Results include the initial sales of NERLYNX ® in the U.S.
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company,
announced financial results for the third quarter and nine months ended
September 30, 2017. Unless otherwise stated, all comparisons are for the
third quarter and nine months of 2017 compared to the third quarter and
nine months of 2016.
On July 17, 2017, Puma Biotechnology received approval from the U.S.
Food and Drug Administration (FDA) for NERLYNX® (neratinib)
for the treatment of early stage HER2-positive breast cancer following
adjuvant trastuzumab-based therapy, and began shipments to wholesalers
at the end of July 2017. In the third quarter of 2017, the Company
reported net revenue from initial sales of NERLYNX of approximately $6.1
million.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss applicable to common stock of $77.2
million, or $2.07 per share, for the third quarter of 2017, compared to
a net loss applicable to common stock of $65.8 million, or $2.02 per
share, for the third quarter of 2016. Net loss applicable to common
stock for the first nine months of 2017 was $227.9 million, or $6.15 per
share, compared to $203.4 million, or $6.26 per share, for the first
nine months of 2016.
Non-GAAP adjusted net loss was $50.7 million, or $1.36 per share, for
the third quarter of 2017, compared to non-GAAP adjusted net loss
of $36.0 million, or $1.11 per share, for the third quarter of 2016.
Non-GAAP adjusted net loss for the nine months ended September 30, 2017
was $144.7 million, or $3.90 per share, compared to non-GAAP adjusted
net loss of $115.4 million, or $3.55 per share, for the nine months
ended September 30, 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 third quarter of 2017 was
$54.9 million. Net cash used in operating activities for the nine months
ended September 30, 2017 was $136.9 million. At September 30, 2017, Puma
had cash and cash equivalents of $79.7 million and marketable securities
of $26.6 million, compared to cash and cash equivalents of $194.5
million and marketable securities of $35.0 million at December 31, 2016.
Effective October 31, 2017, Puma entered into a credit facility with
Silicon Valley Bank and Oxford Finance for a term loan of up to $100
million, subject to funding in two tranches. The Company received gross
proceeds of $50 million from the first tranche of the credit facility
upon closing on October 31, 2017 and intends to use the funds for
general corporate purposes and to further support NERLYNX commercial
initiatives. The second tranche of $50 million may be drawn at the
Company’s option and is subject to the achievement of certain
milestones. The loan will mature on October 31, 2022.
“With the U.S. approval and launch of NERLYNX in the third quarter, we
began providing early stage HER2-positive breast cancer patients with an
additional option to reduce their risk of disease recurrence,” said Puma
Chief Executive Officer and President Alan H. Auerbach. “We are pleased
with the feedback that we have received from patients, prescribers and
payors during the initial launch and we look forward to continuing to
execute our commercial activities throughout 2017 and beyond.
“Looking forward, we anticipate the following milestones: (i) reporting
additional data from the Phase II CONTROL trial in the fourth quarter of
2017; (ii) receiving a regulatory opinion from the Committee for
Medicinal Products for Human Use (CHMP) for neratinib in extended
adjuvant HER2-positive early stage breast cancer in the first quarter of
2018; and (iii) reporting Phase III trial results in third-line HER2-
positive metastatic breast cancer patients in the first half of 2018.”
Product Revenue
Net revenue consists of sales of NERLYNX, Puma’s first and only
commercial product to date. The FDA approved NERLYNX in July 2017 and
the Company commenced shipment to wholesalers in late July. For the
three and nine months ended September 30, 2017, net revenue was
approximately $6.1 million.
Operating Expenses
Operating expenses were $83.5 million for the third quarter of 2017,
compared to $66.0 million for the third quarter of 2016. Operating
expenses for the nine months ended September 30, 2017 were $234.9
million, compared to $203.7 million for the nine months ended September
30, 2016.
Cost of Sales:
Cost of sales was $1.5 million for the third quarter and nine months
ended September 30, 2017. The Company had no product sales prior to the
third quarter of 2017.
Selling, General and Administrative Expenses:
Selling, general and administrative (SG&A) expenses were $32.5 million
for the third quarter of 2017, compared to $14.0 million for the third
quarter of 2016. SG&A expenses for the nine months ended September 30,
2017 were $75.8 million, compared to $37.3 million for the nine months
ended September 30, 2016. The $38.5 million increase during the first
nine months of 2017, compared to the first nine months of 2016, resulted
primarily from increases of approximately $24.2 million for professional
fees and expenses, $8.2 million in payroll and related costs, $3.2
million for stock-based compensation, $2.4 million for other expenses
such as travel and related costs to support the commercial launch of
NERLYNX, and $0.4 million for facility and equipment costs. These
increases reflect overall corporate growth.
Research and Development Expenses:
Research and development (R&D) expenses were $49.5 million for the third
quarter of 2017, compared to $52.0 million for the third quarter of
2016. R&D expenses for the nine months ended September 30, 2017 were
$157.6 million, compared to $166.4 million for the nine months ended
September 30, 2016. The approximately $8.8 million decrease during the
first nine months of 2017, compared to the first nine months of 2016,
resulted primarily from decreases of approximately $5.0 million due to a
decrease in regulatory submission activity, decreased preclinical study
activities and decreased drug supply manufacturing logistics, and $8.0
million for stock-based compensation, partially offset by increases
during the first nine months of 2017, compared to the first nine months
of 2016, of approximately $2.2 million for internal clinical
development, internal regulatory affairs and quality assurance and
internal chemical manufacturing, and $2.0 million for consultants and
contractors.
Conference Call
Puma Biotechnology will host a conference call to report its third
quarter financial results and provide an update on the company's
business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday,
November 9, 2017. The call may be accessed by dialing 1-877-709-8150
(domestic) or 1-201-689-8354 (international) at least 10 minutes prior
to the start of the call and referencing the “Puma Biotechnology
Conference Call.” A live webcast of the conference call and presentation
slides may be accessed on the Investors section of the Puma
Biotechnology website at http://www.pumabiotechnology.com/.
A replay of the call will be available approximately one hour after
completion of the call and will be archived on the company's website for
90 days.
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, oral) 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. 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 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 potential treatment of several
other cancers that over-express or have a mutation in HER2.
Further information about Puma Biotechnology may 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 and the webcast of the presentation contain
forward-looking statements, including statements regarding the benefits
of NERLYNX and neratinib, the Company’s clinical trials and the
announcement of data relative to those trials. All forward-looking
statements 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 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 September 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.
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
|
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in millions except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
|
(Unaudited)
|
|
(Unaudited)
|
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue, net
|
|
|
|
$
|
6.1
|
|
|
$
|
-
|
|
|
$
|
6.1
|
|
|
$
|
-
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
|
1.5
|
|
|
|
-
|
|
|
|
1.5
|
|
|
|
-
|
|
Selling, general and administrative
|
|
|
32.5
|
|
|
|
14.0
|
|
|
|
75.8
|
|
|
|
37.3
|
|
Research and development
|
|
|
|
|
49.5
|
|
|
|
52.0
|
|
|
|
157.6
|
|
|
|
166.4
|
|
Totals
|
|
|
|
|
83.5
|
|
|
|
66.0
|
|
|
|
234.9
|
|
|
|
203.7
|
|
Loss from operations
|
|
|
|
|
(77.4
|
)
|
|
|
(66.0
|
)
|
|
|
(228.8
|
)
|
|
|
(203.7
|
)
|
Other income (expenses):
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
0.3
|
|
|
|
0.2
|
|
|
|
1.0
|
|
|
|
0.7
|
|
Other income (expense)
|
|
|
|
|
(0.1
|
)
|
|
|
-
|
|
|
|
(0.1
|
)
|
|
|
(0.4
|
)
|
Totals
|
|
|
|
|
0.2
|
|
|
|
0.2
|
|
|
|
0.9
|
|
|
|
0.3
|
|
Net loss
|
|
|
|
$
|
(77.2
|
)
|
|
$
|
(65.8
|
)
|
|
$
|
(227.9
|
)
|
|
$
|
(203.4
|
)
|
Net loss per common share—basic and diluted
|
|
$
|
(2.07
|
)
|
|
$
|
(2.02
|
)
|
|
$
|
(6.15
|
)
|
|
$
|
(6.26
|
)
|
Weighted-average common shares outstanding—basic and diluted
|
|
|
37,214,002
|
|
|
|
32,497,168
|
|
|
|
37,046,765
|
|
|
|
32,489,584
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
|
LIQUIDITY AND CAPITAL RESOURCES
|
(in millions, unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
79.7
|
|
|
$
|
194.5
|
|
|
|
|
|
Marketable securities
|
|
|
|
|
26.6
|
|
|
|
35.0
|
|
|
|
|
|
Working capital
|
|
|
|
|
22.3
|
|
|
|
199.0
|
|
|
|
|
|
Stockholders' equity
|
|
|
|
|
79.2
|
|
|
|
209.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
|
|
Nine Months
|
|
|
|
|
|
|
|
|
Ended
|
|
Ended
|
|
|
|
|
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
|
|
Cash provided by (used in):
|
|
|
|
|
|
|
|
|
|
|
Operating activities
|
|
|
|
$
|
(136.9
|
)
|
|
$
|
(100.7
|
)
|
|
|
|
|
Investing activities
|
|
|
|
|
8.1
|
|
|
|
121.4
|
|
|
|
|
|
Financing activities
|
|
|
|
|
14.0
|
|
|
|
0.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
|
|
$
|
(114.8
|
)
|
|
$
|
21.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 nine months ended September 30, 2017,
stock-based compensation represented approximately 34.3% and 36.5% 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 September 30,
|
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
GAAP net loss
|
|
$
|
(77.2
|
)
|
|
$
|
(65.8
|
)
|
|
|
Adjustments:
|
|
|
|
|
|
|
Stock-based compensation -
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
8.3
|
|
|
|
7.7
|
|
|
(1)
|
Research and development
|
|
|
18.2
|
|
|
|
22.1
|
|
|
(2)
|
Non-GAAP adjusted net loss
|
|
$
|
(50.7
|
)
|
|
$
|
(36.0
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic and diluted
|
|
$
|
(2.07
|
)
|
|
$
|
(2.02
|
)
|
|
|
Adjustment to net loss (as detailed above)
|
|
|
0.71
|
|
|
|
0.91
|
|
|
|
Non-GAAP adjusted net loss per share
|
|
$
|
(1.36
|
)
|
|
$
|
(1.11
|
)
|
|
(3)
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
GAAP net loss
|
|
$
|
(227.9
|
)
|
|
$
|
(203.4
|
)
|
|
|
Adjustments:
|
|
|
|
|
|
|
Stock-based compensation -
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
23.0
|
|
|
|
19.7
|
|
|
(1)
|
Research and development
|
|
|
60.2
|
|
|
|
68.3
|
|
|
(2)
|
Non-GAAP adjusted net loss
|
|
$
|
(144.7
|
)
|
|
$
|
(115.4
|
)
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic and diluted
|
|
$
|
(6.15
|
)
|
|
$
|
(6.26
|
)
|
|
|
Adjustment to net loss (as detailed above)
|
|
|
2.25
|
|
|
|
2.71
|
|
|
|
Non-GAAP adjusted net loss per share
|
|
$
|
(3.90
|
)
|
|
$
|
(3.55
|
)
|
|
(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
37,214,002 and 32,497,168 weighted average common
|
shares outstanding for the three months ended September 30, 2017 and
2016, respectively.
|
(4) Non-GAAP adjusted net loss per share was calculated based on
37,046,765 and 32,489,584 weighted average common
|
shares outstanding for the nine months ended September 30, 2017 and
2016, respectively.
|
Contact: