LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company,
announced financial results for the fourth quarter and year ended
December 31, 2018. Unless otherwise stated, all comparisons are for the
fourth quarter and full year 2018, compared to the fourth quarter and
full year 2017.
Product revenue, net consists entirely of sales revenue from NERLYNX,
Puma’s first commercial product. Net NERLYNX revenue in the fourth
quarter of 2018 was $61.1 million, compared to net NERLYNX revenue of
$20.1 million in the fourth quarter of 2017. Net NERLYNX revenue for the
full year 2018 was $200.5 million, compared to net NERLYNX revenue of
$26.2 million in 2017. Puma 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 on July 17, 2017, and the Company began
shipment to wholesalers at the end of July 2017.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss of $30.7 million, or $0.80 per share,
for the fourth quarter of 2018, compared to a net loss of $64.1 million,
or $1.71 per share, for the fourth quarter of 2017. Net loss for the
full year 2018 was $113.6 million, or $2.99 per share, compared to
$292.0 million, or $7.85 per share, for the full year 2017.
Non-GAAP adjusted net loss was $12.2 million, or $0.32 per share, for
the fourth quarter of 2018, compared to non-GAAP adjusted net loss of
$38.6 million, or $1.03 per share, for the fourth quarter of 2017.
Non-GAAP adjusted net loss for the full year 2018 was $26.7 million, or
$0.70 per share, compared to non-GAAP adjusted net loss of $183.3
million, or $4.93 per share, for the full year 2017. Non-GAAP adjusted
net loss excludes stock-based compensation expense. 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 provided by operating activities for the fourth quarter of 2018
was $7.1 million, compared to net cash used in operating activities of
$35.6 million for the fourth quarter of 2017. Net cash used in operating
activities for the full year 2018 was $24.1 million, compared to $172.5
million for the full year 2017. At December 31, 2018, Puma had cash and
cash equivalents of $108.4 million and marketable securities of $57.0
million, compared to cash and cash equivalents of $81.7 million at
December 31, 2017.
“2018 was a strong year for Puma as we continued to grow NERLYNX sales,
expanded our global presence and made progress in expanding the
potential indications for the drug,” said Alan H. Auerbach, Chairman,
Chief Executive Officer and President of Puma. “This was highlighted by
the European Commission granting marketing authorization in Europe,
additional licensing agreements designed to provide access to NERLYNX in
China, Latin America, Israel and Canada, and announcing data from the
Phase III NALA trial, Phase II CONTROL trial, and Phase II SUMMIT
trials.”
Mr. Auerbach added, “During 2019, we anticipate the following key
milestones for Puma: (i) meeting with the FDA and the European Medicines
Agency to discuss data from the Phase III trial in third-line metastatic
breast cancer patients in the first half of 2019; (ii) meeting with the
FDA to discuss the clinical development and regulatory strategy for the
SUMMIT trial in the first half of 2019; (iii) announcing regulatory
decisions on neratinib for the extended adjuvant HER2-positive early
stage breast cancer indication in countries outside of the United States
and Europe in the first half of 2019; (iv) presenting data from the
Phase III trial in third-line HER2-positive metastatic breast cancer
treatment (NALA) in the first half of 2019; (v) reporting additional
data from the Phase II CONTROL trial in the first half of 2019; and (vi)
reporting Phase II data from the SUMMIT basket trial of neratinib in
patients with HER2 mutations in the first half of 2019.”
Revenue
Total revenue consists of product revenue, net from sales of NERLYNX,
Puma’s first commercial product, and license revenue. For the fourth
quarter ended December 31, 2018, total revenue was $71.1 million, of
which $61.1 million was net NERLYNX revenue and $10.0 million was
license revenue. For the year ended December 31, 2018, total revenue was
$251.0 million, of which $200.5 million was net NERLYNX revenue and
$50.5 million was license revenue received from Puma’s sub-licensees.
This compares to total revenue of $27.7 million in 2017, of which $26.2
million was net NERLYNX revenue and $1.5 million was license revenue.
Operating Costs and Expenses
Total operating costs and expenses were $89.7 million for the fourth
quarter of 2018, compared to $85.2 million for the fourth quarter of
2017. Total operating costs and expenses were $345.7 million for the
full year 2018 compared to $320.1 million for the full year 2017.
Cost of Sales:
Cost of sales was $10.3 million for the fourth quarter and $34.6 million
for the full year 2018, compared to $4.1 million for the fourth quarter
and $5.6 million for the full year 2017.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $41.0 million for the
fourth quarter of 2018, compared to selling, general and administrative
expenses of $30.9 million for the fourth quarter of 2017. Selling,
general and administrative expenses for full year 2018 were $146.2
million, compared to $106.7 million for full year 2017, an increase of
approximately $39.5 million. Increases in SG&A expenses for the full
year 2018 primarily related to the hiring of a sales force and the
commercial launch of NERLYNX, including approximately $18.9 million in
payroll and related expenses, $8.2 million in travel and meetings, $6.0
million in professional fees, such as marketing, market access and
analytics, $3.7 million in stock-based compensation and $2.6 million in
other expenses, such as software and facilities, to support overall
corporate growth.
Research and Development Expenses:
Research and development expenses were $38.4 million for the fourth
quarter of 2018, compared to $50.2 million for the fourth quarter of
2017. Research and development expenses for the full year 2018 were
$164.9 million, compared to $207.8 million for the full year 2017. The
decrease of $42.9 million during the full year 2018 compared to the full
year 2017 resulted primarily from decreases of approximately $25.5
million in stock-based compensation, $16.8 million in clinical trial
expense, $2.6 million in consultant and contractor expense, partially
offset by increases of approximately $2.0 million in R&D expenses
primarily related to headcount additions in the medical affairs, quality
assurance, regulatory affairs and pharmacovigilance.
Total Other Income (Expenses)
Total other expenses were $12.1 million for the fourth quarter of 2018,
compared to total other expenses of $0.5 million for the fourth quarter
of 2017. Total other expenses were $18.9 million for the year ended
December 31, 2018, compared to total other income of $0.4 million for
the year ended December 31, 2017. Other expense recorded in the fourth
quarter of 2018 includes $9.0 million that represents an initial
estimate of potential amounts that may be owed to class action
participants as a result of the February 2019 jury verdict in a class
action lawsuit, Hsu vs. Puma Biotechnology, Inc., et al.. The
total amount of aggregate class-wide damages is uncertain and will be
ascertained only after an extensive claims process and the exhaustion of
any appeals. It is possible that the total damages will be higher than
this estimate.
Conference Call
Puma will host a conference call to report its fourth quarter and full
year 2018 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,
February 28, 2019. 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. Puma in-licenses the global development and
commercialization rights to three drug candidates — PB272 (neratinib,
oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was
approved by the FDA in July 2017 for the extended adjuvant treatment of
adult patients with early stage HER2-overexpressed/amplified breast
cancer, following adjuvant trastuzumab-based therapy, and is marketed in
the United States as NERLYNX® (neratinib) tablets. NERLYNX
was granted marketing authorization by the European Commission for the
extended adjuvant treatment of hormone receptor-positive HER2-positive
early stage breast cancer in September 2018. NERLYNX is a registered
trademark of Puma Biotechnology, Inc.
Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.
Important Safety Information Regarding NERLYNX
®
(neratinib)
U.S. Indication
NERLYNX® (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated
for the extended adjuvant treatment of adult patients with 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 inpatients
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.
To help ensure patients have access to NERLYNX, Puma has implemented the
Puma Patient Lynx support program to assist patients and health care
providers with reimbursement support and referrals to resources that can
help with financial assistance. More information on the Puma Patient
Lynx program can be found at www.NERLYNX.com
or 1-855-816-5421.
The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given
orally once daily with food, continuously for one year. Antidiarrheal
prophylaxis should be initiated with the first dose of NERLYNX and
continued during the first 2 months (56 days) of treatment and as needed
thereafter.
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 Puma’s anticipated milestones for 2019 and initial
estimate of damages to be paid to participants in a class-action lawsuit
against Puma. All forward-looking statements involve risks and
uncertainties that could cause Puma’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 Puma with the
Securities and Exchange Commission from time to time, including Puma’s
Annual Report on Form 10-K for the year ended December 31, 2018. Readers
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Puma 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
|
|
Twelve Months Ended
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Product revenue, net
|
|
|
$
|
61.1
|
|
|
$
|
20.1
|
|
|
$
|
200.5
|
|
|
$
|
26.2
|
|
License revenue
|
|
|
|
10.0
|
|
|
|
1.5
|
|
|
|
50.5
|
|
|
|
1.5
|
|
Total revenue
|
|
|
|
71.1
|
|
|
|
21.6
|
|
|
|
251.0
|
|
|
|
27.7
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
10.3
|
|
|
|
4.1
|
|
|
|
34.6
|
|
|
|
5.6
|
|
Selling, general and administrative
|
|
|
|
41.0
|
|
|
|
30.9
|
|
|
|
146.2
|
|
|
|
106.7
|
|
Research and development
|
|
|
|
38.4
|
|
|
|
50.2
|
|
|
|
164.9
|
|
|
|
207.8
|
|
Total operating costs and expenses
|
|
|
|
89.7
|
|
|
|
85.2
|
|
|
|
345.7
|
|
|
|
320.1
|
|
Loss from operations
|
|
|
|
(18.6
|
)
|
|
|
(63.6
|
)
|
|
|
(94.7
|
)
|
|
|
(292.4
|
)
|
Other income (expenses):
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
0.7
|
|
|
|
0.2
|
|
|
|
1.8
|
|
|
|
1.2
|
|
Interest expense
|
|
|
|
(3.8
|
)
|
|
|
(0.7
|
)
|
|
|
(11.0
|
)
|
|
|
(0.7
|
)
|
Other expense
|
|
|
|
(9.0
|
)
|
|
|
-
|
|
|
|
(9.7
|
)
|
|
|
(0.1
|
)
|
Total other income (expenses)
|
|
|
|
(12.1
|
)
|
|
|
(0.5
|
)
|
|
|
(18.9
|
)
|
|
|
0.4
|
|
Net loss
|
|
|
$
|
(30.7
|
)
|
|
$
|
(64.1
|
)
|
|
$
|
(113.6
|
)
|
|
$
|
(292.0
|
)
|
Net loss per common share—basic and diluted
|
|
|
$
|
(0.80
|
)
|
|
$
|
(1.71
|
)
|
|
$
|
(2.99
|
)
|
|
$
|
(7.85
|
)
|
Weighted-average common shares outstanding—basic and diluted
|
|
|
|
38,201,056
|
|
|
|
37,534,410
|
|
|
|
37,942,411
|
|
|
|
37,169,678
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
|
LIQUIDITY AND CAPITAL RESOURCES
|
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
$
|
108.4
|
|
|
$
|
81.7
|
|
|
|
|
|
Marketable securities
|
|
|
|
57.0
|
|
|
|
—
|
|
|
|
|
|
Working capital
|
|
|
|
135.9
|
|
|
|
48.1
|
|
|
|
|
|
Stockholders' equity
|
|
|
|
34.3
|
|
|
|
53.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve Months
|
|
Twelve Months
|
|
|
|
|
|
|
|
Ended
|
|
Ended
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
|
|
|
Cash provided by (used in):
|
|
|
|
|
|
|
|
|
|
Operating activities
|
|
|
$
|
(24.1
|
)
|
|
$
|
(172.5
|
)
|
|
|
|
|
Investing activities
|
|
|
|
(57.6
|
)
|
|
|
(15.4
|
)
|
|
|
|
|
Financing activities
|
|
|
|
108.4
|
|
|
|
75.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents, and restricted
cash
|
|
|
$
|
26.7
|
|
|
$
|
(112.8
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Financial Measures
In addition to operating results as calculated in accordance with GAAP,
Puma uses certain non-GAAP financial measures when planning, monitoring,
and evaluating operational performance. The following table presents
Puma’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 twelve months ended December 31, 2018,
stock-based compensation represented approximately 60.3% and 76.5% of
net loss, respectively. Puma’s management believes that these non-GAAP
financial measures are useful to enhance understanding of Puma’s
financial performance, are more indicative of its 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 Loss Per Share
|
(in millions except share and per share data)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31,
|
|
|
|
|
2018
|
|
2017
|
|
|
GAAP net loss
|
|
$
|
(30.7
|
)
|
|
$
|
(64.1
|
)
|
|
|
Adjustments:
|
|
|
|
|
|
|
Stock-based compensation -
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
7.9
|
|
|
|
8.2
|
|
|
(1)
|
Research and development
|
|
|
10.6
|
|
|
|
17.3
|
|
|
(2)
|
Non-GAAP adjusted net loss
|
|
$
|
(12.2
|
)
|
|
$
|
(38.6
|
)
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic
|
|
$
|
(0.80
|
)
|
|
$
|
(1.71
|
)
|
|
|
Adjustment to net loss (as detailed above)
|
|
|
0.48
|
|
|
|
0.68
|
|
|
|
Non-GAAP adjusted net loss per share
|
|
$
|
(0.32
|
)
|
|
$
|
(1.03
|
)
|
|
(3)
|
|
|
|
|
|
|
|
|
|
Twelve Months Ended December 31,
|
|
|
|
|
2018
|
|
2017
|
|
|
GAAP net loss
|
|
$
|
(113.6
|
)
|
|
$
|
(292.0
|
)
|
|
|
Adjustments:
|
|
|
|
|
|
|
Stock-based compensation -
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
34.9
|
|
|
|
31.2
|
|
|
(1)
|
Research and development
|
|
|
52.0
|
|
|
|
77.5
|
|
|
(2)
|
Non-GAAP adjusted net loss
|
|
$
|
(26.7
|
)
|
|
$
|
(183.3
|
)
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share - basic and diluted
|
|
$
|
(2.99
|
)
|
|
$
|
(7.85
|
)
|
|
|
Adjustment to net loss (as detailed above)
|
|
|
2.29
|
|
|
|
2.92
|
|
|
|
Non-GAAP adjusted net loss per share
|
|
$
|
(0.70
|
)
|
|
$
|
(4.93
|
)
|
|
(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
38,201,056 and 37,534,410 weighted average shares of common stock
outstanding for the three months ended December 31, 2018 and 2017,
respectively.
|
(4) Non-GAAP adjusted net loss per share was calculated based on
37,942,411 and 37,169,678 weighted average shares of common stock
outstanding for the twelve months ended December 31, 2018 and 2017,
respectively.
|
Contact: