Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical
company, announced financial results for the fourth quarter and
year ended December 31, 2019. Unless otherwise stated, all
comparisons are for the fourth quarter and full year 2019, compared
to the fourth quarter and full year 2018.
Product revenue, net consists entirely of sales revenue from
NERLYNX®, Puma’s first commercial product. Net product revenue in
the fourth quarter of 2019 was $58.7 million, compared to net
product revenue of $61.1 million in the fourth quarter of 2018. Net
product revenue for the full year 2019 was $211.6 million, compared
to net product revenue of $200.5 million for the full year
2018.
Based on accounting principles generally accepted in the United
States (GAAP), Puma reported a net loss of $11.2 million, or $0.29
per share, for the fourth quarter of 2019, compared to a net loss
of $30.7 million, or $0.80 per share, for the fourth quarter of
2018. Net loss for the full year 2019 was $75.6 million, or $1.95
per share, compared to $113.6 million, or $2.99 per share, for the
full year 2018.
Non-GAAP adjusted net income was $0.3 million, or $0.01 per
share, for the fourth quarter of 2019, compared to non-GAAP
adjusted net loss of $12.2 million, or $0.32 per share, for the
fourth quarter of 2018. Non-GAAP adjusted net loss for the full
year 2019 was $18.3 million, or $0.47 per share, compared to
non-GAAP adjusted net loss of $26.7 million, or $0.70 per share,
for the full year 2018. Non-GAAP adjusted net income (loss)
excludes stock-based compensation expense. For a reconciliation of
GAAP net loss to non-GAAP adjusted net income (loss) and GAAP net
loss per share to non-GAAP adjusted net income (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 2019 was $1.6 million, compared to net cash provided by
operating activities of $7.1 million for the fourth quarter of
2018. Net cash provided by operating activities for the full year
2019 was $22.4 million, compared to net cash used in operating
activities of $24.1 million for the full year 2018. At December 31,
2019, Puma had cash, cash equivalents and marketable securities of
$111.6 million, compared to $165.4 million at December 31,
2018.
“During 2019, Puma made broad strides to increase global
commercial access to NERLYNX by HER2-positive breast cancer
patients, as well as to expand the label and potential therapeutic
indications of NERLYNX,” said Alan H. Auerbach, Chairman, Chief
Executive Officer and President of Puma. “Our year concluded with a
label expansion to address NERLYNX side effects, registration
approval in Hong Kong and marketing approval in Singapore for
NERLYNX, an expanded license agreement with Pierre Fabre, as well
as several clinical data presentations at SABCS. We believe these
regulatory, commercial, partnering and clinical milestones position
Puma for improved results in 2020 and beyond.”
Mr. Auerbach added, “We anticipate the following key milestones
over the next 12 months: (i) modifying the SUMMIT basket trial to
expand the HER2-mutated breast cancer cohort in the first quarter
of 2020; (ii) receiving a [U.S.] regulatory decision on neratinib
in third-line HER2-positive metastatic breast cancer in the second
quarter of 2020; (iii) conducting a pre-NDA meeting with the FDA to
discuss accelerated approval of neratinib in HER2 mutated hormone
receptor positive breast cancer and HER2 mutated cervical cancer in
the fourth quarter of 2020; (iv) reporting Phase II data from the
HER-positive breast and cervical cancer cohorts from the SUMMIT
trial of neratinib in patients with HER2 mutations in the fourth
quarter of 2020; (v) reporting additional data from the Phase II
CONTROL trial in the fourth quarter of 2020; and (vi) receiving
regulatory decisions for an extended adjuvant HER2-positive early
stage breast cancer indication in additional countries.”
Revenue
Total revenue consists of product revenue, net from sales of
NERLYNX, Puma’s first commercial product, license revenue and
royalty revenue. For the fourth quarter of 2019, total revenue was
$62.9 million, of which $58.7 million was net product revenue, $4.0
million was license revenue received from Puma’s sub-licensees, and
$0.2 million was royalty revenue. This compares to total revenue of
$71.1 million in the fourth quarter of 2018, of which $61.1 million
was net product revenue and $10.0 million was license revenue
received from Puma’s sub-licensees. For the year ended December 31,
2019, total revenue was $272.3 million, of which $211.6 million was
net product revenue, $60.3 million was license revenue received
from Puma’s sub-licensees and $0.4 million was royalty revenue.
This compares to total revenue of $251.0 million for the year ended
December 31, 2018, of which $200.5 million was net product revenue
and $50.5 million was license revenue received from Puma’s
sub-licensees.
Operating Costs and Expenses
Total operating costs and expenses were $71.6 million for the
fourth quarter of 2019, compared to $89.7 million for the fourth
quarter of 2018. Total operating costs and expenses were $311.4
million for the full year 2019 compared to $345.7 million for the
full year 2018.
Cost of Sales
Cost of sales was $10.1 million for the fourth quarter of 2019
and $36.8 million for the full year 2019, compared to $10.3 million
for the fourth quarter of 2018 and $34.6 million for the full year
2018.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $31.3 million
for the fourth quarter of 2019, compared to $41.0 million for the
fourth quarter of 2018. Selling, general and administrative
expenses for the full year 2019 were $141.7 million, compared to
$146.2 million for full year 2018, a decrease of approximately $4.5
million. The decrease in SG&A expenses for the full year 2019
primarily related to decreases in stock-based compensation expense
of approximately $7.0 million, and payroll and related costs of
approximately $1.3 million. These decreases were partially offset
by an increase in professional fees and expenses of approximately
$2.7 million and an impairment loss of approximately $1.2
million.
Research and Development Expenses
Research and development expenses were $30.2 million for the
fourth quarter of 2019, compared to $38.4 million for the fourth
quarter of 2018. Research and development expenses for the full
year 2019 were $132.9 million, compared to $164.9 million for the
full year 2018. The decrease of approximately $32.0 million for the
full year 2019 resulted primarily from decreases in stock-based
compensation expense of approximately $22.6 million, internal
R&D expense of approximately $4.7 million, clinical trial
expenses of approximately $4.2 million, and consultant and
contractor costs of approximately $0.5 million.
Total Other Income (Expenses)
Total other expenses were $2.5 million for the fourth quarter of
2019, compared to $12.1 million for the fourth quarter of 2018.
Total other expenses were $36.5 million for the year ended December
31, 2019, compared to $18.9 million for the year ended December 31,
2018. The increase of $17.6 million during the full year 2019
compared to the full year 2018 primarily resulted from an increase
in debt extinguishment loss of approximately $8.1 million, an
increase in legal verdict expense of approximately $7.4 million,
and an increase in interest expense of approximately $4.0 million,
partially offset by an increase in interest and other income of
approximately $1.9 million.
Conference Call
Puma Biotechnology will host a conference call to report its
fourth quarter and full year 2019 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 20, 2020. The call may be accessed
by dialing 1-877-709-8150 (domestic) or 1-201-689-8354
(international). Please dial in at least 10 minutes in advance and
inform the operator that you would like to join 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 Puma’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 PB272 (neratinib,
oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral
was approved by the U.S. Food and Drug Administration in 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 in 2018 for the extended
adjuvant treatment of adult patients with early stage hormone
receptor-positive HER2-overexpressed/amplified breast cancer and
who are less than one year from completion of prior adjuvant
trastuzumab-based therapy. 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 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, 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. When patients require gastric acid reducing
agents, use an H2-receptor antagonist or antacid. Separate NERLYNX
by at least 3 hours with antacids. Separate NERLYNX by at least 2
hours before or 10 hours after H2-receptor antagonists.
- 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.
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.
To help ensure patients have access to NERLYNX, Puma has
implemented the Puma Patient Lynx support program to assist
patients and healthcare 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.
