LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage
biopharmaceutical company (“Puma” or the “Company”), today announced
financial results for the fourth quarter and year ended December 31,
2012.
Unless otherwise stated, all comparisons are for the fourth quarter and
full year 2012, compared to the fourth quarter and full year 2011,
respectively. The adjusted net loss applicable to common stock and
adjusted operating expenses discussed below exclude stock-based
compensation expense and costs associated with ongoing clinical trials
that we assumed from the licensor and which we refer to as licensor
legacy clinical trials.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss applicable to common stock of $21.9
million, or $0.83 per share, for the quarter ended December 31, 2012.
Net loss applicable to common stock for the full year was $74.3 million,
or $3.42 per share.
The Company reported adjusted net loss applicable to common stock of
$6.6 million, or $0.25 per share, for the quarter ended December 31,
2012. Adjusted net loss applicable to common stock for the full year was
$16.8 million, or $0.77 per share.
Net cash used in operating activities for the quarter ended December 31,
2012, was $24.8 million. Net cash used in operating activities for the
full year was $44.0 million.
As of December 31, 2012, Puma had cash and cash equivalents of $137.4
million, compared to $53.4 million at December 31, 2011. On October 24,
2012, the Company announced the closing of an underwritten public
offering from which it received net proceeds of approximately $129.2
million, after deducting the underwriting discount and offering expenses
payable by the Company.
Based on GAAP, operating expenses for the quarter ended December 31,
2012, were $22.0 million. Operating expenses for the full year were
$74.4 million. Operating expenses in the quarter and for the full year
were primarily driven by clinical development expenses associated with
the licensor legacy clinical trials and stock- based compensation.
Total adjusted operating expenses for the quarter ended December 31,
2012, were $6.7 million. Total adjusted operating expenses for the full
year, were $16.9 million. Operating expenses in the quarter were
primarily driven by clinical development expenses for the Company’s lead
product candidate, PB272 (neratinib), transition of the PB272 clinical
trial program to Puma from the drug’s licensor, hiring of staff and
building of the Company’s corporate infrastructure.
“During 2012, Puma made significant progress with the clinical
development of our drug candidate PB272 in HER2-positive metastatic
breast cancer, HER2-positive neoadjuvant breast cancer, HER2-mutated
non-small cell lung cancer, and in HER2-negative breast cancer that has
a HER2 mutation,” said Alan H. Auerbach, Chief Executive Officer and
President. “We plan to continue to move forward aggressively with the
clinical development of PB272 during 2013. Our clinical development plan
includes (i) initiating our Phase III clinical trial of PB272 in
combination with chemotherapy in HER2-positive metastatic breast cancer
patients who have failed previous HER2 directed therapy (third-line
disease), which we anticipate will occur in the second quarter; (ii)
completing the on-going Phase II trial of neratinib in combination with
temsirolimus in fourth line HER2-positive metastatic breast cancer,
which we anticipate reporting additional data from later this year, and
subsequently initiating the Phase III trial of the combination of
neratinib plus temsirolimus, which we anticipate will begin later in
2013; (iii) completing the on-going Phase II trial of PB272 in patients
with HER2-positive metastatic breast cancer that has metastasized to the
brain, which we also anticipate reporting data from later in 2013; (iv)
completing our two ongoing Phase II trials of PB272 as a neoadjuvant
treatment for patients with HER2-positive breast cancer, which we expect
to report data from in mid-2013 and late 2013, respectively; (v)
continuing our Phase II trial of PB272 in patients with HER2 mutated
non-small cell lung cancer, which we have the potential to report
initial data from later this year; and (vi) continuing our Phase II
trial of PB272 in HER2-negative breast cancer patients who have a HER2
mutation, which we also have the potential to report initial data from
later this year.”
Fourth Quarter and Full Year 2012 Financial
Highlights
General and Administrative (G&A) Expenses:
On a GAAP basis, G&A expenses for the fourth quarter of 2012 were $13.8
million, compared to $9.0 million for the fourth quarter of 2011. The
increase was largely due to a $4.6 million increase in stock-based
compensation expense, which was primarily attributable to the
recognition of additional expense associated with the anti-dilutive
warrant previously issued to the Company’s CEO. In connection with the
consummation of the Company’s public offering in October 2012, the final
fair value of the anti-dilutive warrant was determined and an additional
charge of $12.0 million associated with the warrant was recognized in
the fourth quarter. The Company will not recognize additional
stock-based compensation expense associated with this warrant going
forward.
Adjusted G&A expenses exclude the impact of stock-based compensation
expense and were $1.6 million for the fourth quarter of 2012, compared
to $1.4 million for the fourth quarter of 2011. The increase was
primarily due to charges associated with Puma only occupying its current
office suites for one month during the fourth quarter of 2011, compared
to the full three months in the fourth quarter of 2012, and payment of
business taxes.
On a GAAP basis, G&A expenses for the full year 2012 were $24.8 million,
compared to $9.3 million for the full year 2011. The primarily driver of
the increase was additional stock-based compensation of $18.2 million,
which was primarily attributable to the recognition of additional
expense associated with the anti-dilutive warrant previously issued to
the Company’s CEO and described above. The remaining increase was
primarily due to the Company being operational for a full 12 months in
2012, compared to three months in 2011.
For the full year 2012, adjusted G&A expenses were $6.1 million,
compared to $1.7 million for the full year 2011. The increase was
primarily due to the Company being operational for a full 12 months in
2012, compared to only three months in 2011.
Research and Development (R&D) Expenses:
On a GAAP basis, R&D expenses for the fourth quarter of 2012 were $8.2
million, compared to $0.8 million for the fourth quarter of 2011. The
increase was primarily due to being fully staffed for the fourth quarter
of 2012 and assuming operational control of the various clinical trials
that were ongoing at the time that Puma licensed PB272 from the
licensor. The increase also included $2.7 million in costs associated
with the licensor legacy clinical trials.
Adjusted R&D expenses, which exclude the impact of stock-based
compensation expense and costs associated with the licensor legacy
clinical trials, were $5.1 million for the fourth quarter ended December
31, 2012, compared to $0.8 million for the fourth quarter of 2011. The
quarter to quarter increase represents a full three months of operations
for the fourth quarter of 2012, compared to only two months during the
fourth quarter of 2011. The fourth quarter also reflects the hiring of
staff, primarily in the early part of 2012, along with preliminary work
on the Company’s initiated Phase III and Phase II clinical trials.
On a GAAP basis, R&D expenses for the full year 2012 were $49.6 million,
compared to $0.8 million for full year 2011. The increase was primarily
attributable to a $41.0 million increase in outside CRO/licensor
services and outside other clinical development costs, which primarily
resulted from costs associated with certain licensor legacy clinical
trials. Puma’s license agreement for PB272 established a limit on the
Company’s expenses related to the licensor legacy clinical trials. The
Company reached this limit during the fourth quarter of 2012; therefore,
the licensor will be responsible for the future expenses related to
these trials until such trials are completed. Excluding the impact of
the costs associated with the licensor legacy clinical trials, the
primary factors contributing to the remaining increase were staff
additions and being fully functional for 12 months in 2012.
Adjusted R&D expenses for the full year 2012 were $10.8 million,
compared to $0.8 million for the full year 2011. The increase resulted
from the R&D operation being fully staffed and functional for 12 months
in 2012, compared to staff additions during the two months of operations
in 2011.
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 metastatic breast cancer and non-small cell lung
cancer.
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 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.
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.
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(A DEVELOPMENT STAGE COMPANY)
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CONDENSED STATEMENTS OF OPERATIONS
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(Unaudited)
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(in millions except per share data)
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Period from
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September 15,
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Three Months Ended
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Twelve Months Ended
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2010 (date
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December 31,
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December 31,
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of inception) to
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2012
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2011
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2012
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2011
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December 31, 2012
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Operating expenses:
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General and administrative
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$
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13.8
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$
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9.0
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$
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24.8
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$
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9.3
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$
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34.1
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Research and development
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8.2
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0.8
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49.6
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0.8
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50.5
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Totals
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22.0
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9.8
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74.4
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10.1
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84.6
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Loss from operations
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(22.0
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)
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(9.8
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)
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(74.4
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)
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(10.1
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)
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(84.6
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)
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Other income (expenses):
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Interest income
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0.1
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-
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0.1
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-
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0.1
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Other income (expense)
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-
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(0.1
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)
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-
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(0.1
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)
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(0.1
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)
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Totals
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0.1
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(0.1
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)
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0.1
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(0.1
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)
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0.0
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Net loss
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$
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(21.9
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)
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$
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(9.9
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)
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$
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(74.3
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)
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$
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(10.2
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)
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$
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(84.6
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)
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Net loss per common share—basic and diluted
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$
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(0.83
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)
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$
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(0.52
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)
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$
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(3.42
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)
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$
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(1.32
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)
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Weighted-average common shares outstanding—basic and diluted
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26,511,141
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18,863,945
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21,725,986
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7,746,529
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PUMA BIOTECHNOLOGY, INC.
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(A DEVELOPMENT STAGE COMPANY)
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LIQUIDITY AND CAPITAL RESOURCES
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(in millions except per share data)
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December 31,
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December 31,
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2012
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2011
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Cash and cash equivalents
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$
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137.4
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$
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53.4
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Working capital
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127.3
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53.1
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Stockholders' equity
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128.9
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54.4
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The Year
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September 15,
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Ended
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2010 (date of
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December 31,
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inception) to
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2012
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December 31, 2012
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Cash provided by (used in):
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Operating activities
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$
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(44.0
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)
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$
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(45.8
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)
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Investing activities
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(1.2
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)
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(3.0
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)
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Financing activities
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129.3
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186.2
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Increase (decrease) in cash
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$
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84.1
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$
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137.4
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Reconciliation of GAAP and Non-GAAP
Financial Information
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(in millions except share and per share
data)
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GAAP
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Non-GAAP
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Measure
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Measure
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(Reported)
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Expense adjustments
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(Adjusted)
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Year Ended
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Stock-based
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Licensor legacy
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Year Ended
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December 31, 2012
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|
compensation
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clinical trials
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December 31, 2012
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2012 Operating expense:
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General and administrative
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$
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24.8
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$
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(18.7
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)
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$
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-
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$
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6.1
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Research and development
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49.6
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(0.9
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)
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|
|
(37.9
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)
|
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10.8
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|
Loss from operations
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|
|
(74.4
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)
|
|
|
19.6
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|
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37.9
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(16.9
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)
|
Other income (expense):
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|
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|
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|
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Interest income
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|
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|
0.1
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|
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-
|
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|
|
-
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|
|
|
|
0.1
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Other expense
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-
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|
-
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-
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|
-
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Totals
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|
|
0.1
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|
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-
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-
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|
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0.1
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Net loss
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|
|
|
$
|
(74.3
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)
|
|
$
|
19.6
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|
|
$
|
37.9
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|
|
$
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(16.8
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)
|
Net loss applicable to common stock
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|
|
|
$
|
(74.3
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)
|
|
$
|
19.6
|
|
|
$
|
37.9
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|
|
|
$
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(16.8
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)
|
Net loss per common share - basic and diluted
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|
|
|
$
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(3.42
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)
|
|
$
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0.90
|
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$
|
1.74
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$
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(0.77
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)
|
Weighted-average common shares outstanding - basic and diluted
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|
|
|
|
21,725,986
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|
|
21,725,986
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|
21,725,986
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21,725,986
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|
|
|
|
|
|
|
|
|
|
|
|
|
4th Quarter 2012 Operating expense:
|
|
|
|
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|
|
|
|
|
|
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General and administrative
|
|
|
|
$
|
13.8
|
|
|
$
|
(12.2
|
)
|
|
$
|
-
|
|
|
|
$
|
1.6
|
|
Research and development
|
|
|
|
|
8.2
|
|
|
|
(0.4
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)
|
|
|
(2.7
|
)
|
|
|
|
5.1
|
|
Loss from operations
|
|
|
|
|
(22.0
|
)
|
|
|
12.6
|
|
|
|
2.7
|
|
|
|
|
(6.7
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
0.1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
0.1
|
|
Other expense
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
-
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Totals
|
|
|
|
|
0.1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
0.1
|
|
Net loss
|
|
|
|
$
|
(21.9
|
)
|
|
$
|
12.6
|
|
|
$
|
2.7
|
|
|
|
$
|
(6.6
|
)
|
Net loss applicable to common stock
|
|
|
|
$
|
(21.9
|
)
|
|
$
|
12.6
|
|
|
$
|
2.7
|
|
|
|
$
|
(6.6
|
)
|
Net loss per common share - basic and diluted
|
|
|
|
$
|
(0.83
|
)
|
|
$
|
0.48
|
|
|
$
|
0.10
|
|
|
|
$
|
(0.25
|
)
|
Weighted-average common shares outstanding - basic and diluted
|
|
|
|
|
26,511,141
|
|
|
|
26,511,141
|
|
|
|
26,511,141
|
|
|
|
|
26,511,141
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 Operating expense:
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
|
$
|
9.3
|
|
|
$
|
(7.6
|
)
|
|
$
|
-
|
|
|
|
$
|
1.7
|
|
Research and development
|
|
|
|
|
0.8
|
|
|
|
(0.1
|
)
|
|
|
-
|
|
|
|
|
0.7
|
|
Loss from operations
|
|
|
|
|
(10.1
|
)
|
|
|
7.7
|
|
|
|
-
|
|
|
|
|
(2.4
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
-
|
|
Other expense
|
|
|
|
|
(0.1
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
(0.1
|
)
|
Totals
|
|
|
|
|
(0.1
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
(0.1
|
)
|
Net loss
|
|
|
|
$
|
(10.2
|
)
|
|
$
|
7.7
|
|
|
$
|
-
|
|
|
|
$
|
(2.5
|
)
|
Net loss applicable to common stock
|
|
|
|
$
|
(10.2
|
)
|
|
$
|
7.7
|
|
|
$
|
-
|
|
|
|
$
|
(2.5
|
)
|
Net loss per common share - basic and diluted
|
|
|
|
$
|
(1.32
|
)
|
|
$
|
0.99
|
|
|
$
|
-
|
|
|
|
$
|
(0.33
|
)
|
Weighted-average common shares outstanding - basic and diluted
|
|
|
|
|
7,746,259
|
|
|
|
7,746,259
|
|
|
|
7,746,259
|
|
|
|
|
7,746,259
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|

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