Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced financial results for the fourth quarter and
year ended December 31, 2022. Unless otherwise stated, all
comparisons are for the fourth quarter and full year 2022, compared
to the fourth quarter and full year 2021.
Product revenue, net consists entirely of revenue from sales of
NERLYNX®, Puma’s first commercial product. Product revenue, net for
the fourth quarter of 2022 was $53.7 million, compared to $51.0
million in the fourth quarter of 2021. Product revenue, net for the
full year 2022 was $200.0 million, compared to $189.1 million in
2021.
Based on accounting principles generally accepted in the United
States (GAAP), Puma reported a net loss of $5.6 million, or $0.12
per share, for the fourth quarter of 2022, compared to net income
of $4.2 million, or $0.10 per basic and diluted share, for the
fourth quarter of 2021. In the fourth quarter of 2022, Puma
increased its legal accrual by approximately $12.4 million to
reflect the settlement of a lawsuit. Net income for full year 2022
was $0.0 million, or $0.00 per basic and diluted share, compared to
a net loss of $29.1 million, or $0.72 per share, for full year
2021.
Non-GAAP adjusted net loss was $3.0 million, or $0.07 per share,
for the fourth quarter of 2022, compared to non-GAAP adjusted net
income of $8.4 million, or $0.21 per basic and diluted share, for
the fourth quarter of 2021. Non-GAAP adjusted net income for full
year 2022 was $11.8 million, or $0.26 per basic and diluted share,
compared to non-GAAP adjusted net income of $3.5 million, or $0.09
per basic share and $0.08 per diluted share, for full year 2021.
Non-GAAP adjusted net income/loss 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 fourth quarter
of 2022 was $7.7 million, compared to net cash used in operating
activities of $5.4 million for the fourth quarter of 2021. Net cash
used in operating activities for full year 2022 was $15.8 million,
compared to net cash provided by operating activities of $20.7
million for full year 2021. At December 31, 2022, Puma had cash,
cash equivalents, and marketable securities of $81.1 million,
compared to cash, cash equivalents, and marketable securities of
$82.1 million at December 31, 2021.
“In the fourth quarter of 2022, we are very pleased to have
achieved $53.7 million in NERLYNX revenues,” said Alan H. Auerbach,
Chairman, Chief Executive Officer and President of Puma. “This is
being driven by the U.S. commercial revenues from NERLYNX and our
commercial execution, which is designed to support increased
patient awareness and access to NERLYNX. Puma also continued to
execute on its key milestones during the quarter, which included
presentation of updated findings from the Phase II SUMMIT basket
trial of neratinib for EGFR exon 18-mutant non-small cell lung
cancer (NSCLC) patients at the EORTC/NCI/AACR Molecular Targets and
Cancer Therapeutics Symposium, as well as the presentation of data
from the TBCRC-022 trial at the 2022 San Antonio Breast Cancer
Symposium,” said Mr. Auerbach. “We remain committed to supporting
patients with HER2-positive breast cancer with NERLYNX and, with
the addition of alisertib to our pipeline, we hope to be able to
support more cancer patients in the future.”
Mr. Auerbach added, “We anticipate the following key milestones
over the next 12 months: (i) publication of the biomarker studies
from the randomized trial of alisertib plus fulvestrant versus
alisertib alone in hormone receptor positive, HER2-negative breast
cancer (H1 2023); (ii) reporting biomarker data from the randomized
trial of alisertib plus paclitaxel versus paclitaxel alone in
hormone receptor positive, HER2-negative breast cancer (H1 2023);
(iii) 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); (iv) conducting a meeting with the FDA to discuss the
registration pathway for alisertib in small cell lung cancer (H1
2023); and (v) conducting a meeting with the FDA to discuss the
registration pathway for alisertib in hormone receptor positive,
HER2-negative breast cancer (H2 2023).”
Revenue
Total revenue consists of product revenue, net from sales of
NERLYNX, license revenue and royalty revenue. For the fourth
quarter of 2022, total revenue was $65.7 million, of which $53.7
million was product revenue, net, and $12.0 million was royalty
revenue. This compares to total revenue of $55.4 million for the
fourth quarter of 2021, of which $51.0 million was product revenue,
net, $1.5 million was license revenue received from Puma’s
sub-licensees, and $2.9 million was royalty revenue. For the year
ended December 31, 2022, total revenue was $228.0 million, of which
$200.0 million was product revenue, net, and $28.0 million was
royalty revenue. This compares to total revenue in 2021 of $253.2
million, of which $189.1 million was product revenue, net, $51.8
million was license revenue received from Puma’s sub-licensees,
which included a $50 million upfront payment for providing
development, manufacturing and commercial rights to NERLYNX in
Greater China to Pierre Fabre, and $12.3 million was royalty
revenue.
