LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company,
today announced financial results for the second quarter ended June 30,
2016.
Unless otherwise stated, all comparisons are for the second quarter and
six months ended June 30, 2016, compared to the second quarter and six
months ended June 30, 2015.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss applicable to common stock of $66.6
million, or $2.05 per share, for the second quarter of 2016, compared to
a net loss applicable to common stock of $64.7 million, or $2.01 per
share, for the second quarter of 2015. Net loss applicable to common
stock for the first half of 2016 was $137.6 million, or $4.23 per share,
compared to $117.1 million, or $3.68 per share, for the first half of
2015.
Non-GAAP adjusted net loss was $37.9 million, or $1.17 per share, for
the second quarter of 2016, compared to non-GAAP adjusted net loss of
$36.5 million, or $1.13 per share, for the second quarter of 2015.
Non-GAAP adjusted net loss for the first half of 2016 was $79.3 million,
or $2.44 per share, compared to $68.8 million, or $2.16 per share, for
the first half of 2015. 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. The Company
anticipates that non-GAAP net loss will continue to decrease in
subsequent quarters due to a continued reduction in clinical trial
expenses and due to a reduction in expenses associated with the
completion of the regulatory filings for neratinib for the extended
adjuvant treatment of HER2-positive early stage breast cancer in Europe
and the United States, which were submitted in June and July,
respectively.
Net cash used in operating activities for the second quarter of 2016 was
$30.8 million. Net cash used in operating activities for the first half
of 2016 was $65.8 million. At June 30, 2016, Puma had cash and cash
equivalents of $57.8 million and marketable securities of $85.9 million,
compared to cash and cash equivalents of $31.6 million and marketable
securities of $184.3 million at December 31, 2015. The Company
anticipates that net cash used in operating activities will continue to
decrease in subsequent quarters due to a reduction in the expenses
described above.
“We are very pleased with the accomplishments of the Company,” said Alan
H. Auerbach, Chairman, Chief Executive Officer and President of Puma.
“These milestones include the submission of the Marketing Authorization
Application (MAA) to the European Medicines Agency (EMA) in June and the
submission of a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) in July for neratinib for the extended adjuvant
treatment of HER2-positive early stage breast cancer based on the
positive ExteNET Phase III trial. We also reported positive Phase II
data from an investigator sponsored trial of neratinib in patients with
HER2 mutated, non-amplified breast cancer in June. In addition, our
Phase II trial of neratinib in the front-line treatment of HER2-positive
metastatic breast cancer (NEfERT-T trial) was published in JAMA
Oncology in April, and positive results from the I-SPY 2
Phase II clinical trial of neratinib for the neoadjuvant treatment of
breast cancer was published in the July 7 issue of The New England
Journal of Medicine.
“In the second half of 2016, we look forward to several regulatory and
clinical milestones with neratinib. From the regulatory perspective, we
look forward to working with the EMA and FDA as they review our MAA and
NDA submission, respectively. We also look forward to continuing our
development of neratinib in the second half of 2016 and beyond. We
anticipate (i) reporting additional data from the Phase II trial of
neratinib as an extended adjuvant treatment in HER2-positive early stage
breast cancer using loperamide prophylaxis in the fourth quarter of
2016; (ii) reporting additional Phase II data from the FB-7 neoadjuvant
HER2-positive breast cancer trial in the subgroup of patients who are
MammaPrint High in the fourth quarter of 2016; (iii) reporting data from
the Phase II trial of neratinib plus fulvestrant in patients with HER2
non-amplified breast cancer that has a HER2 mutation during the fourth
quarter of 2016; (iv) reporting data from the Phase III trial of
neratinib in third-line HER2-positive metastatic breast cancer patients
in either the fourth quarter of 2016 or the first quarter of 2017; and
(v) reporting data from the Phase II trial of neratinib in metastatic
breast cancer patients with brain metastases during the fourth quarter
of 2016.”
Operating Expenses
Operating expenses were $66.5 million for the second quarter of 2016,
compared to $64.9 million for the second quarter of 2015. Operating
expenses for the first half of 2016 were $137.7 million compared to
$117.5 million for the first half of 2015.
General and Administrative Expenses:
General and administrative expenses were $12.3 million for the second
quarter of 2016, compared to $5.5 million for the second quarter of
2015. General and administrative expenses for the first half of 2016
were $23.3 million compared to $13.4 million for the first half of 2015.
The increase of approximately $9.9 million resulted primarily from
increases of approximately $4.6 million in stock-based compensation,
$2.9 million in professional fees and expenses, $1.3 million in payroll
and related costs, and $1.0 million in facility and equipment costs.
These increases reflect higher legal and compliance expenses, as well as
overall corporate growth.
Research and Development Expenses:
Research and development expenses were $54.2 million for the second
quarter of 2016, compared to $59.4 million for the second quarter of
2015. Research and development expenses for the first half of 2016 were
$114.4 million, compared to $104.1 million for the first half of 2015.
The increase of approximately $10.3 million resulted primarily from
increases of approximately $5.3 million in stock-based compensation and
$4.3 million for internal clinical development, regulatory and quality
assurance expenses. We expect research and development expenses to
decrease in subsequent quarters as we complete clinical trials and as
our regulatory filings for neratinib for the extended adjuvant treatment
of HER2-positive early stage breast cancer have been submitted in the
United States and European Union.
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 is a
potent irreversible tyrosine kinase inhibitor that blocks signal
transduction through the epidermal growth factor receptors, HER1, HER2
and HER4. Currently, the Company is primarily focused on the development
of the oral version of neratinib, and its most advanced drug candidates
are directed at the treatment of HER2-positive breast cancer. The
Company believes that neratinib has clinical application in the
treatment of several other cancers as well, including non-small cell
lung cancer and other tumor types that over-express or have a mutation
in HER2.
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 the commencement and completion of various clinical
trials and the announcement of data relative to these trials and the
expected decrease in non-GAAP net loss, certain expenses and net cash
used in operating activities in subsequent quarters. 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 and current 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, 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.
(Financial Tables Follow)
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
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|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
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(in millions except share and per share data)
|
|
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
$
|
12.3
|
|
|
$
|
5.5
|
|
|
$
|
23.3
|
|
|
$
|
13.4
|
|
|
Research and development
|
|
|
54.2
|
|
|
|
59.4
|
|
|
|
114.4
|
|
|
|
104.1
|
|
|
Totals
|
|
|
66.5
|
|
|
|
64.9
|
|
|
|
137.7
|
|
|
|
117.5
|
|
|
Loss from operations
|
|
|
(66.5
|
)
|
|
|
(64.9
|
)
|
|
|
(137.7
|
)
|
|
|
(117.5
|
)
|
|
Other income (expenses):
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
0.3
|
|
|
|
0.2
|
|
|
|
0.5
|
|
|
|
0.3
|
|
|
Other income (expense)
|
|
|
(0.4
|
)
|
|
|
—
|
|
|
|
(0.4
|
)
|
|
|
0.1
|
|
|
Totals
|
|
|
(0.1
|
)
|
|
|
0.2
|
|
|
|
0.1
|
|
|
|
0.4
|
|
|
Net loss
|
|
$
|
(66.6
|
)
|
|
$
|
(64.7
|
)
|
|
$
|
(137.6
|
)
|
|
$
|
(117.1
|
)
|
|
Net loss per common share—basic and diluted
|
|
$
|
(2.05
|
)
|
|
$
|
(2.01
|
)
|
|
$
|
(4.23
|
)
|
|
$
|
(3.68
|
)
|
|
Weighted-average common shares outstanding—basic and diluted
|
|
|
32,493,092
|
|
|
|
32,158,108
|
|
|
|
32,485,750
|
|
|
|
31,874,346
|
|
|
|
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
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LIQUIDITY AND CAPITAL RESOURCES
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|
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
57.8
|
|
|
$
|
31.6
|
|
|
Marketable securities
|
|
|
85.9
|
|
|
|
184.3
|
|
|
Receivable
|
|
|
1.2
|
|
|
|
—
|
|
|
Working capital
|
|
|
114.8
|
|
|
|
191.1
|
|
|
Stockholders' equity
|
|
|
127.1
|
|
|
|
206.0
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
Six Months
|
|
|
|
Ended
|
|
Ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
|
2016
|
|
|
|
2015
|
|
|
Cash provided by (used in):
|
|
|
|
|
|
Operating activities
|
|
$
|
(65.8
|
)
|
|
$
|
(84.6
|
)
|
|
Investing activities
|
|
|
91.9
|
|
|
|
(120.8
|
)
|
|
Financing activities
|
|
|
0.2
|
|
|
|
226.7
|
|
|
|
|
|
|
|
|
Increase in cash and cash equivalents
|
|
$
|
26.3
|
|
|
$
|
21.3
|
|
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.
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
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|
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 June 30,
|
|
|
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
|
GAAP net loss
|
|
$
|
(66.6
|
)
|
|
$
|
(64.7
|
)
|
|
|
|
Adjustments:
|
|
|
|
|
|
|
|
Stock-based compensation -
|
|
|
|
|
|
|
|
General and administrative
|
|
|
6.1
|
|
|
|
2.7
|
|
|
(1)
|
|
Research and development
|
|
|
22.6
|
|
|
|
25.5
|
|
|
(2)
|
|
Non-GAAP adjusted net loss
|
|
$
|
(37.9
|
)
|
|
$
|
(36.5
|
)
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic and diluted
|
|
$
|
(2.05
|
)
|
|
$
|
(2.01
|
)
|
|
|
|
Adjustment to net loss (as detailed above)
|
|
|
0.88
|
|
|
|
0.88
|
|
|
|
|
Non-GAAP adjusted net loss per share
|
|
$
|
(1.17
|
)
|
|
$
|
(1.13
|
)
|
|
(3)
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
|
GAAP net loss
|
|
$
|
(137.6
|
)
|
|
$
|
(117.1
|
)
|
|
|
|
Adjustments:
|
|
|
|
|
|
|
|
Stock-based compensation -
|
|
|
|
|
|
|
|
General and administrative
|
|
|
12.1
|
|
|
|
7.4
|
|
|
(1)
|
|
Research and development
|
|
|
46.2
|
|
|
|
40.9
|
|
|
(2)
|
|
Non-GAAP adjusted net loss
|
|
$
|
(79.3
|
)
|
|
$
|
(68.8
|
)
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic and diluted
|
|
$
|
(4.23
|
)
|
|
$
|
(3.68
|
)
|
|
|
|
Adjustment to net loss (as detailed above)
|
|
|
1.79
|
|
|
|
1.52
|
|
|
|
|
Non-GAAP adjusted net loss per share
|
|
$
|
(2.44
|
)
|
|
$
|
(2.16
|
)
|
|
(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
32,493,092 and 32,158,108 weighted average common shares
outstanding for the three months ended June 30, 2016 and 2015,
respectively.
|
|
(4)
|
|
Non-GAAP adjusted net loss per share was calculated based on
32,485,750 and 31,874,346 weighted average common shares
outstanding for the six months ended June 30, 2016 and 2015,
respectively.
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Contact: