Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced financial results for the first quarter ended
March 31, 2023. Unless otherwise stated, all comparisons are for
the first quarter of 2023 compared to the first quarter of
2022.
Product revenue, net consists entirely of revenue from sales of
NERLYNX®, Puma’s first commercial product. Product revenue, net in
the first quarter of 2023 was $46.8 million, compared to product
revenue, net of $40.7 million in the first quarter of 2022.
Based on accounting principles generally accepted in the United
States (GAAP), Puma reported net income of $1.4 million, or $0.03
per basic and diluted share, for the first quarter of 2023,
compared to net loss of $3.4 million, or $0.08 per share, for the
first quarter of 2022.
Non-GAAP adjusted net income was $4.2 million, or $0.09 per
basic and diluted share, for the first quarter of 2023, compared to
non-GAAP adjusted net loss of $0.3 million, or $0.01 per share, for
the first quarter of 2022. Non-GAAP adjusted net income excludes
stock-based compensation expense. For a reconciliation of GAAP net
income (loss) to non-GAAP adjusted net income (loss) and GAAP net
income (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 first quarter
of 2023 was $2.6 million, compared to net cash used in operating
activities of $26.9 million in the first quarter of 2022. At March
31, 2023, Puma had cash, cash equivalents and marketable securities
of $71.2 million, compared to cash, cash equivalents and marketable
securities of $81.1 million at December 31, 2022.
“We are pleased to deliver positive net income for the first
quarter of 2023. We are additionally pleased to see the recently
published results from the TBCRC-041 trial evaluating alisertib in
patients with ER-positive HER2-negative metastatic breast cancer
that were published in JAMA Oncology in March,” said Alan H.
Auerbach, Chairman, Chief Executive Officer and President of Puma.
“We look forward to meeting with the U.S. Food and Drug
Administration and discussing the next steps for the development of
alisertib in both small cell lung cancer and ER-positive
HER2-negative metastatic breast cancer during 2023. Additionally,
we will continue to focus our efforts toward achieving our goal of
increasing awareness of and access to NERLYNX as an option for
patients battling HER2-positive breast cancer.”
Mr. Auerbach added, “We anticipate the following key milestones
over the next 12 months: (i) reporting biomarker data from the
randomized trial of alisertib plus paclitaxel versus paclitaxel
alone in hormone receptor positive, HER2-negative breast cancer (Q2
2023); (ii) reporting data from an ongoing investigator sponsored
Phase I/II trial of alisertib plus pembrolizumab for the treatment
of patients with Rb-deficient head and neck squamous cell cancer
(2023); (iii) conducting a meeting with the FDA to discuss the
registration pathway for alisertib in small cell lung cancer (Q2
2023); and (iv) conducting a meeting with the FDA to discuss the
registration pathway for alisertib in hormone receptor positive,
HER2-negative breast cancer (Q4 2023).”
Revenue
Total revenue consists of product revenue, net from sales of
NERLYNX, Puma’s first commercial product, license revenue from
Puma’s sub-licensees and royalty revenue. For the first quarter
ended March 31, 2023, total revenue was $52.8 million, of which
$46.8 million was net product revenue and $6.0 million was royalty
revenue. This compares to total revenue of $45.7 million in the
first quarter of 2022, of which $40.7 million was net product
revenue and $5.0 million was royalty revenue.
Operating Costs and Expenses
Total operating costs and expenses were $48.4 million for the
first quarter of 2023, compared to $46.4 million for the first
quarter of 2022.
Cost of Sales
Cost of sales was $13.2 million for the first quarter of 2023,
compared to $10.8 million for the first quarter of 2022. The $2.4
million increase resulted primarily from higher royalty expense
related to increased net product sales, as well as increased
intangible amortization related to the $12.5 million paid to Pfizer
for meeting a commercial sales milestone as of December 31,
2022.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $22.5 million
for the first quarter of 2023, compared to $20.4 million for the
first quarter of 2022. The $2.1 million increase resulted primarily
from an increase in payroll and related costs of approximately $1.6
million, primarily due to salary increases beginning in 2023 as
well as higher headcount, and higher travel and meeting
expenses.
Research and Development Expenses
Research and development expenses were $12.7 million for the
first quarter of 2023, compared to $15.2 million for the first
quarter of 2022. The $2.5 million decrease resulted primarily from
a decrease in clinical trial expense of approximately $3.2 million,
primarily due to the reduction and closing of SUMMIT clinical trial
sites, and was partially offset by an increase in internal R&D
of approximately $0.8 million, primarily due to an increase in
payroll-related expenses in 2023.
Total Other Income (Expenses)
Total other expenses were $2.8 million for the first quarter of
2023, compared to total other expenses of $2.7 million for the
first quarter of 2022. The increase resulted primarily from higher
interest rates.
Second Quarter and Full Year 2023 Financial Outlook
Second Quarter 2023
Full Year 2023
Net Product Revenue
$47 - $50 million
$205 - $210 million
Royalty Revenue
$2 - $3 million
$25 - $30 million
Net Income/(Loss)
$0 - $1.5 million
$20 - $24 million
Gross to Net Adjustment
20% - 21%
19% - 20%
Conference Call
Puma Biotechnology will host a conference call to report its
first quarter 2023 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 4, 2023. 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 https://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-licensed 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.
In September 2022, Puma entered into an exclusive license
agreement for the development and commercialization of the
anti-cancer drug alisertib, a selective, small molecule, orally
administered inhibitor of aurora kinase A. Initially, Puma intends
to focus the development of alisertib on the treatment of small
cell lung cancer and breast cancer.
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
https://www.NERLYNX.com or by calling 1-855-816-5421.
Further information about Puma Biotechnology may be found at
https://www.pumabiotechnology.com.
INDICATIONS
- NERLYNX® (neratinib) tablets, for oral use, 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.
Important Safety Information Regarding NERLYNX® (neratinib)
U.S. Indication
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Diarrhea: Manage diarrhea through either NERLYNX dose
escalation or loperamide prophylaxis. 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. Separate NERLYNX by at least 2 hours before or 10
hours after H2-receptor antagonists. Or separate NERLYNX by at
least 3 hours with antacids.
- Strong CYP3A4 inhibitors: Avoid concomitant use.
- P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant
use.
- Strong or moderate CYP3A4 inducers: Avoid concomitant use.
- Certain P-gp substrates: Monitor for adverse reactions of P-gp
substrates for which minimal concentration change may lead to
serious adverse reactions 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 Puma’s anticipated milestones and
estimates of future financial results for the second quarter and
full year 2023. 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, any changes in Puma’s product candidates’
regulatory approvals, results from Puma’s clinical trials, any
litigation involving Puma, any changes to Puma’s in-licensed
intellectual property 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, 2022 and
subsequent filings. 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
March 31,
2023
2022
(Unaudited) (Unaudited) Revenues: Product revenue, net
$
46.8
$
40.7
License revenue
—
—
Royalty revenue
6.0
5.0
Total revenue
52.8
45.7
Operating costs and expenses: Cost of sales
13.2
10.8
Selling, general and administrative
22.5
20.4
Research and development
12.7
15.2
Total operating costs and expenses
48.4
46.4
Income (loss) from operations
4.4
(0.7
)
Other expenses: Interest income
0.5
—
Interest expense
(3.3
)
(2.7
)
Total other expenses
(2.8
)
(2.7
)
Net income (loss) before income taxes
1.6
(3.4
)
Income tax expense
(0.2
)
—
Net income (loss)
$
1.4
$
(3.4
)
Net income (loss) per share of common stock—basic
$
0.03
$
(0.08
)
Net income (loss) per share of common stock—diluted
$
0.03
$
(0.08
)
Weighted-average shares of common stock outstanding—basic
46,636,083
42,207,709
Weighted-average shares of common stock outstanding—diluted
47,157,904
42,207,709
PUMA BIOTECHNOLOGY, INC. AND
SUBSIDIARY
LIQUIDITY AND CAPITAL
RESOURCES
(in millions)
March 31, December 31,
2023
2022
(Unaudited) Cash and cash equivalents
$
61.4
$
76.2
Marketable securities
9.8
4.9
Working capital
63.6
56.8
Long term debt
98.6
98.3
Stockholders' equity (deficit)
25.8
21.6
Three Months
Ended
March 31,
Three Months
Ended
March 31,
2023
2022
(Unaudited) (Unaudited) Cash provided by (used in): Operating
activities
$
2.6
$
(26.9
)
Investing activities
(17.4
)
9.0
Financing activities
—
9.8
Increase (decrease) in cash and cash equivalents, and
restricted cash
$
(14.8
)
$
(8.1
)
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 income (loss) and net
income (loss) per share calculated in accordance with GAAP and as
adjusted to remove the impact of stock-based compensation expense.
For the three months ended March 31, 2023, stock-based compensation
represented approximately 8.1% of total selling, general and
administrative expense and research and development expense, and
8.8% for the same period in 2022. 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
Income (Loss) to Non-GAAP Adjusted Net Income (Loss) and
GAAP Net Income (Loss) Per
Share to Non-GAAP Adjusted Net Income (Loss) Per Share
(in millions except share and
per share data)
(Unaudited)
Three Months Ended March 31,
2023
2022
GAAP net income (loss)
$
1.4
$
(3.4
)
Adjustments: Stock-based compensation - Selling, general and
administrative (1)
2.0
2.2
Research and development (2)
0.8
0.9
Non-GAAP adjusted net income (loss)
$
4.2
$
(0.3
)
GAAP net income (loss) per share—basic
$
0.03
$
(0.08
)
Adjustment to net income (loss) (as detailed above)
0.06
0.07
Non-GAAP adjusted basic net income (loss) per share
$
0.09
(3)
$
(0.01
)
(3
)
GAAP net income (loss) per share—diluted
$
0.03
$
(0.08
)
Adjustment to net income (loss) (as detailed above)
0.06
0.07
Non-GAAP adjusted diluted net income (loss) per share
$
0.09
(4)
$
(0.01
)
(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 per share was calculated based on 46,636,083 and
42,207,709 weighted-average shares of common stock outstanding for
the three months ended March 31, 2023 and 2022, respectively. (4)
Non-GAAP adjusted diluted net income per share was calculated based
on 47,157,904 weighted-average shares of common stock outstanding
for the three months ended March 31, 2023. (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 March 31, 2022, as these
shares would be considered anti-dilutive.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230504005326/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull, Russo Partners, +1 212 845 4200
david.schull@russopartnersllc.com
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