Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced financial results for the first quarter ended
March 31, 2020. Unless otherwise stated, all comparisons are for
the first quarter of 2020 compared to the first quarter of
2019.
Product revenue, net consists entirely of sales revenue from
NERLYNX®, Puma’s first commercial product. Net product revenue in
the first quarter of 2020 was $48.6 million, compared to net
product revenue of $45.6 million in the first quarter of 2019.
Based on accounting principles generally accepted in the United
States (GAAP), Puma reported a net loss of $16.9 million, or $0.43
per share, for the first quarter of 2020, compared to a net loss of
$10.1 million, or $0.26 per share, for the first quarter of
2019.
Non-GAAP adjusted net loss was $8.0 million, or $0.20 per share,
for the first quarter of 2020, compared to non-GAAP adjusted net
income of $8.1 million, or $0.21 per basic share and $0.20 per
diluted share, for the first quarter of 2019. 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 used in operating activities for the first quarter of
2020 was $11.5 million, compared to $16.1 million used in the first
quarter of 2019. At March 31, 2020, Puma had cash, cash equivalents
and marketable securities of $100.6 million, compared to cash, cash
equivalents and marketable securities of $111.6 million at December
31, 2019.
“We remain focused on providing a significant impact to cancer
patients in need. The earlier-than-expected approval of the sNDA of
NERLYNX in combination with capecitabine to treat adult patients
with HER2-positive metastatic breast cancer who have received two
or more prior anti HER2-based regimens in the metastatic setting is
an important step toward this goal,” said Alan H. Auerbach,
Chairman, Chief Executive Officer and President of Puma. “Our
global partners also are working hard to bring the drug to market
in their respective territories, thereby increasing global access
to NERLYNX. Earlier today, we announced that our licensing partner
CANbridge Pharmaceuticals received marketing approval of NERLYNX in
mainland China. In addition, we are closely monitoring the changing
COVID-19 situation. We are pleased to announce that we maintain a
significant stock of NERLYNX and do not anticipate any disruption
of supply to existing or new patients.”
Mr. Auerbach added, “We anticipate the following key milestones
over the next 12 months: (i) 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 first quarter of 2021; (ii) reporting Phase II data
from the HER-positive breast and cervical cancer cohort from the
SUMMIT trial of neratinib in patients with HER2 mutations in the
fourth quarter of 2020; (iii) reporting additional data from the
Phase II CONTROL trial in the fourth quarter of 2020; and (iv)
receiving regulatory decisions for an extended adjuvant
HER2-positive early stage breast cancer indication in additional
countries.”
Revenue
Total revenue consists of net product revenue from sales of
NERLYNX, Puma’s first commercial product, license revenue and
royalty revenue. For the first quarter of 2020, total revenue was
$51.2 million, of which $48.6 million was net product revenue, $2.0
million was license revenue from a Puma sub-licensee and $0.6
million was royalty revenue. This compares to total revenue of
$99.1 million in the first quarter of 2019, of which $45.6 million
was net product revenue and $53.5 million was license revenue from
Puma’s sub-licensees.
Operating Costs and Expenses
Total operating costs and expenses were $65.5 million for the
first quarter of 2020, compared to $89.2 million for the first
quarter of 2019.
Cost of Sales
Cost of sales was $9.1 million for the first quarter of 2020,
compared to $8.0 million for the first quarter of 2019.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $30.9 million
for the first quarter of 2020, compared to selling, general and
administrative expenses of $45.5 million for the first quarter of
2019. The $14.6 million decrease resulted primarily from decreases
in professional fees and expenses of approximately $8.7 million,
stock-based compensation expense of approximately $5.2 million,
payroll and payroll-related expenses of approximately $0.6 million,
and travel and meetings of approximately $0.3 million. These
decreases were partially offset by an increase in training expenses
and compliance fees of approximately $0.2 million.
Research and Development Expenses
Research and development expenses were $25.5 million for the
first quarter of 2020, compared to $35.7 million for the first
quarter of 2019. The $10.2 million decrease resulted primarily from
decreases in clinical trial expense of approximately $4.9 million,
stock-based compensation expense of approximately $4.0 million, and
consultant and contractors expenses of approximately $1.4
million.
Total Other Income (Expenses)
Total other expenses were $2.6 million for the first quarter of
2020, compared to total other expenses of $20.0 million for the
first quarter of 2019. The $17.4 million decrease resulted
primarily from decreases in legal verdict expense of approximately
$16.3 million and interest expense of approximately $1.5 million.
These decreases were partially offset by a decrease in interest
income of approximately $0.5 million.
Conference Call
Puma Biotechnology will host a conference call to report its
first quarter 2020 financial results and provide an update on the
Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on
Thursday, May 7, 2020. The call may be accessed by dialing
1-866-548-4713 (domestic) or 1-323-794-2093 (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 shortly 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) 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 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 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, 2019 and, once filed, Puma’s Quarterly Report on
Form 10-Q for the quarter ended March 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.
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES CONSOLIDATED
STATEMENTS OF OPERATIONS (in millions except share and per
share data)
Three Months Ended
March 31,
2020
2019
(Unaudited) (Unaudited) Revenues: Product revenue, net
$
48.6
$
45.6
License revenue
2.0
53.5
Royalty revenue
0.6
— Total revenue
51.2
99.1
Operating costs and expenses: Cost of sales
9.1
8.0
Selling, general and administrative
30.9
45.5
Research and development
25.5
35.7
Total operating costs and expenses
65.5
89.2
Profit (loss) from operations
(14.3
)
9.9
Other income (expenses): Interest income
0.4
0.9
Interest expense
(3.0
)
(4.5
)
Legal verdict expense
(0.1
)
(16.4
)
Other income (expense)
0.1
— Total other expenses
(2.6
)
(20.0
)
Net loss
$
(16.9
)
$
(10.1
)
Net loss per common share—basic and diluted
$
(0.43
)
$
(0.26
)
Weighted-average common shares outstanding—basic and diluted
39,291,162
38,481,824
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES
LIQUIDITY AND CAPITAL RESOURCES (in millions)
March 31, December 31,
2020
2019
(Unaudited) Cash and cash equivalents
$
83.4
$
60.0
Marketable securities
17.2
51.6
Working capital
68.2
75.5
Stockholders' equity
9.4
17.5
Three Months Three Months Ended Ended March 31, March
31,
2020
2019
(Unaudited) (Unaudited) Cash provided by (used in): Operating
activities
$
(11.5
)
$
(16.1
)
Investing activities
34.3
(44.6
)
Financing activities —
1.1
Increase (decrease) in cash and cash equivalents, and
restricted cash
$
22.8
$
(59.6
)
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 ended March 31, 2020 and 2019, stock-based compensation
represented approximately 15.8% and 22.4% 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 Income (Loss) Per
Share (in millions except share and per share data)
(Unaudited) Three Months Ended March 31,
2020
2019
GAAP net loss
$
(16.9
)
$
(10.1
)
Adjustments: Stock-based compensation - Selling, general and
administrative
4.7
9.9
(1)
Research and development
4.2
8.3
(2)
Non-GAAP adjusted net income (loss)
$
(8.0
)
$
8.1
GAAP net loss per share—basic
$
(0.43
)
$
(0.26
)
Adjustment to net loss (as detailed above)
0.23
0.47
Non-GAAP adjusted basic net income (loss) per share
$
(0.20
)
$
0.21
(3)
GAAP net loss per share—diluted
$
(0.43
)
$
(0.26
)
Adjustment to net loss (as detailed above)
0.23
0.46
Non-GAAP adjusted diluted net income (loss) per share
$
(0.20
)
(4)
$
0.20
(5)
(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 income (loss) per share was calculated based on
39,291,162 and 38,481,824 weighted-average shares of common stock
outstanding for the three months ended March 31, 2020 and 2019,
respectively. (4) 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 March 31, 2020 as these shares would be
considered anti-dilutive. (5) Non-GAAP adjusted diluted net income
per share was calculated based on 39,281,714 weighted-average
shares of common stock outstanding for the three months ended March
31, 2019.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200507005746/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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