LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company,
announced financial results for the second quarter ended June 30, 2017.
Unless otherwise stated, all comparisons are for the second quarter and
six months ended June 30, 2017, compared to the second quarter and six
months ended June 30, 2016.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss applicable to common stock of $77.8
million, or $2.10 per share, for the second quarter of 2017, compared to
a net loss applicable to common stock of $66.6 million, or $2.05 per
share, for the second quarter of 2016. Net loss applicable to common
stock for the first six months of 2017 was $150.7 million, or $4.08 per
share, compared to $137.6 million, or $4.23 per share, for the first six
months of 2016.
Non-GAAP adjusted net loss was $50.9 million, or $1.38 per share, for
the second quarter of 2017, compared to non-GAAP adjusted net loss of
$37.9 million, or $1.17 per share, for the second quarter of 2016.
Non-GAAP adjusted net loss for the first six months of 2017 was $94.0
million, or $2.54 per share, compared to non-GAAP adjusted net loss of
$79.3 million, or $2.44 per share, for the first six months 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 second quarter of 2017 was
$45.9 million. Net cash used in operating activities for the first six
months of 2017 was $82.0 million. At June 30, 2017, Puma had cash and
cash equivalents of $80.8 million and marketable securities of $70.8
million, compared to cash and cash equivalents of $194.5 million and
marketable securities of $35.0 million at December 31, 2016.
“During the second quarter of 2017, we achieved a significant milestone
for Puma with the U.S. Food and Drug Administration’s (FDA) Oncologic
Drugs Advisory Committee meeting, which led to last month’s FDA approval
of NERLYNX™ (neratinib) for the extended adjuvant treatment of
HER2-positive early stage breast cancer. This marked a major milestone
for breast cancer patients and for Puma,” said Alan H. Auerbach,
Chairman, Chief Executive Officer and President of Puma. “Despite
advances in early stage HER2-positive breast cancer treatment, there
continues to be a need to reduce the risk of disease recurrence. NERLYNX
has been demonstrated to significantly reduce that risk and offers
physicians and their patients another treatment option. NERLYNX is now
commercially available by prescription in the United States. We are also
working with the European Medicines Agency (EMA) on their review of our
marketing authorization application (MAA) for this indication and we
expect the Committee for Medicinal Products for Human Use (CHMP), the
scientific committee of the EMA, to issue an opinion regarding the MAA
for neratinib in the first quarter of 2018.”
Mr. Auerbach added, “Also, during the second quarter, we presented data
at the 2017 American Society of Clinical Oncology Annual Meeting from a
Phase II trial of neratinib, which highlighted positive results from the
TBCRC 022 trial in patients with HER2-positive metastatic breast cancer
with brain metastases. In addition, during the quarter, we also achieved
the targeted patient enrollment in our Phase III NALA trial of neratinib
in patients with HER2-positive metastatic breast cancer who have failed
two or more prior lines of HER2-directed treatments (third-line disease)
in the setting of metastatic disease. We anticipate that primary
analysis of data related to the NALA trial will be available during the
first half of 2018.
“In the second half of this year, we anticipate the following clinical
milestones: (i) presentation of the 5-year disease free survival (DFS)
data from the ExteNET Phase III trial of NERLYNX as an extended adjuvant
treatment in HER2-positive early stage breast cancer in the third
quarter of 2017 and (ii) reporting additional data in the fourth quarter
of 2017 from the Phase II trial of neratinib as an extended adjuvant
treatment in HER2-positive early stage breast cancer using loperamide,
budesonide and colestipol antidiarrheal prophylaxis.”
Operating Expenses
Operating expenses were $78.2 million for the second quarter of 2017,
compared to $66.5 million for the second quarter of 2016. Operating
expenses for the first six months of 2017 were $151.4 million, compared
to $137.7 million for the first six months of 2016.
Selling, General and Administrative Expenses:
Selling, general and administrative (SG&A) expenses were $24.9 million
for the second quarter of 2017, compared to $12.3 million for the second
quarter of 2016. SG&A expenses for the first six months of 2017 were
$43.3 million, compared to $23.3 million for the first six months of
2016. The approximately $20.0 million increase during the first six
months of 2017 compared to the first six months of 2016 resulted
primarily from increases of approximately $2.6 million for stock-based
compensation, $13.7 million for professional fees and expenses, and $2.1
million for payroll and related costs. These increases reflect overall
corporate growth.
Research and Development Expenses:
Research and development (R&D) expenses were $53.3 million for the
second quarter of 2017, compared to $54.2 million for the second quarter
of 2016. R&D expenses for the first six months of 2017 were $108.1
million, compared to $114.4 million for the first six months of 2016.
The approximately $6.3 million decrease during the first six months of
2017, compared to the first six months of 2016, resulted primarily from
decreases of approximately $4.1 million for stock-based compensation and
$3.6 million for clinical trial expenses, offset by increases of $0.9
million for internal clinical development and $0.7 million for
consultants and contractors related 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. NERLYNX™ (neratinib)
is approved for commercial use by prescription in the United States as
extended adjuvant therapy for early stage HER2-positive breast cancer
following adjuvant trastuzumab-based therapy and is marketed as NERLYNX.
Nertatinib 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 commercialization of NERLYNX and the continued
development of its other advanced drug candidates directed at the
treatment of HER2-positive breast cancer. The Company believes that
NERLYNX 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.
IMPORTANT SAFETY INFORMATION
NERLYNX™ (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated
for the extended adjuvant treatment of adult patients with early-stage
HER2 overexpressed/amplified breast cancer, to follow adjuvant
trastuzumab-based therapy.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
• Diarrhea: Aggressively manage diarrhea occurring despite
recommended prophylaxis with additional antidiarrheals, fluids, and
electrolytes as clinically indicated. Withhold NERLYNX in patients
experiencing severe and/or persistent diarrhea. Permanently discontinue
NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea
that occurs after maximal dose reduction.
• Hepatotoxicity: Monitor liver function tests monthly for the
first 3 months of treatment, then every 3 months while on treatment and
as clinically indicated. Withhold NERLYNX in patients experiencing Grade
3 liver abnormalities and permanently discontinue NERLYNX in patients
experiencing Grade 4 liver abnormalities.
• Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise
patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were
diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis,
decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail
disorder, dry skin, abdominal distention, epistaxis, weight decreased
and urinary tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology,
Inc. at 1-844-NERLYNX (1-844-637-5969) and
www.NERLYNX.com
or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
.
DRUG INTERACTIONS:
-
Gastric acid reducing agents: Avoid concomitant use with proton pump
inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3
hours after antacid dosing.
-
Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
-
Strong or moderate CYP3A4 inducers: Avoid concomitant use.
-
P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of
narrow therapeutic agents that are P-gp substrates when used
concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:
• Lactation: Advise women not to breastfeed.
Please see Full
Prescribing Information for additional safety information.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding the benefits of NERLYNX, the CHMP’s opinion
regarding the MAA for neratinib, 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 only recently commenced commercialization and shipment of
its only FDA approved product; the Company’s dependence upon the
commercial success of NERLYNX™ (neratinib); the Company’s history of
operating losses and its expectation that it will continue to incur
losses for the foreseeable future; risks and uncertainties related to
the Company’s ability to achieve or sustain profitability; the Company’s
ability to predict its future prospects and forecast its financial
performance and growth; failure to obtain sufficient capital to fund the
Company’s operations; the effectiveness of sales and marketing efforts;
the Company’s ability to obtain FDA approval or other regulatory
approvals in the United States or elsewhere for other indications for
neratinib or other product candidates; 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; risks pertaining to securities class action, derivative and
defamation lawsuits; 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 Quarterly Report
on Form 10-Q for the quarter ended June 30, 2017. 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)
|
|
|
|
|
|
Three Months Ended
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|
Six Months Ended
|
|
|
|
June 30,
|
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June 30,
|
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
$
|
24.9
|
|
|
$
|
12.3
|
|
|
$
|
43.3
|
|
|
$
|
23.3
|
|
|
Research and development
|
|
|
53.3
|
|
|
|
54.2
|
|
|
|
108.1
|
|
|
|
114.4
|
|
|
Totals
|
|
|
78.2
|
|
|
|
66.5
|
|
|
|
151.4
|
|
|
|
137.7
|
|
|
Loss from operations
|
|
|
(78.2
|
)
|
|
|
(66.5
|
)
|
|
|
(151.4
|
)
|
|
|
(137.7
|
)
|
|
Other income (expenses):
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
0.4
|
|
|
|
0.3
|
|
|
|
0.7
|
|
|
|
0.5
|
|
|
Other income (expense)
|
|
|
-
|
|
|
|
(0.4
|
)
|
|
|
-
|
|
|
|
(0.4
|
)
|
|
Totals
|
|
|
0.4
|
|
|
|
(0.1
|
)
|
|
|
0.7
|
|
|
|
0.1
|
|
|
Net loss
|
|
$
|
(77.8
|
)
|
|
$
|
(66.6
|
)
|
|
$
|
(150.7
|
)
|
|
$
|
(137.6
|
)
|
|
Net loss per common share—basic and diluted
|
|
$
|
(2.10
|
)
|
|
$
|
(2.05
|
)
|
|
$
|
(4.08
|
)
|
|
$
|
(4.23
|
)
|
|
Weighted-average common shares outstanding—basic and diluted
|
|
|
36,992,017
|
|
|
|
32,493,092
|
|
|
|
36,961,760
|
|
|
|
32,485,750
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
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LIQUIDITY AND CAPITAL RESOURCES
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(in millions, unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
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December 31,
|
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
80.8
|
|
|
$
|
194.5
|
|
|
Marketable securities
|
|
|
70.8
|
|
|
|
35.0
|
|
|
Working capital
|
|
|
113.6
|
|
|
|
199.0
|
|
|
Stockholders' equity
|
|
|
120.1
|
|
|
|
209.8
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
Six Months
|
|
|
|
Ended
|
|
Ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
2017
|
|
2016
|
|
Cash provided by (used in):
|
|
|
|
|
|
Operating activities
|
|
$
|
(82.0
|
)
|
|
$
|
(65.8
|
)
|
|
Investing activities
|
|
|
(36.0
|
)
|
|
|
91.9
|
|
|
Financing activities
|
|
|
4.3
|
|
|
|
0.2
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
|
|
$
|
(113.7
|
)
|
|
$
|
26.3
|
|
|
|
|
|
|
|
|
|
|
|
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 and six months ended June 30, 2017,
stock-based compensation represented approximately 34.6% and 43.1% of
net loss, respectively. 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.
|
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
|
|
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 June 30,
|
|
|
|
|
|
2017
|
|
2016
|
|
|
|
GAAP net loss
|
|
$
|
(77.8
|
)
|
|
$
|
(66.6
|
)
|
|
|
|
Adjustments:
|
|
|
|
|
|
|
|
Stock-based compensation -
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
7.3
|
|
|
|
6.1
|
|
|
(1)
|
|
Research and development
|
|
|
19.6
|
|
|
|
22.6
|
|
|
(2)
|
|
Non-GAAP adjusted net loss
|
|
$
|
(50.9
|
)
|
|
$
|
(37.9
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic and diluted
|
|
$
|
(2.10
|
)
|
|
$
|
(2.05
|
)
|
|
|
|
Adjustment to net loss (as detailed above)
|
|
|
0.72
|
|
|
|
0.88
|
|
|
|
|
Non-GAAP adjusted net loss per share
|
|
$
|
(1.38
|
)
|
|
$
|
(1.17
|
)
|
|
(3)
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
|
|
2017
|
|
2016
|
|
|
|
GAAP net loss
|
|
$
|
(150.7
|
)
|
|
$
|
(137.6
|
)
|
|
|
|
Adjustments:
|
|
|
|
|
|
|
|
Stock-based compensation -
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
14.6
|
|
|
|
12.1
|
|
|
(1)
|
|
Research and development
|
|
|
42.1
|
|
|
|
46.2
|
|
|
(2)
|
|
Non-GAAP adjusted net loss
|
|
$
|
(94.0
|
)
|
|
$
|
(79.3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic and diluted
|
|
$
|
(4.08
|
)
|
|
$
|
(4.23
|
)
|
|
|
|
Adjustment to net loss (as detailed above)
|
|
|
1.54
|
|
|
|
1.79
|
|
|
|
|
Non-GAAP adjusted net loss per share
|
|
$
|
(2.54
|
)
|
|
$
|
(2.44
|
)
|
|
(4)
|
|
|
|
|
|
|
|
|
|
(1)
|
|
To reflect a non-cash charge to operating expense for Selling,
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
36,992,017 and 32,493,092 weighted average common shares
outstanding for the three months ended June 30, 2017 and 2016,
respectively.
|
|
(4)
|
|
Non-GAAP adjusted net loss per share was calculated based on
36,961,760 and 32,485,750 weighted average common shares
outstanding for the six months ended June 30, 2017 and 2016,
respectively.
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|
|
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|
Contact: