LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company,
announced financial results for the third quarter ended September 30,
2015.
Unless otherwise stated, all comparisons are for the third quarter and
nine months ended September 30, 2015, compared to the third quarter and
nine months ended September 30, 2014.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss of $60.4 million, or $1.87 per share,
for the third quarter of 2015, compared to a net loss of $35.9 million,
or $1.19 per share, for the third quarter of 2014. Net loss for the nine
months ended September 30, 2015 was $177.6 million, or $5.55 per share,
compared to $94.5 million, or $3.16 per share, for the nine months ended
September 30, 2014.
Non-GAAP adjusted net loss was $35.5 million, or $1.10 per share, for
the third quarter of 2015, compared to $25.4 million, or $0.84 per
share, for the third quarter of 2014. Non-GAAP adjusted net loss for the
nine months ended September 30, 2015 was $104.3 million, or $3.26 per
share, compared to $71.7 million, or $2.40 per share, for the nine
months ended September 30, 2014. Non-GAAP adjusted net loss 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 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 used in operating activities for the third quarter of 2015 was
$36.8 million. Net cash used in operating activities for the nine months
ended September 30, 2015 was $121.4 million. At September 30, 2015, Puma
had cash and cash equivalents of $23.6 million and marketable securities
of $224.2 million, compared to cash and cash equivalents of $38.5
million and marketable securities of $102.8 million at December 31,
2014. Puma's current level of cash and cash equivalents and marketable
securities includes net proceeds of approximately $205.1 million from a
public offering of the Company's common stock, which was completed in
January 2015.
“We continued to make significant progress with the neratinib clinical
program in the third quarter,” said Alan H. Auerbach, Chairman, Chief
Executive Officer and President of Puma. “Puma achieved a number of
milestones, including the presentation of additional data on patients
with centrally confirmed HER2-positive disease from our Phase III
ExteNET Trial at the American Society of Clinical Oncology (ASCO) 2015
Breast Cancer Symposium and the publication in the Journal of the
National Comprehensive Cancer Network of a patient with HER2
non-amplified (HER2-negative) metastatic breast cancer who also had a
HER2 activating mutation and was successfully treated with PB272. We
continue to anticipate filing for regulatory approval of PB272 for the
extended adjuvant treatment of HER2-positive breast cancer in the first
quarter of 2016.
“We anticipate a number of additional milestones through the end of 2015
and beyond. These include (i) presentations of additional data from the
Phase III ExteNET Trial in the extended adjuvant treatment of early
stage HER2-positive breast cancer (anticipated in the fourth quarter of
2015); (ii) publication of Phase III ExteNET Trial results (anticipated
in the fourth quarter of 2015); (iii) presentation of the Phase II FB-7
trial of PB272 as a neoadjuvant treatment for patients with
HER2-positive breast cancer (anticipated in the fourth quarter of 2015);
(iv) presentation of data from our Phase II trial of PB272 in HER2
non-amplified breast cancer that has a HER2 mutation (anticipated in the
fourth quarter of 2015); (v) reporting initial data from the Phase II
trial of neratinib in extended adjuvant HER2-positive early stage breast
cancer using loperamide prophylaxis (anticipated in the fourth quarter
of 2015); (vi) publication of results to date on the use of prophylactic
loperamide to reduce the neratinib-related diarrhea (anticipated in the
fourth quarter of 2015); (vii) completing the ongoing Phase II trial of
PB272 in patients with HER2-positive metastatic breast cancer that has
metastasized to the brain (anticipated in the first half of 2016); and
(viii) expanding additional cohorts in our Phase II basket trial of
PB272 in patients with solid tumors with activating HER2 mutations
(anticipated in the fourth quarter of 2015).”
Operating Expenses
Based on GAAP, operating expenses were $60.7 million for the third
quarter of 2015, compared to $36.0 million for the third quarter of
2014. Operating expenses for the nine months ended September 30, 2015
were $178.2 million, compared to $94.7 million for the nine months ended
September 30, 2014. The increase in operating expenses for the third
quarter of 2015 compared to the third quarter of 2014 was primarily
driven by an increase in stock-based compensation expense of $14.4
million, an increase in clinical trial expense of $5.1 million and an
increase in internal research and development expense of $3.0 million.
The increase in operating expenses for the nine months ended September
30, 2015 compared to the same period in 2014 was primarily driven by an
increase in stock-based compensation of $50.5 million, an increase in
clinical trial expense of $19.4 million and an increase in internal
research and development expense of $8.2 million.
General and Administrative Expenses:
Based on GAAP, general and administrative expenses were $8.8 million for
the third quarter of 2015, compared to $3.9 million for the third
quarter of 2014. General and administrative expenses for the nine months
ended September 30, 2015 were $22.2 million compared to $11.3 million
for the nine months ended September 30, 2014.
Research and Development Expenses:
Based on GAAP, research and development expenses were $51.9 million for
the third quarter of 2015, compared to $32.1 million for the third
quarter of 2014. Research and development expenses for the nine months
ended September 30, 2015 were $156.0 million, compared to $83.4 million
for the nine months ended September 30, 2014.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on
the acquisition, development and commercialization of innovative
products to enhance cancer care. The Company aims to acquire proprietary
rights to these products, by license or otherwise, fund their research
and development and bring the products to market. 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 regulatory filings and 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, 2014 and Quarterly Reports on Form 10-Q for the
quarters ended June 30, 2015 and September 30, 2015. 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
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(in millions except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
$
|
8.8
|
|
|
$
|
3.9
|
|
|
$
|
22.2
|
|
|
$
|
11.3
|
|
|
Research and development
|
|
|
51.9
|
|
|
|
32.1
|
|
|
|
156.0
|
|
|
|
83.4
|
|
|
Totals
|
|
|
|
|
60.7
|
|
|
|
36.0
|
|
|
|
178.2
|
|
|
|
94.7
|
|
|
Loss from operations
|
|
|
|
|
(60.7
|
)
|
|
|
(36.0
|
)
|
|
|
(178.2
|
)
|
|
|
(94.7
|
)
|
|
Other income (expenses):
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
0.3
|
|
|
|
0.1
|
|
|
|
0.6
|
|
|
|
0.2
|
|
|
Other income (expense)
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
Totals
|
|
|
|
|
0.3
|
|
|
|
0.1
|
|
|
|
0.6
|
|
|
|
0.2
|
|
|
Net loss
|
|
|
|
$
|
(60.4
|
)
|
|
$
|
(35.9
|
)
|
|
$
|
(177.6
|
)
|
|
$
|
(94.5
|
)
|
|
Net loss per common share—basic and diluted
|
|
$
|
(1.87
|
)
|
|
$
|
(1.19
|
)
|
|
$
|
(5.55
|
)
|
|
$
|
(3.16
|
)
|
|
Weighted-average common shares outstanding—basic and diluted
|
|
|
32,303,203
|
|
|
|
30,117,819
|
|
|
|
32,018,869
|
|
|
|
29,936,254
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
|
|
LIQUIDITY AND CAPITAL RESOURCES
|
|
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
|
|
|
2015
|
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
23.6
|
|
|
|
$
|
38.5
|
|
|
Marketable securities
|
|
|
|
|
224.2
|
|
|
|
|
102.8
|
|
|
Licensor receivable
|
|
|
|
|
-
|
|
|
|
|
1.8
|
|
|
Working capital
|
|
|
|
|
229.3
|
|
|
|
|
105.0
|
|
|
Stockholders' equity
|
|
|
|
|
244.8
|
|
|
|
|
117.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
|
|
Nine Months
|
|
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
|
|
|
2015
|
|
|
|
|
2014
|
|
|
Cash provided by (used in):
|
|
|
|
|
|
|
Operating activities
|
|
|
|
$
|
(121.4
|
)
|
|
|
$
|
(58.7
|
)
|
|
Investing activities
|
|
|
|
|
(125.5
|
)
|
|
|
|
(85.5
|
)
|
|
Financing activities
|
|
|
|
|
232.0
|
|
|
|
|
129.4
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in cash and cash equivalents
|
|
$
|
(14.9
|
)
|
|
|
$
|
(14.8
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Financial Measures:
In addition to our operating results, as calculated in accordance with
GAAP, we use certain non-GAAP financial measures when planning,
monitoring, and evaluating our operational performance. The following
table presents our net loss and net loss per share, as calculated in
accordance with GAAP, as adjusted to remove the impact of employee
stock-based compensation. These non-GAAP financial measures are not, and
should not be viewed as, substitutes for GAAP reporting measures. We
believe these non-GAAP measures enhance understanding of our financial
performance, are more indicative of our operational performance and
facilitate a better comparison among fiscal periods.
|
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
|
|
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
|
|
(in millions except share and per share data)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
|
|
GAAP net loss
|
|
$
|
(60.4
|
)
|
|
$
|
(35.9
|
)
|
|
|
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
Stock-based compensation -
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
4.7
|
|
|
|
1.4
|
|
|
|
(1)
|
|
Research and development
|
|
|
20.2
|
|
|
|
9.1
|
|
|
|
(2)
|
|
Non-GAAP adjusted net loss
|
|
$
|
(35.5
|
)
|
|
$
|
(25.4
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic and diluted
|
|
$
|
(1.87
|
)
|
|
$
|
(1.19
|
)
|
|
|
|
|
Adjustment to net loss (as detailed above)
|
|
|
0.77
|
|
|
|
0.35
|
|
|
|
|
|
Non-GAAP adjusted net loss per share
|
|
$
|
(1.10
|
)
|
|
$
|
(0.84
|
)
|
|
|
(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
|
|
GAAP net loss
|
|
$
|
(177.6
|
)
|
|
$
|
(94.5
|
)
|
|
|
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
Stock-based compensation -
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
12.2
|
|
|
|
4.1
|
|
|
|
(1)
|
|
Research and development
|
|
|
61.1
|
|
|
|
18.7
|
|
|
|
(2)
|
|
Non-GAAP adjusted net loss
|
|
$
|
(104.3
|
)
|
|
$
|
(71.7
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic and diluted
|
|
$
|
(5.55
|
)
|
|
$
|
(3.16
|
)
|
|
|
|
|
Adjustment to net loss (as detailed above)
|
|
|
2.29
|
|
|
|
0.76
|
|
|
|
|
|
Non-GAAP adjusted net loss per share
|
|
$
|
(3.26
|
)
|
|
$
|
(2.40
|
)
|
|
|
(4)
|
|
|
|
|
|
|
|
|
|
|
(1) To reflect a non-cash charge to operating expense for General
and Administrative stock-based compensation.
|
|
|
(2) To reflect a non-cash charge to operating expense for Research
and Development stock-based compensation.
|
|
|
|
|
(3) Non-GAAP adjusted net loss per share was calculated based on
32,303,203 and 30,117,819 weighted average common
|
|
|
shares outstanding for the three months ended September 30, 2015 and
2014, respectively.
|
|
|
|
|
|
|
(4) Non-GAAP adjusted net loss per share was calculated based on
32,018,869 and 29,936,254 weighted average common
|
|
|
shares outstanding for the nine months ended September 30, 2015 and
2014, respectively.
|
|
|
|
|
|
Contact: