LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company,
announced financial results for the third quarter ended September 30,
2016.
Unless otherwise stated, all comparisons are for the third quarter and
nine months ended September 30, 2016, compared to the third quarter and
nine months ended September 30, 2015.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss applicable to common stock of $65.8
million, or $2.02 per share, for the third quarter of 2016, compared to
a net loss of $60.4 million, or $1.87 per share, for the third quarter
of 2015. Net loss applicable to common stock for the nine months ended
September 30, 2016 was $203.4 million, or $6.26 per share, compared to
$177.6 million, or $5.55 per share, for the nine months ended September
30, 2015.
Non-GAAP adjusted net loss was $36.0 million, or $1.11 per share, for
the third quarter of 2016, compared to non-GAAP adjusted net loss of
$35.5 million, or $1.10 per share, for the third quarter of 2015.
Non-GAAP adjusted net loss for the nine months ended September 30, 2016
was $115.4 million, or $3.55 per share, compared to $104.3 million, or
$3.26 per share, for the nine months ended September 30, 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.
Net cash used in operating activities for the third quarter of 2016 was
$34.9 million. Net cash used in operating activities for the nine months
ended September 30, 2016 was $100.7 million. At September 30, 2016, Puma
had cash and cash equivalents of $52.5 million and marketable securities
of $56.4 million, compared to cash and cash equivalents of $31.6 million
and marketable securities of $184.3 million at December 31, 2015. The
Company’s balance of cash, cash equivalents and marketable securities at
the end of the quarter does not include the net proceeds of
approximately $162 million received from the Company’s public offering
in October 2016.
“During the third quarter, we achieved several key milestones, including
the European Medicines Agency’s (EMA) validation of the Marketing
Authorization Application (MAA) for neratinib as an extended adjuvant
treatment of HER2-positive early stage breast cancer in Europe, and the
U.S. Food and Drug Administration’s (FDA) acceptance of the New Drug
Application (NDA) for neratinib as an extended adjuvant treatment for
patients with early stage HER2-overexpressed/amplified breast cancer who
have received prior adjuvant trastuzumab (Herceptin)-based therapy,”
said Alan H. Auerbach, Chairman, Chief Executive Officer and President
of Puma.
“We anticipate a number of additional milestones through the end of 2016
and first half of 2017,” Mr. Auerbach added. “These include: (i)
reporting additional data in the fourth quarter of 2016 from the Phase
II trial of neratinib as an extended adjuvant treatment in HER2-positive
early stage breast cancer using loperamide and budesonide prophylaxis;
(ii) reporting additional Phase II data in the fourth quarter of 2016
from the FB-7 neoadjuvant HER2-positive breast cancer trial in the
subgroup of patients who are MammaPrint High; (iii) reporting data in
the fourth quarter of 2016 from the Phase II trial of neratinib plus
fulvestrant in patients with HER2 non-amplified breast cancer that has a
HER2 mutation; (iv) reporting data in the first half of 2017 from the
Phase III trial of neratinib in third-line HER2-positive metastatic
breast cancer patients; and (v) reporting data during the first half of
2017 from the Phase II trial of neratinib in HER2-positive metastatic
breast cancer patients with brain metastases.”
Operating Expenses
Operating expenses were $66.0 million for the third quarter of 2016,
compared to $60.7 million for the third quarter of 2015. Operating
expenses for the nine months ended September 30, 2016 were $203.7
million, compared to $178.2 million for the nine months ended September
30, 2015.
General and Administrative Expenses:
General and administrative expenses were $14.0 million for the third
quarter of 2016, compared to $8.8 million for the third quarter of 2015.
General and administrative expenses for the nine months ended September
30, 2016 were $37.3 million, compared to $22.2 million for the nine
months ended September 30, 2015. The increase of approximately $15.1
million during the nine months ended September 30, 2016 compared to the
same period in 2015 resulted primarily from increases of approximately
$7.5 million in stock-based compensation, $1.9 million in payroll and
related costs, $3.7 million in professional fees and expenses, and $1.6
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 $52.0 million for the third
quarter of 2016, compared to $51.9 million for the third quarter of
2015. Research and development expenses for the nine months ended
September 30, 2016 were $166.4 million, compared to $156.0 million for
the nine months ended September 30, 2015. The increase of approximately
$10.4 million during the nine months ended September 30, 2016 compared
to the same period in 2015 resulted primarily from increases of
approximately $7.2 million in stock-based compensation, $3.7 million for
internal clinical development, regulatory affairs and quality assurance
and internal chemical manufacturing expenses, and $2.7 million in
consultants and contractors related expenses, offset by a $3.3 million
decrease in clinical trial expenses.
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. 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.
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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)
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Three Months Ended
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Nine Months Ended
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September 30,
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September 30,
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(Unaudited)
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(Unaudited)
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2016
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2015
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2016
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2015
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Operating expenses:
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General and administrative
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$
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14.0
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$
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8.8
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$
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37.3
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$
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22.2
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Research and development
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52.0
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51.9
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166.4
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156.0
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Totals
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66.0
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60.7
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203.7
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178.2
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Loss from operations
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(66.0
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(60.7
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(203.7
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(178.2
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Other income (expenses):
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Interest income
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0.2
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0.3
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0.7
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0.6
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Other income (expense)
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-
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-
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(0.4
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-
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Totals
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0.2
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0.3
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0.3
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0.6
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Net loss
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$
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(65.8
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$
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(60.4
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$
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(203.4
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$
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(177.6
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Net loss per common share—basic and diluted
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$
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(2.02
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)
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$
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(1.87
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)
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$
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(6.26
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)
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$
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(5.55
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)
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Weighted-average common shares outstanding—basic and diluted
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32,497,168
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32,303,203
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32,489,584
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32,018,869
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
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LIQUIDITY AND CAPITAL RESOURCES
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(in millions)
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September 30,
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December 31,
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2016
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2015
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Cash and cash equivalents
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$
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52.5
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$
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31.6
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Marketable securities
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56.4
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184.3
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Receivable
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1.2
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-
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Working capital
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79.8
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191.1
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Stockholders' equity
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91.1
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206.0
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Nine Months
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Nine Months
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Ended
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Ended
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September 30,
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September 30,
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2016
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2015
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Cash provided by (used in):
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Operating activities
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$
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(100.7
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$
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(121.4
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Investing activities
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121.4
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(125.5
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Financing activities
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0.3
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232.0
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Increase in cash and cash equivalents
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$
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21.0
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$
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(14.9
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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
|
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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 September 30,
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2016
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2015
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GAAP net loss
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$
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(65.8
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$
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(60.4
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Adjustments:
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Stock-based compensation -
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General and administrative
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7.7
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4.7
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(1)
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Research and development
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22.1
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20.2
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(2)
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Non-GAAP adjusted net loss
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$
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(36.0
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)
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$
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(35.5
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)
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|
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|
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GAAP net loss per share - basic and diluted
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$
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(2.02
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)
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$
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(1.87
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)
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Adjustment to net loss (as detailed above)
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0.91
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0.77
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Non-GAAP adjusted net loss per share
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$
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(1.11
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$
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(1.10
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(3)
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Nine Months Ended September 30,
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2016
|
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2015
|
|
|
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GAAP net loss
|
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|
|
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$
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(203.4
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)
|
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|
|
|
|
$
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(177.6
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)
|
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|
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Adjustments:
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|
|
|
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Stock-based compensation -
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|
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|
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General and administrative
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19.7
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|
|
|
|
|
|
12.2
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(1)
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Research and development
|
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|
|
|
|
|
68.3
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|
|
|
|
|
|
61.1
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|
(2)
|
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Non-GAAP adjusted net loss
|
|
|
|
|
|
$
|
(115.4
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)
|
|
|
|
|
|
$
|
(104.3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic and diluted
|
|
|
|
|
|
$
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(6.26
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)
|
|
|
|
|
|
$
|
(5.55
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)
|
|
|
|
Adjustment to net loss (as detailed above)
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|
|
|
|
|
2.71
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|
|
|
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|
|
2.29
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|
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Non-GAAP adjusted net loss per share
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|
|
|
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$
|
(3.55
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)
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$
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(3.26
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)
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(4)
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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
32,497,168 and 32,303,203 weighted average common shares
outstanding for the three months ended September 30, 2016 and
2015, respectively.
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(4)
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Non-GAAP adjusted net loss per share was calculated based on
32,489,584 and 32,018,869 weighted average common shares
outstanding for the nine months ended September 30, 2016 and 2015,
respectively.
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Contact: