU is granted to reduce the RSU expense to be recognized over the life of the award. The estimated forfeiture rate considers historical employee turnover rates stratified into employee pools, actual forfeiture experience and other factors. The RSU expense is adjusted upon the actual forfeiture of an RSU grant and the Company periodically revises the estimated forfeiture rate in subsequent periods if actual forfeitures differ from those estimates. Compensation expense related to modified restricted stock units is measured based on the fair value for the awards as of the modification date. Any incremental compensation expense arising from the excess of the fair value of the awards on the modification date compared to the fair value of the awards immediately before the modification date is recognized at the modification date or ratably over the requisite service period, as appropriate.

Warrants (refer to Note 11 for further details) granted to employees and nonemployees are normally valued at the fair value of the instrument on the grant date and are recognized in the statement of operations over the requisite service period. When the requisite service period precedes the grant date and a market condition exists in the warrant, the Company values the warrant using the Monte Carlo Simulation Method. When the terms of the warrant become fixed, the Company values the warrant using the Black-Scholes Option Pricing Method. As allowed by ASC 718, the Company’s estimate of expected volatility is based on its average volatilities using its publicly traded history. The risk-free rate for periods within the contractual life of the warrant is based on the U.S. Treasury yield curve in effect at the time of grant valuation. In determining the value of the warrant until the terms are fixed, the Company factors in the probability of the market condition occurring and several possible scenarios. When the requisite service period precedes the grant date and is deemed to be complete, the Company records the fair value of the warrant at the time of issuance as an equity stock-based compensation transaction. The grant date is determined when all pertinent information, such as exercise price and quantity are known.

The Company follows ASC Topic 740, Income Taxes, or ASC 740, which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or tax returns. Under this method, deferred tax assets and liabilities are based on the differences between the consolidated financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the ~~temporary~~ differences are expected to ~~be recovered or settled.~~ reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than not that the asset will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.

The standard addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the consolidated financial statements. Under ASC 740, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the tax authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such a position should be measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. ASC 740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. As of September 30, 2020, the Company’s uncertain tax position reserves include a reserve for its R&D credits.

The carrying value of financial instruments, such as cash equivalents, accounts receivable and accounts payable, approximate their fair value because of their short-term nature. The carrying value of long-term debt approximates its fair value as the principal amounts outstanding are subject to variable interest rates that are based on market rates, which are regularly reset.

The Company classifies all highly liquid instruments with an original maturity of three months or less as cash equivalents.

Restricted cash represents cash held at financial institutions that is pledged as collateral for stand-by letters of credit for lease and legal verdict commitments. The lease-related letters of credit will lapse at the end of the respective lease terms through 2026. At September 30, 2020 and December 31, 2019, the Company ~~has established~~had restricted cash in the amount of $12.2 million and $13.2 million, respectively.

The Company classifies all investment securities (short-term and long-term) as available-for-sale, as the sale of such securities may be required prior to maturity to implement management’s strategies. These securities are carried at fair value, with the unrealized gains and losses reported as a ~~reserve~~component of ~~20%~~accumulated other comprehensive income (loss) in stockholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis. In accordance with ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, credit losses on available-for-sale securities are reported using an expected loss model and recorded to an allowance. Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method. Interest income is recognized when earned.

ASC Topic 820, Fair Value Measurement, or ASC 820, provides a single definition of fair value and a common framework for measuring fair value as well as disclosure requirements for fair value measurements used in financial statements. Under ASC 820, fair value is determined based upon the exit price that would be received by a company to sell an asset or paid by a company to transfer a liability in an orderly transaction between market participants, exclusive of any transaction costs. Fair value measurements are determined by either the principal market or the most advantageous market. The principal market is the market with the greatest level of activity and volume for the asset or liability. Absent a principal market to measure fair value, the Company uses the most advantageous market, which is the market from which the Company would receive the highest selling price for the asset or pay the lowest price to settle the liability, after considering transaction costs. However, when using the most advantageous market, transaction costs are only considered to determine which market is the most advantageous and these costs are then excluded when applying a fair value measurement. ASC 820 creates a three-level hierarchy to prioritize the inputs used in the valuation techniques to derive fair values. The basis for fair value measurements for each level within the hierarchy is described below, with Level 1 having the highest priority and Level 3 having the lowest.

Following are the major categories of assets measured at fair value on a recurring basis as of September 30, 2020 and December 31, 2019, using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3) (in thousands):

September 30, 2020	Level 1		Level 2		Level 3		Total
Cash equivalents	$	74,360	$	—	$	—	$	74,360
Commercial paper		—		18,942		—		18,942
Totals	$	74,360	$	18,942	$	—	$	93,302

December 31, 2019	Level 1		Level 2		Level 3		Total
Cash equivalents	$	41,295	$	—	$	—	$	41,295
Corporate bonds		—		41,557		—		41,557
U.S. government securities		10,050		—		—		10,050
Totals	$	51,345	$	41,557	$	—	$	92,902

The following tables summarize the Company’s short-term investments (in thousands):

	Maturity	Amortized		Unrealized				Estimated
September 30, 2020	(in years)	cost		Gains		Losses		fair value
Cash equivalents		$	74,360	$	—	$	—	$	74,360
Commercial paper	Less than 1		18,942		—		—		18,942
Totals		$	93,302	$	—	$	—	$	93,302

	Maturity	Amortized		Unrealized				Estimated
December 31, 2019	(in years)	cost		Gains		Losses		fair value
Cash equivalents		$	41,295	$	—	$	—	$	41,295
Corporate bonds	Less than 1		41,507		50		—		41,557
U.S. government securities	Less than 1		10,038		12		—		10,050
Totals		$	92,840	$	62	$	—	$	92,902

Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash and cash equivalents, marketable securities, and accounts receivable, net. The Company’s cash and cash equivalents and restricted cash in excess of the Federal Deposit Insurance Corporation and the Securities Investor Protection Corporation insured limits at September 30, 2020, were approximately $102.6 million. The Company does not believe it is exposed to any significant credit risk due to the quality nature of the financial instruments in which the money is held. Pursuant to the Company’s internal investment policy, investments must be rated A-1/P-1 or better by Standard and Poor’s Rating Service and Moody’s Investors Service at the time of purchase.

The Company sells its products in the United States primarily through specialty pharmacies and specialty distributors. Therefore, wholesale distributors and large pharmacy chains account for a large portion of its ~~R&D credit carryover balance.~~

~~Management has determined that~~accounts receivables, net and product revenues, net. The creditworthiness of its customers is continuously monitored, and the Company ~~operates~~has internal policies regarding customer credit limits. The Company estimates an allowance for doubtful accounts primarily based on the credit worthiness of its customers, historical payment patterns, aging of receivable balances and general economic conditions. The Company recorded $0 as an allowance for doubtful accounts as of September 30, 2020 and December 31, 2019.

The Company’s success depends on its ability to successfully commercialize NERLYNX. The Company currently has a single product and limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth. The Company has invested a significant portion of its efforts and financial resources in ~~1 business segment, which is~~ the development and commercialization of ~~innovative drugs~~the lead product, NERLYNX, and expects NERLYNX to ~~enhance cancer care.~~constitute the vast majority of product revenue for the foreseeable future.

The Company relies exclusively on third parties to formulate and manufacture NERLYNX and its drug candidates. The commercialization of NERLYNX and any other drug candidates, if approved, could be stopped, delayed or made less profitable if those third parties fail to provide sufficient quantities of product or fail to do so at acceptable quality levels or prices. The Company

has no experience in drug formulation or manufacturing and does not intend to establish its own manufacturing facilities. The Company lacks the resources and expertise to formulate or manufacture NERLYNX and other drug candidates. While the drug candidates were being developed by Pfizer, both the drug substance and drug product were manufactured by third-party contractors. The Company is using the same third-party contractors to manufacture, supply, store and distribute drug supplies for clinical trials and the commercialization of NERLYNX. If the Company is unable to continue its relationships with one or more of these third-party contractors, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers. The Company intends to rely on one or more third-party contractors to manufacture the commercial supply of drugs.

The Company values its inventories at the lower of cost and estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within the cost of sales in the consolidated statements of operations. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as a cost of sales in the consolidated statements of operations.

The Company capitalizes inventory costs associated with the Company’s products after regulatory approval, if any, when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory that can be used in either the production of clinical or commercial product is recorded as R&D Expenses when selected for use in a clinical trial. Starter kits, provided to patients prior to insurance approval, are expensed by the Company to selling, general and administrative expense as incurred.

As of September 30, 2020, the Company’s inventory balance consisted primarily of raw materials purchased subsequent to FDA approval of NERLYNX.

~~Basic net loss per share of common stock~~Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which is generally three years for computer hardware and software, three years for phone equipment, and seven years for furniture and fixtures. Leasehold improvements are amortized using the straight-line method over the lesser of the useful life or the lease term. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred.

The Company reviews its long-lived assets used in operations for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable, as required by ~~dividing net~~ASC Topic 360, Property, Plant, and Equipment, or ASC 360. The Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows over the life of the asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would then determine the fair value of the long-lived asset and recognize an impairment loss ~~applicable~~for the amount in excess of the carrying value.

ASC Topic 842, Leases, as adopted in the first quarter of 2019, requires lessees to ~~common stockholders by~~recognize most leases on the ~~weighted average number~~balance sheet with a corresponding right-of-use asset, or ROU asset. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of ~~shares of common stock outstanding during~~fixed lease payments over the ~~periods presented,~~ lease term. ROU assets are evaluated for impairment using the long-lived assets impairment guidance, as required by ASC ~~260,~~ 360~~Earnings per Share~~.~~. For purposes~~ A significant indication of ~~calculating diluted loss per share~~impairment of ~~common stock,~~an ROU asset would include a change in the ~~denominator includes both~~extent or manner in which the ~~weighted average number of shares of common stock outstanding~~asset is being used. The Company must make assumptions which underlie the most significant and subjective estimates in determining whether any impairment exists. Those estimates, and the ~~number~~underlying assumptions, include estimates of ~~dilutive common stock equivalents, such~~future cash flow utilizing market lease rates and determination of fair value. If an ROU asset related to an operating lease is impaired, the carrying value of the ROU asset post-impairment should be amortized on a straight-line basis through the earlier of the end of the useful life of the ROU asset or the end of the lease term. Post impairment, a lessee must calculate the amortization of the ROU asset and interest expense on the lease liability separately, although the sum of the two continues to be presented as ~~stock~~a single lease cost. If a lease is planned to be abandoned with no intention of subleasing, the ROU asset should be assessed for impairment.

Leases will be classified as financing or operating, which will drive the expense recognition pattern. The Company elects to exclude short-term leases if and when the Company has them. For additional information, see Note 6—Leases.

The Company leases office space and copy machines, all of which are operating leases. Most leases include the option to renew and the exercise of the renewal options ~~RSUs and warrants. A common stock equivalent~~ is ~~not included~~at the Company’s sole discretion. Options to extend or terminate a lease are considered in the ~~denominator~~lease term to the extent that the option is reasonably certain of exercise. The leases do not include options to purchase the leased property. The depreciable life of assets and leasehold improvements is limited by the expected lease term. Covenants imposed by the leases include letters of credit required to be obtained by the lessee.

The incremental borrowing rate, or IBR, represents the rate of interest the Company would expect to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. When determinable, the Company uses the rate implicit in the lease to determine the present value of lease payments. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The Company’s average IBR for existing leases as of September 30, 2020 is 10.9%.

The Company decided to cease the use of a portion of its leased office space in 2019. In connection with the decreased need for the right to use the ROU asset, the Company entered into a sublease for the underlying asset, in which the sublease income is less than the original lease payments, indicating impairment. In performing the recoverability test on the effective date, the undiscounted future estimated cash flows and carrying value were identified for the subleased portion of the leased building, as an individual asset group, defined under ASC 360. A reduction to the carrying value of the ROU asset of approximately $1.2 million was recorded, representing the fair value amount in excess of the carrying value, with a corresponding impairment charge recorded as selling, general and administration expense, in the consolidated statements of operations for the year ended December 31, 2019. There were no indications for impairment during the quarter ended September 30, 2020.

The Company expenses amounts paid to acquire licenses associated with products under development when ~~calculating diluted earnings per common share~~the ultimate recoverability of the amounts paid is uncertain and the technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon the asset achieving technological feasibility in accordance with management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates is reached when the requisite regulatory approvals are obtained to make the product available for sale. The Company capitalizes technology licenses upon reaching technological feasibility.

The Company maintains definite-lived intangible assets related to the license agreement with Pfizer. These assets are amortized over their remaining useful lives, which are estimated based on the shorter of the remaining patent life or the estimated useful life of the underlying product. Intangible assets are amortized using the economic consumption method if anticipated future revenues can be reasonably estimated. The straight-line method is used when future revenues cannot be reasonably estimated. Amortization costs are recorded as part of cost of sales.

The Company assesses its intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the receipt of additional clinical or nonclinical data regarding one of the Company’s drug candidates or a potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or new information regarding potential sales for the drug. If impairment indicators are present or changes in circumstance suggest that impairment may exist, the Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would determine the fair value of the intangible asset and recognize an impairment loss if the ~~effect~~carrying value of ~~such common stock equivalent would be anti-dilutive. For~~the intangible asset exceeds its fair value. In connection with the FDA approval of NERLYNX in July 2017, the Company triggered a one-time milestone payment pursuant to its license agreement with Pfizer. In June 2020, the Company entered into a letter agreement with Pfizer relating to the method of payment associated with a milestone payment under the Company’s license agreement with Pfizer (see Note 13-Commitments and Contingencies). The Company capitalized the milestones as intangible assets and is amortizing the assets to cost of sales on a straight-line basis over the estimated useful life of the licensed patent through 2030. The Company recorded amortization expense related to its intangible assets of $2.0 million and $4.3 million for the three and nine months ended September 30, ~~2019, potentially dilutive securities excluded from the calculations were 5,076,766 shares issuable upon exercise~~2020, respectively. As of ~~options, 2,116,250 shares issuable upon exercise of a warrant, and 1,635,242 shares underlying RSUs that were subject to vesting and were antidilutive. For the three and nine months ended~~ September 30, ~~2018, potentially dilutive securities excluded from~~2020, estimated future amortization expense related to the ~~calculations were 5,763,609 shares issuable upon exercise~~Company’s intangible assets was approximately $2.0 million for the remainder of ~~options, 2,116,250 shares issuable upon exercise of a warrant,~~2020 and ~~1,541,970 shares underlying RSUs that were subject to vesting~~$8.0 million for each year starting 2021 through 2029, and ~~were antidilutive.~~ $2.0 million for 2030.

