LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage
biopharmaceutical company, announced financial results for the first
quarter ended March 31, 2014.
Unless otherwise stated, all comparisons are for the first quarter of
2014 compared to the first quarter of 2013.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss applicable to common stock of $19.8
million, or $0.67 per share, for the first quarter of 2014, compared to
a net loss of $11.8 million, or $0.41 per share, for the first quarter
of 2013.
Adjusted net loss applicable to common stock was $14.6 million, or $0.50
per share, for the first quarter of 2014, compared to an adjusted net
loss applicable to common stock of $10.3 million, or $0.36 per share,
for the first quarter of 2013. 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 the 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.
As of March 31, 2014, Puma reported cash and cash equivalents of $163.4
million and marketable securities of $32.7 million, compared to cash and
cash equivalents of $43.0 million and marketable securities of $40.9
million at December 31, 2013. Puma’s current level of cash and cash
equivalents includes net proceeds of approximately $129.4 million from a
public offering of the Company’s common stock, which was completed in
February 2014. As previously noted, Puma’s license agreement for PB272
established a limit on the Company’s expenses related to the licensor
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 March 31, 2014, the Company reported a receivable of
approximately $13.3 million associated with outstanding invoices to the
licensor.
“During the first quarter of 2014 we achieved several important
milestones, including the continued advancement of our Phase II and
Phase III clinical trials for PB272. We also strengthened the Company’s
intellectual property portfolio through the successful outcome of the
European patent opposition proceedings, which resulted in our patent
claims for treating cancers with T790M mutations being upheld, and
strengthened the Company’s financial position with a public offering
that resulted in net proceeds of approximately $129 million,” said Alan
H. Auerbach, Chairman, Chief Executive Officer and President of Puma.
“We look forward to continuing to advance the clinical development of
PB272 during the remainder of 2014,” noted Mr. Auerbach. “More
specifically, we anticipate that we will (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 in the second half of 2014; (ii) initiate a
Phase III trial of the combination of PB272 plus temsirolimus in the
second 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, with the potential to report data in 2014;
(iv) complete our ongoing Phase II trial of PB272 as a neoadjuvant
treatment for patients with HER2-positive breast cancer (NSABP FB-7),
which we expect to report data from in the first half of 2014; (v)
report data from our Phase II trial of PB272 in patients with
HER2-mutated non-small cell lung cancer in 2014; (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 in 2014; (vii) continue our Phase II basket trial of PB272 in
patients with solid tumors with an activating HER2 mutation, which we
also have the potential to report initial data from in 2014; (viii)
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 (ix) 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 $19.8 million for the first
quarter of 2014, compared to $11.8 million for the first quarter of 2013.
Adjusted operating expenses were $14.7 million for the first quarter of
2014, compared to $10.4 million for the first quarter of 2013. Adjusted
operating expenses exclude stock-based compensation expenses and
licensor legacy clinical trial costs. 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 $3.5 million for
the first quarter of 2014, compared to $2.3 million for the first
quarter of 2013.
Adjusted general and administrative expenses were $2.2 million for the
first quarter of 2014, compared to $1.8 million for the first quarter of
2013.
Research and Development Expenses:
Based on GAAP, research and development expenses were $16.3 million for
the first quarter of 2014, compared to $9.5 million for the first
quarter of 2013.
Adjusted research and development expenses were $12.5 million for the
first quarter of 2014, compared to $8.5 million for the first quarter of
2013. The increase in adjusted research and development expenses from
the first quarter of 2013 was driven primarily by increases of $1.7
million in internal clinical development expenses, $1.2 million in
outside other clinical development expenses, $0.4 million in outside
CRO/licensor services and $0.3 million in internal regulatory affairs
and quality assurance expenses.
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 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, 2013. 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.
|
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
|
(A DEVELOPMENT STAGE COMPANY)
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
(in millions except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 15,
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
2010 (date
|
|
|
|
|
|
|
|
March 31,
|
|
|
|
|
of inception) to
|
|
|
|
|
|
|
|
|
2014
|
|
|
|
|
|
|
2013
|
|
|
|
|
|
March 31, 2014
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
|
|
|
|
$
|
3.5
|
|
|
|
|
|
$
|
2.3
|
|
|
|
|
|
$
|
47.5
|
|
Research and development
|
|
|
|
|
|
|
|
16.3
|
|
|
|
|
|
|
9.5
|
|
|
|
|
|
|
111.8
|
|
Totals
|
|
|
|
|
|
|
|
19.8
|
|
|
|
|
|
|
11.8
|
|
|
|
|
|
|
159.3
|
|
Loss from operations
|
|
|
|
|
|
|
|
(19.8
|
)
|
|
|
|
|
|
(11.8
|
)
|
|
|
|
|
|
(159.3
|
)
|
Other income (expenses):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
|
|
|
0.0
|
|
|
|
|
|
|
0.0
|
|
|
|
|
|
|
0.3
|
|
Other income (expense)
|
|
|
|
|
|
|
|
(0.0
|
)
|
|
|
|
|
|
0.0
|
|
|
|
|
|
|
(0.1
|
)
|
Totals
|
|
|
|
|
|
|
|
0.0
|
|
|
|
|
|
|
0.0
|
|
|
|
|
|
|
0.2
|
|
Net loss
|
|
|
|
|
|
|
$
|
(19.8
|
)
|
|
|
|
|
$
|
(11.8
|
)
|
|
|
|
|
$
|
(159.0
|
)
|
Net loss applicable to common stock
|
|
|
|
|
|
|
$
|
(19.8
|
)
|
|
|
|
|
$
|
(11.8
|
)
|
|
|
|
|
$
|
(159.0
|
)
|
Net loss per common share—basic and diluted
|
|
|
|
|
|
|
$
|
(0.67
|
)
|
|
|
|
|
$
|
(0.41
|
)
|
|
|
|
|
|
Weighted-average common shares outstanding—basic and diluted
|
|
|
|
|
|
|
|
29,567,071
|
|
|
|
|
|
|
28,676,666
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
|
(A DEVELOPMENT STAGE COMPANY)
|
LIQUIDITY AND CAPITAL RESOURCES
|
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2013
|
|
Cash and cash equivalents
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
163.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
43.0
|
|
Marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40.9
|
|
Licensor receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9.8
|
|
Working capital
|
|
|
|
|
|
|
|
|
|
|
|
|
|
191.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
77.1
|
|
Stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
198.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
84.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ended
|
|
|
|
|
|
|
|
|
|
|
|
|
Ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2013
|
|
Cash provided by (used in):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(17.0
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(18.5
|
)
|
Investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(27.3
|
)
|
Financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
129.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
120.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(45.8
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP and Non-GAAP
Financial Information
|
(in millions except share and per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
|
|
|
|
|
|
|
Measure
|
|
|
|
|
|
|
|
|
|
|
|
Measure
|
|
|
|
|
|
|
(Reported)
|
|
|
|
Expense Adjustments
|
|
|
|
(Adjusted)
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
Stock-based
|
|
|
|
Licensor legacy
|
|
|
Three Months Ended
|
|
|
|
|
|
|
March 31, 2014
|
|
|
|
compensation
|
|
|
|
clinical trials
|
|
|
|
March 31, 2014
|
2014 Operating expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
|
|
|
$
|
3.5
|
|
|
|
|
$
|
(1.3
|
)
|
|
|
|
$
|
-
|
|
|
|
|
$
|
2.2
|
|
Research and development
|
|
|
|
|
|
|
16.3
|
|
|
|
|
|
(3.8
|
)
|
|
|
|
|
-
|
|
|
|
|
|
12.5
|
|
Loss from operations
|
|
|
|
|
|
|
(19.8
|
)
|
|
|
|
|
5.1
|
|
|
|
|
|
-
|
|
|
|
|
|
(14.7
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
|
|
0.0
|
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
0.0
|
|
Other expense
|
|
|
|
|
|
|
(0.0
|
)
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
(0.0
|
)
|
Totals
|
|
|
|
|
|
|
0.0
|
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
0.0
|
|
Net loss
|
|
|
|
|
|
$
|
(19.8
|
)
|
|
|
|
$
|
5.1
|
|
|
|
|
$
|
-
|
|
|
|
|
$
|
(14.7
|
)
|
Net loss applicable to common stock
|
|
|
|
|
|
$
|
(19.8
|
)
|
|
|
|
$
|
5.1
|
|
|
|
|
$
|
-
|
|
|
|
|
$
|
(14.7
|
)
|
Net loss per common share - basic and diluted
|
|
|
|
|
|
$
|
(0.67
|
)
|
|
|
|
$
|
0.17
|
|
|
|
|
$
|
-
|
|
|
|
|
$
|
(0.50
|
)
|
Weighted-average common shares outstanding - basic and diluted
|
|
|
|
|
|
|
29,567,071
|
|
|
|
|
|
29,567,071
|
|
|
|
|
|
29,567,071
|
|
|
|
|
|
29,567,071
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
|
|
|
|
|
|
|
Measure
|
|
|
|
|
|
|
|
|
|
|
|
Measure
|
|
|
|
|
|
|
(Reported)
|
|
|
|
Expense Adjustments
|
|
|
|
(Adjusted)
|
|
|
|
|
|
|
Three Months
|
|
|
|
|
|
|
|
Licensor
|
|
|
|
Three Months
|
|
|
|
|
|
|
Ended
|
|
|
|
Stock-based
|
|
|
|
legacy
|
|
|
|
Ended
|
|
|
|
|
|
|
March 31, 2013
|
|
|
|
compensation
|
|
|
|
clinical trials
|
|
|
|
March 31, 2013
|
2013 Operating expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
|
|
|
$
|
2.3
|
|
|
|
|
$
|
(0.4
|
)
|
|
|
|
$
|
-
|
|
|
|
|
$
|
1.9
|
|
Research and development
|
|
|
|
|
|
|
9.5
|
|
|
|
|
|
(0.7
|
)
|
|
|
|
|
(0.3
|
)
|
|
|
|
|
8.5
|
|
Loss from operations
|
|
|
|
|
|
|
(11.8
|
)
|
|
|
|
|
1.1
|
|
|
|
|
|
0.3
|
|
|
|
|
|
(10.4
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
Other expense
|
|
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
Totals
|
|
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
Net loss
|
|
|
|
|
|
$
|
(11.8
|
)
|
|
|
|
$
|
1.1
|
|
|
|
|
$
|
0.3
|
|
|
|
|
$
|
(10.4
|
)
|
Net loss applicable to common stock
|
|
|
|
|
|
$
|
(11.8
|
)
|
|
|
|
$
|
1.1
|
|
|
|
|
$
|
0.3
|
|
|
|
|
$
|
(10.4
|
)
|
Net loss per common share - basic and diluted
|
|
|
|
|
|
$
|
(0.41
|
)
|
|
|
|
$
|
0.04
|
|
|
|
|
$
|
0.01
|
|
|
|
|
$
|
(0.36
|
)
|
Weighted-average common shares outstanding - basic and diluted
|
|
|
|
|
|
|
28,676,666
|
|
|
|
|
|
28,676,666
|
|
|
|
|
|
28,676,666
|
|
|
|
|
|
28,676,666
|
|

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