Puma Biotechnology Reports Second Quarter 2019 Financial Results

Puma Biotechnology Reports Second Quarter 2019 Financial Results

LOS ANGELES, Calif., Aug. 8, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the

second quarter ended June 30, 2019. Unless otherwise stated, all comparisons are for the second quarter 2019 compared to the second quarter of 2018.

Product revenue, net consists entirely of sales revenue from NERLYNX , Puma s first commercial product. Net NERLYNX revenue in the second quarter of

2019 was $53.8 million, compared to net NERLYNX revenue of $50.8 million in the second quarter of 2018. Net NERLYNX revenue in the first six months of 2019 was $99.4 million, compared to net NERLYNX revenue of $86.8 million in

the first six months of 2018.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of

$37.4 million, or $0.97 per share, for the second quarter of 2019, compared to a net loss of $44.3 million, or $1.17 per share, for the second quarter of 2018. Net loss for the first six months of 2019 was $47.5 million, or $1.23 per

share, compared to a net loss of $68.7 million, or $1.82 per share, for the first six months of 2018.

Non-GAAP adjusted net loss was $22.0 million, or $0.57 per share for the second quarter of 2019, compared to non-GAAP adjusted net loss of $22.2 million, or $0.59 per share for the second quarter of 2018. Non-GAAP adjusted net loss for the first six months of 2019 was

$13.9 million, or $0.36 per share, compared to non-GAAP adjusted net loss of $21.2 million, or $0.56 per share, for the first six months of 2018. Non-GAAP

adjusted net loss excludes stock-based compensation expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP

adjusted net loss per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the second

quarter of 2019 was $44.2 million, compared to net cash used in operating activities of $17.6 million in the second quarter of 2018. Net cash provided by operating activities for the first six months of 2019 was $28.1 million,

compared to net cash used in operating activities of $23.9 million in the first six months of 2018. At June 30, 2019, Puma had cash, cash equivalents, and marketable securities of $117.7 million, compared to cash, cash equivalents and

marketable securities of $165.4 million at December 31, 2018. The reduction in cash, cash equivalents and marketable securities in the second quarter was the result of the previously disclosed repayment of the $155 million outstanding

loan using cash on hand and $100 million in new borrowings from an amended and restated loan agreement in June 2019.

The second quarter of

2019 included the achievement of several key milestones for Puma, said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. This included sequential NERLYNX sales growth and the expansion of our global presence with

NERLYNX with our European licensing agreement with Pierre Fabre. We saw the achievement of additional key milestones in July with the filing of the new drug application for neratinib in the metastatic breast cancer indication and obtaining approval

for NERLYNX in the extended adjuvant indication from Health Canada.

Mr. Auerbach added, We anticipate the following key milestones during the remainder of 2019: (i)

meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the third quarter of 2019; (ii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2019; and

(iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries.

Total revenue consists of product revenue, net

from sales of NERLYNX, Puma s first commercial product, license revenue and royalty revenue. For the second quarter ended June 30, 2019, total revenue was $53.9 million, of which $53.8 million was net NERLYNX revenue and

$0.1 million was royalty revenue received from Puma s sub-licensees. This compares to total revenue of $50.8 million in the second quarter of 2018, all of which was net product revenue. For the

first six months of 2019, total revenue was $153.0 million, of which $99.4 million was net product revenue, $53.5 million was license revenue received from Puma s sub-licensees, and

$0.1 million was royalty revenue. This compares to total revenue for the first six months of 2018 of $117.3 million, of which $86.8 million was net product revenue and $30.5 million was license revenue.

Operating Costs and Expenses

Total operating costs and

expenses were $79.7 million in the second quarter of 2019, compared to $92.2 million in the second quarter of 2018. Operating costs and expenses in the first six months of 2019 were $168.9 million, compared to $182.1 million in

the first six months of 2018.

of sales was $9.3 million for the second quarter of 2019 and $17.3 million for the first six months of 2019, compared to $8.8 million for the second quarter of 2018 and $15.2 for the first six months of 2018.

Selling, General and Administrative Expenses:

general and administrative expenses (SG&A) were $33.5 million for the second quarter of 2019, compared to $40.1 million for the second quarter of 2018. SG&A expenses for the first six months of 2019 were $79.0 million,

compared to $76.7 million for the first six months of 2018. The approximately $2.3 million year-to-date increase resulted primarily from increases of

approximately $2.9 million for professional fees, such as legal fees and marketing and commercial support, $0.6 million in office and banking expenses, and $0.4 million in payroll and payroll-related expenses. These were partially

offset by decreases of approximately $1.4 million in travel and meeting-related expenses and $0.2 million related to stock-based compensation expense.

Research and Development Expenses:

development (R&D) expenses were $36.9 million for the second quarter of 2019, compared to $43.3 million for the second quarter of 2018. R&D expenses for the first six months of 2019 were $72.6 million, compared to

$90.2 million for the first six months of 2018. The $17.6 million year-to-date decrease resulted primarily from decreases of approximately $13.8 million

for stock-based compensation, $3.5 million for internal R&D primarily related to payroll and payroll-related expenses, and $0.5 million in consulting fees related to clinical trials.

Total Other Income (Expenses)

Total other expenses were

$11.6 million for the second quarter and $31.6 million for the first six months of 2019, compared to total other expenses of $2.9 million for the second quarter and $3.9 million for the first six months of 2018. The increase in

other expenses recorded in the first six months of 2019 primarily included $16.4 million related to a March 2019 jury verdict against Puma and $8.1 million related to the debt refinancing.

Puma Biotechnology will host a conference call to report its second quarter 2019 financial results and provide an update on the Company s business and

outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 8, 2019. The call may be accessed by dialing 1-877-709-8150

(domestic) or 1-201-689-8354 (international) at least 10 minutes prior to the start of the call and referencing the Puma

Biotechnology Conference Call. A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at http://www.pumabiotechnology.com/. A replay of the call will be

available approximately one hour after completion of the call and will be archived on the company s website for 90 days.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer

care. The Company in-licenses the global development and commercialization rights to three drug candidates PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved

by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib)

tablets. NERLYNX was granted marketing authorization by the European Commission in September 2018 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 completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

information about Puma Biotechnology may be found at www.pumabiotechnology.com.

IMPORTANT SAFETY INFORMATION

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2

overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reactions

( 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention,

epistaxis, weight decreased and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at

1-844-NERLYNX (1-844-637-5969) and

www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS:

Please see Full Prescribing Information for additional safety information.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding Puma s anticipated milestones for 2019. All forward-looking

statements involve risks and uncertainties that could cause the Puma s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current

expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic and current reports

filed by Puma with the Securities and Exchange Commission from time to time, including Puma s Annual Report on Form 10-K for the year ended December 31, 2018. Readers are cautioned not to place undue

reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law.

Alan H. Auerbach or Mariann Ohanesian, Puma

Biotechnology, Inc., +1 424 248 6500

David Schull, Russo Partners, +1 212

(Financial Tables Follow)

PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(in millions except share and per share data)

PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES

LIQUIDITY AND CAPITAL RESOURCES

(in millions, unaudited)

Non-GAAP Financial Measures

In addition to operating results as calculated in accordance with GAAP, Puma uses certain non-GAAP financial measures

when planning, monitoring, and evaluating operational performance. The following table presents the Company s net loss and net loss per share calculated in accordance with GAAP and as adjusted to remove the impact of employee stock-based

compensation. For the three months and six months ended June 30, 2019, stock-based compensation represented approximately 21.9% and 22.1% of operating expenses, respectively, in each case excluding cost of sales. Puma s management believes

that these non-GAAP financial measures are useful to enhance understanding of Puma s financial performance, and are more indicative of its operational performance and facilitate a better comparison among