LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company,
announced financial results for the first quarter ended March 31, 2017.
Unless otherwise stated, all comparisons are for the first quarter 2017
compared to the first quarter 2016.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss applicable to common stock of $72.9
million, or $1.97 per share, for the first quarter of 2017, compared to
a net loss applicable to common stock of $71.0 million, or $2.19 per
share, for the first quarter of 2016.
Non-GAAP adjusted net loss was $43.1 million, or $1.16 per share, for
the first quarter of 2017, compared to non-GAAP adjusted net loss of
$41.5 million, or $1.28 per share, for the first quarter of 2016.
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 first quarter of 2017 was
$36.0 million. At March 31, 2017, Puma had cash and cash equivalents of
$105.1 million and marketable securities of $88.9 million, compared to
cash and cash equivalents of $194.5 million and marketable securities of
$35.0 million at December 31, 2016.
“We made significant progress with our lead investigational drug,
neratinib, during the first quarter of 2017,” said Alan H. Auerbach,
Chairman, Chief Executive Officer and President of Puma. “We look
forward to continuing to work with the U.S. Food and Drug Administration
(FDA) and European Medicines Agency (EMA) as they review our New Drug
Application (NDA) and Marketing Authorization Application (MAA) filings,
respectively, and we look forward to presenting the data on neratinib at
the upcoming FDA Oncologic Drugs Advisory Committee on May 24th.
“Data on neratinib was also presented at the 2017 American Association
for Cancer Research Annual Meeting in April which included data on the
use of antidiarrheal prophylaxis to reduce the diarrhea with neratinib
in the extended adjuvant treatment of patients with early stage
HER2-overexpressed/amplified breast cancer who have received prior
adjuvant trastuzumab-based therapy (CONTROL trial). There was also
clinical data presented on neratinib in the treatment of patients who
have solid tumors with activating HER2 or HER3 mutations (SUMMIT trial).
Additional data was also presented on the combination of T-DM1 and
neratinib in patients with HER2 positive metastatic breast cancer (MBC)
that has previously been treated with pertuzumab and trastuzumab. We
look forward to continuing to achieve our objectives and believe that
Puma is very well-positioned to build value for our shareholders.”
Mr. Auerbach added, “During 2017, we anticipate the following key
milestones with neratinib: (i) reporting data from the Phase III trial
in third-line HER2-positive MBC patients in the second quarter of 2017;
(ii) reporting data in the second quarter of 2017 from the TBCRC-022
Phase II trial of neratinib plus capecitabine in HER2-positive MBC
patients with brain metastases; (iii) reporting final 5-year disease
free survival (DFS) data during the second quarter of 2017 from the
ExteNET Phase III trial of neratinib as an extended adjuvant treatment
in HER2-positive early stage breast cancer; and (iv) announcing
regulatory decisions in the United States and European Union on
neratinib for the extended adjuvant treatment of patients with
HER2-positive early stage breast cancer in the third quarter of 2017.”
Operating Expenses
Operating expenses were $73.2 million for the first quarter of 2017,
compared to $71.2 million for the first quarter of 2016.
General and Administrative Expenses:
General and administrative expenses were $18.4 million for the first
quarter of 2017, compared to $11.0 million for the first quarter of
2016. The approximately $7.4 million increase resulted primarily from
increases of approximately $1.4 million for stock-based compensation,
$3.9 million for professional fees, $1.3 million for payroll and related
costs, and $0.5 million for facility and equipment costs. These
increases reflect overall corporate growth.
Research and Development Expenses:
Research and development (R&D) expenses were $54.8 million for the first
quarter of 2017, compared to $60.2 million for the first quarter of
2016. The approximately $5.4 million decrease resulted primarily from
decreases of approximately $1.1 million for stock-based compensation and
$5.0 million for clinical trial expenses, partially offset by an
increase of $0.6 million for consultants and contractors. For our
existing clinical trials, we expect R&D expenses to decrease in
subsequent quarters as clinical trials wind down.
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 potential announcement of regulatory decisions
in the United States and European Union on neratinib for the extended
adjuvant treatment of patients with HER2-positive early stage breast
cancer and the Company’s 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, 2016. 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.
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
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CONSOLIDATED STATEMENTS OF OPERATIONS
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(in millions except share and per share data)
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Three Months Ended
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March 31,
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(Unaudited)
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2017
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2016
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Operating expenses:
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General and administrative
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$
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18.4
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$
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11.0
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Research and development
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54.8
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60.2
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Totals
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73.2
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71.2
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Loss from operations
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(73.2
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)
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(71.2
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)
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Other income (expenses):
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Interest income
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0.3
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0.3
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Other income (expense)
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-
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-
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Totals
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0.3
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0.3
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Net loss
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$
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(72.9
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$
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(71.0
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Net loss per common share—basic and diluted
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$
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(1.97
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)
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$
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(2.19
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)
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Weighted-average common shares outstanding—basic and diluted
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36,931,167
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32,478,408
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
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LIQUIDITY AND CAPITAL RESOURCES
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(in millions, unaudited)
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March 31,
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December 31,
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2017
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2016
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Cash and cash equivalents
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$
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105.1
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$
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194.5
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Marketable securities
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88.9
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35.0
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Working capital
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160.9
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199.0
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Stockholders' equity
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167.4
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209.8
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Three Months
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Three Months
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Ended
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Ended
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March 31,
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March 31,
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2017
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2016
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Cash provided by (used in):
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Operating activities
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$
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(36.0
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$
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(35.0
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Investing activities
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(54.1
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81.5
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Financing activities
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0.7
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0.2
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Increase (decrease) in cash and cash equivalents
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$
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(89.4
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)
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$
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46.7
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Non-GAAP Financial Measures
In addition to operating results as calculated in accordance with
generally accepted accounting principles, or GAAP, the Company uses
certain non-GAAP financial measures when planning, monitoring, and
evaluating operational performance. The following table presents the
Company’s net loss and net loss per share calculated in accordance with
GAAP and as adjusted to remove the impact of employee stock-based
compensation. For the three months ended March 31, 2017, stock-based
compensation represented approximately 40.9% of net loss. Although net
loss is important to measure financial performance, the Company
currently places an emphasis on cash burn and, more specifically, cash
used in operations. Stock-based compensation appears in GAAP net loss
but is removed from net loss to arrive at cash used in operations on the
statement of cash flows. Due to its noncash nature, the Company believes
these non-GAAP measures enhance understanding of financial performance,
are more indicative of operational performance and facilitate a better
comparison among fiscal periods. These non-GAAP financial measures are
not, and should not be viewed as, substitutes for GAAP reporting
measures.
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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
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GAAP Net Loss Per Share to Non-GAAP Adjusted Net Loss Per Share
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(in millions except share and per share data)
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(Unaudited)
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Three Months Ended March 31,
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2017
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2016
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GAAP net loss
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$
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(72.9
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$
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(71.0
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)
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Adjustments:
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Stock-based compensation -
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General and administrative
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7.3
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5.9
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(1)
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Research and development
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22.5
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23.6
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(2)
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Non-GAAP adjusted net loss
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$
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(43.1
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)
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$
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(41.5
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)
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GAAP net loss per share - basic and diluted
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$
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(1.97
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)
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$
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(2.19
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)
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Adjustment to net loss (as detailed above)
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0.81
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0.91
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Non-GAAP adjusted net loss per share
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$
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(1.16
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)
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$
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(1.28
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)
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(3)
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(1)
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To reflect a non-cash charge to operating expense for General and
Administrative stock-based compensation.
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(2)
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To reflect a non-cash charge to operating expense for Research and
Development stock-based compensation.
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(3)
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Non-GAAP adjusted net loss per share was calculated based on
36,931,167 and 32,478,408 weighted average common shares
outstanding for the three months ended March 31, 2017 and 2016,
respectively.
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Contact: