LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company,
announced financial results for the first quarter ended March 31, 2018.
Unless otherwise stated, all comparisons are for the first quarter 2018
compared to the first quarter 2017.
On July 17, 2017, Puma Biotechnology received approval from the U.S.
Food and Drug Administration (FDA) for NERLYNX® (neratinib) for the
treatment of early stage HER2-positive breast cancer following adjuvant
trastuzumab-based therapy, and the Company began shipment to wholesalers
at the end of July 2017. Prior to the launch of NERLYNX the Company had
no product revenue. Net product revenue from sales of NERLYNX in the
first quarter of 2018 amounted to $36.0 million, compared to net product
revenue of $6.1 million and $20.1 million in the third and fourth
quarters of 2017, respectively.
Based on accounting principles generally accepted in the United States
(GAAP), Puma reported a net loss applicable to common stock of $24.3
million, or $0.65 per share, for the first quarter of 2018, compared to
a net loss applicable to common stock of $72.9 million, or $1.97 per
share, for the first quarter of 2017.
Non-GAAP adjusted net income was $1.1 million, or $0.03 per basic share
and $0.02 per diluted share, for the first quarter of 2018, compared to
non-GAAP adjusted net loss of $43.1 million, or $1.16 per basic and
diluted share, for the first quarter of 2017. Non-GAAP adjusted net
income (loss) excludes stock-based compensation expense, which
represents a significant portion of overall expense and has no impact on
the cash position of the Company. 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 2018 was
$6.3 million. At March 31, 2018, Puma had cash and cash equivalents of
$78.6 million, compared to cash and cash equivalents of $81.7 million at
December 31, 2017.
“We made substantial progress in the commercialization of our lead
product, NERLYNX® (neratinib), during the first quarter of 2018,” said
Alan H. Auerbach, Chairman, Chief Executive Officer and President of
Puma. “We quickly built momentum in the U.S. market, with net sales
steadily rising since our launch. Our exclusive licensing agreements to
date, with Pint Pharma in Latin America, CANbridge in mainland China and
Taiwan, Medison Pharma in Israel, and Specialised Therapeutics Asia in
South East Asia, demonstrate our commitment to also make NERLYNX
accessible to patients globally while we continue to grow the U.S.
market.
“We are also pleased with the updated National Comprehensive Cancer
Network (NCCN) guidelines, which designate NERLYNX as a recommended
combination treatment option for breast cancer patients with brain
metastases. In addition, data on neratinib were published in the journal Nature,
which included initial results from Puma’s ongoing SUMMIT Phase II
‘basket’ clinical trial in patients with tumors harboring HER2 or HER3
mutations. SUMMIT is designed to evaluate the contributions of both
genetic mutation and cancer type on individual patient response to
neratinib. Information generated from the trial will help guide
neratinib-based targeted therapy across a broad spectrum of tumor types
with HER2 or HER3 mutations, including patients with rare tumors who may
not otherwise have access to investigational therapies. We believe the
publication of the initial SUMMIT data in this prestigious journal
reflects the novelty and quality of this precision-medicine trial
design, as well as the growing understanding that both tumor type and
gene mutations play an important role in individual patients’ response
to cancer therapies such as neratinib.”
Mr. Auerbach added, “During 2018, we anticipate the following key
milestones: (i) reporting updated Phase I/II data from neratinib plus
Kadcyla (T-DM1) in the HER2-positive metastatic breast cancer trial in
the second quarter of 2018; (ii) re-assessment of the Marketing
Authorisation Application for neratinib by the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) in
mid-2018; (iii) reporting data from the Phase III trial in third-line
metastatic breast cancer patients in the second half of 2018; (iv)
submitting for regulatory approval for the extended adjuvant
HER2-positive early stage breast cancer indication in select countries
in the second half of 2018; and (v) reporting additional data from the
Phase II CONTROL trial in the fourth quarter of 2018.”
Revenue
Total revenue consists of net product revenue from sales of NERLYNX,
Puma’s first and only commercial product to date, and license revenue.
The FDA approved NERLYNX for commercial sale in the United States in
July 2017 and the Company commenced shipment to wholesalers in late
July. For the first quarter of 2018, total revenue was $66.5 million, of
which $36.0 million was net product revenue and $30.5 million was
license revenue received from Puma’s sub-licensees.
Operating Expenses
Operating expenses were $89.9 million for the first quarter of 2018,
compared to $73.2 million for the first quarter of 2017.
Cost of Sales:
Cost of sales was $6.4 million for the first quarter of 2018. The
Company had no product sales prior to the third quarter of 2017.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were $36.6 million for the
first quarter of 2018, compared to $18.4 million for the first quarter
of 2017. The $18.2 million increase resulted primarily from increases of
approximately $7.8 million in payroll and related costs, $6.6 million in
marketing, market access, and legal expenses, $1.7 million in travel and
related costs, and $1.7 million in stock-based compensation. These
increases reflect the commercial launch of NERLYNX and overall corporate
growth.
Research and Development Expenses:
Research and development (R&D) expenses were $46.9 million for the first
quarter of 2018, compared to $54.8 million for the first quarter of
2017. The $7.9 million decrease resulted primarily from decreases of
approximately $6.1 million for stock-based compensation and $4.0 million
for clinical trial expenses, partially offset by an increase of $2.2
million for payroll and related costs in medical affairs and commercial
quality assurance. For our existing clinical trials, we expect R&D
expenses to decrease in subsequent quarters as clinical trials continue
to wind down.
Conference Call
Puma Biotechnology will host a conference call to report its first
quarter 2018 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 Wednesday, May 9,
2018. The call may be accessed by dialing 1-877-709-8150 (domestic) or
1-201-689-8354 (international) at least 10 minutes prior to the start of
the call and referencing 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 the company'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. The Company in-licenses the global development and
commercialization rights to three drug candidates — PB272 (neratinib,
oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was
approved by the U.S. Food and Drug Administration in July 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 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
for the extended adjuvant treatment of adult patients with early stage
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, epistaxis, 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 (PPI) and H2-receptor antagonists. Separate NERLYNX by 3
hours after antacid dosing.
-
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.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding the benefits of NERLYNX and neratinib, the progress
and expected timing of the Company’s clinical trials, the announcement
of data relative to those trials and the timing for anticipated
regulatory approvals. All forward-looking statements involve risks and
uncertainties that could cause the Company’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, the risk factors
disclosed in the periodic and current reports filed by the Company with
the Securities and Exchange Commission from time to time, including the
Company’s Annual Report on Form 10-K for the year ended December 31,
2017. Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. The
Company assumes no obligation to update these forward-looking
statements, except as required by law.
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
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CONSOLIDATED STATEMENTS OF OPERATIONS
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(in millions except share and per share data)
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Three Months Ended
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March 31,
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(Unaudited)
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2018
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2017
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Product revenue, net
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$
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36.0
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$
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—
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License revenue
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30.5
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—
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Total revenue
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66.5
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—
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Operating costs and expenses:
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Cost of sales
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6.4
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—
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Selling, general and administrative
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36.6
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18.4
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Research and development
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46.9
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54.8
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Totals
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89.9
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73.2
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Loss from operations
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(23.4
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)
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(73.2
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)
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Other income (expenses):
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Interest income
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0.2
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0.3
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Interest expense
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(1.1
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)
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—
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Totals
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(0.9
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)
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0.3
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Net loss
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$
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(24.3
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)
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$
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(72.9
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Net loss per common share—basic and diluted
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$
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(0.65
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)
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$
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(1.97
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)
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Weighted-average common shares outstanding—basic and diluted
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37,699,024
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36,931,167
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
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LIQUIDITY AND CAPITAL RESOURCES
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(in millions, unaudited)
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March 31,
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December 31,
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2018
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2017
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Cash and cash equivalents
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$
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78.6
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$
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81.7
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Marketable securities
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—
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—
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Working capital
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53.1
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48.1
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Stockholders' equity
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57.5
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53.3
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Three Months
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Three Months
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Ended
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Ended
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March 31,
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March 31,
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2018
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2017
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Cash provided by (used in):
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Operating activities
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$
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(6.3
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)
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$
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(36.0
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Investing activities
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-
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(54.1
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)
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Financing activities
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3.2
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0.7
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Decrease in cash and cash equivalents
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$
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(3.1
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$
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(89.4
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)
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Non-GAAP Financial Measures
In addition to operating results as calculated in accordance with
generally accepted accounting principles, or GAAP, the Company 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, 2018 and 2017,
stock-based compensation represented approximately 28.3% and 40.7% of
operating expense, respectively. Although net loss is important to
measure financial performance, the Company currently places an emphasis
on cash burn and, more specifically, cash used in operations.
Stock-based compensation appears in GAAP net loss but is removed from
net loss to arrive at cash used in operations on the statement of cash
flows. Due to its noncash nature, the Company believes these non-GAAP
measures enhance understanding of financial performance, are more
indicative of 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.
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PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY
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Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Income
(Loss) and
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GAAP Net Loss Per Share to Non-GAAP Adjusted Net Income (Loss)
Per Share
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(in millions except share and per share data)
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(Unaudited)
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Three Months Ended March 31,
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2018
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2017
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GAAP net loss
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$
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(24.3
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)
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$
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(72.9
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)
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Adjustments:
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Stock-based compensation -
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Selling, general and administrative
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9.0
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7.3
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(1)
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Research and development
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16.4
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22.5
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(2)
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Non-GAAP adjusted net income (loss)
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$
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1.1
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$
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(43.1
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)
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GAAP net loss per share - basic
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$
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(0.65
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)
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$
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(1.97
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)
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Adjustment to net loss (as detailed above)
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0.68
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0.81
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Non-GAAP adjusted basic net income (loss) per share
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$
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0.03
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$
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(1.16
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)
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(3)
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GAAP net loss per share—diluted
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$
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(0.60
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)
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$
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(1.97
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)
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Adjustment to net loss (as detailed above)
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0.62
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0.81
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Non-GAAP adjusted diluted net income (loss) per share
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$
|
0.02
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(4)
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$
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(1.16
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)
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(5)
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(1) To reflect a non-cash charge to operating expense for selling,
general and administrative stock-based compensation.
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(2) To reflect a non-cash charge to operating expense for research
and development stock-based compensation.
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(3) Non-GAAP adjusted net income (loss) per share was calculated
based on 37,699,024 and 36,931,167 weighted average common shares
outstanding for the three months ended March 31, 2018 and 2017,
respectively.
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(4) Non-GAAP adjusted diluted net income per share was calculated
based on 40,642,311 weighted average common shares outstanding and
potentially dilutive common stock equivalents (stock options,
restricted stock units and warrants) for the three months ended
March 31, 2018.
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(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, 2017 as these shares would be considered
anti-dilutive.
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Contact: