LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company,
announced financial results for the fourth quarter and year ended
December 31, 2015.
Unless otherwise stated, all comparisons are for the fourth quarter and
full year 2015 compared to the fourth quarter and full year 2014,
respectively.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss applicable to common stock of $61.7
million, or $1.90 per share, for the fourth quarter of 2015, compared to
a net loss of $47.5 million, or $1.57 per share, for the fourth quarter
of 2014. Net loss applicable to common stock for the full year 2015 was
$239.3 million, or $7.45 per share, compared to $142.0 million, or $4.73
per share, for the full year 2014.
Non-GAAP adjusted net loss was $40.0 million, or $1.23 per share, for
the fourth quarter of 2015, compared to non-GAAP adjusted net loss of
$31.1 million, or $1.03 per share, for the fourth quarter of 2014.
Non-GAAP adjusted net loss for the full year 2015 was $144.3 million, or
$4.49 per share, compared to $102.8 million, or $3.43 per share, for the
full year 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 Company’s cash position. 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 fourth quarter of 2015 was
$33.3 million. Net cash used in operating activities for the full year
2015 was $154.5 million. At December 31, 2015, Puma had cash and cash
equivalents of $31.6 million and marketable securities of $184.3
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.
“During the fourth quarter of 2015, Puma accomplished several clinical
and regulatory milestones that contributed significant value to the
shareholders of the Company,” said Alan H. Auerbach, Chairman, Chief
Executive Officer and President of Puma. “From the clinical perspective,
in December we reported additional data from our Phase III ExteNET trial
at the San Antonio Breast Cancer Symposium (SABCS), which continued to
demonstrate that after 3 years of follow up, treatment with neratinib
resulted in a statistically significant benefit in disease-free survival
in patients with early stage HER2 positive breast cancer who had
completed one year of adjuvant trastuzumab therapy. In addition, at
SABCS we presented interim data from the Phase II trial of neratinib in
patients with HER2-negative breast cancer who have a HER2 mutation that
showed compelling benefit with neratinib, both as a monotherapy and in
combination with fulvestrant. We also announced the interim data from
our Phase II trial of neratinib monotherapy in patients with early stage
HER2- positive breast cancer who had completed treatment with adjuvant
trastuzumab, which demonstrated that using the loperamide prophylaxis
with neratinib monotherapy treatment resulted in a lower rate of overall
diarrhea, specifically grade 3 diarrhea, and resulted in diarrhea that
was short term in duration and self-limiting. From the regulatory
perspective, in November we announced that based on our Marketing
Authorization Application (MAA) pre-submission meeting with the European
Medicines Agency (EMA), at which the EMA assessed that there were no
critical concerns that would prevent us from submitting a complete MAA
for European centralized review in support of neratinib for the extended
adjuvant treatment of HER2-positive early stage breast cancer in
patients who have previously been treated with a trastuzumab-containing
regimen, that we anticipate submitting an MAA for neratinib in this
indication in the first half of 2016.
“We look forward to continuing to contribute value to shareholders with
neratinib during 2016. We anticipate (i) submitting a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) during
the first quarter of 2016 and submitting the MAA to the EMA during the
first half of 2016 for neratinib for the extended adjuvant treatment of
HER2-positive early stage breast cancer based on the positive ExteNET
Phase III trial; (ii) 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 during the first half
of 2016; (iii) reporting additional Phase II data from the FB-7
neoadjuvant HER2-positive breast cancer trial in the subgroup of
patients who are MammaPrint High, during the first half of 2016; (iv)
reporting Phase II data from an investigator sponsored trial of
neratinib in patients with HER2-negative breast cancer who have a HER2
mutation in mid-2016; (v) 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; (vi)
reporting data from the Phase II trial of neratinib in metastatic breast
cancer patients with brain metastases during the fourth quarter of 2016;
and (vii) 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.”
Operating Expenses
Operating expenses were $62.1 million for the fourth quarter of 2015,
compared to $47.6 million for the fourth quarter of 2014. Operating
expenses for the full year 2015 were $239.3 million compared to $142.3
million for the full year 2014.
General and Administrative Expenses:
General and administrative expenses were $9.6 million for the fourth
quarter of 2015, compared to $8.1 million for the fourth quarter of
2014. General and administrative expenses for the full year 2015 were
$31.8 million compared to $19.4 million for the full year 2014.
Approximately $8.0 million of the year-over-year increase resulted from
an increase in stock-based compensation expense, with the majority of
the remaining increase made up of approximately $2.2 million in
professional fees, $0.9 million in payroll and related expenses and $0.6
million in facility and equipment costs. These increases reflect our
corporate growth.
Research and Development Expenses:
Research and development expenses were $52.5 million for the fourth
quarter of 2015, compared to $39.5 million for the fourth quarter of
2014. Research and development expenses for the full year 2015 were
$208.5 million, compared to $122.9 million for the full year 2014.
Approximately $47.8 million of the year-over-year increase resulted from
an increase in stock-based compensation expense, with the majority of
the remaining increase made up of approximately $22.9 million in
clinical trial expense, $9.0 million in internal costs such as payroll
and related expenses, and $5.9 million in expenses related to
consultants and contractors. These increases reflect our increased
clinical trial activity.
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 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 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.
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
|
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in millions except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Years Ended
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
(Unaudited)
|
|
(Audited)
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
2015
|
|
|
|
2014
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
$
|
9.6
|
|
|
$
|
8.1
|
|
|
$
|
31.8
|
|
|
$
|
19.4
|
|
Research and development
|
|
|
|
52.5
|
|
|
|
39.5
|
|
|
|
208.5
|
|
|
|
122.9
|
|
Totals
|
|
|
|
62.1
|
|
|
|
47.6
|
|
|
|
240.3
|
|
|
|
142.3
|
|
Loss from operations
|
|
|
|
(62.1
|
)
|
|
|
(47.6
|
)
|
|
|
(240.3
|
)
|
|
|
(142.3
|
)
|
Other income (expenses):
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
0.4
|
|
|
|
0.1
|
|
|
|
1.0
|
|
|
|
0.3
|
|
Other income (expense)
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Totals
|
|
|
|
0.4
|
|
|
|
0.1
|
|
|
|
1.0
|
|
|
|
0.3
|
|
Net loss
|
|
|
$
|
(61.7
|
)
|
|
$
|
(47.5
|
)
|
|
$
|
(239.3
|
)
|
|
$
|
(142.0
|
)
|
Net loss per common share—basic and diluted
|
|
$
|
(1.90
|
)
|
|
$
|
(1.57
|
)
|
|
$
|
(7.45
|
)
|
|
$
|
(4.73
|
)
|
Weighted-average common shares outstanding—basic and diluted
|
|
|
32,444,270
|
|
|
|
30,232,718
|
|
|
|
32,126,094
|
|
|
|
30,010,979
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
|
LIQUIDITY AND CAPITAL RESOURCES
|
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
December 31,
|
|
|
|
|
|
|
2015
|
|
|
|
|
|
2014
|
|
Cash and cash equivalents
|
|
|
|
|
$
|
31.6
|
|
|
|
|
$
|
38.5
|
|
Marketable securities
|
|
|
|
|
|
184.3
|
|
|
|
|
|
102.8
|
|
Licensor receivable
|
|
|
|
|
|
-
|
|
|
|
|
|
1.8
|
|
Working capital
|
|
|
|
|
|
191.1
|
|
|
|
|
|
104.9
|
|
Stockholders' equity
|
|
|
|
|
|
206.0
|
|
|
|
|
|
117.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
|
|
Year Ended
|
|
|
|
|
|
December 31,
|
|
|
|
December 31,
|
|
|
|
|
|
|
2015
|
|
|
|
|
|
2014
|
|
Cash provided by (used in):
|
|
|
|
|
|
|
|
|
|
Operating activities
|
|
|
|
|
$
|
(154.5
|
)
|
|
|
|
$
|
(77.2
|
)
|
Investing activities
|
|
|
|
|
|
(85.9
|
)
|
|
|
|
|
(63.3
|
)
|
Financing activities
|
|
|
|
|
|
233.4
|
|
|
|
|
|
136.0
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash
|
|
|
|
|
$
|
(7.0
|
)
|
|
|
|
$
|
(4.5
|
)
|
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.
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 December 31,
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
GAAP net loss
|
|
$
|
(61.7
|
)
|
|
$
|
(47.5
|
)
|
|
|
Adjustments:
|
|
|
|
|
|
|
Stock-based compensation -
|
|
|
|
|
|
|
General and administrative
|
|
|
5.0
|
|
|
|
5.1
|
|
|
(1)
|
Research and development
|
|
|
16.7
|
|
|
|
11.3
|
|
|
(2)
|
Non-GAAP adjusted net loss
|
|
$
|
(40.0
|
)
|
|
$
|
(31.1
|
)
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic and diluted
|
|
$
|
(1.90
|
)
|
|
$
|
(1.57
|
)
|
|
|
Adjustment to net loss (as detailed above)
|
|
|
0.67
|
|
|
|
0.54
|
|
|
|
Non-GAAP adjusted net loss per share
|
|
$
|
(1.23
|
)
|
|
$
|
(1.03
|
)
|
|
(3)
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
GAAP net loss
|
|
$
|
(239.3
|
)
|
|
$
|
(142.0
|
)
|
|
|
Adjustments:
|
|
|
|
|
|
|
Stock-based compensation -
|
|
|
|
|
|
|
General and administrative
|
|
|
17.2
|
|
|
|
9.2
|
|
|
(1)
|
Research and development
|
|
|
77.8
|
|
|
|
30.0
|
|
|
(2)
|
Non-GAAP adjusted net loss
|
|
$
|
(144.3
|
)
|
|
$
|
(102.8
|
)
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic and diluted
|
|
$
|
(7.45
|
)
|
|
$
|
(4.73
|
)
|
|
|
Adjustment to net loss (as detailed above)
|
|
|
2.96
|
|
|
|
1.30
|
|
|
|
Non-GAAP adjusted net loss per share
|
|
$
|
(4.49
|
)
|
|
$
|
(3.43
|
)
|
|
(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
32,444,270 and 30,232,718 weighted average common shares
outstanding for the three months ended December 31, 2015 and 2014,
respectively.
|
(4) Non-GAAP adjusted net loss per share was calculated based on
32,126,094 and 30,010,979 weighted average common shares
outstanding for the years ended December 31, 2015 and 2014,
respectively.
|

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