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.
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS (in millions except
share and per share data) Three Months Ended
Six Months Ended June 30, 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
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY LIQUIDITY
AND CAPITAL RESOURCES (in millions, unaudited)
June 30, 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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version on businesswire.com: http://www.businesswire.com/news/home/20170809006107/en/
Puma Biotechnology, Inc.Alan H. Auerbach or Mariann
Ohanesian+1-424-248-6500info@pumabiotechnology.comir@pumabiotechnology.comorRusso
PartnersDavid Schull or Amiad
Finkelthal+1-212-845-4200david.schull@russopartnersllc.comamiad.finkelthal@russopartnersllc.com
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