pbyi20210930

pbyi20210930_10q.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2021

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-35703

PUMA BIOTECHNOLOGY, INC.

(Exact name of registrant as specified in its charter)

Delaware

77-0683487

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification Number)

10880 Wilshire Boulevard, Suite 2150, Los Angeles, CA 90024

(Address of principal executive offices) (Zip code)

(424) 248-6500

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Exchange Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

PBYI

The NASDAQ Stock Market LLC

(NASDAQ Global Select Market)

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 such 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.

Large accelerated filer	☐	Accelerated filer	☒

Non-accelerated filer	☐	Smaller reporting company	☐

Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the 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. 40,885,645 shares of Common Stock, par value $0.0001 per share, were outstanding as of October 29, 2021.

Table of Contents

PUMA BIOTECHNOLOGY, INC.

- INDEX -

		Page
PART I – FINANCIAL INFORMATION:		1
Item 1.	Financial Statements (Unaudited):	1
	Condensed Consolidated Balance Sheets as of September 30, 2021 and December 31, 2020	1
	Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2021 and 2020	2
	Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2021 and 2020	3
	Condensed Consolidated Statements of Stockholders’ Deficit for the Three and Nine Months Ended September 30, 2021 and 2020	4
	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020	6
	Notes to the Unaudited Condensed Consolidated Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	34
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	49
Item 4.	Controls and Procedures	49
PART II – OTHER INFORMATION:		50
Item 1.	Legal Proceedings	50
Item 1A.	Risk Factors	51
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	51
Item 3.	Defaults Upon Senior Securities	51
Item 4.	Mine Safety Disclosures	51
Item 5.	Other Information	51
Item 6.	Exhibits	52
Signatures		53

Table of Contents

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

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:

•

the commercialization of NERLYNX® (neratinib);

•

the development of our drug candidates, including when we expect to undertake, initiate and complete clinical trials of our product candidates;

•

the impact of the global COVID-19 pandemic, and measures to control the spread of COVID-19, on business, financial condition, results of operations and ongoing trials;

•

the anticipated timing of regulatory filings;

•

the regulatory approval of our drug candidates;

•

our use of clinical research organizations and other contractors;

•

our ability to find collaborative partners for research, development and commercialization of potential products;

•

efforts of our sub-licensees to obtain regulatory approval and commercialize NERLYNX in areas outside the United States;

•

our ability to market any of our products;

•

our expectations regarding our costs and expenses;

•

our anticipated capital requirements and estimates regarding our needs for additional financing;

•

our ability to compete against other companies and research institutions;

•

our ability to secure adequate protection for our intellectual property;

•

our intention and ability to vigorously defend against any litigation to which we are or may become party;

•

our estimates for damages that we may be required to pay in connection with the class action lawsuit to which we are a party;

•

our ability to attract and retain key personnel; and

•

our ability to obtain adequate financing.

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, 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, 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.

Table of Contents

Part I – FINANCIAL INFORMATION

Item 1. Financial Statements

PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

(unaudited)

	*September 30, 2021*		*December 31, 2020*
*ASSETS*
Current assets:
Cash and cash equivalents	$	63,947	$	85,293
Marketable securities		23,596		8,096
Accounts receivable, net of allowance for credit loss of $0 and $1,000		23,799		25,543
Inventory, net		7,206		3,454
Prepaid expenses, current		9,074		11,262
Restricted cash, current		8,850		8,850
Other current assets		451		3,641
Total current assets		136,923		146,139
Lease right-of-use assets, net		14,641		16,404
Property and equipment, net		1,924		2,481
Intangible assets, net		68,129		74,140
Restricted cash, long-term		3,311		3,311
Prepaid expenses and other, long-term		1,359		1,745
Total assets	$	226,287	$	244,220
*LIABILITIES AND STOCKHOLDERS' DEFICIT*
Current liabilities:
Accounts payable	$	20,047	$	12,076
Accrued expenses, current		90,782		61,325
Accrued in-licensed rights, current		—		20,993
Post-marketing commitment liability, current		1,978		2,481
Lease liabilities, current		3,454		3,094
Current portion of long-term debt		—		14,286
Total current liabilities		116,261		114,255
Accrued expenses, long-term		1,212		25,963
Lease liabilities, long-term		16,911		19,549
Post-marketing commitment liability, long-term		6,023		6,379
Long-term debt		96,802		84,025
Total liabilities		237,209		250,171
Commitments and contingencies (Note 13)
Stockholders' deficit:
Common stock - $.0001 par value per share; 100,000,000 shares authorized; 40,860,842 shares issued and outstanding at September 30, 2021 and 40,086,387 issued and outstanding at December 31, 2020		4		4
Additional paid-in capital		1,360,057		1,331,676

SEC Form 10-Q filed by Puma Biotechnology Inc