In ~~February~~June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 requires that credit losses be reported using an expected losses model rather than the incurred losses model that is currently used, and establishes additional disclosures related to credit risks. For trade accounts receivable, the Company recognizes credit losses based on lifetime expected losses. For available-for-sale debt securities with unrealized losses, this standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. These amendments under ASU 2016-13 are effective for interim and annual fiscal periods beginning after December 15, 2019. The Company adopted ASU 2016-13, and the adoption did not have a material effect on the Company’s current financial position, results of operations or financial statement disclosures.

In August 2018, the FASB issued ASU No. ~~2016-02,~~ 2018-13, ~~Leases~~Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement.. The amendments in ASU ~~2016-02 require organizations that lease assets, with lease terms of more than 12 months, to recognize~~2018-13 modifies the disclosure requirements on their balance sheet the assets and liabilities for the rights and obligations created by those leases. Consistent with GAAP, the recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee primarily depends on its classification as a finance or operating lease. However, unlike previous GAAP that requires only capital leases to be recognized on the balance sheet,fair value measurements. ASU ~~No. 2016-02 requires both types of leases to be recognized on the balance sheet. ASU 2016-02~~2018-13 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, ~~2018, including interim periods within those fiscal years. For lessees,~~2019, with early adoption permitted for any removed or modified disclosures. The amendments did not have an impact on the Company’s financial statement disclosures.

In December 2019, the FASB issued ASU No 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, as part of its Simplification Initiative to reduce the cost and complexity in accounting for income ~~statement presentation and expense recognition pattern for financing and operating leases is similar~~taxes. The amendments in ASU 2019-12 remove certain exceptions related to the ~~current model~~approach for ~~capital~~intraperiod tax allocation, the methodology for calculating income taxes in an interim period and ~~operating leases, respectively. Companies may elect~~the recognition of deferred tax liabilities for outside basis differences. ASU 2019-12 also amends other aspects of the guidance to ~~exclude short-term leases.~~help simplify and promote consistent application of GAAP. The ~~update also requires additional disclosures that will better enable users of financial statements to assess the amount, timing,~~guidance is effective for interim and ~~uncertainty of cash flows arising from leases.~~annual periods beginning after December 15, 2020, with early adoption permitted. The Company ~~adopted~~does not expect ASU ~~No. 2016-02 in~~2019-12 to have a material effect on the ~~first quarter of 2019 using the effective date transition method. As permitted under the effective date transition method,~~Company’s current financial information and disclosure for periods prior to the date of initial application will not be updated. The adoption of ASU No. 2016-02 resulted in an increase in its assets and liabilities on its consolidated balance sheets related to recording right-of-use assets and corresponding lease liabilities of approximately $21.6 million and $27.4 million, respectively. The difference between the additional lease assets and lease liabilities represent deferred rent for leases that existed as of the date of adoption. As a result of the adoption there was no material impact to the consolidated statementposition, results of operations or financial statement ~~of cash flows.~~disclosures.

	September 30, 2019		December 31, 2018		September 30, 2020		December 31, 2019
Accounts receivable	$	24,682	$	20,773
Accounts receivable, net					$	24,637	$	26,396
License revenue receivable		2,500		—		2,500		2,500
Total accounts receivable, net	$	27,182	$	20,773	$	27,137	$	28,896

Accounts receivable, net, consists entirely of amounts owed from our customers related to product sales. The license revenue receivable as of September 30, 2020 and December 31, 2019 relates to ~~amounts~~an amount owed from Pint Pharma International, S.A. relating to license revenue recognized during the third quarter of 2019.

	September 30, 2019		December 31, 2018		September 30, 2020		December 31, 2019
Current:
CRO services	$	4,661	$	5,824	$	1,420	$	4,810
Other clinical development		2,053		888		2,752		2,043
Insurance		407		2,446		590		3,452
Professional fees		597		272		831		544
Other		2,272		2,967		2,432		2,410
		9,990		12,397		8,025		13,259
Long-term:
CRO services		1,657		1,073		687		400
Other clinical development		7		650		369		468
Other		1,267		1,706		1,764		1,131
		2,931		3,429		2,820		1,999
Totals	$	12,921	$	15,826	$	10,845	$	15,258

Other current prepaid amounts consist primarily of deposits, signing bonuses, licenses, subscriptions and software. Other long-term prepaid amounts consist primarily of deposits, signing bonuses, licenses, subscriptions, software, a capitalized sublease commission and ~~professional fees.~~a sublease tenant improvement allowance, net of amortization.

	September 30, 2019		December 31, 2018		September 30, 2020		December 31, 2019
Insurance receivable	$	—	$	1,175
Deposit for manufacturing costs					$	3,376	$	—
Other		322		612		50		323
Totals	$	322	$	1,787	$	3,426	$	323

Other current asset amounts consist primarily of capitalized sublease commission and a sublease tenant improvement ~~allowances,~~allowance, net of amortization.

In December 2011, the Company entered into a non-cancelable operating lease for office space in Los Angeles, California, which was subsequently amended in November 2012, December 2013, March 2014, July 2015, and December 2017. The initial term of the lease was for seven years and commenced on December 10, 2011. As amended, the Company rents approximately 65,656 square feet. The term of the lease runs until March 2026, and rent amounts payable by the Company increase approximately 3% per year. Concurrent with the execution of the lease, the Company provided the landlord an automatically renewable stand-by letter of credit in the amount of $2.0 million. The stand-by letter of credit is collateralized by a high-yield savings account, which is classified as restricted cash, long-term on the accompanying consolidated balance sheets.

In June 2012, the Company entered into a long-term lease agreement for office space in South San Francisco, California, which was subsequently amended in May 2014 and July 2015. As amended, the Company rents approximately 29,470 square feet. The term of this lease runs until March 2026, with the option to extend for an additional five-year term, and rents payable by the Company increase approximately 3% per year. The Company provided the landlord an automatically renewable stand-by letter of credit in the amount of $1.1 million. The stand-by letter of credit is collateralized by a high-yield savings account, which is classified as restricted cash, long-term on the accompanying consolidated balance sheets.

The Company also leases copier equipment for use in the office spaces. Components of lease expense include fixed lease expense and variable lease expense of approximately ~~$3.6~~$3.5 million and ~~$0.3~~$0.3 million, respectively, for the nine months ended September 30, ~~2019.~~2020. Fixed lease expense and variable lease expense for the nine months ended September 30, 2019, was approximately $3.6 million and $0.3 million, respectively. For purposes of determining straight-line rent expense, the lease term is calculated from the date the Company first takes possession of the facility, including any periods of free rent and any renewal option periods that the Company is reasonably certain of exercising. ~~Our~~The Company’s office and equipment leases generally have contractually specified minimum rent and annual rent increases that are included in the measurement of the ~~right-of-use~~ROU asset and related lease liability. Additionally, under these lease arrangements, wethe Company may be required to pay directly, or reimburse the lessors, for real estate taxes, insurance, utilities, maintenance and other operating costs. Such amounts are generally variable and therefore not included in the measurement of the ROU asset and related lease liability but are instead recognized as variable lease expense in selling, general and administrative costs in the consolidated statements of operations ~~and comprehensive loss~~ when they are incurred. The Company recorded operating sublease income of $0.1 million for the three and nine months ended September 30, 2019 in other income in the consolidated statements of operations and comprehensive loss.incurred

Supplemental cash flow information related to leases for the nine months ended September 30, ~~2019:~~2020:

Operating cash flows from operating leases (in thousands)	$	4,050
Operating cash flows for operating leases (in thousands)				$	4,194
Right-of-use assets obtained in exchange for new operating lease liabilities		—			—
Weighted average remaining lease term (in years)		6.5			5.5
Weighted average discount rate		10.9	%		10.9	%

The maturity of lease liabilities as of September 30, ~~2019~~2020 were as follows (in thousands):

	Amount			Amount
2019 (remaining)	$	1,274
2020		5,207
2020 (remaining)				$	1,312
2021		5,365			5,365
2022		5,483			5,483
2023		5,631			5,631
2024					5,805
Thereafter		13,296			7,491
Total	$	36,256		$	31,087
Less: imputed interest		(10,404	)		(7,751	)
Total lease liabilities	$	25,852		$	23,336

In February 2019, the Company entered into a long-term sublease agreement for 12,429 square feet of the office space in Los Angeles, California. The term of the lease runs until March 2026 and rent amounts payable to the Company increase approximately 3% per year. The Company recorded operating sublease income of $0.1 million and $0.3 million for the three and nine months ended September 30, 2020, respectively, in other income (expenses) in the consolidated statements of operations.

The future minimum lease payments to be received as of ~~December 31, 2018 under ASC 840~~September 30, 2020 were as follows (in thousands):

	Amount		Amount
2019	$	4,924
2020		5,141
2020 (remaining)			$	115
2021		5,300		467
2022		5,464		481
2023		5,631		495
2024				510
Thereafter		13,296		659
Total	$	39,756	$	2,727

	September 30, 2019			December 31, 2018			September 30, 2020			December 31, 2019
Leasehold improvements	$	3,780		$	4,048		$	3,779		$	3,779
Computer equipment		2,367			2,402			2,213			2,698
Telephone equipment		340			343			340			340
Furniture and fixtures		2,346			2,346			2,359			2,346
		8,833			9,139			8,691			9,163
Less: accumulated depreciation		(5,629	)		(5,176	)		(6,032	)		(5,859	)
Totals	$	3,204		$	3,963		$	2,659		$	3,304

For the three ~~months~~ and nine months ended September 30, ~~2019,~~2020, the Company incurred depreciation expense of $0.2 million and $0.7 million, respectively.

Intangible assets, net consisted of the following ~~(dollars in~~(in thousands):

	September 30, 2019			Estimated Useful Life	September 30, 2020			December 31, 2019
Acquired and in-licensed rights	$	50,000		13 Years	$	90,000		$	50,000
Less: accumulated amortization		(8,553	)			(13,856	)		(9,539	)
Total intangible asset, net	$	41,447			$	76,144		$	40,461

For the three ~~months~~ and nine months ended September 30, ~~2019,~~2020, the Company incurred amortization expense of ~~$1.0~~$2.0 million and ~~$3.0~~$4.3 million, respectively. In June 2020, the Company entered into a letter agreement with Pfizer relating to the method of payment associated with a one-time milestone payment under the Company’s license agreement with Pfizer(see Note 13-Commitments and Contingencies). The estimated remaining useful life of the intangible assets as of September 30, 2020 is 9.5 years.

	September 30, 2019		December 31, 2018		September 30, 2020		December 31, 2019
Current:
Accrued legal verdict expense	$	31,350	$	9,000	$	22,569	$	31,350
Accrued royalties						8,002		8,866
Accrued CRO services		13,923		10,187		3,510		8,502
Accrued royalties		8,040		9,162
Accrued variable consideration		6,406		3,818		13,368		7,978
Accrued bonus						5,968		1,618
Accrued compensation		3,569		4,435		4,688		4,138
Accrued other clinical development						1,531		2,546
Accrued professional fees		1,061		2,175		2,430		1,775
Accrued other clinical development		3,425		2,380
Accrued bonus		5,119		1,705
Accrued legal fees		886		1,379		545		266
Accrued manufacturing costs		1,095		788		494		869
Other		1,897		1,402		366		1,122
						63,471		69,030
Long-term:
Accrued legal verdict expense						24,822		—
Accrued CRO services						542		—
Accrued compensation						92
Other						37		—
						25,493		—
Totals	$	76,771	$	46,431	$	88,964	$	69,030

Accrued CRO services, accrued other clinical development expenses, and accrued legal fees represent the Company’s estimates of such costs and are recognized as incurred. Accrued royalties represent royalties incurred in connection with the Company’s license agreement with Pfizer. Accrued compensation includes accrued commissions and accrued vacation, which is accrued at the rate the employee earns vacation and reduced as vacation is used by the employee. Accrued variable consideration represents estimates of adjustments to product revenue, net for which reserves are established. Other accrued expenses consist primarily of accrued contractor/consultant costs, business license fees, taxes, insurance, and marketing fees.

~~Accrued~~Long-term accrued legal verdict expense represents anthe Company’s estimate of ~~a range between $9.0 million and $18.0~~$24.8 million that may be owed to class action participants as a result of the ~~recent~~ jury verdict in Hsu v. Puma Biotechnology, Inc., While the final claims report received in Hsu reflects a total of $50.5 million in claimed damages, the Company intends to challenge these claims and estimates that actual claims could be as low as $24.8 million. The actual amount of damages in Hsu is uncertain and will be ascertained only after an ~~initial~~extensive claims challenge process, the completion of post-trial proceedings and the exhaustion of any appeals. As a result, the Company has estimated the legal verdict expense for Hsu to be $24.8 million. Actual damages in the Hsu matter may be higher than the Company’s estimate. In addition, on September 9, 2019, the Court entered an order specifying the rate of prejudgment interest to be awarded on any valid claims at the 52-week Treasury Bill rate. Current accrued legal verdict expense represents an estimate of ~~$22.4~~$22.6 million that may be owed to the plaintiff as a result of the ~~recent~~ jury verdict in Eshelman v. Puma Biotechnology, Inc., et al. The total amount of damages in ~~Hsu~~ ~~and~~ Eshelman is uncertain and will be ascertained only after ~~an extensive claims process in~~ ~~Hsu,~~ ~~and~~ the completion of post-trial proceedings and the exhaustion of any ~~appeals in both cases.~~appeals. It is also reasonably possible that the total damages inEshelman will be higher than ~~these estimates.~~this estimate.

Long term debt consisted of the following ~~at September 30, 2019 (dollars in~~(in thousands):

	September 30, 2019			Maturity Date	September 30, 2020			Maturity Date
Long term debt	$	100,000		June 1, 2024
Total debt					$	100,000		June 1, 2024
Accretion of final interest payment		1,603				2,951
Less: current portion of long-term debt						(5,714	)
Less: deferred financing costs		(7,418	)			(5,523	)
Total long term debt, net	$	94,185
Total long-term debt, net					$	91,714

In October 2017, the Company entered into a loan and security agreement with Silicon Valley Bank, or SVB, as administrative agent, and the lenders party thereto from time to time, or the Original Lenders, including Oxford Finance LLC, or Oxford, and SVB. Pursuant to the terms of the credit facility provided for by the loan and security agreement, or the Original Credit Facility, the Company borrowed $50.0 million.

In May 2018, the Company entered into an amendment to the loan and security agreement, which provided for an amended credit facility, or the Amended Credit Facility. Under the Amended Credit Facility, the Original Lenders agreed to make term loans available to the Company in an aggregate amount of $155.0 million, consisting of (i) an aggregate amount of $125.0 million, the proceeds of which, in part, were used to repay the $50.0 million borrowed under the Original Credit Facility, and (ii) an aggregate amount of $30.0 million that the Company drew in December 2018, which was available under the Amended Credit Facility as a result of achieving a specified minimum revenue milestone. ~~The Company was in compliance with all applicable financial covenants during the entire term of the Amended Credit Facility.~~

Prior to the amendment and restatement of the loan and security agreement in June 2019, which provided for a new credit facility, or the New Credit Facility, the term loans under the Amended Credit Facility bore interest at an annual rate equal to the greater of (i) 8.25% and (ii) the sum of (a) the “prime rate,” as reported in The Wall Street Journal on the last business day of the month that immediately preceded the month in which the interest accrued, plus (b) 3.5%. The Company was required to make monthly interest-only payments on each term loan commencing on the first calendar day of the calendar month following the funding date of such term loan, and continuing on the first calendar day of each calendar month thereafter through July 1, 2020. Commencing on July 1, 2020, and continuing on the first calendar day of each calendar month thereafter, the Company would have been required to make consecutive equal monthly payments of principal, together with applicable interest, in arrears to each original lender, calculated pursuant to the Amended Credit Facility. All unpaid principal and accrued and unpaid interest with respect to each term loan would have been due and payable in full on May 1, 2023. Upon repayment of the term loans, the Company was also required to make a final payment to the Original Lenders equal to 7.5% of the original principal amount of term loans funded.

The Company was also permitted to prepay the outstanding principal balance of any term loan under the Amended Credit Facility, in whole but not in part, subject to a prepayment fee of 3.0% of any amount prepaid if the prepayment were to occur through and including the first anniversary of the funding date of such term loan, 2.0% of any amount prepaid if the prepayment were to occur after the first anniversary of the funding date of such term loan through and including the second anniversary of the funding date of such term loan, and 1.0% of the amount prepaid if the prepayment were to occur after the second anniversary of the funding date of such term loan and prior to May 1, 2023.

On June 28, 2019, or the Effective Date, the Company entered into an amendment and restatement of the loan and security agreement, which provided for a new credit facility, or the New Credit Facility, with Oxford, as collateral agent, and the lenders party thereto from time to time, including Oxford, pursuant to which the Company repaid the $155.0 million outstanding under the Amended Credit Facility, as well as all applicable exit and prepayment fees owed to the Original Lenders under the Amended Credit Facility, using cash on hand and $100.0 million in new borrowings from the New Credit Facility. Under the New Credit Facility, the Company issued to Oxford new and/or replacement secured promissory notes in an aggregate principal amount for all such promissory notes of $100.0 million evidencing the New Credit Facility. NaN additional money remains available to the Company under the New Credit Facility.

The New Credit Facility is secured by substantially all of the Company’s personal property other than its intellectual property. The Company also pledged 65% of the issued and outstanding capital stock of its subsidiaries, Puma Biotechnology Ltd. and Puma Biotechnology B.V. The New Credit Facility limits the Company’s ability to grant any interest in its intellectual property to certain permitted licenses and permitted encumbrances set forth in the agreement.

The term loans under the New Credit Facility bear interest at an annual rate equal to the greater of (i) 9.0% and (ii) the sum of (a) the “prime rate,” as reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 3.5%. The Company is required to make monthly interest-only payments on each term loan under the New Credit Facility commencing on the first calendar day of the calendar month following the funding date of such term loan, and continuing on the first calendar day of each calendar month thereafter through August 1, 2021, or the Amortization Date. Commencing on the Amortization Date, and continuing on the first calendar day of each calendar month thereafter, the Company will make consecutive equal monthly payments of principal, together with applicable interest, in arrears to each lender under the New Credit Facility, calculated pursuant to the New Credit Facility. All unpaid principal and accrued and unpaid interest with respect to each term loan under the New Credit Facility is due and payable in full on June 1, 2024, or the Maturity Date. Upon repayment of such term loans, the Company is also required to make a final payment to the lenders equal to ~~7.5%~~7.5% of the aggregate principal amount of such term loans outstanding as of the Effective Date. The effective interest rate as of September 30, 2020 was 12.75%.

At the Company’s option, the Company may prepay the outstanding principal balance of any term loan in whole but not in part, subject to a prepayment fee of 3.0% of any amount prepaid if the prepayment occurs through and including the first anniversary of the funding date of such term loan, 2.0% of the amount prepaid if the prepayment occurs after the first anniversary of the funding date of such term loan through and including the second anniversary of the funding date of such term loan, and 1.0% of the amount prepaid if the prepayment occurs after the second anniversary of the funding date of such term loan and prior to the Maturity Date.

The New Credit Facility includes affirmative and negative covenants applicable to the Company, its current ~~subsidiary~~subsidiaries and any subsidiaries the Company creates in the future. The affirmative covenants include, among others, covenants requiring the Company to maintain its legal existence and governmental approvals, deliver certain financial reports, maintain insurance coverage and satisfy certain requirements regarding deposit accounts. The Company must also achieve certain product revenue targets, measured as of the last day of each fiscal quarter on a trailing ~~year to date basis, for the periods ending June 30, 2019, September 30, 2019 and December 31, 2019.~~year-to-date basis. New minimum revenue levels will be established for each subsequent fiscal year by mutual agreement of the Company, Oxford, as collateral agent, and the ~~new lenders.~~lenders under the New Credit Facility. The negative covenants include, among others, restrictions on the Company’s transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets and suffering a change in control, in each case subject to certain exceptions.

The New Credit Facility also includes events of default, the occurrence and continuation of which could cause interest to be charged at the rate that is otherwise applicable plus 5.0% and would provide Oxford, as collateral agent, with the right to exercise remedies against the Company and the collateral securing the New Credit Facility, including foreclosure against the property securing the New Credit Facility, including ~~its~~the Company’s cash. These events of default include, among other things, the Company’s failure to pay principal or interest due under the New Credit Facility, a breach of certain covenants under the New Credit Facility, the Company’s insolvency, a material adverse change, the occurrence of any default under certain other indebtedness in an amount greater than $500,000 and one or more judgments against the Company in an amount greater than $500,000 individually or in the aggregate that remains unsatisfied, unvacated, or unstayed for a period of 10 days after its entry.

On August 5, 2020, the Company entered into an amendment to the amended and restated loan and security agreement to revise the minimum revenue levels that it must achieve under the terms of the New Credit Facility for the year-to-date periods ending September 30, 2020 and December 31, 2020.

As of September 30, ~~2019,~~2020, there ~~was~~were $100.0 million in term loans outstanding under the New Credit Facility, representing all of the Company’s long-term debt outstanding as of that ~~date, and~~date. As of September 30, 2020, the Company was in compliance with all applicable covenants under the New Credit Facility.

The future minimum principal payments under the New Credit Facility as of September 30, 2020 were as follows (in thousands):

Deferred financing costs are financing costs related to the Company’s outstanding debt. Amortization of debt issuance costs is expensed using the effective interest method and is included in interest expense. For the nine months ended September 30, 2020 and 2019, the Company recorded approximately $1.4 million and $1.1 million, respectively, of interest expense related to the amortization of debt issuance costs.

On April 20, 2020, the Company received loan proceeds from SVB of $8.4 million under the Paycheck Protection Program, or PPP, of the Coronavirus Aid, Relief, and Economic Security Act. Following the issuance of additional guidance from the U.S. Small Business Administration regarding eligibility requirements for borrowers under the PPP, the Company returned the full amount of the loan to SVB on April 30, 2020.

The Company issued ~~87,625~~12,000 and ~~187,754~~87,625 shares of common stock upon exercise of stock options during the nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively. The Company issued ~~531,112~~505,627 and ~~332,173~~531,112 shares of common stock upon vesting of RSUs during the nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, respectively.

The Company has 100,000,000 shares of stock authorized for issuance, all of which are common stock, par value $0.0001 per share.

In October 2011, the Company issued an anti-dilutive warrant to Alan Auerbach, the Company’s founder and chief executive officer. The warrant was issued to provide Mr. Auerbach with the right to maintain ownership of at least 20% of the Company’s common stock in the event that the Company raised capital through the sale of its securities in the future.

In connection with the closing of a public offering in October 2012, the exercise price and number of shares underlying the warrant issued to Mr. Auerbach were established and, accordingly, the final value of the warrant became fixed. Pursuant to the terms of the warrant, Mr. Auerbach may exercise the warrant to acquire 2,116,250 shares of the Company’s common stock at $16 per share until October 4, 2021.

The Company’s 2011 Incentive Award Plan, as amended, or the 2011 Plan, was adopted by the Company’s ~~board~~Board of ~~directors~~Directors on September 15, 2011. Pursuant to the 2011 Plan, the Company may grant incentive stock options and nonqualified stock options, as well as other forms of equity-based compensation. Incentive stock options may be granted only to employees, while consultants, employees, officers and directors are eligible for the grant of nonqualified options under the 2011 Plan. The maximum term of stock options granted under the 2011 Plan is 10 ~~years.~~years and the awards generally vest over a three-year period. The exercise price of incentive stock options granted under the 2011 Plan must be at least equal to the fair value of such shares on the date of grant. Through September 30, ~~2019,~~2020, a total of 12,529,412 shares of the Company’s common stock had been reserved for issuance under the 2011 Plan.

All of the options awarded by the Company have been “plain vanilla options” as determined by the SEC Staff Accounting Bulletin 107 - Share Based Payment. As of September 30, ~~2019, 6,146,363~~2020, 6,108,663 shares of the Company’s common stock are issuable upon the exercise of outstanding ~~awards~~stock options and vesting of RSUs granted under the 2011 Plan and ~~2,801,058~~2,204,978 shares of the Company’s common stock are available for future issuance under the 2011 Plan. The fair value of options granted to employees and nonemployees was estimated using the Black-Scholes Option Pricing Method (see Note 2) with the following weighted-average assumptions used during the nine months ended September ~~30, 2019 and 2018:~~30:

	2019			2018			2020			2019
Dividend yield		0.0	%		0.0	%		0.0	%		0.0	%
Expected volatility		99.9	%		95.5	%		100.6	%		99.9	%
Risk-free interest rate		2.5	%		2.5	%		0.9	%		2.5	%
Expected life in years		5.76			5.85			5.81			5.76

The Company’s 2017 Employment Inducement Incentive Award Plan, or the 2017 Plan, was adopted by the Company’s Board of Directors on April 27, 2017. Pursuant to the 2017 Plan, the Company may grant stock options and RSUs, as well as other forms of equity-based compensation to employees, as an inducement to join the Company. The maximum term of stock options granted under the 2017 Plan is 10 ~~years.~~years and the awards generally vest over a three-year period. The exercise price of stock options granted under the 2017 Plan must be at least equal to the fair market value of such shares on the date of grant. As of September 30, ~~2019,~~2020, a total of ~~1,000,000~~2,000,000 shares of the Company’s common stock have been reserved for issuance under the 2017 Plan. As of September 30, ~~2019, 565,645~~2020, 1,308,533 shares ~~have been awarded~~of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting of RSUs granted under the 2017 Plan and 453,538 shares of the Company’s common stock are available for future issuance under the 2017 Plan.

Stock-based compensation expense was as follows ~~for the three and nine months ended September 30~~ (in thousands):

	For the Three Months Ended				For the Nine Months Ended				For the Three Months Ended				For the Nine Months Ended
	September 30,				September 30,				September 30,				September 30,
	2019		2018		2019		2018		2020		2019		2020		2019
Stock-based compensation:
Options -
Selling, general, and administrative	$	1,768	$	3,132	$	6,706	$	11,721	$	1,025	$	1,768	$	2,908	$	6,706
Research and development		1,786		5,387		6,001		22,689		723		1,786		2,295		6,001
Restricted stock units -
Selling, general, and administrative		3,832		6,280		16,221		15,228		3,076		3,832		10,615		16,221
Research and development		4,827		6,008		16,863		18,705		2,741		4,827		11,284		16,863
Total stock-based compensation expense	$	12,213	$	20,807	$	45,791	$	68,343	$	7,565	$	12,213	$	27,102	$	45,791

Activity with respect to options granted under the 2011 Plan and 2017 Plan is summarized as follows:

Shares

Weighted
Average
Exercise
Price

Weighted
Average
Remaining
Contractual
Term (years)

Aggregate
Intrinsic Value
(in thousands)

Outstanding at December 31, 2018

5,708,544

$
87.49

6.1

$
7,762

Granted

129,734

$
27.76

9.4

Forfeited

(69,969
)

$
40.50

Exercised

(87,625
)

$
15.42

$
995

Expired

(603,918
)

$
102.39

Outstanding at September 30, 2019

5,076,766

$
86.08

5.4

$
2,450

Nonvested at September 30, 2019

396,948

$
39.99

8.6

	Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (years)		Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2019		5,042,325		$	82.42		5.2	$	1,951
Granted		700,853		$	10.03		-
Exercised		(12,000	)	$	3.75			$	80
Expired		(551,597	)	$	92.49
Outstanding at September 30, 2020		5,179,581		$	71.73		5.3	$	3,351
Nonvested at September 30, 2020		1,008,221		$	12.10		9.3		1,213
Exercisable		4,171,360		$	86.14		4.3	$	2,138

At September 30, ~~2019,~~2020, total estimated unrecognized employee compensation cost related to non-vested stock options granted prior to that date was approximately ~~$10.0~~$7.7 million, which is expected to be recognized over a weighted-average period of ~~1.4~~1.9 years. At September 30, ~~2019,~~2020, the total estimated unrecognized employee compensation cost related to non-vested RSUs was approximately ~~$48.8~~$24.3 million, which is expected to be recognized over a weighted-average period of ~~1.6~~1.5 years. The weighted-average grant date fair value of options granted during the nine months ended September 30, 2020 and 2019 was $7.81 and ~~2018 was~~ $21.82 ~~and $56.46~~ per share, respectively. The weighted average grant date fair value of RSUs awarded during the nine months ended September 30, 2020 and 2019 was $10.57 and ~~2018 was~~ $20.36 ~~and $62.11~~ per share, respectively.

Stock options	Shares			Weighted Average Grant-Date Fair Value
Nonvested shares at December 31, 2018		779,292		$	33.75
						Shares			Weighted Average Grant-Date Fair Value
Nonvested shares at December 31, 2019							1,991,125		$	27.63
Granted		129,734			21.82		1,174,491			10.57
Vested/Issued		(442,109	)		35.13		(505,627	)		42.19
Forfeited		(69,969	)		25.06		(422,374	)		23.18
Nonvested shares at September 30, 2019		396,948		$	29.85
Nonvested shares at September 30, 2020							2,237,615		$	16.23

~~The~~During 2012, the Company ~~maintains~~adopted a 401(k) savings plan for the benefit of its employees. The Company is required to make matching contributions to the 401(k) plan equal to 100% of the first 3% of wages deferred by each participating employee and 50% on the next 2% of wages deferred by each participating employee. The Company incurred expenses for employer matching contributions of approximately ~~$1.2~~$1.1 million and ~~$1.3~~$1.2 million for the nine months ended September 30, 2020 and 2019, ~~and 2018,~~ respectively.

Contractual obligations represent future cash commitments and liabilities under agreements with third parties, and exclude contingent liabilities for which the Company cannot reasonably predict future payment. The Company’s contractual obligations result primarily from obligations for various contract manufacturing organizations and clinical research organizations, which include potential payments we may be required to make under our agreements. The contracts also contain variable costs and milestones that are hard to predict as they are based on such things as patients enrolled and clinical trial sites. The timing of payments and actual amounts paid under contract manufacturing organization, or CMO, and CRO agreements may be different depending on the timing of receipt of goods or services or changes to agreed-upon terms or amounts for some obligations. Also, those agreements are cancelable upon written notice by the Company and, therefore, not long-term liabilities.

In August 2011, the Company entered into an agreement pursuant to which Pfizer agreed to grant it a worldwide license for the development, manufacture and commercialization of PB272 neratinib (oral), PB272 neratinib (intravenous) and PB357, and certain related compounds. The license is exclusive with respect to certain patent rights owned by or licensed to Pfizer. Under the agreement, the Company is obligated to commence a new clinical trial for a product containing one of these compounds within a specified period of time and to use commercially reasonable efforts to complete clinical trials and to achieve certain milestones as provided in a development plan. From the closing date of the agreement through December 31, 2011, Pfizer continued to conduct the existing clinical trials on behalf of the Company at Pfizer’s sole expense. At the Company’s request, Pfizer has agreed to continue to perform certain services in support of the existing clinical trials at the Company’s expense. These services will continue through the completion of the transitioned clinical trials. The license agreement “capped” the out of pocket expense the Company would ~~be responsible for completing~~incur to complete the then existing clinical trials. All agreed upon costs incurred by the Company above the “cost cap” would be reimbursed by Pfizer. The Company exceeded the “cost cap” during the fourth quarter of 2012. In accordance with the license agreement, the Company billed Pfizer for agreed upon costs above the “cost cap” until December 31, 2013.

On July 18, 2014, the Company entered into an amendment to the license agreement with Pfizer. The amendment amends the agreement to (1) reduce the royalty rate payable by the Company to Pfizer on sales of licensed products; (2) release Pfizer from its obligation to pay for certain out-of-pocket costs incurred or accrued on or after January 1, 2014 to complete certain ongoing clinical studies; and (3) provide that Pfizer and the Company will continue to cooperate to effect the transfer to the Company of certain records, regulatory filings, materials and inventory controlled by Pfizer as promptly as reasonably practicable.

As consideration for the license, the Company is required to make substantial payments upon the achievement of certain milestones totaling approximately $187.5 million if all such milestones are achieved. In connection with the FDA approval of NERLYNX in July of 2017, the Company triggered a one-time milestone payment pursuant to the agreement. In June 2020, the Company entered into a letter agreement, or the Letter Agreement, with Pfizer relating to the method of payment associated with a one-time milestone payment under the license agreement with Pfizer. The Letter Agreement permits the Company to make the milestone payment in installments with the amounts payable to Pfizer (including interest) to be made in November 2020 for approximately $10.4 million and in September 2021 for approximately $21.9 million. Unpaid portions of the milestone payment will accrue interest at 6.25% per annum until paid. The installment payments and accrued interest are included in accrued in-licensed rights on the accompanying consolidated balance sheets. The Company may trigger additional milestone payments in the future. Should the Company commercialize any more of the compounds licensed from Pfizer or any products containing any of these compounds, the Company will be obligated to pay to Pfizer annual royalties at a fixed rate in the low-to-mid teens of net sales of all such products, subject to certain reductions and offsets in some circumstances. The Company’s royalty obligation continues, on a product-by-product and country-by-country basis, until the later of (1) the last to expire licensed patent covering the applicable licensed product in such country, or (2) the earlier of generic competition for such licensed product reaching a certain level in such country or expiration of a certain time period after first commercial sale of such licensed product in such country. In the event that the Company sublicenses the rights granted to the Company under the license agreement with Pfizer to a third party, the same milestone and royalty payments are required. The Company can terminate the license agreement at will, or for safety concerns, in each case upon specified advance notice.

The Company and certain of its executive officers were named as defendants in the lawsuits detailed below. The Company records a liability in the consolidated financial statements for loss contingencies when a loss is known or considered probable and the amount can be reasonably estimated. If the reasonable estimate of a known or probable loss is a range, and no amount within the range is a better estimate than any other, the minimum amount of the range is accrued. If a loss is reasonably possible but not known or probable, and can be reasonably estimated, the estimated loss or range of loss is disclosed. When determining the estimated loss or range of loss, significant judgment is required to estimate the amount and timing of a loss to be recorded. Currently, the Company has accrued estimated losses of $9$24.8 million related to Hsu v. Puma Biotechnology, Inc. and ~~$22.4~~$22.6 million related to Eshelman v. Puma Biotechnology, Inc., et al. as detailed below. For certain legal expenses related to the verdicts listed below, the Company has received reimbursements from its insurers.

On June 3, 2015, Hsingching Hsu, individually and on behalf of all others similarly situated, filed a class action lawsuit against the Company and certain of its executive officers in the United States District Court for the Central District of California (Case No. 8:15-cv-00865-AG-JCG). On October 16, 2015, lead plaintiff Norfolk Pension Fund filed a consolidated complaint on behalf of all persons who purchased the Company’s securities between July 22, 2014 and May 29, 2015. A trial on the claims relating to four statements alleged to have been false or misleading was held from January 15, 2019 to January 29, 2019. At trial, the jury found that three of the four challenged statements were not false or misleading, and thus found in the defendants’ favor on those claims. The jury found liability as to one statement and awarded a maximum of $4.50 per share in damages, which represents approximately 5% of the total claimed damages of $87.20 per share. The total amount of aggregate class-wide damages is uncertain and will be ascertained only after an extensive claims process and the exhaustion of any appeals. Trading models suggest that approximately 10 million shares traded during the class period may be eligible to claim damages. Based on prior lawsuits, the Company believes that the number of stockholders who submit proof of claims sufficient to recover damages is typically in the range of 20% to 40% of the total eligible shares. Based on these assumptions, total damages after claims could range from $9 million to $18 million. It is also reasonably possible that the total damages will be higher than this estimate, however, at this time, the amount is not estimable.

On September 9, 2019, the Court entered an order specifying the rate of prejudgment interest to be awarded on any valid claims at the 52-week Treasury Bill rate. On September 8, 2020, the claims administrator submitted its final claims report to the Court and, on October 9, 2020, the claims administrator submitted its supplemental claims report. The ~~Court’s order also established~~claims report reflects approximately $50.5 million in claimed damages. The Company disagrees with the amount of claimed damages and has submitted a proposal to the Court for challenging claims. Based on a review of specific claims and subject to the outcome of the claims challenge process, ~~which~~the Company believes that total claimed damages after all claims challenges have been adjudicated could range from $24.8 million to $51.3 million. The total amount of aggregate class-wide damages still remains uncertain and will be ascertained only after the claims challenge process and the exhaustion of any appeals. It is ~~expected to take about twelve months.~~reasonably possible that the final total damages awarded will differ from these estimates; however, the amount is not estimable at this time. A final judgment has not yet been entered.

Additionally, after trial, the plaintiff filed a motion seeking approximately $3 million in attorneys’ fees, as well as prejudgment interest. In the Court’s March 2 ruling, it denied the motion for attorneys’ fees but granted the request for prejudgment interest, bringing the total judgment to $26.3 million. On March 30, 2020, the plaintiff filed a notice of cross-appeal and conditional cross-appeal, appealing the Court’s order denying the plaintiff’s request for attorneys’ fees and conditionally cross-appealing a Court ruling that certain communications between Mr. Auerbach and his attorneys were protected by attorney-client privilege and a related evidentiary ruling. The Company estimates the high end of potential damages in the matter could be approximately ~~$26.3~~$27.2 million; however, the actual amount of damages payable by the Company is still uncertain and will be ascertained only after completion of ~~post-trial~~the appeal and any subsequent proceedings, ~~and the exhaustion of any appeals,~~ and such amount could be greater than the amount of expense already recognized or the high end of the estimate. Due to the appeal, the Company secured a bond for the potential damages, which is collateralized by an automatically renewable stand-by letter of credit in the amount of $8.9 million. The stand-by letter of credit is collateralized by a high-yield savings account, which is classified as restricted cash, current on the accompanying consolidated balance sheets.

On July 28, 2020, the Company filed a request for arbitration against CANbridge Biomed Limited, or CANbridge, before the ICC International Court of Arbitration. The Company is asserting that CANbridge has violated the terms of the Company’s agreement with CANbridge in which it granted CANbridge an exclusive sublicense to develop and commercialize NERLYNX throughout greater China. The Company is seeking an arbitral award that CANbridge breached, or alternatively is in anticipatory breach of, the Company’s agreement with CANbridge; that CANbridge’s conduct constitutes grounds for termination of the agreement; that CANbridge has failed to use commercially reasonable efforts to commercialize NERLYNX as required under the agreement; and that CANbridge must obtain the Company’s consent before transferring the agreement to a third party, subject to certain limitations that do not currently apply. The Company is also seeking damages, costs, and attorneys’ fees. On August 26, 2020, CANbridge filed its response to the Company’s request for arbitration and brought counterclaims for breach of contract; tortious interference with business relations; unjust enrichment; breach of the implied covenant of good faith and fair dealing; and declaratory relief. CANbridge’s counterclaims additionally seek damages, costs and attorneys’ fees. The Company believes that CANbridge’s counterclaims are without merit and responded to CANbridge’s counterclaims on September 30, 2020. As of September 30, 2020, the Company has recorded approximately $0.1 million in legal expense related to the arbitration. The arbitration remains pending.

On September 17, 2020, the Company filed a lawsuit against Hedrick Gardner Kincheloe & Garofalo, L.L.P. and David L. Levy, the attorneys who previously represented the Company in Eshelman v. Puma Biotechnology, Inc., et al. in the Superior Court of Mecklenburg County, North Carolina. The Company is alleging legal malpractice based on the defendants’ negligent handling of the defense of the Company in Eshelman v. Puma Biotechnology, Inc., et al. as detailed above. The Company is seeking recovery of the entire amount awarded in Eshelman v. Puma Biotechnology, Inc., et al. as detailed above.

On October 9, 2020, the claims administrator submitted its supplemental claims report. The claims report reflects approximately $50.5 million in claimed damages. The Company ~~noted no events or transactions subsequent~~disagrees with the amount of claimed damages and has submitted a proposal to the ~~balance-sheet date~~Court for challenging claims. Based on a review of specific claims and subject to the outcome of the claims challenge process, the Company believes that ~~would~~total claimed damages after all claims challenges have ~~a material effect on~~been adjudicated could range from $24.8 million to $51.3 million. The total amount of aggregate class-wide damages still remains uncertain and will be ascertained only after the ~~financial statements.~~claims challenge process and the exhaustion of any appeals. It is reasonably possible that the final total damages awarded will differ from these estimates; however, the amount is not estimable at this time. A final judgment has not yet been entered.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and the notes thereto included in Item 1 in this Quarterly Report on Form ~~10-Q.~~10-Q, or this Quarterly Report. The following discussion should also be read in conjunction with our audited consolidated financial statements and the notes thereto and “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, ~~2018.~~2019.

Unless otherwise provided in this Quarterly Report, references to the “Company,” “we,” “us,” and “our” refer to Puma Biotechnology, Inc., a Delaware corporation, together with its wholly owned subsidiaries.

We are a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. We ~~have in-licensed~~in-license from Pfizer, Inc., or Pfizer, the global development and commercialization rights to PB272 (neratinib, ~~(oral))~~oral), PB272 (neratinib, ~~(intravenous))~~intravenous) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the human epidermal growth factor receptors, HER1, HER2 and HER4. Currently, we are primarily focused on the development and commercialization of the oral version of neratinib, and our most advanced drug candidates are directed at the treatment of HER2-positive breast ~~cancer.~~cancer and HER2 mutated cancers. We believe neratinib has clinical application in the treatment of several other cancers as well, including other tumor types that over-express or have a mutation in HER2 or EGFR, such as breast cancer, cervical cancer, lung cancer or other solid tumors.

Prior to 2017, our efforts and resources had been focused primarily on acquiring and developing our pharmaceutical technologies, raising capital and recruiting personnel. ~~During~~In 2017, the ~~United States~~U.S. Food and Drug Administration, or FDA, approved NERLYNX, formally known as PB272 (neratinib, ~~(oral))~~oral), for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. ~~We currently market~~In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the United States using our direct specialty sales force consisting of approximately 80 sales specialists. Our sales specialists are supported by an experienced sales leadership team consisting of regional managers, and our commercial team of experienced professionals in marketing, access and reimbursement, managed markets, marketing research, commercial operations and sales force planning and management. metastatic setting. In ~~September~~ 2018, the European Commission, or EC, granted marketing ~~authorisation~~authorization for NERLYNX in the European Union for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and inwho are less than one year from the ~~third quarter~~completion of ~~2019, our licensees, Knight Therapeutics, or Knight, and Pint Pharma International SA, or Pint, received marketing authorization for NERLYNX in Canada and Argentina, respectively.~~ prior adjuvant trastuzumab-based therapy.

We have entered into ~~other~~ exclusive ~~license~~sub-license agreements with various parties to pursue regulatory approval, if necessary, and commercialize NERLYNX, if approved, in numerous regions outside the United States, including Europe (excluding Russia and Ukraine), Canada, ~~South East~~China, Southeast Asia, Israel, ~~greater China,~~ Mexico, ~~various countries in North Africa and West Africa,~~South Korea, and various countries and territories in Central and South America ~~respectively.~~. We plan to continue to pursue commercialization of NERLYNX in other countries outside the United States, if approved, and will evaluate various commercialization options in those countries, including developing a direct salesforce, contracting with third parties to provide sales and marketing capabilities, or some combination of these two options. We expect that our expenses will continue to increase as we continue commercialization efforts.approved.

Our expenses to date have been related to hiring staff, commencing company-sponsored clinical trials and the build out of our corporate infrastructure and, since 2017, the commercial launch of NERLYNX. To date, our major sources of working capital have been proceeds from product and license revenue, public offerings of our common stock, proceeds from our credit facility and sales of our common stock in private placements.

Our priorities during the COVID-19 pandemic are protecting the health and safety of our employees while continuing our mission to develop and commercialize innovative products to enhance cancer care. Substantially all geographic regions in which our U.S. sales force operates have imposed, and those regions or other regions in which our sales force operates may in the future impose, “shelter-in-place” orders, quarantines or similar orders or restrictions to control the spread of COVID-19. These types of restrictions may deter or prevent cancer patients from traveling to see their doctors and result in a decline in revenue for NERLYNX, our only commercial product. Additionally, our commercial team and sales force have limited travel and personal interactions with physicians and customers, including visits to healthcare provider offices due to limitations that have been imposed at certain hospitals and medical facilities, and are currently conducting a large percentage of promotional activities virtually. These types of restrictions have adversely impacted our ability to engage with our customers and have adversely impacted sales of NERLYNX, our only commercial product, and they may continue to do so. The respective commercial teams of certain of the companies to which we sub-license the commercial rights to NERLYNX, and on which we rely for our international sales, have chosen or have been forced to take similar action, and other sub-licensees of NERLYNX may choose or be forced to take similar action. Furthermore, the COVID-19 pandemic has resulted in dramatic increases in unemployment rates, which may result in a substantial number of people becoming uninsured or underinsured. Any of these developments may have an adverse effect on our revenue. We have observed disruptions in patient enrollments in the United States and in our SUMMIT basket trial. If the COVID-19 pandemic continues to spread in the geographies in which we are conducting clinical trials, we may experience additional disruptions in those clinical trials, which could have a material adverse impact on our clinical trial plans and timelines.

Our ability to continue to operate without any significant negative impacts will in part depend on the length and severity of the COVID-19 pandemic and our ability to protect our employees and our supply chain. We continue to follow and monitor recommended actions of government and health authorities to protect our employees worldwide. For the nine months ended September 30, 2020, we and our key third-party suppliers and manufacturers were able to broadly maintain operations. We rely exclusively on third-party manufacturers to manufacture NERLYNX.

We intend to satisfy our near-term liquidity requirements through a combination of our existing cash and cash equivalents and marketable securities as of September 30, 2020 and proceeds that will become available to us through product sales, royalties and license milestone payments. However, this intention is based on assumptions that may prove to be wrong. Changes may occur that would consume our available capital faster than anticipated, including the length and severity of the COVID-19 pandemic and measures taken to control the spread of COVID-19, as well as changes in and progress of our development activities, the impact of commercialization efforts, acquisitions of additional drug candidates and changes in regulation. Any of these developments may have an adverse effect on our revenue and thus our ability to satisfy the minimum revenue covenants in our loan and security agreement.

As of the date of the filing of this Quarterly Report, we believe there have been no material changes to our critical accounting policies and estimates during the three months and nine months ended September 30, ~~2019~~2020 from our accounting policies at December 31, ~~2018,~~2019, as reported in our Annual Report on Form 10-K for the fiscal year ended December 31, ~~2018.~~2019. We ~~had~~accounted for the following ~~activity~~ related to ~~license~~sub-license agreements during the nine months ended September 30, ~~2019:~~2020:

We recognize license revenue under certain of our ~~license~~sub-license agreements that are within the scope of ASC 606. The terms of these agreements may contain multiple performance obligations, which may include licenses and research and development activities. We evaluate these agreements under ASC 606 to determine the distinct performance obligations. Non-refundable, up-front fees that are not contingent on any future performance and require no consequential continuing involvement by us, are recognized as revenue when the license term commences and the licensed data, technology or product is delivered. We defer recognition of non-refundable upfront license fees if the performance obligations are not satisfied.

Prior to recognizing revenue, we make estimates of the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur and when the uncertainty associated with the variable consideration is subsequently resolved. Variable consideration may include nonrefundable upfront license fees, payments for research and development activities, reimbursement of certain third-party costs, payments based upon the achievement of specified milestones, and royalty payments based on product sales derived from the collaboration.

If there are multiple distinct performance obligations, we allocate the transaction price to each distinct performance obligation based on its relative standalone selling price. The standalone selling price is generally determined based on the prices charged to customers or using expected ~~cost plus~~cost-plus margin. Revenue is recognized by measuring the progress toward complete satisfaction of the performance obligations.

On January 9, 2019, we entered into a license agreement, or the Knight Agreement, with Knight. Pursuant to the Knight Agreement, we granted to Knight, under certain of our intellectual property rights relating to neratinib, an exclusive, sublicensable (under certain circumstances) license (i) to commercialize any product containing neratinib and certain related compounds in Canada, (ii) to seek and maintain regulatory approvals for the licensed products in Canada and (iii) to manufacture the licensed products anywhere in the world solely for the development and commercialization of the licensed products in Canada for human use, subject to the terms of the Knight Agreement and the related supply agreement. During the first quarter of 2019, we received a non-refundable, upfront license fee, which we recognized as license revenue in accordance with ASC Topic 606. We satisfied the necessary performance obligations to recognize this license revenue under the terms of the arrangement. The Knight Agreement met the contract existence criteria and contained distinct, identifiable performance obligations for which the stand-alone selling prices were readily determinable and allocable. As a separate promise under the terms of the Knight Agreement, we are obligated to supply Knight with the licensed product in accordance with the supply agreement entered in connection with the license agreement. We are also obligated to participate in a Joint Steering Committee, which was identified as a separate performance obligation. To determine the stand-alone selling price, we estimated the transaction prices, including any variable consideration, at contract inception and determined the fair value of such obligations based on similar arrangements. When determining the transaction prices, we assumed that the goods or services will be transferred to the customer based on the terms of the existing contract, and did not take into consideration the possibility of a contract being canceled, renewed, or modified. We noted there was no additional variable consideration, significant financing components, non-cash consideration, or consideration payable to the customer in this agreement. The Knight Agreement also includes potential future milestone and royalty payments due to us upon successful completion of certain separate, distinct performance obligations. Pursuant to the Knight Agreement, we will potentially receive upfront, regulatory and sales-based milestone payments totaling up to $7.2 million. In addition, we are entitled to receive double-digit royalties calculated as a percentage of net sales of the licensed products in Canada. At this time, we cannot estimate when these milestone-related performance obligations might be achieved.

~~Additionally, during the first quarter of 2019, we entered into a license agreement, or the Pierre Fabre Agreement,~~ with Pierre Fabre Medicament SAS, or Pierre Fabre. The Pierre Fabre Agreement granted intellectual property rights and set forth the parties’ respective obligations with respect to development, commercialization and supply of the licensed productin ~~European countries excluding Russia and Ukraine, along with countries in North Africa and francophone countries of West Africa.~~During the first quarter of 2019, we recognized a non-refundable, upfront license fee of $51.0 million as license revenue in accordance with ASC Topic 606. We satisfied the necessary performance obligations to recognize this license revenue under the terms of the arrangement. The Pierre Fabre Agreement met the contract existence criteria and contained distinct, identifiable performance obligations for which the stand-alone selling prices were readily determinable and allocable. As a separate promise under the terms of the Pierre Fabre Agreement, we are obligated to supply Pierre Fabre with the licensed product in accordance with the related supply agreement. This supply arrangement has been identified as a separate promise. We are also obligated to participate in a Joint Steering Committee and Transition Plan, which were identified as separate performance obligations. To determine the respective stand-alone selling prices, we estimated the transaction prices, including any variable consideration, at contract inception and determined the fair value of such obligations based on similar arrangements. When determining the transaction prices, we assumed that the goods or services will be transferred to the customer based on the terms of the existing contract, and did not take into consideration the possibility of a contract being canceled, renewed, or modified. We noted approximately $9.0 million in additional variable consideration ~~related to a post-marketing commitment liability~~, while no significant financing components, non-cash consideration, or consideration payable to the customer were noted. The Pierre Fabre Agreement also includes potential future milestone and royalty payments due to us upon successful completion of certain separate, distinct performance obligations. Pursuant to the Pierre Fabre Agreement, we will potentially receive additional regulatory and sales based milestone payments totaling up to $345 million. ~~In addition, we will receive double-digit royalties on NERLYNX sales throughout the territory covered by the Pierre Fabre Agreement.~~ ~~At this time, we cannot estimate when these milestone-related performance obligations might be achieved.~~

During the first quarter of 2018, we entered into a license agreement, or the Pint Agreement, with Pint. The Pint Agreement granted intellectual property rights and set forth the respective obligations with respect to development, commercialization and supply of NERLYNX in Mexico and 21 countries and territories in Central and South America. The Pint Agreement includes potential future milestone and royalty payments due to us upon successful completion of certain performance obligations, such as achieving regulatory approvals. Pursuant to the Pint Agreement, we received an upfront payment of $10.0 million during the third quarter of 2018 and will potentially receive additional regulatory and commercial milestone payments totaling up to approximately $24.5 million, as well as double-digit royalties on NERLYNX sales throughout the territory covered by the Pint Agreement. During the third quarter of 2019, we achieved a certain development-based milestone, which satisfied a performance obligation necessary to recognize the associated license revenue. The payment associated with this license revenue is expected to be received from Pint during the third quarter of 2020. At this time, we cannot estimate when these remaining milestone-related performance obligations might be achieved.

Product revenue, net consists of revenue from sales of NERLYNX. We sell NERLYNX to a limited number of specialty pharmacies and specialty distributors in the United States. We record revenue at the net sales price, which includes an estimate for variable consideration for which reserves are established. Variable consideration consists of trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates and other incentives.

License revenue consists of consideration earned for performance obligations satisfied pursuant to our license agreements.

Royalty revenue consists of consideration earned related to product sales made by our licensees in their respective territories pursuant to our license agreements.

Cost of sales consists of third-party manufacturing costs, freight, and indirect overhead costs associated with sales of NERLYNX. Cost of sales also includes period costs related to royalty charges payable to Pfizer, the amortization of a milestone ~~payment~~payments made to Pfizer, ~~after obtaining FDA approval of NERLYNX,~~ certain inventory manufacturing services, inventory adjustment charges, unabsorbed manufacturing and overhead costs, and manufacturing variances.

Selling, general and administrative expenses, or SG&A ~~expenses~~Expenses, consist primarily of salaries and ~~related personnel~~payroll-related costs, ~~including~~ stock-based compensation expense, professional fees, business insurance, rent, general legal activities, and other corporate expenses. Internal expenses primarily consist of payroll-related costs, but also include facilities and equipment costs, travel expenses and supplies. External expenses primarily consist of legal fees, insurance expenses and consulting for activities suchWe expense SG&A Expenses as ~~sales, marketing and software implementations to support corporate growth.~~

~~We expect overall SG&A expenses in 2019 to be similar to those in 2018. Additionally, we~~they are currently appealing the verdicts in two trials and may incur substantial legal expenses in connection with these appeals. However, we are currently unable to estimate the magnitude of such legal expenses and when these expenses will cease. incurred.

Research and development expenses, or R&D ~~expenses~~Expenses, include costs associated with services provided by consultants who conduct clinical services on our behalf, contract organizations for the manufacturing of clinical materials and clinical trials. During the three and nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, our R&D ~~expenses~~Expenses consisted primarily of clinical research organization, or CRO, fees; fees paid to consultants; salaries and related personnel costs; and stock-based compensation. We expense our R&D ~~costs~~Expenses as they are incurred. Internal R&D ~~expenses~~Expenses primarily consist of payroll-related costs, ~~but~~and also include equipment costs, travel expenses and supplies. ~~External expenses primarily consist of clinical trial expenses and consultant and contractor expense, and also include costs such as legal fees, insurance costs and manufacturing expense.~~

While we expect clinical R&D expenses to decline in 2019 as compared to 2018, some areas of R&D are expected to increase, such as medical affairs, pharmacovigilance and regulatory affairs as we prepare to apply for global regulatory approval of NERLYNX both in the current and future indications.

Three Months Ended September 30, ~~2019~~2020 Compared to Three Months Ended September 30, ~~2018~~2019

For the three months ended September 30, ~~2019,~~2020, total revenue was approximately ~~$56.4~~$50.8 million, compared to ~~$62.6~~$56.4 million for the three months ended September 30, ~~2018.~~ 2019.

Product revenue, net was approximately $49.3 million for the three months ended September 30, 2020, compared to $53.5 million for the three months ended September 30, ~~2019, compared~~2019. The decrease in product revenue, net was attributable to ~~$52.6 million~~a volume decrease of approximately 23% in bottles of NERLYNX sold, and an increase in reserves for variable consideration from approximately 12% of product revenue for the three months ended September 30, ~~2018.~~2019 to approximately 16% of product revenue for the three months ended September 30, 2020. The increase in reserves for variable consideration is primarily due to an increase in government rebates as a percentage of gross revenue. The decrease in product revenue, net was ~~primarily attributable to a~~partially offset by an approximately 10% increase in gross selling price that occurred in the first quarter of ~~2019~~2020 and again in the third quarter of ~~2019, partially offset by an increase in variable consideration of approximately 12% in the third quarter of 2019 as compared to approximately 7% in the third quarter of 2018.~~2020.

~~License~~There was no license revenue ~~was approximately~~for the three months ended September 30, 2020, compared to $2.8 million for the three months ended September 30, ~~2019, compared to $10.0~~2019.

Royalty revenue was $1.4 million for the three months ended September 30, ~~2018. The decrease in license revenue related to our having achieved performance-based milestones under two different license agreements in the three months ended September 30, 2019,~~2020, compared to ~~an upfront payment for the satisfaction of a performance obligation under another license agreement during the three months ended September 30, 2018.~~

~~Royalty revenue was~~ $0.1 million for the three months ended September 30, ~~2019, compared to no royalty revenue for the three months ended September 30, 2018.~~2019. The increase was due to ~~royalty revenue recognized related to~~increased product sales by our ~~licensees~~sub-licensees as they ~~begin~~began to ~~sell~~commercialize NERLYNX in ~~their respective~~additional territories.

~~For the three months ended September 30, 2019, cost~~Cost of sales was approximately ~~$9.4 million compared to $9.0~~$9.9 million for the three months ended September 30, ~~2018.~~2020, compared to $9.4 million for the three months ended September 30, 2019. The increase in cost of sales was primarily attributable to an increase in the amortization of the milestone payments made to Pfizer and increased royalty expense due to Pfizer related to the increase in royalty revenue, which was partially offset by decreased royalty expenses due to Pfizer ~~directly~~ related to the ~~increase~~decrease in product ~~revenue.~~revenue, net.

For the three months ended September 30, ~~2019,~~2020, SG&A ~~expenses~~Expenses were approximately ~~$31.4~~$29.6 million, compared to approximately ~~$28.5~~$31.4 million for the three months ended September 30, ~~2018.~~2019. SG&A ~~expenses~~Expenses for the three months ended September 30, ~~2019~~2020 and ~~2018~~2019 were as follows:

Selling, general, and administrative expenses	For the Three Months Ended				Change						For the Three Months Ended				Change
in thousands	September 30,				$			%
(in thousands)											September 30,				$			%
	2019		2018		2019/2018			2019/2018			2020		2019		2020/2019			2020/2019
Payroll and related costs	$	9,586	$	10,918	$	(1,332	)		-12.2	%	$	10,274	$	9,586	$	688			7.2	%
Professional fees and expenses		10,526		3,037		7,489			246.6	%		11,271		10,526		745			7.1	%
Travel and meetings		2,964		2,428		536			22.1	%		1,090		2,964		(1,874	)		-63.2	%
Facilities and equipment costs		1,439		1,558		(119	)		-7.6	%		1,412		1,439		(27	)		-1.9	%
Stock-based compensation												4,101		5,600		(1,499	)		-26.8	%
Other		1,287		1,150		137			11.9	%		1,450		1,287		163			12.7	%
Stock-based compensation		5,600		9,411		(3,811	)		-40.5	%
	$	31,402	$	28,502	$	2,900			10.2	%	$	29,598	$	31,402	$	(1,804	)		-5.7	%

For the three months ended September 30, ~~2019,~~2020, SG&A ~~expenses increased~~Expenses decreased by approximately ~~$2.9~~$1.8 million compared to the same period in ~~2018,~~2019, primarily attributable to the following:

For the three months ended September 30, ~~2019,~~2020, R&D ~~expenses~~Expenses were approximately ~~$30.0~~$23.3 million, compared to approximately ~~$36.4~~$30.0 million for the three months ended September 30, ~~2018.~~2019. R&D ~~expenses~~Expenses for the three months ended September 30, ~~2019~~2020 and ~~2018~~2019 were as follows:

Research and development expenses	For the Three Months Ended				Change						For the Three Months Ended				Change
in thousands	September 30,				$			%
(in thousands)											September 30,				$			%
	2019		2018		2019/2018			2019/2018			2020		2019		2020/2019			2020/2019
Clinical trial expense	$	11,251	$	12,222	$	(971	)		-7.9	%	$	8,257	$	11,251	$	(2,994	)		-26.6	%
Internal R&D		9,512		10,441		(929	)		-8.9	%		9,441		9,512		(71	)		-0.7	%
Consultant and contractors		2,651		2,302		349			15.2	%		2,183		2,651		(468	)		-17.7	%
Stock-based compensation		6,613		11,395		(4,782	)		-42.0	%		3,463		6,613		(3,150	)		-47.6	%
	$	30,027	$	36,360	$	(6,333	)		-17.4	%	$	23,344	$	30,027	$	(6,683	)		-22.3	%

For the three months ended September 30, ~~2019,~~2020, R&D ~~expenses~~Expenses decreased approximately ~~$6.3~~$6.7 million compared to the same period in ~~2018,~~2019, primarily attributable to the following:

~~These decreases were partially offset by an increase in consultant and contractor expenses of approximately $0.4 million primarily attributable to regulatory-related activities.~~

Other income (expenses)	For the Three Months Ended						Change						For the Three Months Ended						Change
in thousands	September 30,						$			%
(in thousands)													September 30,						$			%
	2019			2018			2019/2018			2019/2018			2020			2019			2020/2019			2020/2019
Interest income	$	569		$	590		$	(21	)		-3.6	%	$	22		$	569		$	(547	)		-96.1	%
Interest expense		(3,052	)		(3,499	)		447			-12.8	%		(3,627	)		(3,052	)		(575	)		18.8	%
Other income (expenses)		46			(11	)		57			-518.2	%
Legal verdict expense														(15,855	)		—			(15,855	)		-100.0	%
Other income														128			46			82			178.3	%
	$	(2,437	)	$	(2,920	)	$	483			-16.5	%	$	(19,332	)	$	(2,437	)	$	(16,895	)		693.3	%

For the three months ended September 30 ~~2019, we recognized approximately $0.6 million in~~, 2020, interest income ~~compared to~~decreased approximately ~~$0.6~~$0.5 million ~~of interest income~~ for the three months ended September 30, ~~2018.~~2020 compared to the same period in 2019. The decrease in interest income reflects less cash invested in money market accounts and high-yield savings accounts in 2020 compared to 2019.

For the three months ended September 30 ~~2019,~~, 2020, we recognized approximately ~~$3.1~~ $3.6 million in interest expense, compared to ~~$3.5~~$3.1 million of interest expense for the three months ended September 30 ~~2018.~~, 2019. The ~~decrease~~increase in interest expense was primarily the result of ~~decreased borrowings~~the interest expense for the milestone payments being paid to Pfizer in ~~June 2019.~~installments.

For the quarter ended September 30, 2020, we recognized $15.9 million in legal verdict expense, which primarily represents an increase to our estimate of potential amounts that may be owed to class action participants as a result of the Hsu v. Puma Biotechnology, Inc. claims process. During the three months ended September 30, 2020, we changed our estimate of the legal verdict expense and the associated legal expense accrual for the Hsu lawsuit. Our previous estimate was based on data and assumptions that were available at the time. During the third and fourth quarter of 2020, we obtained additional data, previously unavailable, from the claims report and amended claims report filed with the Court. The claims report asserts $50.5 million in damages, which is larger than the amount previously estimated. We intend to challenge these claims and estimate that the damages could range from $24.8 million to $51.3 million. As a result, we have increased our estimate of the legal accrual on a prospective basis beginning in the third quarter of 2020 to $24.8 million, resulting in the additional $15.7 million legal verdict expense. The total amount of aggregate class-wide damages still remains uncertain and will be ascertained only after an extensive claims challenge process and the exhaustion of any appeals.

Nine Months Ended September 30, ~~2019~~2020 Compared to Nine Months Ended September 30, ~~2018~~2019

For the nine months ended September 30, ~~2019,~~2020, total revenue was approximately ~~$209.3~~$172.6 million, compared to ~~$179.9~~$209.3 million for the nine months ended September 30, ~~2018.~~ 2019.

Product revenue, net was approximately $146.7 million for the nine months ended September 30, 2020, compared to $152.9 million for the nine months ended September 30, ~~2019, compared to $139.4 million for the nine months ended September 30, 2018.~~2019. The ~~increase~~decrease in product revenue, net was ~~primarily~~ attributable to a volume ~~increase~~decrease of approximately 5%18% in ~~sales~~bottles of NERLYNX asold, partially offset by an approximately 10% increase in gross selling price that occurred in ~~January~~the first quarter of ~~2019,~~2020 and ~~a 10% increase~~again in ~~gross selling price that occurred in September~~the third quarter of ~~2019, partially offset by an increase in variable consideration of~~2020.

License revenue was approximately ~~14%~~$22.7 million for the nine months ended September 30, ~~2019 as~~2020, compared to ~~approximately 8% for the nine months ended September 30, 2018.~~

~~License revenue was~~ $56.3 million for the nine months ended September 30, ~~2019,~~2019. The decrease in license revenue is primarily due to a decrease in upfront payments and satisfaction of different performance-based milestones related to sub-license agreements in the nine months ended September 30, 2020, compared to ~~$40.5~~the nine months ended September 30, 2019.

Royalty revenue was $3.1 million for the nine months ended September 30, ~~2018. The increase was primarily due~~2020, compared to ~~upfront payments for the satisfaction of performance obligations related to license agreements, as well as the satisfaction of performance-based milestones related to license agreements.~~

~~Royalty revenue was~~ $0.2 million for the nine months ended September 30, ~~2019, compared to no royalty revenue for the nine months ended September 30, 2018.~~2019. The increase was due to ~~royalty revenue recognized related to the start of~~increased product sales by our ~~licensees.~~sub-licensees as they began to commercialize NERLYNX in additional territories.

For the nine months ended September 30, ~~2019,~~2020, cost of sales was approximately ~~$26.7~~$28.4 million compared to ~~$24.3~~$26.7 million for the nine months ended September 30, ~~2018.~~2019. The increase in cost of sales was primarily attributable to increased royalty expense due to Pfizer ~~directly~~ related to the increase in ~~sales~~royalty revenue and an increase in the amortization of ~~NERLYNX for~~ the ~~nine months ended September 30, 2019 as compared~~milestone payments made to Pfizer, which was partially offset by decreased royalty expenses due to Pfizer related to the ~~nine months ended September 30, 2018.~~decrease in product revenue, net.

For the nine months ended September 30, ~~2019,~~2020, SG&A ~~expenses~~Expenses were approximately ~~$110.4~~$89.9 million, compared to approximately ~~$105.2~~$110.4 million for the nine months ended September 30, ~~2018.~~2019. SG&A ~~expenses~~Expenses for the nine months ended September 30, ~~2019~~2020 and ~~2018~~2019 were as follows:

Selling, general, and administrative expenses	For the Nine Months Ended				Change						For the Nine Months Ended				Change
in thousands	September 30,				$			%
(in thousands)											September 30,				$			%
	2019		2018		2019/2018			2019/2018			2020		2019		2020/2019			2020/2019
Payroll and related costs	$	31,409	$	32,352	$	(943	)		-2.9	%	$	31,658	$	31,409	$	249			0.8	%
Professional fees and expenses		39,218		28,829		10,389			36.0	%		32,252		39,218		(6,966	)		-17.8	%
Travel and meetings		8,419		9,272		(853	)		-9.2	%		4,023		8,419		(4,396	)		-52.2	%
Facilities and equipment costs		4,378		4,435		(57	)		-1.3	%		4,276		4,378		(102	)		-2.3	%
Stock-based compensation												13,523		22,927		(9,404	)		-41.0	%
Other		4,084		3,402		682			20.0	%		4,150		4,084		66			1.6	%
Stock-based compensation		22,927		26,949		(4,022	)		-14.9	%
	$	110,435	$	105,239	$	5,196			4.9	%	$	89,882	$	110,435	$	(20,553	)		-18.6	%

For the nine months ended September 30, ~~2019,~~2020, SG&A ~~expenses increased~~Expenses decreased by approximately ~~$5.2~~$20.6 million compared to the same period in ~~2018,~~2019, primarily attributable to the following:

For the nine months ended September 30, 2019, R&D expenses were approximately $102.6 million, compared to approximately $126.5 million for the nine months ended September 30, 2018. R&D expenses for the nine months ended September 30, 2019 and 2018 were as follows:

~~For the nine months ended September 30, 2019, R&D expenses decreased approximately $23.9 million compared to the same period in 2018, primarily attributable to the following:~~

For the nine months ended September 30, 2020, R&D Expenses were approximately $73.5 million, compared to approximately $102.6 million for the nine months ended September 30, 2019. R&D Expenses for the nine months ended September 30, 2020 and 2019 were as follows:

For the nine months ended September 30, 2020, R&D Expenses decreased approximately $29.1 million compared to the same period in 2019, primarily attributable to the following:

Other income (expenses)	For the Nine Months Ended						Change						For the Nine Months Ended						Change
in thousands	September 30,						$			%
(in thousands)													September 30,						$			%
	2019			2018			2019/2018			2019/2018			2020			2019			2020/2019			2020/2019
Interest income	$	2,349		$	1,093		$	1,256			114.9	%	$	474		$	2,349		$	(1,875	)		-79.8	%
Interest expense		(11,943	)		(7,165	)		(4,778	)		66.7	%		(10,479	)		(11,943	)		1,464			-12.3	%
Legal verdict expense		(16,350	)		—			(16,350	)		100.0	%		(16,041	)		(16,350	)		309			-1.9	%
Loss on debt extinguishment		(8,103	)		—			(8,103	)		100.0	%		—			(8,103	)		8,103			-100.0	%
Other income (expenses)		31			(690	)		721			-104.5	%
Other income														298			31			267			861.3	%
	$	(34,016	)	$	(6,762	)	$	(27,254	)		403.0	%	$	(25,748	)	$	(34,016	)	$	8,268			-24.3	%

For the nine months ended September 30 ~~2019,~~, 2020, we recognized approximately ~~$2.3~~$0.5 million in interest income compared to approximately ~~$1.1~~$2.3 million of interest income for the nine months ended September 30 ~~2018.~~, 2019. The ~~increase~~decrease in interest income reflects ~~more~~less cash invested in money market accounts and ~~“high yield”~~high-yield savings accounts in ~~2019~~2020 compared to ~~2018.~~2019.

For the nine months ended September 30, 2020, we recognized approximately $10.5 million in interest expense, compared to $11.9 million of interest expense for the nine months ended September 30, 2019. The decrease in interest expense was primarily the result of having less borrowings outstanding in 2020 than in 2019. The decrease was partially offset by an increase in interest expense for the milestone payments being paid to Pfizer in installments.

For the nine months ended September 30, 2020, we recognized an additional $16.0 million in legal verdict expense that primarily represents an increase to our prior estimate of potential amounts that may be owed to class action participants as a result of the Hsu v. Puma Biotechnology, Inc. claims process. During the period ended September 30, 2020, we changed our estimate of the legal verdict expense and the associated legal expense accrual for the Hsu lawsuit. Our previous estimate was based on data and assumptions that were available at the time. During the third and fourth quarter of 2020, we obtained additional data, previously unavailable, from the claims report and amended claims report filed with the Court. The claims report asserts $50.5 million in damages, which is larger than the amount previously estimated. We intend to challenge these claims and estimate that the damages could range from $24.8 million to $51.3 million. As a result, we have increased our estimate of the legal accrual on a prospective basis beginning in the third quarter of 2020 to $24.8 million, resulting in the additional $15.7 million legal verdict expense. The total amount of aggregate class-wide damages still remains uncertain and will be ascertained only after an extensive claims challenge process and the exhaustion of any appeals.

For the nine months ended September 30, 2019, we recognized approximately ~~$11~~.9 ~~million in interest expense, compared to $7.2 million of interest expense for the nine months ended September 30, 2018.~~ ~~The increase in interest expense was the result of increased borrowings as well as a higher interest rate.~~

~~For the nine months ended September 30, 2019, we recognized approximately $16.4~~$16.4 million in legal verdict expense related to the Eshelman v. Puma Biotechnology, Inc., et al.verdict. The legal verdict expense of $16.4 million isfor the nine months ended September 30, 2019 was the result of our initial estimate of the total damages payable in the matter of $22.4 million, net of $6.0 million in insurance reimbursements.

For the nine months ended September 30, 2019, we recognized approximately $8.1 million in loss on debt extinguishment related to the fees paid in connection with our debt refinancing during the second quarter of ~~2019 that resulted in the reduction of our long-term debt by approximately $55.0 million.~~2019.

~~For the nine months ended September 30, 2018, we recognized approximately $0.7 million in other expense, which primarily consisted of fees from the modification of debt.~~

The following table summarizes our liquidity and capital resources as of September 30, ~~2019~~2020 and December 31, ~~2018,~~2019, and for the nine months ended September 30, ~~2019~~2020 and ~~2018,~~2019, and is intended to supplement the more detailed discussion that follows:

							As of			As of
Liquidity and capital resources (in thousands)	September 30, 2019			December 31, 2018			September 30, 2020			December 31, 2019
Cash and cash equivalents	$	58,904		$	108,419		$	90,082		$	60,037
Marketable securities	$	51,535		$	57,002		$	18,942		$	51,607
Working capital	$	62,752		$	135,888		$	41,607		$	75,459
Stockholders' equity	$	17,180		$	34,306
Stockholders' (deficit) equity							$	(453	)	$	17,463

	Nine Months Ended			Nine Months Ended			Nine Months Ended			Nine Months Ended
	September 30, 2019			September 30, 2018			September 30, 2020			September 30, 2019
Cash provided by (used in):
Operating activities	$	20,810		$	(31,152	)	$	6,408		$	20,810
Investing activities		5,595			(60,205	)		22,580			5,595
Financing activities		(67,066	)		77,959			45			(67,066	)
Decrease in cash and cash equivalents	$	(40,661	)	$	(13,398	)
Net increase (decrease) in cash, cash equivalents and restricted cash							$	29,033		$	(40,661	)

For the nine months ended September 30, ~~2019,~~2020, we reported a net loss of approximately ~~$64.4~~$45.0 million, compared to approximately ~~$82.9~~$64.4 million for the same period in ~~2018.~~2019. Additionally, cash provided by operating activities for the nine months ended September 30, ~~2019~~2020 was approximately ~~$20.8~~$6.4 million compared to approximately ~~$31.2~~$20.8 million of cash ~~used in~~provided by operating activities for the same ~~periods~~period in ~~2018,~~2019, respectively.

Cash provided by operating activities for the nine months ended September 30, 2020 consisted of a net loss of approximately $45.0 million, offset by approximately $34.2 million of non-cash items, such as stock-based compensation and depreciation and amortization, an increase in accrued expense and other of approximately $21.0 million, a decrease in prepaid expenses and other of approximately $4.4 million, and a decrease in accounts receivable, net of approximately $1.8 million. These increases were partially offset by a decrease in accounts payable of approximately $6.7 million, an increase in other current assets of approximately $3.1 million and other immaterial changes.

Cash provided by operating activities for the nine months ended September 30, 2019 consisted of a net loss of approximately $64.4 million, a decrease in prepaid expenses and other of approximately $2.9 million, a decrease in other current assets of approximately $1.5 million, an increase of approximately $30.3 million in accrued expenses and other, an increase of approximately $9.0 million in a post-marketing commitment liability, and approximately $60.0 million of non-cash items, such as stock-based compensation, depreciation and amortization, and debt extinguishment fees; partially offset by an increase in net accounts receivable of approximately $6.4 million, an increase in inventory of approximately $0.5 million, and a decrease in accounts payable of approximately $11.6 million.

Cash used in operating activities for the nine months ended September 30, 2018 consisted of a net loss of approximately $82.9 million, an increase in net accounts receivable of approximately $10.1 million, an increase in other current assets of approximately $11.5 million, an increase of approximately $10.9 million in accrued expenses and an increase of approximately $0.8 million in inventory, offset by a decrease of approximately $11.4 million in accounts payable, $0.2 million decrease in prepaid expenses and other and $73.9 million of non-cash items such as stock-based compensation, depreciation and amortization, and loss on modification of debt.

During the nine months ended September 30, ~~2019,~~2020, net cash provided by investing activities was approximately ~~$5.6~~$22.6 million, compared to net cash ~~used in~~provided by investing activities of ~~$60.2~~$5.6 million for the same period in ~~2018.~~ 2019.

Net cash provided by investing activities during the nine months ended September 30, 2020 consisted of approximately $57.0 million of maturities of available-for-sale securities, partially offset by the purchase of available for sale securities of approximately $24.4 million and an increase in intangible assets relating to the milestone achieved under the Company’s license agreement with Pfizer of $10.0 million.

Net cash provided by investing activities during the nine months ended September 30, 2019 consisted of approximately ~~$133.6~~$132.7 million of sales or maturities of available-for-sale securities, partially offset by ~~$128.0~~$127.1 million of ~~cash invested in~~purchases of available-for-sale securities. Net cash used in investing activities during the nine months ended September 30, 2018 was made up of approximately $71.1 million of cash invested in available-for-sale securities, offset by approximately $11.5 million of sales or maturities of available-for-sales securities, and approximately $0.3 million of cash used to purchase property and equipment.

During the nine months ended September 30, 2020, net cash was unchanged by financing activities. During April 2020, approximately $8.4 million was borrowed and fully repaid with no penalty or interest from Silicon Valley Bank, or SVB, under the Paycheck Protection Program, or PPP, of the Coronavirus Aid, Relief, and Economic Security Act.

During the same period in 2019, cash used in financing activities was approximately $67.1 million, which consisted of approximately $80.0 million in debt repayments, approximately $7.8 million in debt extinguishment costs and approximately $5.6 million in debt issuance costs, partially offset by approximately $25.0 million in proceeds from long-term debt and approximately $1.3 million in proceeds from the exercise of stock options. During the same period in 2018, cash provided by financing activities was approximately $78.0 million, which consisted of approximately $75.0 million of incremental proceeds from long-term debt, and approximately $7.2 million in net proceeds from the exercise of stock options, partially offset by approximately $4.2 million of payments related to debt issuance costs.

In October 2017, we entered into ~~the Original Credit Facility~~a loan and security agreement with SVB, as administrative agent, and the lenders party thereto from time to time, or the Original ~~Lenders.~~Lenders, including Oxford Finance, LLC, or Oxford, and SVB. Pursuant to the terms of the credit facility provided ~~for~~ by the ~~original~~ loan and security agreement, or the Original Credit Facility, we borrowed $50 million.In May 2018, we entered into an amendment to the loan and security agreement, which provided for an amended credit facility, or the Amended Credit Facility. Under the Amended Credit Facility, the Original Lenders agreed to make term loans available to us in an aggregate amount of $155 million, consisting of (i) a term loan in an aggregate amount of $125 million, the proceeds of which, in part, were used to repay the $50 million we borrowed under the Original Credit Facility, and (ii) a term loan in an aggregate amount of $30 million that we drew in December 2018, which was available to us under the Amended Credit Facility as a result of achieving a specified minimum revenue milestone. ~~The Company was in compliance with all applicable financial covenants during the entire term of the Amended Credit Facility.~~

On June 28, 2019, or the Effective Date, we entered into a new credit facility, or the New Credit Facility, with Oxford, as collateral agent, and the lenders party thereto from time to time, including Oxford, pursuant to which we repaid the $155.0 million outstanding under the Amended Credit Facility, as well as all applicable exit and prepayment fees owed to the Original Lenders under the Amended Credit Facility, using cash on hand and $100.0 million in new borrowings from the New Credit Facility. Under the New Credit Facility, we issued to Oxford new and/or replacement secured promissory notes in an aggregate principal amount for all such promissory notes of $100.0 million evidencing the New Credit Facility. No additional money remains available to us under the New Credit Facility.

The New Credit Facility is secured by substantially all of our personal property other than our intellectual property. We also pledged 65% of the issued and outstanding capital stock of our subsidiaries, Puma Biotechnology Ltd. and Puma Biotechnology B.V. The New Credit Facility limits our ability to grant any interest in our intellectual property to certain permitted licenses and permitted encumbrances set forth in the agreement.

The term loans under the New Credit Facility bear interest at an annual rate equal to the greater of (i) 9.0% and (ii) the sum of (a) the “prime rate,” as reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 3.5%. We are required to make monthly interest-only payments on each term loan under the New Credit Facility commencing on the first calendar day of the calendar month following the funding date of such term loan, and continuing on the first calendar day of each calendar month thereafter through August 1, 2021, or the Amortization Date. Commencing on the Amortization Date, and continuing on the first calendar day of each calendar month thereafter, we will make consecutive equal monthly payments of principal, together with applicable interest, in arrears to each lender under the New Credit Facility, calculated pursuant to the New Credit Facility. All unpaid principal and accrued and unpaid interest with respect to each term loan under the New Credit Facility is due and payable in full on June 1, 2024, or the Maturity Date. Upon repayment of such term loans, we are also required to make a final payment to the new lenders equal to 7.5% of the aggregate principal amount of such term loans outstanding as of the Effective Date.

At our option, we may prepay the outstanding principal balance of any term loan in whole but not in part, subject to a prepayment fee of 3.0% of any amount prepaid if the prepayment occurs through and including the first anniversary of the funding date of such term loan, 2.0% of the amount prepaid if the prepayment occurs after the first anniversary of the funding date of such term loan through and including the second anniversary of the funding date of such term loan, and 1.0% of the amount prepaid if the prepayment occurs after the second anniversary of the funding date of such term loan and prior to the Maturity Date.

The New Credit Facility includes affirmative and negative covenants applicable to us, our current ~~subsidiary~~subsidiaries and any subsidiaries we create in the future. The affirmative covenants include, among others, covenants requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports, maintain insurance coverage and satisfy certain requirements regarding deposit accounts. We must also achieve certain product revenue targets, measured as of the last day of each fiscal quarter on a trailing ~~year to date basis, for the periods ending June 30, 2019, September 30, 2019 and December 31, 2019.~~year-to-date basis. New minimum revenue levels will be established for each subsequent fiscal year by mutual agreement of us, Oxford, as collateral agent, and the lenders under the New Credit Facility. The negative covenants include, among others, restrictions on our transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets and suffering a change in control, in each case subject to certain exceptions.

The New Credit Facility also includes events of default, the occurrence and continuation of which could cause interest to be charged at the rate that is otherwise applicable plus 5.0% and would provide Oxford, as collateral agent, with the right to exercise remedies against us and the collateral securing the New Credit Facility, including foreclosure against the property securing the New Credit Facility, including our cash. These events of default include, among other things, our failure to pay principal or interest due under the New Credit Facility, a breach of certain covenants under the New Credit Facility, our insolvency, a material adverse change, the occurrence of any default under certain other indebtedness in an amount greater than $500,000 and one or more judgments against us in an amount greater than $500,000 individually or in the aggregate that remains unsatisfied, unvacated, or unstayed for a period of 10 days after its entry.

On August 5, 2020, we entered into an amendment to the amended and restated loan and security agreement to revise the minimum revenue levels that we must achieve under the terms of the New Credit Facility for the year-to-date periods ending September 30, 2020 and December 31, 2020.

As of September 30, ~~2019,~~2020, there ~~was~~were $100.0 million in term loans outstanding under the New Credit Facility, representing all of our long-term debt outstanding as of that date, and we were in compliance with all applicable covenants under the New Credit Facility.

We did not receive or record any product ~~revenue~~revenues until the third quarter of 2017. We have spent, and expect to continue to spend, substantial amounts in connection with implementing our business strategy, including our planned product development efforts, our clinical trials, our ~~R&D~~research and development efforts and our commercialization efforts. ~~Given the current and desired pace of clinical development of our product candidates, we expect R&D spending to decline over the next 12 months.~~

~~Additionally, we expect SG&A expenses to remain consistent as we continue commercialization efforts.~~

We may choose to begin new ~~R&D~~research and development efforts or we may choose to launch additional marketing efforts. These efforts may require funding in addition to the cash and cash equivalents totaling approximately ~~$58.9~~$90.1 million and ~~$51.5~~$18.9 million in marketable securities available at September 30, ~~2019.~~ 2020. While our consolidated financial statements have been prepared on a going concern basis, we expect to continue incurring significant losses for the foreseeable future and will ~~continue~~need to ~~remain dependent on our ability to obtain sufficient funding~~generate significant revenue to sustain operations and successfully commercialize neratinib. While we have been successful in raising financing in the past, there can be no assurance that we will be able to do so in the future. Our ability to obtain funding may be adversely impacted by uncertain market conditions, including on account of the global COVID-19 pandemic, our success in commercializing neratinib, unfavorable decisions of regulatory authorities or adverse clinical trial results. The outcome of these matters cannot be predicted at this time. We believe that our existing cash and cash equivalents and marketable securities as of September 30, 2019 and proceeds that will become available to us through product sales and license payments are sufficient to satisfy our operating cash and needs for at least one year after the filing of the Quarterly Report on Form 10-Q.

In addition, we have based our estimate of capital needs on assumptions that may prove to be wrong. Changes may occur that would consume our available capital faster than anticipated, including the length and severity of the COVID-19 pandemic and measures taken to control the spread of COVID-19, as well as changes in and progress of our development activities, the impact of commercialization efforts, acquisitions of additional drug candidates and changes in regulation. Potential sources of financing include strategic relationships, public or private sales of equity or debt and other sources of funds. We may seek to access the public or private equity markets when conditions are favorable due to our long-term capital requirements. If we raise funds by selling additional shares of common stock or other securities convertible into common stock, the ownership interests of our existing stockholders will be diluted. If we are not able to obtain financing when needed, we may be unable to carry out our business plan. As a result, we may have to significantly limit our operations, and our business, financial condition and results of operations would be materially harmed. In such an event, we will be required to undertake a thorough review of our programs, and the opportunities presented by such programs, and allocate our resources in the manner most prudent.

In addition to our operating results, as calculated in accordance with generally accepted accounting principles, or GAAP, we use certain non-GAAP financial measures when planning, monitoring, and evaluating our operational performance. The following table presents our net loss and net loss per share, as calculated in accordance with GAAP, as adjusted to remove the impact of stock-based compensation. For the three and nine months ended September 30, ~~2019,~~2020, stock-based compensation represented approximately ~~19.9%~~14.3% and ~~21.5%~~16.6% of our operating expenses, respectively, and ~~32.1%~~19.9% and ~~29.5%~~21.5% for the same period in ~~2018.~~2019, in each case excluding cost of sales. Our management believes that these non-GAAP financial measures are useful to enhance understanding of our financial performance, are more indicative of our operational performance and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures.

Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net ~~(Loss) Income~~Loss and

GAAP Net Loss Per Share to Non-GAAP Adjusted Net ~~(Loss) Income~~Loss Per Share

	For the Three Months Ended September 30,								For the Nine Months Ended September 30,							For the Three Months Ended September 30,								For the Nine Months Ended September 30,
	2019				2018				2019			2018				2020				2019				2020				2019
GAAP net loss	$	(16,885	)		$	(14,201	)		$	(64,396	)	$	(82,880	)		$	(31,463	)		$	(16,885	)		$	(45,001	)		$	(64,396	)
Adjustments:
Stock-based compensation -
Selling, general and administrative		5,600				9,412		(1)		22,927			26,949		(1)		4,101				5,600				13,523				22,927		(1)
Research and development		6,613				11,395		(2)		22,864			41,394		(2)		3,464				6,613				13,579				22,864		(2)
Non-GAAP adjusted net loss	$	(4,672	)		$	6,606			$	(18,605	)	$	(14,537	)		$	(23,898	)		$	(4,672	)		$	(17,899	)		$	(18,605	)

GAAP net loss per share—basic	$	(0.44	)		$	(0.37	)		$	(1.67	)	$	(2.19	)		$	(0.79	)		$	(0.44	)		$	(1.14	)		$	(1.67	)
Adjustment to net loss (as detailed above)		0.32				0.54				1.19			1.81				0.19				0.32				0.69				1.19
Non-GAAP adjusted basic net (loss) income per share	$	(0.12	)		$	0.17		(3)	$	(0.48	)	$	(0.38	)	(4)

GAAP net loss per share—diluted	$	(0.44	)		$	(0.36	)		$	(1.67	)	$	(2.19	)
Adjustment to net loss (as detailed above)		0.32				0.52				1.19			1.81
Non-GAAP adjusted diluted net (loss) income per share	$	(0.12	)	(5)	$	0.16		(6)	$	(0.48	)	$	(0.38	)	(7)
Non-GAAP adjusted basic net loss per share																$	(0.60	)	(3)	$	(0.12	)	(4)	$	(0.45	)	(3)	$	(0.48	)	(4)

We do not have any “off-balance sheet agreements,” as defined by SEC regulations.

In June 2020, we entered into a letter agreement, or the Letter Agreement, with Pfizer relating to the method of payment associated with our achievement of a milestone that triggered a $40 million payment under our license agreement with Pfizer. The Letter Agreement permits us to make the milestone payment in installments with the majority of the amounts payable to Pfizer (including interest) to be made in 2021 and the final payment occurring on September 30, 2021. Unpaid portions of the milestone payment will accrue interest at 6.25% per annum until paid.

Other than as described in the preceding paragraph, there have been no material changes outside the ordinary course of business to our contractual obligations and commitments as described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2019.

Some of the securities that we invest in have market risk in that a change in prevailing interest rates may cause the principal amount of the cash equivalents to fluctuate. Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash and cash equivalents. We invested our excess cash primarily in cash equivalents such as money market investments as of September 30, ~~2019.~~2020. The primary objectives of our investment activities are to ensure liquidity and to preserve principal while at the same time maximizing the income we receive from our cash and cash equivalents without significantly increasing risk. Additionally, we established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity.

Because of the short-term maturities of our cash equivalents, we do not believe that a 10% increase in interest rates would have a material effect on the realized value of our cash equivalents.

We also have interest rate exposure as a result of borrowings outstanding under our loan and security agreement. As of September 30, ~~2019,~~2020, the outstanding principal amount of our borrowings was $100.0 million. Our borrowings under the loan and security agreement, as amended, bear interest at an annual rate equal to the greater of (i) 9.0% and (ii) the sum of (a) the “prime rate,” as reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 3.5%. Changes in the prime rate may therefore affect our interest expense associated with our borrowings under the loan and security agreement.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Exchange Act, is recorded, processed, summarized and reported within the timelines specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives and in reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we have evaluated the effectiveness of our disclosure controls and procedures (as defined under Exchange Act Rule 13a-15(e)), as of September 30, ~~2019.~~2020. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that these disclosure controls and procedures were effective as of September 30, ~~2019.~~2020.

~~Effective January 1, 2019, we adopted Accounting Standards Codification 842, Leases (Topic 842). As a result, we~~have made changes to certain internal controls over financial reporting to address risks associated with the required lease accounting and disclosure requirements. This includes the enhancement of our lease evaluation processes and the implementation of controls to address risks associated with the calculation of right-of-use assets and corresponding lease liabilities. There were no ~~other~~ changes in our internal control over financial reporting that occurred during the three months ended September 30, ~~2019~~2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

On June 3, 2015, Hsingching Hsu, individually and on behalf of all others similarly situated, filed a class action lawsuit against us and certain of our executive officers in the United States District Court for the Central District of California (Case No. 8:15-cv-00865-AG-JCG). On October 16, 2015, lead plaintiff Norfolk Pension Fund filed a consolidated complaint on behalf of all persons who purchased our securities between July 22, 2014 and May 29, 2015. A trial on the claims relating to four statements alleged to have been false or misleading was held from January 15 to January 29, 2019. At trial, the jury found that three of the four challenged statements were not false or misleading, and thus found in the defendants’ favor on those claims. The jury found liability as to one statement and awarded a maximum of $4.50 per share in damages, which represents approximately 5% of the total claimed damages of $87.20 per share. The total amount of aggregate class-wide damages is uncertain and will be ascertained only after an extensive claims process and the exhaustion of any appeals. Trading models suggest that approximately ten million shares traded during the class period may be eligible to claim damages. Based on prior lawsuits, we believe that the number of stockholders who submit proof of claims sufficient to recover damages is typically in the range of 20% to 40% of the total eligible shares. Based on these assumptions, total damages after claims could range from $9 million to $18 million. It is also reasonably possible that the total damages will be higher than this estimate, however, at this time, the amount is not estimable.

On September 9, 2019, the Court entered an order specifying the rate of prejudgment interest to be awarded on any valid claims at the 52-week Treasury Bill rate. On September 8, 2020, the claims administrator submitted its final claims report to the Court and, on October 9, 2020, the claims administrator submitted its supplemental claims report. The ~~Court’s order also established~~claims report reflects approximately $50.5 million in claimed damages. We disagree with the amount of claimed damages and have submitted a proposal to the Court for challenging claims. Based on a review of specific claims and subject to the outcome of the claims challenge process, ~~which~~we believe that total claimed damages after all claims challenges have been adjudicated could range from $24.8 million to $51.3 million. The total amount of aggregate class-wide damages still remains uncertain and will be ascertained only after the claims challenge process and the exhaustion of any appeals. It is ~~expected to take about twelve months.~~reasonably possible that the final total damages awarded will differ from these estimates; however, the amount is not estimable at this time. A final judgment has not been entered.

In February 2016, Fredric N. Eshelman filed a lawsuit against our Chief Executive Officer and President, Alan H. Auerbach, and us in the United States District Court for the Eastern District of North Carolina (Case No. 7:16-cv-00018-D). The complaint generally alleged that we and Mr. Auerbach made defamatory statements regarding Dr. Eshelman in connection with a proxy contest. In May 2016, Dr. Eshelman filed a notice of voluntary dismissal of the claims against Mr. Auerbach. A trial on the remaining defamation claims against us took place from March 11 to March 15, 2019. At trial, the jury found us liable and awarded Dr. Eshelman $15.9 million in compensatory damages and $6.5 million in punitive damages. ~~Plaintiff has since filed motions seeking attorneys’ fees and pre-judgment interest, which if granted could increase the judgment amount.~~ We strongly disagree with the verdict and, on April 22, 2019, filed a motion for a new trial or, in the alternative, a reduced damages award. ~~If the verdict is upheld, pending the outcome of~~The Court denied that motion ~~we intend~~on March 2, 2020. We have appealed that ruling and the verdict. Additionally, after trial, the plaintiff filed a motion seeking approximately $3 million in attorneys’ fees, as well as pre-judgment interest. In the Court’s March 2 ruling, it denied the motion for attorneys’ fees but granted the request for pre-judgment interest, bringing the total judgment to ~~appeal~~$26.3 million. On March 30, 2020, the ~~verdict.~~plaintiff filed a notice of cross-appeal and conditional cross-appeal, appealing the Court’s order denying the plaintiff’s request for attorneys’ fees and conditionally cross-appealing a Court ruling that certain communications between Mr. Auerbach and his attorneys were protected by attorney-client privilege and a related evidentiary ruling. We estimate the high end of potential damages in the matter could be approximately ~~$26.3~~$27.2 million; however, the actual amount of damages payable by us is still uncertain and will be ascertained only after completion of ~~post-trial proceedings~~the appeal and ~~the exhaustion of~~ any ~~appeals,~~subsequent proceeding, and such ~~amounts~~amount could be greater than the amount of expense already recognized or the high end of the ~~estimate.~~estimate.

On July 28, 2020, we filed a request for arbitration against CANbridge Biomed Limited, or CANbridge, before the ICC International Court of Arbitration. We are asserting that CANbridge has violated the terms of our agreement with CANbridge in which we granted CANbridge an exclusive sublicense to develop and commercialize NERLYNX throughout greater China. We are seeking an arbitral award that CANbridge breached, or alternatively is in anticipatory breach of, our agreement; that CANbridge’s conduct constitutes grounds for termination of the agreement; that CANbridge has failed to use commercially reasonable efforts to commercialize NERLYNX as required under the agreement; and that CANbridge must obtain our consent before transferring the agreement to a third party, subject to certain limitations that do not currently apply. We are also seeking damages, costs, and attorneys’ fees. On August 26, 2020, CANbridge filed its response to our request for arbitration and brought counterclaims for breach of contract; tortious interference with business relations; unjust enrichment; breach of the implied covenant of good faith and fair dealing; and declaratory relief. CANbridge’s counterclaims additionally seek damages, costs and attorneys’ fees. We believe that CANbridge’s counterclaims are without merit and responded to CANbridge’s counterclaims on September 30, 2020. As of September 30, 2020, we have recorded approximately $0.1 million in legal expense related to the arbitration. The arbitration remains pending.

On September 17, 2020, we filed a lawsuit against Hedrick Gardner Kincheloe & Garofalo, L.L.P. and David L. Levy, the attorneys who previously represented us in Eshelman v. Puma Biotechnology, Inc., et al. in the Superior Court of Mecklenburg County, North Carolina. We are alleging legal malpractice based on the defendants’ negligent handling of the defense of us in Eshelman v. Puma Biotechnology, Inc., et al. as detailed above. We are seeking recovery of the entire amount awarded in Eshelman v. Puma Biotechnology, Inc., et al. as detailed above.

Under Item 1A of our Annual Report on Form 10-K for the year ended December 31, ~~2018, which was filed with~~2019, and our Quarterly Report on Form 10-Q for the ~~SEC on~~quarter ended March ~~1, 2019,~~31, 2020, we identified important factors that could affect our financial performance and could cause our actual results for future periods to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statements made in this ~~Form 10-Q.~~Quarterly Report. There has been no material change in our risk factors subsequent to the filing of our ~~Annual Report.~~prior reports referenced above. However, the risks described in our ~~Annual Report~~reports are not the only risks we face. Additional risks and uncertainties that we currently deem to be immaterial or not currently known to us, as well as other risks reported from time to time in our reports to the SEC, also could cause our actual results to differ materially from our anticipated results or other expectations.

We did not sell any of our equity securities without registration under the Securities Act of 1933, as amended, during the three months ended September 30, ~~2019.~~2020.

Neither we nor any “affiliated purchasers” within the definition of Rule 10b-18(a)(3) promulgated under the Exchange Act made any purchases of our equity securities during the quarter ended September 30, ~~2019.~~2020.

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.

Large accelerated filer	☒☐	Accelerated filer	☐☒

Non-accelerated filer	☐	Smaller reporting company	☐

Emerging growth company	☐

		Page
PART I – FINANCIAL INFORMATION:		1
Item 1.	Financial Statements (Unaudited):	1
	Condensed Consolidated Balance Sheets as of September 30, ~~2019~~2020 and December 31, ~~2018~~2019	1
	Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, ~~2019~~2020 and ~~2018~~2019	2
	Condensed Consolidated Statements of Comprehensive ~~Loss~~(Loss) Income for the Three and Nine Months Ended September 30, ~~2019~~2020 and ~~2018~~ 2019	3
��	Condensed Consolidated Statements of Stockholders’ (Deficit) Equity for the Three and Nine Months Ended September 30, ~~2019~~2020 and ~~2018~~2019	4
	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, ~~2019~~2020 and ~~2018~~2019	6
	Notes to the Unaudited Condensed Consolidated Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2728
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	39
Item 4.	Controls and Procedures	39
PART II – OTHER INFORMATION:		40
Item 1.	Legal Proceedings	40

Item 1A.	Risk Factors	4041
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	41
Item 3.	Defaults Upon Senior Securities	41
Item 4.	Mine Safety Disclosures	41
Item 5.	Other Information	41
Item 6.	Exhibits	42
Signatures		43

	September 30, 2020			December 31, 2019
Deferred financing costs	$	8,668		$	8,668
Less: accumulated amortization		(3,145	)		(1,701	)
Included in long-term debt	$	5,523		$	6,967

Research and development expenses	For the Nine Months Ended				Change
in thousands	September 30,				$			%
	2019		2018		2019/2018			2019/2018
Clinical trial expense	$	40,665	$	41,428	$	(763	)		-1.8	%
Internal R&D		29,485		33,940		(4,455	)		-13.1	%
Consultant and contractors		9,596		9,768		(172	)		-1.8	%
Stock-based compensation		22,864		41,393		(18,529	)		-44.8	%
	$	102,610	$	126,529	$	(23,919	)		-18.9	%

Exhibit Number		Description

3.1		Second Amended and Restated Certificate of Incorporation of the Company, as filed with the Secretary of State of the State of Delaware on June 14, 2016 (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on June 15, 2016 and incorporated herein by reference)

3.2		Third Amended and Restated Bylaws of the Company (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 28, 2019 and incorporated herein by reference)

~~10.1+~~10.1		Second Amendment to Amended ~~Non-Employee Director Compensation Program~~and Restated Loan and Security Agreement, dated July 6, 2020, by and between the Company and Oxford Finance LLC, as collateral agent and Lender (filed as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 6, 2020 and incorporated herein by reference)

10.2*		Third Amendment to Amended and Restated Loan and Security Agreement, dated August 5, 2020, by and between the Company and Oxford Finance LLC, as collateral agent and Lender (filed as Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 6, 2020 and incorporated herein by reference)

31.1+		Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, with respect to the registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, ~~2019~~2020

31.2+		Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, with respect to the registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, ~~2019~~2020

32.1++		Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2++		Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101.INS+		Inline XBRL Instance Document

101.SCH+		Inline XBRL Taxonomy Extension Schema Document

101.CAL+		Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF+		Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB+		Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE+		Inline XBRL Taxonomy Extension Linkbase Document

104+		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

+		Filed herewith

++		Furnished herewith

*		Portions of this exhibit (indicated by asterisks) have been omitted pursuant to Regulation S-K, Item 601(b)(10). Such omitted information is not material and would likely cause competitive harm to the registrant if publicly disclosed.

For the Three Months Ended September 30, 2019
							Receivables		Accumulated
					Additional		from		Other
	Common Stock				Paid-in		Exercises		Comprehensive		Accumulated
	Shares		Amount		Capital		of Options		Income (Loss)		Deficit			Total
Balance at June 30, 2019		38,738,707	$	4	$	1,271,209	$	—	$	110	$	(1,249,552	)	$	21,771
Stock-based compensation		—		—		12,213		—		—		—			12,213
Shares issued or restricted stock units vested under employee stock plans		205,067		—		76		—		—		—			76
Unrealized gain on available-for-sale securities		—		—		—		—		5		—			5
Net loss		—		—		—		—		—		(16,885	)		(16,885	)
Balance at September 30, 2019		38,943,774	$	4	$	1,283,498	$	—	$	115	$	(1,266,437	)	$	17,180

Restricted stock units	Shares			Weighted Average Grant-Date Fair Value
Nonvested shares at December 31, 2018		1,838,670		$	60.08
Granted		776,730			20.36
Vested/Issued		(531,112	)		70.06
Forfeited		(449,046	)		53.02
Nonvested shares at September 30, 2019		1,635,242		$	39.91

	PUMA BIOTECHNOLOGY, INC.

Date: November ~~7, 2019~~5, 2020	By:	/s/ Alan H. Auerbach
		Alan H. Auerbach
		President and Chief Executive Officer
		(Principal Executive Officer)

Date: November ~~7, 2019~~5, 2020	By:	/s/ Maximo F. Nougues
		Maximo Nougues
		Chief Financial Officer
		(Principal Financial and Accounting Officer)