Forward-Looking Statements
This news release includes forward-looking statements, including
statements regarding Puma’s anticipated milestones. All
forward-looking statements involve risks and uncertainties that
could cause 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, once filed, Puma’s Annual Report on Form 10-K for the
year ended December 31, 2019. 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 SUBSIDIARIES CONSOLIDATED
STATEMENTS OF OPERATIONS (in millions except share and per
share data)
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2019
2018
2019
2018
(Unaudited)
(Unaudited)
(Unaudited)
Revenues: Product revenue, net
$
58.7
$
61.1
$
211.6
$
200.5
License revenue
4.0
10.0
60.3
50.5
Royalty revenue
0.2
—
0.4
—
Total revenue
62.9
71.1
272.3
251.0
Operating costs and expenses: Cost of sales
10.1
10.3
36.8
34.6
Selling, general and administrative
31.3
41.0
141.7
146.2
Research and development
30.2
38.4
132.9
164.9
Total operating costs and expenses
71.6
89.7
311.4
345.7
Loss from operations
(8.7
)
(18.6
)
(39.1
)
(94.7
)
Other income (expenses): Interest income
0.5
0.7
2.8
1.8
Interest expense
(3.1
)
(3.8
)
(15.0
)
(11.0
)
Legal verdict expenses
—
(9.0
)
(16.4
)
(9.0
)
Loss on debt extinguishment
—
—
(8.1
)
—
Other income (expense)
0.1
—
0.2
(0.7
)
Total other expenses
(2.5
)
(12.1
)
(36.5
)
(18.9
)
Net loss
$
(11.2
)
$
(30.7
)
$
(75.6
)
$
(113.6
)
Net loss per common share—basic and diluted
$
(0.29
)
$
(0.80
)
$
(1.95
)
$
(2.99
)
Weighted-average common shares outstanding—basic and diluted
39,043,706
38,201,056
38,768,653
37,942,411
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES
LIQUIDITY AND CAPITAL RESOURCES (in millions)
December 31,
December 31,
2019
2018
(Unaudited)
Cash and cash equivalents
$
60.0
$
108.4
Marketable securities
51.6
57.0
Working capital
66.6
135.9
Stockholders' equity
17.5
34.3
Twelve Months
Twelve Months
Ended
Ended
December 31,
December 31,
2019
2018
(Unaudited)
Cash provided by (used in): Operating activities
$
22.4
$
(24.1
)
Investing activities
5.2
(57.6
)
Financing activities
(67.1
)
108.4
Increase (decrease) in cash and cash equivalents, and
restricted cash
$
(39.5
)
$
26.7
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 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
months and twelve months ended December 31, 2019 stock-based
compensation represented approximately 18.7% and 20.9% of operating
expenses, respectively, in each case excluding cost of sales.
Puma’s management believes that these non-GAAP financial measures
are useful to enhance understanding of Puma’s financial
performance, and 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 SUBSIDIARIES Reconciliation
of GAAP Net Loss to Non-GAAP Adjusted Net Income (Loss) and
GAAP Net Loss Per Share to Non-GAAP Adjusted Net Income (Loss)
Per Share (in millions except share and per share data)
(Unaudited)
Three Months Ended December
31,
2019
2018
GAAP net loss
$
(11.2
)
$
(30.7
)
Adjustments: Stock-based compensation - Selling, general and
administrative
5.0
7.9
(1)
Research and development
6.5
10.6
(2)
Non-GAAP adjusted net income (loss)
$
0.3
$
(12.2
)
GAAP net loss per share—basic
$
(0.29
)
$
(0.80
)
Adjustment to net loss (as detailed above)
0.30
0.48
Non-GAAP adjusted basic net income (loss) per share
$
0.01
$
(0.32
)
(3)
GAAP net loss per share—diluted
$
(0.29
)
$
(0.80
)
Adjustment to net loss (as detailed above)
0.30
0.48
Non-GAAP adjusted diluted net income (loss) per share
$
0.01
(4)
$
(0.32
)
(5)
Twelve Months Ended December
31,
2019
2018
GAAP net loss
$
(75.6
)
$
(113.6
)
Adjustments: Stock-based compensation - Selling, general and
administrative
27.9
34.9
(1)
Research and development
29.4
52.0
(2)
Non-GAAP adjusted net loss
$
(18.3
)
$
(26.7
)
GAAP net loss per share—basic and diluted
$
(1.95
)
$
(2.99
)
Adjustment to net loss (as detailed above)
1.48
2.29
Non-GAAP adjusted net loss per share
$
(0.47
)
$
(0.70
)
(6)
(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 basic
net loss per share was calculated based on 39,043,706 and
38,201,056 weighted-average shares of common stock outstanding for
the three months ended December 31, 2019 and 2018, respectively.
(4) Non-GAAP adjusted diluted net income per share was calculated
based on 39,240,704 weighted-average shares of common stock
outstanding and potentially dilutive common stock equivalents
(stock options, restricted stock units, and warrants) for the three
months ended December 31, 2019. (5) Potentially dilutive common
stock equivalents (stock options, restricted stock units and
warrants) were not included in this non-GAAP adjusted diluted net
loss per share for the three months ended December 31, 2018 as
these shares would be considered anti-dilutive. (6) Non-GAAP
adjusted net loss per share was calculated based on 38,768,653 and
37,942,411 weighted-average shares of common stock outstanding for
the years ended December 31, 2019 and 2018, respectively.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200220005300/en/
Alan H. Auerbach or Mariann Ohanesian Puma Biotechnology, Inc.
+1 424 248 6500 info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull or Maggie Beller Russo Partners +1 212 845 4200
david.schull@russopartnersllc.com
maggie.beller@russopartnersllc.com
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