Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced financial results for the fourth quarter and
year ended December 31, 2020. Unless otherwise stated, all
comparisons are for the fourth quarter and full year 2020, compared
to the fourth quarter and full year 2019.
Product revenue, net consists entirely of sales revenue from
NERLYNX®, Puma’s first commercial product. Net NERLYNX revenue in
the fourth quarter of 2020 was $50.0 million, compared to $58.7
million in the fourth quarter of 2019. Net NERLYNX revenue for the
full year 2020 was $196.7 million, compared to $211.6 million for
the full year 2019.
Based on accounting principles generally accepted in the United
States (GAAP), Puma reported a net loss of $15.0 million, or $0.38
per share, for the fourth quarter of 2020, compared to a net loss
of $11.2 million, or $0.29 per share, for the fourth quarter of
2019. Net loss for the full year 2020 was $60.0 million, or $1.52
per share, compared to $75.6 million, or $1.95 per share, for the
full year 2019.
Non-GAAP adjusted net loss was $5.5 million, or $0.14 per basic
and diluted share, for the fourth quarter of 2020, compared to
non-GAAP adjusted net income of $0.3 million, or $0.01 per basic
and diluted share, for the fourth quarter of 2019. Non-GAAP
adjusted net loss for the full year 2020 was $23.4 million, or
$0.59 per share, compared to non-GAAP adjusted net loss of $18.3
million, or $0.47 per share, for the full year 2019. Non-GAAP
adjusted net (loss) income excludes stock-based compensation
expense. For a reconciliation of GAAP net loss to non-GAAP adjusted
net (loss) income and GAAP net loss per share to non-GAAP adjusted
net (loss) income per share, please see the financial tables at the
end of this news release.
Net cash used in operating activities for the fourth quarter of
2020 was $5.6 million, compared to net cash provided by operating
activities of $1.6 million for the fourth quarter of 2019. Net cash
provided by operating activities for the full year 2020 was $0.8
million, compared to net cash provided by operating activities of
$22.4 million for the full year 2019. At December 31, 2020, Puma
had cash, cash equivalents, and marketable securities of $93.4
million, compared to $111.6 million at December 31, 2019.
“During the fourth quarter of 2020 Puma continued to be
negatively impacted by the challenges of COVID-19; however, we were
pleased to be able to achieve NERLYNX revenues that were within the
previously stated guidance,” said Alan H. Auerbach, Chairman, Chief
Executive Officer and President of Puma. “Our year concluded with a
number of positive clinical milestones for the Company, including
the publication of ExteNET data in Clinical Breast Cancer, a
research collaboration with NCCN Oncology, the announcement of
interim SUMMIT data in exon 18 mutated non-small cell lung cancer,
and the presentation of neratinib data at the San Antonio Breast
Cancer Symposium across multiple spotlight and traditional poster
presentations. Although we anticipate that COVID-19 may continue to
impact our operations in 2021, we remain focused on and committed
to providing support to patients battling breast cancer.”
Mr. Auerbach added, “We anticipate the following key milestones
over the next 12 months: (i) completing enrollment in the
randomized cohort in the Phase II SUMMIT trial of neratinib in
hormone receptor positive breast cancer that has a HER2 mutation in
the second quarter of 2021; (ii) reporting top line data from the
randomized cohort in the Phase II SUMMIT trial of neratinib in
hormone receptor positive breast cancer that has a HER2 mutation in
2021; (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 2021;
(iv) reporting Phase II data from the SUMMIT trial of neratinib in
non-small cell lung cancer patients with EGFR exon 18 mutations in
the second half of 2021; (v) reporting data from the Phase II
TBCRC-022 trial of the combination of Kadcyla plus neratinib in
patients with HER2-positive breast cancer with brain metastases who
have previously been treated with Kadcyla in the second half of
2021; (vi) conducting a meeting with the FDA to discuss the
potential for an accelerated approval pathway for neratinib in
non-small cell lung cancer patients with EGFR exon 18 mutations who
have been previously treated with an EGFR tyrosine kinase inhibitor
in 2021; and (vii) receiving regulatory decisions for the extended
adjuvant HER2-positive early stage breast cancer indication in
additional countries in 2021.”
Revenue
Total revenue consists of product revenue, net from sales of
NERLYNX, license revenue and royalty revenue. For the fourth
quarter of 2020, total revenue was $52.6 million, of which $50.0
million was net product revenue and $2.6 million was royalty
revenue from Puma’s sub-licensees. This compares to total revenue
of $62.9 million for the fourth quarter of 2019, of which $58.7
million was net product revenue, $4.0 million was license revenue,
and $0.2 million was royalty revenue from Puma’s sub-licensees. For
the year ended December 31, 2020, total revenue was $225.1 million,
of which $196.7 million was net product revenue, $22.7 million was
license revenue, and $5.7 million was royalty revenue from Puma’s
sub-licensees. This compares to total revenue of $272.3 million for
the year ended December 31, 2019, of which $211.6 million was net
product revenue, $60.3 million was license revenue, and $0.4
million was royalty revenue from Puma’s sub-licensees.
Operating Costs and Expenses
Total operating costs and expenses were $63.9 million for the
fourth quarter of 2020, compared to $71.5 million for the fourth
quarter of 2019. Total operating costs and expenses were $255.5
million for the full year 2020, compared to $311.3 million for the
full year 2019.
Cost of Sales
Cost of sales was $10.9 million for the fourth quarter of 2020
and $39.4 million for the full year 2020, compared to $10.1 million
for the fourth quarter of 2019 and $36.8 million for the full year
2019. The increase in cost of sales was primarily attributable to
increased royalty expense due to the increase in royalty revenue
and an increase in the amortization of the intangible asset related
to the milestone payments made to Pfizer.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $28.8 million
for the fourth quarter of 2020, compared to $31.2 million for the
fourth quarter of 2019. Selling, general and administrative
expenses for the full year 2020 were $118.4 million, compared to
$141.6 million for the full year 2019. The $23.2 million
year-over-year decrease resulted primarily from decreases in
stock-based compensation expense of approximately $10.1 million,
professional fees of approximately $6.1 million, travel and meeting
costs of approximately $6.3 million, and impairment loss of
approximately $1.2 million, offset by an increase in credit loss
expense of $1.0 million.
Research and Development Expenses
Research and development expenses were $24.2 million for the
fourth quarter of 2020, compared to $30.2 million for the fourth
quarter of 2019. Research and development expenses for the full
year 2020 were $97.7 million, compared to $132.9 million for the
full year 2019. The $35.2 million year-over-year decrease resulted
primarily from decreases in stock-based compensation expense of
approximately $10.6 million, internal R&D expenses of
approximately $0.9 million, clinical trial expenses of
approximately $20.1 million, and consultant and contractor expenses
of approximately $3.6 million.
Total Other Income (Expenses)
Total other expenses were $3.7 million for the fourth quarter of
2020, compared to total other expenses of $2.5 million for the
fourth quarter of 2019. Total other expenses were $29.4 million for
the full year 2020, compared to total other expenses of $36.5
million for the full year 2019. The $7.1 million year-over-year
decrease resulted primarily from decreases in interest expense of
approximately $0.9 million and debt extinguishment loss of
approximately $8.1 million, offset by a decrease in interest income
of approximately $2.3 million.
Conference Call
Puma Biotechnology will host a conference call to report its
fourth quarter and full year 2020 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 25, 2021. 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. In February 2020, NERLYNX was also
approved by the FDA in combination with capecitabine for the
treatment of adult patients with advanced or metastatic
HER2-positive breast cancer who have received two or more prior
anti-HER2-based regimens in the metastatic setting. 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
NERLYNX® (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor
indicated:
- As a single agent, for the extended adjuvant treatment of adult
patients with early-stage HER2-positive breast cancer, to follow
adjuvant trastuzumab-based therapy.
- In combination with capecitabine, for the treatment of adult
patients with advanced or metastatic HER2-positive breast cancer,
who have received two or more prior anti-HER2 based regimens in the
metastatic setting.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Diarrhea: Aggressively manage diarrhea. If diarrhea
occurs despite recommended prophylaxis, treat 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 (reported in ≥ 5% of patients)
were as follows:
- NERLYNX as a single agent: Diarrhea, nausea, abdominal pain,
fatigue, vomiting, rash, stomatitis, decreased appetite, muscle
spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin,
abdominal distention, epistaxis, weight decreased, and urinary
tract infection.
- NERLYNX in combination with capecitabine: Diarrhea, nausea,
vomiting, decreased appetite, constipation, fatigue/asthenia,
weight decreased, dizziness, back pain, arthralgia, urinary tract
infection, upper respiratory tract infection, abdominal distention,
renal impairment, and muscle spasms.
To report SUSPECTED ADVERSE REACTIONS, contact Puma
Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) 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 CYP3A4 inhibitors: Avoid concomitant use.
- Moderate CYP3A4 and P-glycoprotein (P-gp) dual 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 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 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, any
adverse impact on Puma’s business or the global economy and
financial markets, generally, from the global COVID-19 pandemic,
and the other 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, 2020. 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.
(Financial Tables Follow)
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,
2020
2019
2020
2019
(Unaudited)
(Unaudited)
(Unaudited)
Revenues: Product revenue, net
$
50.0
$
58.7
$
196.7
$
211.6
License revenue
—
4.0
22.7
60.3
Royalty revenue
2.6
0.2
5.7
0.4
Total revenue
52.6
62.9
225.1
272.3
Operating costs and expenses: Cost of sales
10.9
10.1
39.4
36.8
Selling, general and administrative
28.8
31.2
118.4
141.6
Research and development
24.2
30.2
97.7
132.9
Total operating costs and expenses
63.9
71.5
255.5
311.3
Loss from operations
(11.3
)
(8.6
)
(30.4
)
(39.0
)
Other income (expenses): Interest income
—
0.5
0.5
2.8
Interest expense
(3.6
)
(3.1
)
(14.1
)
(15.0
)
Legal verdict expense
(0.2
)
—
(16.2
)
(16.4
)
Loss on debt extinguishment
—
—
—
(8.1
)
Other income
0.1
0.1
0.4
0.2
Total other expenses
(3.7
)
(2.5
)
(29.4
)
(36.5
)
Loss before income taxes
(15.0
)
(11.1
)
(59.8
)
(75.5
)
Income tax expense
-
(0.1
)
(0.2
)
(0.1
)
Net loss
$
(15.0
)
$
(11.2
)
$
(60.0
)
$
(75.6
)
Net loss per share of common stock—basic and diluted
$
(0.38
)
$
(0.29
)
$
(1.52
)
$
(1.95
)
Weighted-average shares of common stock outstanding—basic and
diluted
39,881,131
39,043,706
39,576,107
38,768,653
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES LIQUIDITY AND
CAPITAL RESOURCES (in millions)
December 31,
December 31,
2020
2019
(Unaudited)
Cash and cash equivalents
$
85.3
$
60.0
Marketable securities
8.1
51.6
Working capital
31.9
75.5
Stockholders' (deficit) equity
(6.0
)
17.5
Twelve Months
Twelve Months
Ended
Ended
December 31,
December 31,
2020
2019
(Unaudited)
Cash provided by (used in): Operating activities
$
0.8
$
22.4
Investing activities
23.3
5.2
Financing activities
0.1
(67.1
)
Increase (decrease) in cash and cash equivalents, and
restricted cash
$
24.2
$
(39.5
)
Use of Non-GAAP 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 stock-based compensation. For the three months and
full year ended December 31, 2020, stock-based compensation
represented approximately 17.9% and 16.9% of operating expenses,
respectively, and 18.8% and 20.9%, respectively, for the same
periods in 2019, 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,
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 (Loss) Income and
GAAP Net Loss Per Share to Non-GAAP Adjusted Net (Loss) Income
Per Share (in millions except share and per share data)
(Unaudited)
Three Months Ended December
31,
2020
2019
GAAP net loss
$
(15.0
)
$
(11.2
)
Adjustments: Stock-based compensation - Selling, general and
administrative
4.3
5.0
(1)
Research and development
5.2
6.5
(2)
Non-GAAP adjusted net (loss) income
$
(5.5
)
$
0.3
GAAP net loss per share—basic
$
(0.38
)
$
(0.29
)
Adjustment to net loss (as detailed above)
0.24
0.30
Non-GAAP adjusted basic net (loss) income per share
$
(0.14
)
$
0.01
(3)
GAAP net loss per share—diluted
$
(0.38
)
$
(0.29
)
Adjustment to net loss (as detailed above)
0.24
0.30
Non-GAAP adjusted diluted net (loss) income per share
$
(0.14
)
(4)
$
0.01
(5)
Twelve Months Ended December
31,
2020
2019
GAAP net loss
$
(60.0
)
$
(75.6
)
Adjustments: Stock-based compensation - Selling, general and
administrative
17.8
27.9
(1)
Research and development
18.8
29.4
(2)
Non-GAAP adjusted net loss
$
(23.4
)
$
(18.3
)
GAAP net loss per share—basic and diluted
$
(1.52
)
$
(1.95
)
Adjustment to net loss (as detailed above)
0.93
1.48
Non-GAAP adjusted net loss per share
$
(0.59
)
$
(0.47
)
(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) income per share was calculated based on 39,881,131 and
39,043,706 weighted-average shares of common stock outstanding for
the three months ended December 31, 2020 and 2019, respectively.
(4) Potentially dilutive common stock equivalents (stock options,
restricted stock units and warrants) were not included in the
non-GAAP adjusted diluted net loss per share for the three months
ended December 31, 2020 as these shares would be considered
anti-dilutive. (5) Non-GAAP adjusted diluted net income per share
was calculated based on 39,240,704 weighted average common shares
outstanding and potentially dilutive common stock equivalents
(stock options, restricted stock units and warrants) for the three
months ended December 31, 2019. (6) Non-GAAP adjusted net loss per
share was calculated based on 39,576,107 and 38,768,653
weighted-average shares of common stock outstanding for the years
ended December 31, 2020 and 2019, respectively.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210225005291/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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