LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage
biopharmaceutical company, announced financial results for the first
quarter ended March 31, 2015.
Unless otherwise stated, all comparisons are for the first quarter 2015
compared to the first quarter 2014.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss applicable to common stock of $52.5
million, or $1.66 per share, for the first quarter of 2015, compared to
a net loss of $19.8 million, or $0.67 per share, for the first quarter
of 2014.
Adjusted net loss applicable to common stock was $32.4 million, or $1.02
per share, for the first quarter of 2015, compared to adjusted net loss
applicable to common stock of $14.7 million, or $0.50 per share, for the
first quarter of 2014. Adjusted net loss applicable to common stock
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 adjusted net loss
applicable to common stock to reported net loss applicable to common
stock, please see the financial tables at the end of this news release.
Net cash used in operating activities for the first quarter of 2015 was
$50.0 million. At March 31, 2015, Puma had cash and cash equivalents of
$155.5 million and marketable securities of $154.9 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 $205.0 million from a public offering of the Company's
common stock, which was completed in January 2015.
“We have continued to make significant progress with the neratinib
clinical program thus far in 2015,” said Alan H. Auerbach, Chairman,
Chief Executive Officer and President of Puma. “In addition to
continuing all of our ongoing neratinib clinical trials, we also
initiated a new Phase II trial of PB272 in early-stage HER2-positive
breast cancer patients who have received adjuvant treatment with
trastuzumab (a population similar to the Phase III ExteNET trial), where
patients will receive primary prophylaxis with high dose loperamide in
order to attempt to reduce the neratinib-related diarrhea. We anticipate
having initial results from this trial in late 2015, which will allow us
to include this data in our NDA filing for neratinib in the extended
adjuvant setting that is currently anticipated for the first quarter of
2016. In April 2015, we also expanded the second cohort from our Phase
II clinical trial of PB272 in patients with solid tumors who have an
activating HER2 mutation (basket trial), where the expanded cohort will
include patients with HER2 mutated metastatic non-small cell lung cancer.
“We expect the pace to continue through 2015 and beyond. In 2015, we
expect to (i) present and publish Phase III ExteNET trial results in the
extended adjuvant treatment of early stage HER2-positive breast cancer
(anticipated mid 2015); (ii) present and publish Phase II results from
our NEfERTT trial of PB272 as a first-line treatment for HER2-positive
metastatic breast cancer (anticipated in mid-2015); (iii) complete our
ongoing Phase II FB-7 trial of PB272 as a neoadjuvant treatment for
patients with HER2-positive breast cancer (anticipated in the first half
of 2015); (iv) report data from our Phase II trial of PB272 in HER2
non-amplified breast cancer that has a HER2 mutation (anticipated in the
second half of 2015); (v) initiate a Phase III trial of the combination
of PB272 plus temsirolimus in fourth-line HER2-positive metastatic
breast cancer (anticipated in the second half of 2015); (vi) complete
the ongoing Phase II trial of PB272 in patients with HER2-positive
metastatic breast cancer that has metastasized to the brain (anticipated
in the second half of 2015); and (vii) expand additional cohorts in our
Phase II basket trial of PB272 in patients with solid tumors with
activating HER2 mutations (anticipated in the second half of 2015).
Operating Expenses
Based on GAAP, operating expenses were $52.6 million for the first
quarter of 2015, compared to $19.8 million for the first quarter of 2014.
General and Administrative Expenses:
Based on GAAP, general and administrative expenses were $7.9 million for
the first quarter of 2015, compared to $3.5 million for the first
quarter of 2014.
Research and Development Expenses:
Based on GAAP, research and development expenses were $44.7 million for
the first quarter of 2015, compared to $16.3 million for the first
quarter of 2014.
About Puma Biotechnology
Puma Biotechnology, Inc. is a development stage biopharmaceutical
company that acquires and develops innovative products for the treatment
of various forms of cancer. The Company focuses on in-licensing drug
candidates that are undergoing or have already completed initial
clinical testing for the treatment of cancer and then seeks to further
develop those drug candidates for commercial use. 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. 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.
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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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March 31,
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(Unaudited)
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2015
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2014
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Operating expenses:
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General and administrative
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$
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7.9
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$
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3.5
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Research and development
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44.7
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16.3
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Totals
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52.6
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19.8
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Loss from operations
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(52.6
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(19.8
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Other income (expenses):
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Interest income
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0.1
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0.0
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Other income (expense)
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0.0
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(0.0
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Totals
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0.1
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0.0
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Net loss
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$
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(52.5
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$
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(19.8
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Net loss per common share—basic and diluted
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$
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(1.66
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$
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(0.67
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Weighted-average common shares outstanding—basic and diluted
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31,588,315
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29,567,071
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PUMA BIOTECHNOLOGY, INC.
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LIQUIDITY AND CAPITAL RESOURCES
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(in millions)
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March 31,
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December 31,
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2015
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2014
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Cash and cash equivalents
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$
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155.5
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$
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38.5
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Marketable securities
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154.9
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102.8
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Licensor receivable
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1.8
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1.8
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Working capital
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290.6
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104.9
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Stockholders' equity
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304.3
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117.0
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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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2015
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2014
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Cash provided by (used in):
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Operating activities
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$
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(50.0
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$
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(17.0
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Investing activities
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(52.7
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7.9
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Financing activities
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219.6
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129.4
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Increase (decrease) in cash
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$
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116.9
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$
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120.3
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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.
PUMA BIOTECHNOLOGY, INC.
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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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2015
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2014
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GAAP net loss
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$
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(52.5
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$
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(19.8
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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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4.7
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1.3
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(1
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Research and development
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15.4
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3.8
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(2
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Non-GAAP adjusted net loss
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$
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(32.4
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$
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(14.7
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GAAP net loss per share - basic and diluted
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$
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(1.66
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$
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(0.67
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Adjustment to net loss (as detailed above)
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0.64
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0.17
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Non-GAAP adjusted net loss per share
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$
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(1.02
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$
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(0.50
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(3
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(1) To reflect a non-cash charge to operating expense for General
and Administrative stock-based compensation.
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(2) To reflect a non-cash charge to operating expense for Research
and Development stock-based compensation.
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(3) Non-GAAP adjusted net loss per share was calculated based on
31,588,315 and 29,567,071 weighted average common shares
outstanding for the three months ended March 31, 2015 and 2014,
respectively.
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