Operating Costs and Expenses
Total operating costs and expenses were $55.7 million for the
fourth quarter of 2022, compared to $48.6 million for the fourth
quarter of 2021. Total operating costs and expenses were $204.3
million for full year 2022, compared to $251.9 million for full
year 2021.
Cost of Sales
Cost of sales was $16.8 million for the fourth quarter of 2022,
compared to $11.9 million for the fourth quarter of 2021. Cost of
sales was $55.1 million for full year 2022, compared to cost of
sales of $63.7 million for full year 2021, of which $20.0 million
was a termination fee paid to a former sub-licensee for the return
of commercial rights to NERLYNX in Greater China.
Selling, General and Administrative Expenses
Selling, general and administrative (SG&A) expenses were
$25.1 million for the fourth quarter of 2022, compared to $22.5
million for the fourth quarter of 2021. SG&A expenses for full
year 2022 were $90.0 million, compared to $116.3 million for full
year 2021. The $26.3 million decrease in SG&A expenses for full
year 2022 compared to 2021 resulted primarily from a decrease in
payroll and related costs of approximately $8.2 million, consisting
of $7.6 million from lower headcount and a $2.0 million payroll tax
credit under the CARES Act,; and a decrease in stock-based
compensation expense of approximately $17.7 million, primarily due
to $13.6 million of incremental expense in 2021, which resulted
from modification to the term of a warrant held by Mr. Auerbach,
offset by an increase of commissions and bonuses of $1.2
million.
Research and Development Expenses
Research and development (R&D) expenses were $13.8 million
for the fourth quarter of 2022, compared to $14.2 million for the
fourth quarter of 2021. R&D expenses for full year 2022 were
$52.2 million, compared to $71.9 million for full year 2021. The
$19.7 million decrease in R&D expenses during full year 2022
compared to full year 2021 resulted primarily from a decrease in
clinical trial expense of approximately $8.7 million, primarily due
to the reduction in the number of patients in certain clinical
trials; a decrease in internal R&D expenses of approximately
$5.6 million; a decrease in consultant and contractors' expense of
approximately $2.3 million, primarily due to the close of the
CONTROL study and a reduction in the number of patients being
treated in the SUMMIT study; and a decrease in stock-based
compensation expense of approximately $3.2 million, primarily due
to the impact of lower headcount combined with the decreased stock
price.
Acquired In-Process Research and Development Expense
In September 2022, the Company entered into an exclusive license
agreement with Takeda Pharmaceutical Company Limited to in-license
the worldwide research and development and commercial rights to
alisertib. The Company recorded acquired in-process research and
development expense related to the up-front payment of $7.0 million
during the year ended December 31, 2022.
Total Other Income (Expenses)
Total other expenses were $15.3 million for the fourth quarter
of 2022, compared to total other expenses of $2.4 million for the
fourth quarter of 2021. Total other expenses were $23.2 million for
full year 2022, compared to $30.1 million for full year 2021. The
$6.9 million decrease in other expenses in full year 2022 consisted
primarily of a net increase in legal verdict expense of $2.9
million, which included a $12.4 million expense related to the
legal settlement in the year ended December 31, 2022; $8.1 million
in loss on debt extinguishment related to our debt refinancing in
July 2021; and a decrease of $1.3 million in lower interest expense
related to our outstanding debt.
Full Year 2023 and First Quarter 2023 Financial
Outlook
Full Year 2023
First Quarter 2023
Net Product Revenue
$205 - $210 million
$43 -$46 million
Royalty Revenue
$25 - $30 million
$4 - $6 million
Net Income/(Loss)
$20 -$24 million
$(5) - $(2) million
Gross to Net Adjustment
19% - 20%
21% - 21.5%
Conference Call
Puma Biotechnology will host a conference call to report its
fourth quarter and full year 2022 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, March 2, 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 dialing 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 first 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 SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS (in millions except
share and per share data) Three Months Ended Twelve
Months Ended December 31, December 31,
2022
2021
2022
2021
(Unaudited) (Unaudited) Revenues: Product revenue, net
$
53.7
$
51.0
200.0
$
189.1
License revenue
—
1.5
-
51.8
Royalty revenue
12.0
2.9
28.0
12.3
Total revenue
65.7
55.4
228.0
253.2
Operating costs and expenses: Cost of sales
16.8
11.9
55.1
63.7
Selling, general and administrative
25.1
22.5
90.0
116.3
Research and development
13.8
14.2
52.2
71.9
Acquired in-process research and development
—
—
7.0
—
Total operating costs and expenses
55.7
48.6
204.3
251.9
Income from operations
10.0
6.8
23.7
1.3
Other income (expenses): Interest income
0.6
—
0.8
0.1
Interest expense
(3.3
)
(2.7
)
(11.5
)
(12.8
)
Legal verdict (expense) credit
(12.4
)
0.2
(12.5
)
(9.6
)
Loss on debt extinguishment
—
—
—
(8.1
)
Other income (expense)
(0.2
)
0.1
—
0.3
Total other expenses
(15.3
)
(2.4
)
(23.2
)
(30.1
)
Net income (loss) before income taxes
(5.3
)
4.4
0.5
(28.8
)
Income tax expense
(0.3
)
(0.2
)
(0.5
)
(0.3
)
Net income (loss)
$
(5.6
)
$
4.2
$
0.0
$
(29.1
)
Net income (loss) per share of common stock—basic
$
(0.12
)
$
0.10
$
0.00
$
(0.72
)
Net income (loss) per share of common stock—diluted
$
(0.12
)
$
0.10
$
0.00
$
(0.72
)
Weighted-average shares of common stock outstanding—basic
45,814,185
40,991,412
44,674,501
40,638,852
Weighted-average shares of common stock outstanding—diluted
45,814,185
41,044,676
44,929,998
40,638,852
PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES LIQUIDITY AND
CAPITAL RESOURCES (in millions) December 31,
December 31,
2022
2021
Cash and cash equivalents
$
76.2
$
63.1
Marketable securities
4.9
19.0
Working capital
56.8
30.4
Stockholders' deficit
21.6
(2.4
)
Twelve Months Twelve Months Ended Ended December 31,
December 31,
2022
2021
Cash provided by (used in): Operating activities
$
(15.8
)
$
20.7
Investing activities
7.1
(10.9
)
Financing activities
12.2
(31.9
)
Increase (decrease) in cash and cash equivalents, and
restricted cash
$
3.5
$
(22.2
)
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 and twelve months ended December 31, 2022,
stock-based compensation represented approximately 6.8% and 8.3% of
operating expenses, respectively, and 11.4% and 17.3% for the same
periods in 2021, in each case excluding cost of sales and acquired
in-process research and development. 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 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
December 31,
2022
2021
GAAP net income (loss)
$
(5.6
)
$
4.2
Adjustments: Stock-based compensation - Selling, general and
administrative
1.8
2.4
(1)
Research and development
0.8
1.8
(2)
Non-GAAP adjusted net income (loss)
$
(3.0
)
$
8.4
GAAP net income (loss) per share—basic
$
(0.12
)
$
0.10
Adjustment to net income (loss) (as detailed above)
0.05
0.11
Non-GAAP adjusted basic net income (loss) per share
$
(0.07
)
(3)
$
0.21
(3)
GAAP net income (loss) per share—diluted
$
(0.12
)
$
0.10
Adjustment to net income (loss) (as detailed above)
0.05
0.11
Non-GAAP adjusted diluted net income (loss) per share
$
(0.07
)
(4)
$
0.21
(5)
Twelve Months Ended December 31,
2022
2021
GAAP net income (loss)
$
0.0
$
(29.1
)
Adjustments: Stock-based compensation - Selling, general and
administrative
8.0
25.7
(1)
Research and development
3.8
6.9
(2)
Non-GAAP adjusted net income
$
11.8
$
3.5
GAAP net income (loss) per share—basic
$
0.00
$
(0.72
)
Adjustment to net income (loss) (as detailed above)
0.26
0.81
Non-GAAP adjusted basic net income per share
$
0.26
(6)
$
0.09
(6)
GAAP net income (loss) per share—diluted
$
0.00
$
(0.70
)
Adjustment to net income (loss) (as detailed above)
0.26
0.78
Non-GAAP adjusted diluted net income per share
$
0.26
(7)
$
0.08
(7)
(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 44,814,185 and
40,991 412 weighted-average shares of common stock outstanding for
the three months ended December 31, 2022 and 2021,
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 as these shares would be considered anti-dilutive.
(5) Non-GAAP adjusted diluted net
income per share was calculated based on 41,044,676 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, 2021.
(6) Non-GAAP adjusted net income
per share was calculated based on 44,674,501 and 40,638,852
weighted-average shares of common stock outstanding for the years
ended December 31, 2022 and 2021, respectively.
(7) Non-GAAP adjusted diluted net
income per share was calculated based on 44,929,998 and 41,558,838
weighted average common shares outstanding and potentially dilutive
common stock equivalents (stock options, restricted stock units and
warrants) for the twelve months ended December 31, 2022 and 2021,
respectively.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230302005302/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull or Olipriya Das, Russo Partners, +1 212 845 4200
david.schull@russopartnersllc.com
olipriya.das@russopartnersllc.com
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