Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its
commitment to deliver innovative, non-opioid pain therapies to
transform the lives of patients, today announced its five-year
growth-oriented plan to accelerate its ongoing transition into an
innovative biopharmaceutical organization and become a therapeutic
area leader in musculoskeletal pain and adjacencies. In addition,
the company reported preliminary unaudited total revenue of $701.0
million for the year ended December 31, 2024, compared with $675.0
million for the year ended December 31, 2023.
5x30 Path to growth and value
creation
The company intends to achieve the following five
objectives by 2030 (“5x30”):
- Patients: More than three million
patients treated per year
- Product revenue: Double-digit
compounded annual growth rate
- Profitability: Five percentage point
gross margin improvement over 2024
- Pipeline: Clinical pipeline expansion
with five novel programs in development
- Partnerships: Establishing five
partnerships including pipeline and commercial agreements
“We enter 2025 with a sharp focus on growth,
operational excellence and a clear mission to deliver innovative,
non-opioid pain therapies to transform the lives of patients,” said
Frank D. Lee, chief executive officer of Pacira BioSciences.
“Looking ahead, I am energized to lead Pacira during this exciting
new chapter as we advance our 5x30 plan to address unmet patient
needs in musculoskeletal pain and adjacencies. With a best-in-class
commercial portfolio that is producing significant cash flow, we
believe we are well equipped to extend our leadership in non-opioid
pain management and transform Pacira into an innovative
biopharmaceutical organization with a robust pipeline to support
sustainable growth and enhanced value creation.”
Preliminary Unaudited Fourth Quarter
Revenue Highlights
- Fourth quarter
EXPAREL net product sales of $147.7 million in 2024, compared with
$143.9 million in 2023. Volume growth and a price increase in 2024
were partially offset by a shift in vial mix and discounting
associated with the company’s new group purchasing organization, or
GPO, partnerships.
- Fourth quarter
ZILRETTA net product sales of $33.1 million in 2024, compared with
$28.7 million in 2023.
- Fourth quarter
iovera° net product sales of $6.5 million in 2024, compared with
$6.0 million in 2023.
- Other revenue,
including sales of bupivacaine liposome injectable suspension and
royalties, was zero in the fourth quarter of 2024, compared with
$2.6 million in the fourth quarter of 2023.
Preliminary Unaudited Full-year Revenue
Highlights
- Full-year EXPAREL
net product sales of $549.0 million in 2024, compared with $538.1
million in 2023. Full-year net product sales were comprised of
average daily volume growth of 4 percent. There were 249 selling
days in 2024 and 250 selling days in 2023.
- Full-year ZILRETTA
net product sales of $118.1 million in 2024, compared with $111.1
million in 2023.
- Full-year iovera°
net product sales of $22.8 million in 2024, compared with $19.7
million in 2023.
- Other revenue,
including sales of bupivacaine liposome injectable suspension and
royalties, was $11.1 million in 2024, compared with $6.1 million in
2023.
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
2024. Pacira expects to report its complete financial results for
the fourth quarter and full-year 2024, along with the company’s
financial guidance, later in the first quarter of 2025.
Inducement Grants Under Nasdaq Listing Rule
5635(c)(4)
Pacira today announced the granting of inducement
awards on January 3, 2025 to eight new employees under Pacira’s
Amended and Restated 2014 Inducement Plan as a material inducement
to each employee's entry into employment with the company. In
accordance with Nasdaq Listing Rule 5635(c)(4), the awards were
approved by the Compensation Committee of the Board of
Directors.
Four employees received stock options to purchase
an aggregate of 20,300 shares of Pacira common stock and eight
employees received restricted stock units for an aggregate of
30,400 shares of Pacira common stock.
The stock options have a 10-year term and a
four-year vesting schedule with 25 percent of the underlying shares
vesting on the first anniversary of the recipient’s first day of
employment and in successive equal quarterly installments over the
36 months thereafter. The stock options have an exercise price of
$18.40 per share, the closing trading price of Pacira common stock
on the Nasdaq Global Select Market on the date of grant. Each
restricted stock unit represents the contingent right to receive
one share of Pacira common stock and the restricted stock unit
awards vest annually in four equal installments beginning on the
first anniversary of January 2, 2025.
Vesting of the equity awards is subject to the
employee’s continued employment with Pacira. Each equity award is
also subject to the terms and conditions of an award agreement.
About Pacira
Pacira delivers innovative, non-opioid pain
therapies to transform the lives of patients. 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, an adductor canal nerve
block, and a sciatic nerve block in the popliteal fossa 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.
The company is also advancing the development of PCRX-201, a novel
locally administered gene therapy with the potential to treat large
prevalent diseases like osteoarthritis. To learn more about Pacira,
visit www.pacira.com.
About EXPAREL®
(bupivacaine liposome injectable suspension)
EXPAREL is indicated to produce postsurgical local
analgesia via infiltration in patients aged 6 years and older, and
postsurgical regional analgesia via an interscalene brachial plexus
block in adults, a sciatic nerve block in the popliteal fossa in
adults, and an adductor canal block in adults. The safety and
effectiveness of EXPAREL have not been established to produce
postsurgical regional analgesia via other nerve blocks besides an
interscalene brachial plexus nerve block, a sciatic nerve block in
the popliteal fossa, or an adductor canal block. 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®
(triamcinolone acetonide extended-release injectable
suspension)
On October 6, 2017, ZILRETTA 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 is used to destroy tissue during
surgical procedures by applying freezing cold. It can also be used
to produce lesions in peripheral nervous tissue by the application
of cold to the selected site for the blocking of pain. It is also
indicated for the relief of pain and symptoms associated with
osteoarthritis of the knee for up to 90 days. In one study, the
majority of the patients suffering from osteoarthritis of the knee
experienced pain and system relief beyond 150 days. When
stimulation compatible components are used, the iovera° system can
also facilitate targeting nerve location by conducting electrical
nerve stimulation from a compatible 3rd party nerve stimulator. The
iovera° system is not indicated for treatment of central nervous
system tissue.
Indication and Select Important Safety
Information for iovera°®
Indication: iovera° applies
freezing cold to peripheral nerve tissue to block and/or relieve
pain for up to 90 days. It should not be used to treat central
nervous system tissue.
Important Safety Information
- Do not receive treatment with iovera° if you experience
hypersensitivity to cold or have open and/or infected wounds near
the treatment site.
- You may experience bruising, swelling, inflammation and/or
redness, local pain and/or tenderness, and altered feeling at the
site of application.
- In treatment area(s), you may experience damage to the skin,
skin darkening or lightening, and dimples in the skin.
- You may experience a temporary loss of your ability to use your
muscles normally outside of the treatment area.
- Talk to your doctor before receiving treatment with
iovera°.
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 ‘5x30’, our
growth and business strategy, our future outlook, contributions of
new executives, our intellectual property and patent terms, our
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, development of products,
strategic alliances, plans with respect to the Non-Opioids Prevent
Addiction in the Nation (“NOPAIN”) Act 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: 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; 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 capital projects; 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; assumptions used for estimated future cash
flows associated with determining the fair value of the Company;
the anticipated funding or benefits of our share repurchase
program; 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. These forward-looking statements involve
known and unknown risks, uncertainties and other important factors
that 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.
Investor Contact:Susan Mesco, (973)
451-4030susan.mesco@pacira.com |
|
Media Contact:Sara Marino, (973)
370-5430sara.marino@pacira.com |
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