LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage
biopharmaceutical company, today announced financial results for the
third quarter ended September 30, 2013.
Unless otherwise stated, all comparisons are for the third quarter and
nine months ended September 30, 2013, compared to the third quarter and
nine months ended September 30, 2012.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss applicable to common stock of $14.3
million, or $0.50 per share, for the third quarter of 2013, compared to
a net loss of $25.9 million, or $1.29 per share, for the third quarter
of 2012. Net loss applicable to common stock for the nine months ended
September 30, 2013, was $38.7 million, or $1.35 per share, compared to
$52.4 million, or $2.62 per share, for the nine months ended September
30, 2012.
Adjusted net loss applicable to common stock was $12.3 million, or $0.43
per share, for the third quarter of 2013, compared to adjusted net loss
applicable to common stock of $3.6 million, or $0.18 per share, for the
third quarter of 2012. Adjusted net loss applicable to common stock for
the nine months ended September 30, 2013, was $33.6 million, or $1.17
per share, compared to $11.5 million, or $0.58 per share, for the nine
months ended September 30, 2012. Adjusted net loss applicable to common
stock excludes stock-based compensation expense and external costs
associated with ongoing clinical trials of our lead product candidate,
PB272 (neratinib (oral)), that Puma assumed from a licensor and which it
refers to as licensor legacy clinical trials. For a reconciliation of
adjusted net loss applicable to common stock to reported net loss
applicable to common stock, please see the financial tables at the end
of this news release.
Net cash used in operating activities for the third quarter of 2013 was
$12.0 million. Net cash used in operating activities for the nine months
ended September 30, 2013, was $41.4 million. At September 30, 2013, Puma
had cash and cash equivalents of $51.3 million and marketable securities
of $44.4 million, compared to $137.4 million of cash and cash
equivalents at December 31, 2012. As previously noted, Puma’s license
agreement for PB272 established a limit on the Company’s expenses
related to certain clinical trials Puma assumed from the licensor, or
legacy clinical trials. Puma reached this limit, or cap, during the
fourth quarter of 2012; therefore, the licensor is responsible for
expenses related to the legacy clinical trials until such trials are
completed. The license agreement requires the Company to bill the
licensor quarterly for external “out-of-pocket” costs in excess of the
cap cost. At September 30, 2013, the Company reported a receivable of
approximately $11.3 million associated with outstanding invoices to the
licensor. The Company anticipates receiving payments for these
outstanding invoices by the end of 2013.
“During the third quarter of 2013, we continued to execute on our
ongoing Phase II and Phase III trials of PB272 (neratinib),” said Alan
H. Auerbach, Chief Executive Officer and President of Puma. “During the
quarter, we also initiated a Phase II trial of PB272 for the treatment
of patients with solid tumors that have a HER2 activating mutation
(basket trial). We anticipate seeing the first results from our basket
trial in the fourth quarter of 2013 or in the beginning of 2014.
“In addition,” noted Mr. Auerbach, “we expect to (i) complete the
ongoing Phase II clinical trial of PB272 in combination with
temsirolimus in fourth-line HER2-positive metastatic breast cancer,
which we anticipate reporting additional data from later in 2013 or in
early 2014; (ii) initiate a Phase III trial of the combination of PB272
plus temsirolimus in the first half of 2014; (iii) complete the ongoing
Phase II trial of PB272 in patients with HER2-positive metastatic breast
cancer that has metastasized to the brain, which we anticipate reporting
data from later in 2013 or in early 2014; (iv) complete our two ongoing
Phase II trials of PB272 as a neoadjuvant treatment for patients with
HER2-positive breast cancer (I-SPY2 and NSABP FB-7), both of which we
expect to report data from in the fourth quarter of 2013; (v) report
data from our Phase II trial of PB272 in patients with HER2 mutated
non-small cell lung cancer later in 2013; (vi) continue our Phase II
trial of PB272 in HER2-negative breast cancer patients who have a HER2
mutation, which we also have the potential to report initial data from
later in 2013; (vii) complete our ongoing Phase II randomized trial of
PB272 as a first-line treatment for HER2-positive metastatic breast
cancer, which we expect to report data from in the first half of 2014;
and (viii) complete our Phase III trial of PB272 as an adjuvant
treatment for HER2 positive breast cancer, which we expect to report
data from in the first half of 2014.”
Operating Expenses
Based on GAAP, operating expenses were $14.3 million for the third
quarter of 2013, compared to $25.9 million for the third quarter of
2012. Operating expenses for the nine months ended September 30, 2013,
were $38.8 million, compared to $52.5 million for the nine months ended
September 30, 2012.
Adjusted operating expenses were $12.3 million for the third quarter of
2013, compared to $3.6 million in the third quarter of 2012. Adjusted
operating expenses exclude stock-based compensation expenses and
licensor legacy clinical trial costs. Adjusted operating expenses for
the nine months ended September 30, 2013, were $33.7 million, compared
to $11.6 million for the nine months ended September 30, 2012. For a
reconciliation of adjusted operating expenses to reported operating
expenses, please see the financial tables at the end of this news
release.
General and Administrative Expenses:
Based on GAAP, general and administrative expenses were $2.3 million in
the third quarter of 2013, compared to $8.1 million in the third quarter
of 2012. General and administrative expenses for the nine months ended
September 30, 2013, were $6.8 million compared to $11.1 million for the
nine months ended September 30, 2012.
Adjusted general and administrative expenses were $1.8 million for the
third quarter of 2013, compared to $1.5 million in the third quarter of
2012. Adjusted general and administrative expenses for the nine months
ended September 30, 2013, were $5.4 million, compared to $4.6 million
for the nine months ended September 30, 2012.
Research and Development Expenses:
Based on GAAP, research and development expenses were $12.0 million in
the third quarter of 2013, compared to $17.8 million in the third
quarter of 2012. Research and development expenses for the nine months
ended September 30, 2013, were $32.0 million, compared to $41.4 million
for the nine months ended September 30, 2012.
Adjusted research and development expenses were $10.5 million in the
third quarter of 2013, compared to $2.1 million in the third quarter of
2012. The increase in adjusted research and development expenses from
the third quarter of 2012 was driven primarily by costs associated with
the initiation of Puma-sponsored clinical trials and the testing and
validation of the active pharmaceutical ingredient of our lead drug
candidate. Adjusted research and development expenses for the nine
months ended September 30, 2013, were $28.3 million, compared to $7.0
million for the nine months ended September 30, 2012.
About Puma Biotechnology
Puma Biotechnology, Inc. is a development stage biopharmaceutical
company that acquires and develops innovative products for the treatment
of various forms of cancer. The Company focuses on in-licensing drug
candidates that are undergoing or have already completed initial
clinical testing for the treatment of cancer and then seeks to further
develop those drug candidates for commercial use. The Company is
initially focused on the development of PB272 (oral neratinib), a potent
irreversible tyrosine kinase inhibitor, for the treatment of patients
with HER2-positive metastatic breast cancer and patients with non-small
cell lung cancer, breast cancer and other solid tumors that have a HER2
mutation.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
Forward-Looking Statements:
This press release contains forward-looking statements, including
statements regarding anticipated timing for the commencement and
completion of various clinical trials and the announcement of data
relative to these trials. All forward-looking statements included in
this press release involve risks and uncertainties that could cause the
Company'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 fact that the Company has no product revenue and no
products approved for marketing, the Company’s dependence on PB272,
which is still under development and may never receive regulatory
approval, the challenges associated with conducting and enrolling
clinical trials, the risk that the results of clinical trials may not
support the Company’s drug candidate claims, even if approved, the risk
that physicians and patients may not accept or use the Company’s
products, the Company’s reliance on third parties to conduct its
clinical trials and to formulate and manufacture its drug candidates,
the Company’s dependence on licensed intellectual property, and the
other risk factors disclosed in the periodic reports filed by the
Company with the Securities and Exchange Commission from time to time,
including the Company’s Annual Report on Form 10-K for the year
ended December 31, 2012. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date hereof. The Company assumes no obligation to update these
forward-looking statements, except as required by law.
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
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(A DEVELOPMENT STAGE COMPANY)
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
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(Unaudited)
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(in millions except per share data)
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Period from
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September 15,
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Three Months Ended
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Nine Months Ended
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2010 (date
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September 30,
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September 30,
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of inception) to
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2013
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2012
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2013
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2012
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September 30, 2013
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Operating expenses:
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General and administrative
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$
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2.3
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$
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8.1
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$
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6.8
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$
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11.1
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$
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41.0
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Research and development
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12.0
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17.8
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32.0
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41.4
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82.5
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Totals
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14.3
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25.9
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38.8
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52.5
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123.5
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Loss from operations
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(14.3
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)
|
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(25.9
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)
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(38.8
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)
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(52.5
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)
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(123.5
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)
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Other income (expenses):
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Interest income
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-
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-
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0.1
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0.1
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0.2
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Other income (expense)
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-
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-
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-
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-
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-
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Totals
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-
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-
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0.1
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|
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0.1
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|
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0.2
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Net loss
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$
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(14.3
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)
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$
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(25.9
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)
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$
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(38.7
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)
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$
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(52.4
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)
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$
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(123.3
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)
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Net loss per common share—basic and diluted
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$
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(0.50
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)
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$
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(1.29
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)
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$
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(1.35
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)
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$
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(2.62
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)
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Weighted-average common shares outstanding—basic and diluted
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28,682,055
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20,040,000
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28,678,439
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20,040,000
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PUMA BIOTECHNOLOGY, INC.
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(A DEVELOPMENT STAGE COMPANY)
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LIQUIDITY AND CAPITAL RESOURCES
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(in millions except per share data)
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September 30,
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December 31,
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2013
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2012
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Cash and cash equivalents
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$
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51.3
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$
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137.4
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Marketable securities
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44.4
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-
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Licensor receivable
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11.3
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10.6
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Working capital
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91.4
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127.3
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Stockholders' equity
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94.8
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128.9
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Nine Months
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Nine Months
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Ended
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Ended
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September 30,
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September 30,
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2013
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2012
|
Cash provided by (used in):
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Operating activities
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|
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$
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(41.4
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)
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$
|
(19.2
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)
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Investing activities
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(44.8
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)
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(0.8
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)
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Financing activities
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0.1
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-
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Increase (decrease) in cash
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$
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(86.1
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)
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$
|
(20.0
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)
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|
Reconciliation of GAAP and Non-GAAP
Financial Information
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(in millions except share and per share
data)
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GAAP Measure
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GAAP Measure
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(Reported)
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Non-GAAP Measure
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(Reported)
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|
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Non-GAAP Measure
|
|
|
|
Three Months
|
|
Expense Adjustments
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|
Three Months
|
|
|
Nine Months
|
|
Expense Adjustments
|
|
Nine Months
|
|
|
|
Ended
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|
Licensor
|
|
Ended
|
|
|
Ended
|
|
|
|
Licensor
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Ended
|
|
|
|
September 30,
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|
Stock-based
|
|
legacy
|
|
September 30,
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|
|
September 30,
|
|
Stock-based
|
|
legacy
|
|
September 30,
|
|
|
|
2013
|
|
compensation
|
|
clinical trials
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|
2013
|
|
|
2013
|
|
compensation
|
|
clinical trials
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|
2013
|
Operating expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
General and administrative
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|
|
|
2.3
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|
|
|
(0.5
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)
|
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|
-
|
|
|
|
1.8
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|
|
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|
6.8
|
|
|
|
(1.4
|
)
|
|
|
-
|
|
|
|
5.4
|
|
Research and development
|
|
|
|
12.0
|
|
|
|
(1.3
|
)
|
|
|
(0.2
|
)
|
|
|
10.5
|
|
|
|
|
32.0
|
|
|
|
(3.0
|
)
|
|
|
(0.7
|
)
|
|
|
28.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
(14.3
|
)
|
|
|
1.8
|
|
|
|
0.2
|
|
|
|
(12.3
|
)
|
|
|
|
(38.8
|
)
|
|
|
4.4
|
|
|
|
0.7
|
|
|
|
(33.7
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
0.1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
0.1
|
|
Other expense
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
0.1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
0.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
(14.3
|
)
|
|
|
1.8
|
|
|
|
0.2
|
|
|
|
(12.3
|
)
|
|
|
|
(38.7
|
)
|
|
|
4.4
|
|
|
|
0.7
|
|
|
|
(33.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stock
|
|
|
|
(14.3
|
)
|
|
|
1.8
|
|
|
|
0.2
|
|
|
|
(12.3
|
)
|
|
|
|
(38.7
|
)
|
|
|
4.4
|
|
|
|
0.7
|
|
|
|
(33.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share—basic and diluted
|
|
|
$
|
(0.50
|
)
|
|
$
|
0.06
|
|
|
$
|
0.01
|
|
|
$
|
(0.43
|
)
|
|
|
$
|
(1.35
|
)
|
|
$
|
0.15
|
|
|
$
|
0.02
|
|
|
$
|
(1.17
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding—basic and diluted
|
|
|
|
28,682,055
|
|
|
|
28,682,055
|
|
|
|
28,682,055
|
|
|
|
28,682,055
|
|
|
|
|
28,678,439
|
|
|
|
28,678,439
|
|
|
|
28,678,439
|
|
|
|
28,678,439
|
|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Measure
|
|
|
|
|
|
|
|
GAAP Measure
|
|
|
|
|
|
|
|
|
(Reported)
|
|
|
|
|
Non-GAAP Measure
|
|
|
(Reported)
|
|
|
|
|
Non-GAAP Measure
|
|
|
|
Three Months
|
|
Expense adjustments
|
|
Three Months
|
|
|
Nine Months
|
|
Expense Adjustments
|
|
Nine Months
|
|
|
|
Ended
|
|
|
|
Licensor
|
|
Ended
|
|
|
Ended
|
|
|
|
Licensor
|
|
Ended
|
|
|
|
September 30,
|
|
Stock-based
|
|
legacy
|
|
September 30,
|
|
|
September 30,
|
|
Stock-based
|
|
legacy
|
|
September 30,
|
|
|
|
2012
|
|
compensation
|
|
clinical trials
|
|
2012
|
|
|
2012
|
|
compensation
|
|
clinical trials
|
|
2012
|
Operating expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
|
8.1
|
|
|
|
(6.6
|
)
|
|
|
-
|
|
|
|
1.5
|
|
|
|
|
11.1
|
|
|
|
(6.5
|
)
|
|
|
-
|
|
|
|
4.6
|
|
Research and development
|
|
|
|
17.8
|
|
|
|
(0.2
|
)
|
|
|
(15.5
|
)
|
|
|
2.1
|
|
|
|
|
41.4
|
|
|
|
(0.5
|
)
|
|
|
(33.9
|
)
|
|
|
7.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
(25.9
|
)
|
|
|
6.8
|
|
|
|
15.5
|
|
|
|
(3.6
|
)
|
|
|
|
(52.5
|
)
|
|
|
7.0
|
|
|
|
33.9
|
|
|
|
(11.6
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
0.1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
0.1
|
|
Other expense
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
0.1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
0.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
(25.9
|
)
|
|
|
6.8
|
|
|
|
15.5
|
|
|
|
(3.6
|
)
|
|
|
|
(52.4
|
)
|
|
|
7.0
|
|
|
|
33.9
|
|
|
|
(11.5
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common stock
|
|
|
|
(25.9
|
)
|
|
|
6.8
|
|
|
|
15.5
|
|
|
|
(3.6
|
)
|
|
|
|
(52.4
|
)
|
|
|
7.0
|
|
|
|
33.9
|
|
|
|
(11.5
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share—basic and diluted
|
|
|
$
|
(1.29
|
)
|
|
$
|
0.34
|
|
|
$
|
0.77
|
|
|
$
|
(0.18
|
)
|
|
|
$
|
(2.62
|
)
|
|
$
|
0.35
|
|
|
$
|
1.69
|
|
|
$
|
(0.58
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding—basic and diluted
|
|
|
|
20,040,000
|
|
|
|
20,040,000
|
|
|
|
20,040,000
|
|
|
|
20,040,000
|
|
|
|
|
20,040,000
|
|
|
|
20,040,000
|
|
|
|
20,040,000
|
|
|
|
20,040,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|

Contact: