LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage
biopharmaceutical company, announced financial results for the third
quarter ended September 30, 2014.
Unless otherwise stated, all comparisons are for the third quarter and
nine months ended September 30, 2014 compared to the third quarter and
nine months ended September 30, 2013.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss applicable to common stock of $35.8
million, or $1.19 per share, for the third quarter of 2014, compared to
a net loss of $14.3 million, or $0.50 per share, for the third quarter
of 2013. Net loss applicable to common stock for the nine months ended
September 30, 2014 was $94.5 million, or $3.17 per share, compared to
$38.7 million, or $1.35 per share, for the nine months ended September
30, 2013.
Adjusted net loss applicable to common stock was $25.4 million, or $0.84
per share, for the third quarter of 2014, compared to adjusted net loss
applicable to common stock of $12.5 million, or $0.44 per share, for the
third quarter of 2013. Adjusted net loss applicable to common stock for
the nine months ended September 30, 2014 was $71.7 million, or $2.41 per
share, compared to $34.3 million, or $1.20 per share, for the nine
months ended September 30, 2013. Adjusted net loss applicable to common
stock excludes stock-based compensation expense, which represents a
significant portion of overall expense and has no impact on the cash
position of the Company. 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 2014 was
$24.3 million. Net cash used in operating activities for the nine months
ended September 30, 2014 was $58.7 million. At September 30, 2014, Puma
had cash and cash equivalents of $28.3 million and marketable securities
of $125.6 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 and marketable
securities includes net proceeds of approximately $129.4 million from a
public offering of the Company's common stock, which was completed in
February 2014.
“We are very proud of the milestones that were achieved by Puma during
the third quarter of 2014,” said Alan H. Auerbach, Chairman, Chief
Executive Officer and President of Puma. “This includes the positive
top-line results that were reported during the quarter from the Phase
III trial of PB272 (neratinib) in extended adjuvant HER2 positive breast
cancer (ExteNET trial), which demonstrated that neratinib achieved a
statistically significant improvement in disease-free survival and
disease-free survival that includes ductal carcinoma in situ. We look
forward to proceeding with the regulatory filings for neratinib in
extended adjuvant HER2 positive breast cancer currently anticipated for
the first half of 2015. During the quarter we also announced Phase II
data from a study of neratinib in patients with non-small cell lung
cancer that has a HER2 mutation. In addition to the results showing that
the combination of neratinib plus temsirolimus had good antitumor
activity, for the first time we demonstrated that the prophylactic use
of the antidiarrheal drug loperamide was able to greatly reduce the
grade 3 or higher diarrhea that is typically seen with neratinib, which
resulted in a greatly improved tolerability profile for the drug.
“In addition,” noted Mr. Auerbach, “we expect to (i) complete and report
data from our ongoing Phase II randomized trial of PB272 as a first-line
treatment for HER2-positive metastatic breast cancer during the fourth
quarter of 2014; (ii) 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 fourth quarter
of 2014; (iii) 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 in the
fourth quarter of 2014; (iv) initiate a Phase III trial of the
combination of PB272 plus temsirolimus during 2015; (v) 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 2015; (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 additional data from in 2015;
and (vii) continue our Phase II basket trial of PB272 in patients with
solid tumors with an activating HER2 mutation.”
Operating Expenses
Based on GAAP, operating expenses were $36.0 million for the third
quarter of 2014, compared to $14.3 million for the third quarter of
2013. Operating expenses for the nine months ended September 30, 2014
were $94.7 million compared to $38.8 million for the nine months ended
September 30, 2013.
Adjusted operating expenses were $25.5 million for the third quarter of
2014, compared to $12.5 million for the third quarter of 2013. Adjusted
operating expenses for the nine months ended September 30, 2014 were
$71.9 million, compared to $34.4 million for the nine months ended
September 30, 2013. Adjusted operating expenses exclude stock-based
compensation expenses. 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 $3.9 million for
the third quarter of 2014, compared to $2.3 million for the third
quarter of 2013. General and administrative expenses for the nine months
ended September 30, 2014 were $11.3 million compared to $6.8 million for
the nine months ended September 30, 2013.
Adjusted general and administrative expenses were $2.5 million for the
third quarter of 2014, compared to $1.8 million for the third quarter of
2013. Adjusted general and administrative expenses for the nine months
ended September 30, 2014 were $7.2 million, compared to $5.4 million for
the nine months ended September 30, 2013.
Research and Development Expenses:
Based on GAAP, research and development expenses were $32.1 million for
the third quarter of 2014, compared to $12.0 million for the third
quarter of 2013. Research and development expenses for the nine months
ended September 30, 2014 were $83.4 million, compared to $32.0 million
for the nine months ended September 30, 2013.
Adjusted research and development expenses were $23.0 million for the
third quarter of 2014, compared to $10.7 million for the third quarter
of 2013. Adjusted research and development expenses for the nine months
ended September 30, 2014 were $64.7 million, compared to $29.0 million
for the nine months ended September 30, 2013.
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.
|
|
(A DEVELOPMENT STAGE COMPANY)
|
|
CONDENSED STATEMENTS OF OPERATIONS
|
|
(Unaudited)
|
|
|
|
(in millions except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
|
|
September 15,
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
2010 (date
|
|
|
|
|
September 30,
|
|
September 30,
|
|
of inception) to
|
|
|
|
|
|
2014
|
|
|
|
2013
|
|
|
|
2014
|
|
|
|
2013
|
|
|
September 30, 2014
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
$
|
3.9
|
|
|
$
|
2.3
|
|
|
$
|
11.3
|
|
|
$
|
6.8
|
|
|
$
|
55.2
|
|
|
Research and development
|
|
|
32.1
|
|
|
|
12.1
|
|
|
|
83.4
|
|
|
|
32.0
|
|
|
|
178.9
|
|
|
Totals
|
|
|
|
36.0
|
|
|
|
14.3
|
|
|
|
94.7
|
|
|
|
38.8
|
|
|
|
234.1
|
|
|
Loss from operations
|
|
|
|
(36.0
|
)
|
|
|
(14.3
|
)
|
|
|
(94.7
|
)
|
|
|
(38.8
|
)
|
|
|
(234.1
|
)
|
|
Other income (expenses):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
0.1
|
|
|
|
0.0
|
|
|
|
0.2
|
|
|
|
0.1
|
|
|
|
0.5
|
|
|
Other income (expense)
|
|
|
|
0.0
|
|
|
|
0.0
|
|
|
|
(0.0
|
)
|
|
|
0.0
|
|
|
|
(0.1
|
)
|
|
Totals
|
|
|
|
0.1
|
|
|
|
0.0
|
|
|
|
0.2
|
|
|
|
0.1
|
|
|
|
0.4
|
|
|
Net loss
|
|
|
$
|
(35.8
|
)
|
|
$
|
(14.3
|
)
|
|
$
|
(94.5
|
)
|
|
$
|
(38.7
|
)
|
|
$
|
(233.7
|
)
|
|
Net loss per common share—basic and diluted
|
|
$
|
(1.19
|
)
|
|
$
|
(0.50
|
)
|
|
$
|
(3.16
|
)
|
|
$
|
(1.35
|
)
|
|
|
|
Weighted-average common shares outstanding—basic and diluted
|
|
|
30,117,819
|
|
|
|
28,682,055
|
|
|
|
29,936,254
|
|
|
|
28,678,439
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PUMA BIOTECHNOLOGY, INC.
|
|
(A DEVELOPMENT STAGE COMPANY)
|
|
LIQUIDITY AND CAPITAL RESOURCES
|
|
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
|
December 31,
|
|
|
|
|
|
|
|
2014
|
|
|
|
2013
|
|
Cash and cash equivalents
|
|
|
|
|
|
$
|
28.3
|
|
|
|
|
$
|
43.0
|
|
|
Marketable securities
|
|
|
|
|
|
|
125.6
|
|
|
|
|
|
40.9
|
|
|
Licensor receivable
|
|
|
|
|
|
|
1.8
|
|
|
|
|
|
9.8
|
|
|
Working capital
|
|
|
|
|
|
|
130.7
|
|
|
|
|
|
77.1
|
|
|
Stockholders' equity
|
|
|
|
|
|
|
141.6
|
|
|
|
|
|
84.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
|
|
|
|
Nine Months
|
|
|
|
|
|
|
|
Ended
|
|
|
|
Ended
|
|
|
|
|
|
|
|
September 30,
|
|
|
|
September 30,
|
|
|
|
|
|
|
|
2014
|
|
|
|
2013
|
|
Cash provided by (used in):
|
|
|
|
|
|
|
|
|
|
|
Operating activities
|
|
|
|
|
|
$
|
(58.7
|
)
|
|
|
|
$
|
(41.5
|
)
|
|
Investing activities
|
|
|
|
|
|
|
(85.5
|
)
|
|
|
|
|
(44.8
|
)
|
|
Financing activities
|
|
|
|
|
|
|
129.4
|
|
|
|
|
|
0.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash
|
|
|
|
|
$
|
(14.8
|
)
|
|
|
|
$
|
(86.1
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP and Non-GAAP
Financial Information
|
|
(in millions except share and per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Measure
|
|
|
|
Non-GAAP
|
|
|
|
GAAP
|
|
|
|
Non-GAAP
|
|
|
|
(Reported)
|
|
Expense
|
|
Measure
|
|
|
|
Measure
|
|
Expense
|
|
Measure
|
|
|
|
Three Months
|
|
Adjustments
|
|
Three Months
|
|
|
|
Nine Months
|
|
Adjustments
|
|
Nine Months
|
|
|
|
Ended
|
|
|
|
Ended
|
|
|
|
Ended
|
|
|
|
Ended
|
|
|
|
September 30,
|
|
Stock-based
|
|
September 30,
|
|
|
|
September 30,
|
|
Stock-based
|
|
September 30,
|
|
|
|
|
2014
|
|
|
compensation
|
|
|
2014
|
|
|
|
|
|
2014
|
|
|
compensation
|
|
|
2014
|
|
|
Operating expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
$
|
3.87
|
|
|
$
|
(1.38
|
)
|
|
$
|
2.49
|
|
|
|
|
$
|
11.30
|
|
|
$
|
(4.08
|
)
|
|
$
|
7.22
|
|
|
Research and development
|
|
|
32.1
|
|
|
|
(9.1
|
)
|
|
|
23.0
|
|
|
|
|
|
83.4
|
|
|
|
(18.7
|
)
|
|
|
64.7
|
|
|
Loss from operations
|
|
|
(36.0
|
)
|
|
|
10.4
|
|
|
|
(25.5
|
)
|
|
|
|
|
(94.7
|
)
|
|
|
22.8
|
|
|
|
(71.9
|
)
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
0.1
|
|
|
|
-
|
|
|
|
0.1
|
|
|
|
|
|
0.2
|
|
|
|
-
|
|
|
|
0.2
|
|
|
Other expense
|
|
|
0.0
|
|
|
|
-
|
|
|
|
0.0
|
|
|
|
|
|
(0.0
|
)
|
|
|
-
|
|
|
|
(0.0
|
)
|
|
Totals
|
|
|
0.1
|
|
|
|
-
|
|
|
|
0.1
|
|
|
|
|
|
0.2
|
|
|
|
-
|
|
|
|
0.2
|
|
|
Net loss
|
|
$
|
(36
|
)
|
|
$
|
10
|
|
|
$
|
(25
|
)
|
|
|
|
$
|
(94
|
)
|
|
$
|
23
|
|
|
$
|
(72
|
)
|
|
Net loss applicable to common stock
|
|
$
|
(35.8
|
)
|
|
$
|
10.4
|
|
|
$
|
(25.4
|
)
|
|
|
|
$
|
(94.5
|
)
|
|
$
|
22.8
|
|
|
$
|
(71.7
|
)
|
|
Net loss per common share—
basic and diluted
|
|
$
|
(1.19
|
)
|
|
$
|
0.35
|
|
|
$
|
(0.84
|
)
|
|
|
|
$
|
(3.16
|
)
|
|
$
|
0.76
|
|
|
$
|
(2.40
|
)
|
|
Weighted-average common shares outstanding—basic and diluted
|
|
|
30,117,819
|
|
|
|
30,117,819
|
|
|
|
30,117,819
|
|
|
|
|
|
29,936,254
|
|
|
|
29,936,254
|
|
|
|
29,936,254
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP
|
|
|
|
|
|
|
|
GAAP
|
|
|
|
|
|
|
|
Measure
|
|
|
|
Non-GAAP
|
|
|
|
Measure
|
|
|
|
Non-GAAP
|
|
|
|
(Reported)
|
|
Expense
|
|
Measure
|
|
|
|
(Reported)
|
|
Expense
|
|
Measure
|
|
|
|
Three Months
|
|
Adjustments
|
|
Three Months
|
|
|
|
Nine Months
|
|
Adjustments
|
|
Nine Months
|
|
|
|
Ended
|
|
|
|
Ended
|
|
|
|
Ended
|
|
|
|
Ended
|
|
|
|
September 30,
|
|
Stock-based
|
|
September 30,
|
|
|
|
September 30,
|
|
Stock-based
|
|
September 30,
|
|
|
|
|
2013
|
|
|
compensation
|
|
|
2013
|
|
|
|
|
|
2013
|
|
|
compensation
|
|
|
2013
|
|
|
Operating expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
$
|
2.26
|
|
|
$
|
(0.47
|
)
|
|
$
|
1.79
|
|
|
|
|
$
|
6.80
|
|
|
$
|
(1.35
|
)
|
|
$
|
5.45
|
|
|
Research and development
|
|
|
12.1
|
|
|
|
(1.3
|
)
|
|
|
10.7
|
|
|
|
|
|
32.0
|
|
|
|
(3.1
|
)
|
|
|
29.0
|
|
|
Loss from operations
|
|
|
(14.3
|
)
|
|
|
1.8
|
|
|
|
(12.5
|
)
|
|
|
|
|
(38.8
|
)
|
|
|
4.4
|
|
|
|
(34.4
|
)
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
0.0
|
|
|
|
-
|
|
|
|
0.0
|
|
|
|
|
|
0.1
|
|
|
|
-
|
|
|
|
0.1
|
|
|
Other expense
|
|
|
0.0
|
|
|
|
-
|
|
|
|
0.0
|
|
|
|
|
|
0.0
|
|
|
|
-
|
|
|
|
0.0
|
|
|
Totals
|
|
|
0.0
|
|
|
|
-
|
|
|
|
0.0
|
|
|
|
|
|
0.1
|
|
|
|
-
|
|
|
|
0.1
|
|
|
Net loss
|
|
$
|
(14.3
|
)
|
|
$
|
1.8
|
|
|
$
|
(12.5
|
)
|
|
|
|
$
|
(38.7
|
)
|
|
$
|
4.4
|
|
|
$
|
(34.3
|
)
|
|
Net loss applicable to common stock
|
|
$
|
(14.3
|
)
|
|
$
|
1.8
|
|
|
$
|
(12.5
|
)
|
|
|
|
$
|
(38.7
|
)
|
|
$
|
4.4
|
|
|
$
|
(34.3
|
)
|
|
Net loss per common share—
basic and diluted
|
|
$
|
(0.50
|
)
|
|
$
|
0.06
|
|
|
$
|
(0.44
|
)
|
|
|
|
$
|
(1.35
|
)
|
|
$
|
0.15
|
|
|
$
|
(1.20
|
)
|
|
Weighted-average common shares outstanding—basic and diluted
|
|
|
28,682,055
|
|
|
|
28,682,055
|
|
|
|
28,682,055
|
|
|
|
|
|
28,678,439
|
|
|
|
28,678,439
|
|
|
|
28,678,439
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact: