Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its
commitment to non-opioid pain management and regenerative health
solutions, today reported preliminary unaudited total revenue of
$675.0 million for the year ended December 31, 2023, compared with
$666.8 million for the year ended December 31, 2022.
“We enter 2024 with a strong financial and operational
foundation to support our mission to expand patient access to
opioid-sparing pain management,” said Frank D. Lee, chief executive
officer of Pacira BioSciences. “In the coming year, we will
continue to invest in long-term growth initiatives to ensure we are
well positioned to fully capitalize on the substantial
opportunities ahead of us, including the upcoming launch of EXPAREL
in two key lower extremity nerve blocks in 2024 and expansion of
patient access with the rollout of the NOPAIN Act in 2025.”
Fourth Quarter 2023 Preliminary Unaudited Revenue
Highlights
- Fourth quarter
EXPAREL net product sales of $143.9 million in 2023, compared with
$138.0 million in 2022. Fourth quarter net product sales were
comprised of average daily volume growth of 4 percent. Pacira
reports average daily growth rates for EXPAREL to account for
differences in the number of selling days per reporting period.
There were 61 selling days in each of the fourth quarters of 2023
and 2022.
- Fourth quarter
ZILRETTA net product sales of $28.7 million in 2023, compared with
$28.0 million in 2022.
- Fourth quarter
iovera° net product sales of $6.0 million in 2023, compared with
$4.6 million in 2022.
- Other revenue,
including sales of bupivacaine liposome injectable suspension and
royalties, was $2.6 million in the fourth quarter of 2023, compared
with $1.4 million in the fourth quarter of 2022.
2023 Full-Year Preliminary Unaudited Revenue
Highlights
- Full-year EXPAREL
net product sales of $538.1 million in 2023, compared with $536.9
million in 2022. Full-year net product sales were comprised of
average daily volume growth of 5 percent, which was offset by a
lower net selling price primarily due to the implementation of 340B
Drug Pricing in October 2022 and other contracted relationships.
There were 250 selling days in 2023 and 252 selling days in
2022.
- Full-year ZILRETTA
net product sales of $111.1 million in 2023, compared with $105.5
million in 2022.
- Full-year iovera°
net product sales of $19.7 million in 2023, compared with $15.3
million in 2022.
- Other revenue,
including sales of bupivacaine liposome injectable suspension and
royalties, was $6.1 million in 2023, compared with $9.1 million in
2022.
The financial information included in this press release is
preliminary, unaudited, and subject to adjustment. It does not
present all information necessary for an understanding of the
company’s financial results for the fourth quarter or full year
2023. Pacira expects to report its complete financial results for
the fourth quarter and full-year 2023, along with the company’s
financial guidance and capital allocation strategy for 2024, in the
first quarter of 2024.
About Pacira
Pacira BioSciences, Inc. (Nasdaq: PCRX) is committed to
providing a non-opioid option to as many patients as possible to
redefine the role of opioids as rescue therapy only. The company is
also developing innovative interventions to address debilitating
conditions involving the sympathetic nervous system, such as
cardiac electrical storm, chronic pain, and spasticity. Pacira has
three commercial-stage non-opioid treatments:
EXPAREL® (bupivacaine liposome injectable suspension), a
long-acting local analgesic currently approved for infiltration,
fascial plane block, and as an interscalene brachial plexus nerve
block for postsurgical pain management;
ZILRETTA® (triamcinolone acetonide extended-release injectable
suspension), an extended-release, intra-articular injection
indicated for the management of osteoarthritis knee pain; and
ioveraº®, a novel, handheld device for delivering immediate,
long-acting, drug-free pain control using precise, controlled doses
of cold temperature to a targeted nerve. To learn more about
Pacira, including the corporate mission to reduce overreliance on
opioids, visit www.pacira.com.
About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is
indicated in patients 6 years of age and older for single-dose
infiltration to produce postsurgical local analgesia, and in adults
as an interscalene brachial plexus nerve block to produce
postsurgical regional analgesia. Safety and efficacy have not been
established in other nerve blocks. The product combines bupivacaine
with multivesicular liposomes, a proven product delivery technology
that delivers medication over a desired time period. EXPAREL
represents the first and only multivesicular liposome local
anesthetic that can be utilized in the peri- or postsurgical
setting. By utilizing the multivesicular liposome platform, a
single dose of EXPAREL delivers bupivacaine over time, providing
significant reductions in cumulative pain scores with up to a 78
percent decrease in opioid consumption; the clinical benefit of the
opioid reduction was not demonstrated. Additional information is
available at www.EXPAREL.com.
Important Safety Information about EXPAREL for
Patients
EXPAREL should not be used in obstetrical paracervical block
anesthesia. In studies in adults where EXPAREL was injected into a
wound, the most common side effects were nausea, constipation, and
vomiting. In studies in adults where EXPAREL was injected near a
nerve, the most common side effects were nausea, fever, and
constipation. In the study where EXPAREL was given to children, the
most common side effects were nausea, vomiting, constipation, low
blood pressure, low number of red blood cells, muscle twitching,
blurred vision, itching, and rapid heartbeat. EXPAREL can cause a
temporary loss of feeling and/or loss of muscle movement. How much
and how long the loss of feeling and/or muscle movement depends on
where and how much of EXPAREL was injected and may last for up to 5
days. EXPAREL is not recommended to be used in patients younger
than 6 years old for injection into the wound, for patients younger
than 18 years old for injection near a nerve, and/or in pregnant
women. Tell your health care provider if you or your child has
liver disease, since this may affect how the active ingredient
(bupivacaine) in EXPAREL is eliminated from the body. EXPAREL
should not be injected into the spine, joints, or veins. The active
ingredient in EXPAREL can affect the nervous system and the
cardiovascular system; may cause an allergic reaction; may cause
damage if injected into the joints; and can cause a rare blood
disorder.
About ZILRETTA®
On October 6, 2017, ZILRETTA (triamcinolone acetonide
extended-release injectable suspension) was approved by the U.S.
Food and Drug Administration as the first and only extended-release
intra-articular therapy for patients confronting osteoarthritis
(OA)- related knee pain. ZILRETTA employs proprietary microsphere
technology combining triamcinolone acetonide—a commonly
administered, short-acting corticosteroid—with a poly
lactic-co-glycolic acid (PLGA) matrix to provide extended pain
relief. The pivotal Phase 3 trial on which the approval of ZILRETTA
was based showed that ZILRETTA significantly reduced OA knee pain
for 12 weeks, with some people experiencing pain relief through
Week 16. Learn more at www.zilretta.com.
Indication and Select Important Safety Information for
ZILRETTA
Indication: ZILRETTA is indicated as an
intra-articular injection for the management of OA pain of the
knee. Limitation of Use: The efficacy and safety of repeat
administration of ZILRETTA have not been demonstrated.
Contraindication: ZILRETTA is
contraindicated in patients who are hypersensitive to triamcinolone
acetonide, corticosteroids or any components of the product.
Warnings and Precautions:
-
Intra-articular Use Only: ZILRETTA has not
been evaluated and should not be administered by epidural,
intrathecal, intravenous, intraocular, intramuscular, intradermal,
or subcutaneous routes. ZILRETTA should not be considered safe for
epidural or intrathecal administration.
- Serious
Neurologic Adverse Reactions with Epidural and Intrathecal
Administration: Serious neurologic events have been
reported following epidural or intrathecal corticosteroid
administration. Corticosteroids are not approved for this use.
-
Hypersensitivity reactions: Serious reactions
have been reported with triamcinolone acetonide injection.
Institute appropriate care if an anaphylactic reaction occurs.
- Joint
infection and damage: A marked increase in joint
pain, joint swelling, restricted motion, fever and malaise may
suggest septic arthritis. If this occurs, conduct appropriate
evaluation and if confirmed, institute appropriate antimicrobial
treatment.
Adverse Reactions: The most commonly
reported adverse reactions (incidence ≥1%) in clinical studies
included sinusitis, cough, and contusions.
Please see ZILRETTALabel.com for full Prescribing
Information.
About iovera°®
The iovera° system uses the body’s natural response to cold to
treat peripheral nerves and immediately reduce pain without the use
of drugs. Treated nerves are temporarily stopped from sending pain
signals for a period of time, followed by a restoration of
function. Treatment with iovera° treatment works by applying
targeted cold to a peripheral nerve. A precise cold zone is formed
under the skin that is cold enough to immediately prevent the nerve
from sending pain signals without causing damage to surrounding
structures. The effect on the nerve is temporary, providing pain
relief until the nerve regenerates and function is restored.
Treatment with iovera° does not include injection of any substance,
opioid, or any other drug. The effect is immediate and can last up
to 90 days. The iovera° system is not indicated for treatment of
central nervous system tissue. Additional information is available
at www.iovera.com.
Important Safety Information for
iovera°®
The iovera° system is contraindicated for use in patients with
the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria;
cold urticaria; Raynaud’s disease; open and/or infected wounds at
or near the treatment line. Potential complications: As with any
surgical treatment that uses needle-based therapy, there is
potential for temporary site-specific reactions, including but not
limited to: bruising (ecchymosis); swelling (edema); inflammation
and/or redness (erythema); pain and/or tenderness; altered
sensation (localized dysesthesia). Typically, these reactions
resolve with no physician intervention. Patients may help the
healing process by applying ice packs to the affected sites, and by
taking over-the-counter analgesics.
Forward-Looking Statements
Any statements in this press release about Pacira’s future
expectations, plans, trends, outlook, projections and prospects,
and other statements containing the words “believes,”
“anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,”
“will,” “would,” “could,” “can” and similar expressions, constitute
forward-looking statements within the meaning of Section 21E of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”),
and the Private Securities Litigation Reform Act of 1995,
including, without limitation, statements related to our
preliminary unaudited revenue, our growth and future operating
results and trends, our strategy, plans, objectives, expectations
(financial or otherwise) and intentions, future financial results
and growth potential, including our plans with respect to the
repayment of our indebtedness, anticipated product portfolio,
development programs, patent terms, development of products,
strategic alliances and intellectual property and other statements
that are not historical facts. For this purpose, any statement that
is not a statement of historical fact should be considered a
forward-looking statement. We cannot assure you that our estimates,
assumptions and expectations will prove to have been correct.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including risks relating to, among others: the successful
transition of our chief executive officer and chairman and
integration of our new chief executive officer; risks associated
with acquisitions, such as the risk that the acquired businesses
will not be integrated successfully, that such integration may be
more difficult, time-consuming or costly than expected or that the
expected benefits of the transaction will not occur; the lingering
impact of the COVID-19 pandemic on elective surgeries, our
manufacturing and supply chain, global and U.S. economic conditions
(including inflation and rising interest rates), and our business,
including our revenues, financial condition, cash flow and results
of operations; the success of our sales and manufacturing efforts
in support of the commercialization of EXPAREL, ZILRETTA and
iovera°; the rate and degree of market acceptance of EXPAREL,
ZILRETTA and iovera°; the size and growth of the potential markets
for EXPAREL, ZILRETTA and iovera° and our ability to serve those
markets; our plans to expand the use of EXPAREL, ZILRETTA and
iovera° to additional indications and opportunities, and the timing
and success of any related clinical trials for EXPAREL, ZILRETTA
and iovera°; the commercial success of EXPAREL, ZILRETTA and
iovera°; the related timing and success of U.S. Food and Drug
Administration supplemental New Drug Applications and premarket
notification 510(k)s; the related timing and success of European
Medicines Agency Marketing Authorization Applications; our plans to
evaluate, develop and pursue additional product candidates
utilizing our proprietary multivesicular liposome (“pMVL”) drug
delivery technology; the approval of the commercialization of our
products in other jurisdictions; clinical trials in support of an
existing or potential pMVL-based product; our commercialization and
marketing capabilities; our ability to successfully complete an
EXPAREL capacity expansion project in San Diego, California; our
ability to successfully complete a ZILRETTA capital project in
Swindon, England; the outcome of any litigation; the ability to
successfully integrate any future acquisitions into our existing
business; the recoverability of our deferred tax assets;
assumptions associated with contingent consideration payments; and
factors discussed in the “Risk Factors” of our most recent Annual
Report on Form 10-K and in other filings that we periodically make
with the Securities and Exchange Commission (the “SEC”). In
addition, the forward-looking statements included in this press
release represent our views as of the date of this press release.
Important factors could cause actual results to differ materially
from those indicated or implied by forward-looking statements, and
as such we anticipate that subsequent events and developments will
cause our views to change. Except as required by applicable law, we
undertake no intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, and readers should not rely on these
forward-looking statements as representing our views as of any date
subsequent to the date of this press release.
These forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause our actual
results, levels of activity, performance or achievements to differ
materially from those expressed or implied by these statements.
These factors include the matters discussed and referenced in the
“Risk Factors” of our most recent Annual Report on Form 10-K and in
other filings that we periodically make with the SEC.
Investor Contact:
Susan Mesco, (973) 451-4030
susan.mesco@pacira.com
Media Contact:
Amber Sears, (973) 254-3587
amber.sears@pacira.com
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