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PACIRA BIOSCIENCES, INC.

(PCRX)
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PACIRA BIOSCIENCES, INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q)

08/03/2022 | 03:49pm EDT
Management's Discussion and Analysis of Financial Condition and Results of
Operations is based upon our condensed consolidated financial statements, which
have been prepared in accordance with generally accepted accounting principles
in the United States of America (GAAP) and in accordance with the rules and
regulations of the United States Securities and Exchange Commission, or SEC.

This Quarterly Report on Form 10-Q and certain other communications made by us
contain 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: the Flexion Acquisition (as defined below) and the costs
and benefits thereof, our growth and future operating results and trends, our
strategy, plans, objectives, expectations (financial or otherwise) and
intentions, future financial results and growth potential, anticipated product
portfolio, development programs, strategic alliances, patent terms and
intellectual property. For this purpose, any statement that is not a statement
of historical fact should be considered a forward-looking statement. We often
use the words "believe," "anticipate," "plan," "estimate," "expect," "intend,"
"may," "will," "would," "could," "can" and similar expressions to help identify
forward-looking statements. We cannot assure you that our estimates, assumptions
and expectations will prove to have been correct. Actual results may differ
materially from these 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 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 possibility that if we do not achieve the
perceived benefits of the Flexion Acquisition as rapidly or to the extent
anticipated by financial analysts or investors, the market price of our shares
could decline; the impact of the COVID-19 pandemic on elective surgeries, our
manufacturing and supply chain, global and United States, or U.S., economic
conditions, and our business, including our revenues, financial condition and
results of operations; the success of our sales and manufacturing efforts in
support of the commercialization of EXPAREL® (bupivacaine liposome injectable
suspension), ZILRETTA® (triamcinolone acetonide extended-release injectable
suspension) and iovera°® and 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 United States Food and Drug
Administration, or FDA, supplemental New Drug Applications, or sNDAs, and
premarket notification 510(k)s; the related timing and success of European
Medicines Agency, or EMA, Marketing Authorization Applications, or MAA; our
plans to evaluate, develop and pursue additional product candidates utilizing
our proprietary multivesicular liposome, or 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
construct an additional EXPAREL manufacturing suite in San Diego, California;
our ability to successfully complete a ZILRETTA capacity expansion project in
Swindon, England; the outcome of any litigation; the ability to successfully
integrate Flexion or any future acquisitions into our existing business; the
recoverability of our deferred tax assets; and assumptions associated with
contingent consideration payments. Important factors could cause our 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 the forward-looking statements as representing
our views as of any date subsequent to the date of the filing of this Quarterly
Report on Form 10-Q.

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 items mentioned herein and the
matters discussed and referenced in Part I-Item 1A. "Risk Factors" included in
our   Annual Report on Form 10-K for the year ended December 31, 2021   and in
other reports as filed with the SEC.

Unless the context requires otherwise, references to "Pacira," "we," the "Company," "us" and "our" in this Quarterly Report on Form 10-Q refer to Pacira BioSciences, Inc. and its subsidiaries.

             Pacira BioSciences, Inc. | Q2 2022 Form 10-Q | Page 32
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Overview

Pacira is the industry leader in our commitment to non-opioid pain management
and providing a non-opioid option to as many patients as possible to redefine
the role of opioids as rescue therapy only. We are also developing innovative
interventions to address debilitating conditions involving the sympathetic
nervous system, such as cardiac electrical storm, chronic pain and spasticity.
Our long-acting, local analgesic EXPAREL® (bupivacaine liposome injectable
suspension) was commercially launched in April 2012. EXPAREL utilizes our unique
pMVL drug delivery technology that encapsulates drugs without altering their
molecular structure and releases them over a desired period of time. In the
U.S., EXPAREL is the only opioid-free, long-acting local and regional analgesic
approved for infiltration, field blocks and interscalene brachial plexus nerve
block to produce local or regional postsurgical analgesia. EXPAREL is also
approved for infiltration in pediatric patients aged six years and older in the
U.S. In Europe, EXPAREL is approved as a brachial plexus block or femoral nerve
block for treatment of post-operative pain in adults, and as a field block for
treatment of somatic post-operative pain from small- to medium-sized surgical
wounds in adults. Since its initial approval in 2011, more than 10 million
patients have been treated with EXPAREL. We drop-ship EXPAREL directly to
end-users based on orders placed to wholesalers or directly to us, and there is
no product held by wholesalers. With the acquisition (the "Flexion Acquisition")
of Flexion Therapeutics, Inc. ("Flexion") in November 2021, we acquired
ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), the
first and only extended-release, intra-articular therapy that can provide major
relief for osteoarthritis, or OA, knee pain for three months and has the
potential to become an alternative to hyaluronic acid, or HA, and platelet rich
plasma, or PRP, injections or other early intervention treatments. With the
acquisition of MyoScience, Inc. (the "MyoScience Acquisition") in April 2019, we
acquired iovera°®, a handheld cryoanalgesia device used to deliver a precise,
controlled application of cold temperature only to targeted nerves, which we
sell directly to end users. The iovera° system is highly complementary to
EXPAREL as a non-opioid therapy that alleviates pain by disrupting pain signals
being transmitted to the brain from the site of injury or surgery. We also
believe ZILRETTA is highly complementary to iovera°.

We expect to continue to pursue the expanded use of EXPAREL, ZILRETTA and
iovera° in additional procedures; progress our earlier-stage product candidate
pipeline; advance regulatory activities for EXPAREL, ZILRETTA, iovera° and other
product candidates; invest in sales and marketing resources for EXPAREL,
ZILRETTA and iovera°; expand and enhance our manufacturing capacity for EXPAREL,
ZILRETTA and iovera°; invest in products, businesses and technologies; and
support legal matters.

Flexion Acquisition


In November 2021, we completed the Flexion Acquisition pursuant to an Agreement
and Plan of Merger (the "Merger Agreement"), under which Flexion became our
wholly owned subsidiary and added ZILRETTA, a non-opioid corticosteroid that
employs a proprietary microsphere technology to provide extended pain relief, to
our commercial offering. The addition of ZILRETTA to our innovative non-opioid
product portfolio directly aligns with our mission to provide an opioid
alternative to as many patients as possible and address medical needs along the
neural pain pathway.

The total consideration of $578.8 million included an initial payment of $428.3
million which represented $8.50 in cash per share of Flexion common stock, $20.2
million paid to settle restricted stock units and in-the-money stock options, an
$85.1 million cash payment to repay Flexion debt that was not assumed by us and
$45.2 million in contingent consideration representing the fair value of
contingent value rights, or CVRs, that were issued in conjunction with the
Flexion Acquisition. The Merger Agreement provided for one non-tradeable CVR per
share of Flexion common stock as well as one CVR per share for certain Flexion
equity awards. Each CVR entitles Flexion shareholders to contingent milestone
payments of up to an aggregate of $8.00 in cash per share of Flexion common
stock if certain milestones are met on or prior to December 31, 2030. Up to an
additional $380.2 million in the aggregate may be payable to holders of the CVRs
if each of the applicable milestones are achieved. For more information, see
Note 4, Flexion Acquisition, to our condensed consolidated financial statements
included herein.

Coronavirus (COVID-19) Pandemic and Global Economic Conditions


Since early 2020, our revenues have been impacted by COVID-19 pandemic-related
challenges that included the significant postponement or suspension in the
scheduling of elective surgical procedures due to public health guidance and
government directives. While the degree of impact has diminished during the
course of the pandemic due to the introduction of vaccines and therapeutics, as
well as the lessening of elective surgery restrictions, certain pandemic-related
operational and staffing challenges persist. It remains unclear how long it will
take the elective surgery market to normalize or if restrictions on elective
procedures will recur due to future COVID-19 variants or otherwise. Direct
effects of the pandemic and global economic conditions may negatively impact our
business, financial condition and results of operations. Such impacts may
include the effect of prolonged periods of inflation on our customers and
suppliers and longer lead-times or the inability to
             Pacira BioSciences, Inc. | Q2 2022 Form 10-Q | Page 33
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secure a sufficient supply of materials. The situation remains dynamic and
subject to rapid and possibly material changes. Additional negative impacts may
also arise that we are unable to foresee. The nature and extent of such impacts
will depend on future developments, which are highly uncertain and cannot be
predicted.

We will continue to actively monitor the situation and implement measures
recommended by federal, state or local authorities, or that we determine are in
the best interests of our patients, employees, partners, suppliers, shareholders
and stakeholders. For a description of risks facing us that relate to the
COVID-19 pandemic or any other future pandemic, epidemic or outbreak of
contagious disease, see our   Annual Report on Form 10-K for the year ended
December 31, 2021  .

Recent Highlights

•The U.S. Patent and Trademark Office issued Patent Nos. 11,304,904, and
11,311,486 in April 2022, and issued Patent No. 11,357,727 in June 2022. The
'904, '486, and '727 patents are listed in the FDA Approved Drug Products with
Therapeutic Equivalence Evaluations (the "Orange Book"). With these three new
patents, there are currently six EXPAREL patents listed in the Orange Book, each
with an expiration date of January 22, 2041.

•In June 2022, we announced the launch of a partnership with the National Safety
Council, or NSC, and the Connect2Prevent program. Connect2Prevent is an
innovative employee-family educational program that increases awareness and
prevention of opioid addiction. The NSC created a comprehensive curriculum
designed to educate employees on the risks associated with opioids and provide
them with the tools to have meaningful discussions with adolescent family
members. The curriculum includes 10-12 weeks of engaging lessons on opioids,
addiction, stigma, risk factors for substance use, refusal skills, harm
reduction, how to talk to doctors about opioid alternatives and more. The
lessons provide easy-to-understand education, action steps and evidence-based
tools to connect and communicate with teens.

•In August 2022, we announced the completion of patient enrollment in our two
Phase 3 studies of EXPAREL as a nerve block in lower extremity surgeries. The
first study is evaluating EXPAREL as an adductor canal block for total knee
arthroplasty, or TKA, and the second is evaluating EXPAREL as a popliteal
sciatic nerve block for bunionectomy. We believe positive results from these
studies will form the basis for an sNDA submission seeking label expansion to
include lower extremity nerve blocks.

EXPAREL


In the U.S., EXPAREL is currently indicated in patients six 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. In the E.U., EXPAREL is indicated as a brachial plexus block and femoral
nerve block for treatment of post-operative pain in adults, and as a field block
for treatment of somatic post-operative pain from small- to medium-sized
surgical wounds in adults.

EXPAREL Label and Global Expansion


•Lower extremity nerve block. We have completed enrollment in two Phase 3
registration studies of EXPAREL as a nerve block in lower extremity surgeries.
One is a popliteal sciatic nerve block for bunionectomy and the second is an
adductor canal block for TKA. We believe positive results from these studies
will form the basis for an sNDA submission seeking label expansion to include
lower extremity nerve blocks. We believe the addition of this indication is
significant as anesthesia-driven regional approaches using nerve and field
blocks continue to expand as institutional protocols.

•Pediatrics. We are working with the FDA to finalize our studies to support
expansion of the EXPAREL single-dose infiltration label to include patients
under six years of age. We have met with the FDA to discuss appropriate studies
of EXPAREL in pediatric patients aged 0 to less than 6 years of age. We expect
that these studies, if successful, will be the basis for an sNDA seeking
expansion of the EXPAREL label to include this patient population for
single-dose infiltration. We are also discussing our regulatory strategy for
EXPAREL administered as a nerve block in the pediatric setting. We are working
with both the FDA and the European Medicines Agency, or EMA, with the goal of
harmonizing our pediatric clinical studies as much as possible between the two
regions.

•Stellate ganglion block. Planning is underway for a multicenter registration
study of EXPAREL as a stellate ganglion block for treating refractory cardiac
ventricular dysrhythmias and for use to prevent postoperative atrial
fibrillation after open heart surgery. We are working with a steering committee
of Key Opinion Leaders in regional anesthesia and
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stellate ganglion blocks who will convene later this year to help finalize study
design. After an FDA meeting to align on our regulatory strategy for expanding
the EXPAREL label to include stellate ganglion block, we expect to proceed with
a registration trial. We believe a stellate ganglion block utilizing EXPAREL
will last for several days and address a significant unmet need in patients with
ventricular and atrial dysrhythmias.

•Global expansion. We have prioritized the European and Latin American markets
for global expansion. In Europe, we were granted marketing authorization by the
EC in November 2020 for EXPAREL as a brachial plexus block or femoral nerve
block for treatment of post-operating pain in adults and as a field block for
treatment of somatic post-operative pain from small- to medium-sized surgical
wounds in adults. We launched EXPAREL in the U.K. and targeted E.U. countries in
the fourth quarter of 2021. In Latin America, we have a distribution agreement
with Eurofarma Laboratories S.A., or Eurofarma, for the development and
commercialization of EXPAREL. Eurofarma has the exclusive right to market and
distribute EXPAREL in 19 countries in Latin America, including Argentina,
Brazil, Colombia and Mexico. In addition, Eurofarma will be responsible for
regulatory filings for EXPAREL in these countries. We will receive royalties and
are also eligible to receive regulatory- and commercial-based milestone payments
that are triggered by the achievement of certain events.

ZILRETTA


ZILRETTA was approved by the FDA in October 2017 and launched in the U.S.
shortly thereafter. We market ZILRETTA through our ZILRETTA and iovera° sales
force of approximately 50 Treatment Solutions Managers who are providing
clinicians with two unique OA treatment options to individualize patient care.
ZILRETTA is the first and only extended-release, intra-articular therapy for
patients confronting OA knee pain. ZILRETTA employs a proprietary microsphere
technology combining triamcinolone acetonide, or TA, a commonly administered,
immediate-release corticosteroid, with a poly lactic-co-glycolic acid, or PLGA,
matrix to provide extended pain relief. PLGA is a proven extended-release
delivery vehicle that is metabolized to carbon dioxide and water as it releases
drug in the intra-articular space and is used in other approved drug products
and surgical devices. The ZILRETTA microspheres slowly and continuously release
triamcinolone acetonide into the knee to provide significant pain relief for 12
weeks, with some people experiencing pain relief through 16 weeks.

We believe ZILRETTA's extended-release profile may also provide effective
treatment for OA pain of the shoulder, and we intend to initiate a Phase 3 trial
investigating ZILRETTA in shoulder OA in 2023 after aligning with the FDA on
study design. In addition, we are planning a study comparing ZILRETTA to
immediate release triamcinolone acetonide in patients with Type 2 diabetes and
are evaluating a repeat dosing study.

ZILRETTA Clinical Benefits


ZILRETTA combines a commonly administered steroid, TA, with PLGA, delivering a
32 milligram dose of TA to provide extended therapeutic concentrations in the
joint and persistent analgesic effect.

Based on the strength of its pivotal and other clinical trials, we believe that
ZILRETTA represents an important treatment option for the millions of patients
in the U.S. in need of safe and effective extended relief from OA knee pain. 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. Both the magnitude and duration of
pain relief provided by ZILRETTA in clinical trials were clinically meaningful
with the magnitude of pain relief amongst the largest seen to date in OA
clinical trials. The overall frequency of treatment-related adverse events in
these trials was similar to those observed with placebo, and no drug-related
serious adverse events were reported. We believe that ZILRETTA holds the
potential to become the corticosteroid of choice given its safety and efficacy
profile, and the fact that it is the first and only extended-release
corticosteroid on the market. In September 2021, the American Association of
Orthopaedic Surgeons, or AAOS, updated its evidence-based clinical practice
guidelines, finding ZILRETTA can improve patient outcomes over traditional
immediate-release corticosteroids.

iovera°


The iovera° system is an FDA-approved, non-opioid handheld cryoanalgesia device
used to produce precise, controlled doses of cold temperature only to targeted
nerves. It has been FDA 510(k) cleared in the U.S., has a CE mark in the E.U.
and is cleared for marketing in Canada for the blocking of pain. We believe the
iovera° system is highly complementary to EXPAREL and ZILRETTA as a non-opioid
therapy that alleviates pain using a non-pharmacological nerve block to disrupt
pain signals being transmitted to the brain from the site of injury or surgery.
It is also indicated for the relief of pain and symptoms associated with
arthritis of the knee for up to 90 days.

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iovera° Clinical Benefits

There is a growing body of clinical data demonstrating success with iovera°
treatment for OA of the knee. Surgical intervention is typically a last resort
for patients suffering from OA of the knee. In one study, the majority of the
patients suffering from OA of the knee experienced pain relief up to 150 days
after being treated with iovera°.

Preliminary findings demonstrated reductions in opioids, including:

•The daily morphine equivalent consumption in the per protocol group analysis was significantly lower at 72 hours (p<0.05), 6 weeks (p<0.05) and 12 weeks (p<0.05).


•Patients who were administered iovera° were far less likely to take opioids six
weeks after surgery. The number of patients taking opioids six weeks after TKA
in the control group was three times the number of patients taking opioids in
the cryoanalgesia group (14% vs. 44%, p<0.01).

•Patients in the iovera° group demonstrated a statistically significant reduction in pain scores from their baseline pain scores at 72 hours (p<0.05) and at 12 weeks (p<0.05).


We believe these data validate iovera° as a clinically meaningful non-opioid
alternative for patients undergoing TKA, and that iovera° offers the opportunity
to provide patients with non-opioid pain control well in advance of any
necessary surgical intervention through a number of key product attributes:

•iovera° is safe and effective with immediate pain relief that can last for months as the nerve regenerates over time;

•iovera° is repeatable;

•The iovera° technology does not risk damage to the surrounding tissue;

•iovera° is a convenient handheld device with a single-use procedure-specific Smart Tip; and

•iovera° can be delivered precisely using ultrasound guidance or an anatomical landmark.

In September 2021, the AAOS updated its evidence-based clinical practice guidelines, reporting that denervation therapy-including cryoneurolysis-may reduce knee pain and improve function in patients with symptomatic OA of the knee.


We are also encouraged by usage of iovera° in other areas. Key opinion leaders
in orthopedics, spine and anesthesia are interested in replacing heat-based
radiofrequency ablation with iovera° cold therapy. There is interest across a
wide range of treatment opportunities such as low back pain, spine, spasticity
and rib fracture. We intend to use investigator-initiated studies and grants to
develop data across these areas.

iovera° Global Expansion


In July 2021, we entered into a licensing agreement with Verve Medical Products,
Inc. for the distribution of iovera° in Canada. We began selling iovera° in
Canada in the fourth quarter of 2021. Additionally, we began selling iovera° in
the E.U. through a contracted sales force in the first quarter of 2022.

The Osteoarthritis Market


OA is the most common form of arthritis. It is also called degenerative joint
disease and occurs most frequently in the hands, hips and knees. With OA, the
cartilage within a joint begins to break down and the underlying bone begins to
change. These changes usually develop slowly and get worse over time. OA can
cause pain, stiffness and swelling. In some cases it also causes reduced
function and disability; some people are no longer able to do daily tasks or
work. According to the CDC, OA affects over 32.5 million adults in the U.S.

The lifetime risk of developing symptomatic knee OA is 45 percent. The
prevalence of symptomatic knee OA increases with each decade of life, with the
annual incidence of knee OA being highest between age 55 and 64 years old. There
are 14 million individuals in the U.S. who have symptomatic knee OA, and nearly
two million are under the age of 45. Surgical intervention is typically a last
resort for patients suffering from OA of the knee.

With the addition of ZILRETTA to our product offering, we can now offer
clinicians the flexibility to individualize OA knee pain treatment with either
ZILRETTA or a drug-free nerve block with iovera° based on patient factors and
preference, physician training, site of care and reimbursement considerations.

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Clinical Development Programs

PCRX-201 and PCRX-301 (Formerly FX-201 and FX-301)


PCRX-201 and PCRX-301 were added to our portfolio as part of the Flexion
Acquisition. PCRX-201 is a gene therapy product candidate designed to provide
"on demand" production of an anti-inflammatory protein, interleukin-1 receptor
antagonist (IL-1Ra) whenever inflammation is detected in the joint. PCRX-301, is
a locally administered NaV1.7 inhibitor, known as funapide, formulated for
extended release in a thermosensitive hydrogel. The initial development of
PCRX-301 was intended to support administration as a peripheral analgesic lower
extremity nerve block for management of post-operative pain.

pMVL-Based Clinical Programs


Given the proven safety, flexibility and customizability of our pMVL drug
delivery technology platform for acute, sub-acute and chronic pain applications,
we have several pMVL-based products in clinical development. Following data
readouts from preclinical and feasibility studies for these candidates, we have
prioritized three programs for clinical development: (i) PCRX-401, a
dexamethasone-pMVL for low back pain; (ii) PCRX-501, a high potency
bupivacaine-pMVL for longer-lasting pain relief (20.0 mg/mL) and (iii) a
bupivacaine-pMVL for intrathecal analgesia (13.3 mg/mL). We are planning to
initiate the second half of our Phase 1 study of low-concentration
bupivacaine-pMVL for intrathecal analgesia in late 2022.

External Innovation


In parallel to our internal clinical programs, our business development team
continues to pursue innovative acquisition targets that are complementary to
EXPAREL, ZILRETTA and iovera° and that we believe are of great interest to the
surgical and anesthesia audiences we are already calling on today. We are using
a combination of strategic investments, in-licensing and acquisition
transactions to build out a pipeline of innovation to improve patients' journeys
along the neural pain pathway. Select strategic investments we have made to
support promising early stage platforms are summarized below.

             Company                 Development Stage          Description of Platform Technology          Potential Therapeutic
                                                                                                                    Areas
                                                           CX-011, an

intra-articular injection designed

         Carthronix, Inc.               Preclinical        to slow joint degeneration by mediating IL-6            Knee OA
                                                                            

cytokines

                                                           Chemogenetic 

platform to reverse the aberrant

     Coda Therapeutics, Inc.            Preclinical          neuronal 

activity underlying neurological Neuropathic pain

                                                            disorders using optimized Adeno-Associated
                                                                        Virus (AAV) vectors
      Genascence Corporation              Phase 1             AAV vector-based gene therapy targeting              Knee OA
                                                            Interleukin 1 

Receptor Antagonist (IL-1Ra)

                                                            Next-generation 

gene transfer vehicles that OA and other

GeneQuine Biotherapeutics GmbH Preclinical enter joint cells to confer multi-year gene musculoskeletal disorders

                                                                            expression
                                                          Remedisc 7-amino acid chain peptide that binds
       Spine BioPharma, LLC            Phase 3-ready      to and induces

down regulation of transforming Degenerative disc disease

                                                                   growth factor, beta 1 (TGF?1)



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Product Portfolio and Internal Pipeline

Our current product portfolio and internal product candidate pipeline, along
with anticipated milestones over the next 12 to 18 months, are summarized in the
table below:

[[Image Removed: pcrx-20220630_g2.jpg]]
* Study designs have not been finalized for infiltration in pediatric patients
aged 0 to 6 years old or for nerve block in pediatric patients.
- NOCITA® is a registered trademark of Aratana Therapeutics, Inc., a wholly
owned subsidiary of Elanco Animal Health, Inc.


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Pacira Training Facilities

In October 2020, we opened the Pacira Innovation and Training center of Tampa
(the "PITT"). We designed this facility to help advance clinician understanding
of the latest local, regional and field block approaches for managing pain. The
PITT provides an unparalleled training environment for healthcare providers
working to reduce or eliminate patient exposure to opioids. The PITT supports a
full range of educational events to advance clinician understanding of the
latest local, regional, and field block approaches for managing pain and
reducing or eliminating exposure to opioids. Our corporate headquarters are also
located at the PITT.

The PITT consists of approximately 13,000 square-feet of fully adaptable space
and is equipped with state-of-the-art technology and audio/visual capabilities
and features several distinct training spaces including a simulation lab
equipped with seven ultrasound scanning stations; a lecture hall featuring a
4½-foot tall by 24-foot wide liquid crystal display video wall to support live,
virtual and even global presentations; and a green-screen broadcast studio
designed to livestream content with single or multiple hosts.

In addition to our EXPAREL programs, we are hosting ongoing workshops to train
new users on best practice techniques for iovera° administration at the PITT.
Led by healthcare professionals, these labs include didactic lectures and
hands-on trainings including live model nerve scanning and identification using
ultrasound and peripheral nerve stimulation.

At no fee to the organization, the PITT also serves as a venue for national anesthesia provider organizations to host their own workshops and training sessions to educate healthcare providers.


We have launched development plans for a second training facility in Houston,
Texas. This 19,000 square-foot state-of-the-art facility will feature an
adaptive lecture hall, broadcast studio and lab space for cadaver and other
interactive workshops. These training centers are core to developing both our
physician champions and community-based clinicians who want to stay on the
forefront of opioid-sparing pain management. We expect to open this facility
before the end of 2022 which would immediately double our capacity and ability
to host programs for EXPAREL, ZILRETTA and iovera°.

Results of Operations

Comparison of the Three and Six Months Ended June 30, 2022 and 2021

Revenues


Net product sales consist of (i) EXPAREL in the U.S., the European Union, or
E.U., and the United Kingdom, or U.K.; (ii) ZILRETTA in the U.S.; (iii) iovera°
in the U.S., Canada and the E.U. and (iv) sales of, and royalties on, our
bupivacaine liposome injectable suspension for veterinary use.

The following table provides information regarding our revenues during the periods indicated, including percent changes (dollar amounts in thousands):

                                       Three Months Ended                                                      Six Months Ended
                                            June 30,                                                               June 30,
                                     2022               2021            % Increase / (Decrease)             2022               2021            % Increase / (Decrease)
Net product sales:
EXPAREL                          $ 137,007          $ 130,058                      5%                   $ 266,212          $ 244,736                      9%
ZILRETTA                            27,417                  -                     N/A                      51,052                  -                     N/A
iovera°                              3,201              3,813                    (16)%                      6,227              7,081                    (12)%
Bupivacaine liposome injectable
suspension                             956                992                     (4)%                      2,512              1,784                     41%
Total net product sales            168,581            134,863                     25%                     326,003            253,601                     29%
Royalty revenue                        830                602                     38%                       1,399                891                     57%
Collaborative licensing and
milestone revenue                        -                125                    (100)%                         -                125                    (100)%
Total revenues                   $ 169,411          $ 135,590                     25%                   $ 327,402          $ 254,617                     29%


EXPAREL revenue increased 5% and 9% in the three and six months ended June 30,
2022 versus 2021, respectively, primarily due to increases of 3.6% and 7.2% in
gross vial volume and increases of 3.7% and 3.8% in gross selling price per
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unit, partially offset by the sales mix of EXPAREL vial sizes. Although the
demand for EXPAREL has continued to increase primarily as a result of Ambulatory
Surgical Centers and anesthesiologists broadening the use of long-acting EXPAREL
regional approaches as a foundation of multimodal opioid-minimization strategies
that enable shifting inpatient procedures to 23-hour sites of care, the elective
surgery market has faced additional pandemic-related challenges due to regional
surges in COVID-19 variant cases, staffing shortages and fatigue from care teams
addressing significant procedure backlogs. EXPAREL utilization remains above the
overall sharp decline in elective surgical procedures relative to pre-pandemic
baseline levels due to increased utilization in outpatient settings and emergent
procedures.

As a result of the Flexion Acquisition, we acquired ZILRETTA in November 2021,
which is an extended-release corticosteroid treatment for OA knee pain. We
recognized net product sales of $27.4 million and $51.1 million for the three
and six months ended June 30, 2022, respectively.

Net product sales of iovera° decreased 16% and 12% in the three and six months
ended June 30, 2022 versus 2021, respectively, primarily due to a delay in the
transition from generation 1 to generation 2 iovera° products and short-term
variations in reimbursement policies in certain territories.

Bupivacaine liposome injectable suspension net product sales decreased and its
related royalties increased nominally in the three months ended June 30, 2022
versus 2021. Bupivacaine liposome injectable suspension net product sales and
its related royalties increased in the six months ended June 30, 2022 versus
2021. These changes versus the prior year periods were due to the timing of
orders placed by Aratana Therapeutics, Inc. for veterinary use.

Any renewed government suspension of or reluctance of patients to have elective
procedures would impact our future sales of EXPAREL, ZILRETTA and iovera° during
the ongoing COVID-19 pandemic.

The following tables provide a summary of activity with respect to our sales related allowances and accruals related to EXPAREL and ZILRETTA for the six months ended June 30, 2022 and 2021 (in thousands):

                                                                                                       Volume
                                          Returns           Prompt Payment         Service           Rebates and           Government
June 30, 2022                           Allowances             Discounts             Fees            Chargebacks             Rebates              Total

Balance at December 31, 2021 $ 3,361 $ 1,178

      $ 3,636          $      3,494          $        761          $ 12,430
Provision                                      817                 5,470            8,123                19,191                   754            34,355
Payments / Adjustments                      (2,503)               (5,540)          (8,876)              (18,960)                 (740)          (36,619)
Balance at June 30, 2022              $      1,675          $      1,108          $ 2,883          $      3,725          $        775          $ 10,166


                                                                                                       Volume
                                          Returns           Prompt Payment         Service           Rebates and           Government
June 30, 2021                           Allowances             Discounts             Fees            Chargebacks            Rebates              Total

Balance at December 31, 2020 $ 1,023 $ 1,007

      $ 1,168          $      1,600          $         -          $  4,798
Provision                                      498                 5,050            3,806                 6,238                    -            15,592
Payments / Adjustments                        (261)               (4,631)          (3,846)               (5,814)                   -           (14,552)
Balance at June 30, 2021              $      1,260          $      1,426          $ 1,128          $      2,024          $         -          $  5,838


Total reductions of gross product sales from sales-related allowances and
accruals were $34.4 million and $15.6 million, or 9.6% and 5.8% of gross product
sales, for the six months ended June 30, 2022 and 2021, respectively. The
overall increase in sales-related allowances and accruals as a percentage of
gross product sales was primarily related to the addition of the
ZILRETTA-related allowances and accruals.
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Cost of Goods Sold


Cost of goods sold primarily relates to the costs to produce, package and
deliver our products to customers. These expenses include labor, raw materials,
manufacturing overhead and occupancy costs, depreciation of facilities, royalty
payments, quality control and engineering.

The following table provides information regarding our cost of goods sold and
gross margin during the periods indicated, including percent changes (dollar
amounts in thousands):

                                            Three Months Ended                                                      Six Months Ended
                                                 June 30,                                                               June 30,
                                          2022              2021            % Increase / (Decrease)              2022                2021            % Increase / (Decrease)
 Cost of goods sold                    $ 50,627          $ 35,248                     43%                   $       86,701       $     66,597                  30%
 Gross margin                                70  %             74  %                                                74   %             74   %


Gross margin decreased four percentage points in the three months ended June 30,
2022 versus 2021 mainly due to higher EXPAREL inventory reserves due to raw
material supply chain delays and the ZILRETTA step-up of fixed assets and
inventory to fair value in accordance with purchase accounting. There was no
change in gross margin in the six months ended June 30, 2022 versus 2021, when a
two percentage point increase due to the prior period's unplanned downtime was
offset by a two percentage point decrease due to higher EXPAREL inventory
reserves attributable to raw material supply chain delays.

Research and Development Expenses


Research and development expenses primarily consist of costs related to clinical
trials and related outside services, product development and other research and
development costs, including trials that we are conducting to generate new data
for EXPAREL, ZILRETTA and iovera° and stock-based compensation expense. Clinical
and preclinical development expenses include costs for clinical personnel,
clinical trials performed by third-parties, toxicology studies, materials and
supplies, database management and other third-party fees. Product development
and manufacturing capacity expansion expenses include development costs for our
products, which include personnel, equipment, materials and contractor costs for
process development and product candidates, development costs related to
significant scale-ups of our manufacturing capacity and facility costs for our
research space. Regulatory and other expenses include regulatory activities
related to unapproved products and indications, medical information expenses and
related personnel. Stock-based compensation expense relates to the costs of
stock option grants, awards of restricted stock units, or RSUs, and our employee
stock purchase plan, or ESPP.

The following table provides a breakout of our research and development expenses
during the periods indicated, including percent changes (dollar amounts in
thousands):
                                       Three Months Ended                                                      Six Months Ended
                                            June 30,                                                               June 30,
                                     2022              2021            % Increase / (Decrease)              2022                2021            % Increase / (Decrease)
Clinical and preclinical
development                       $ 17,734          $  5,111                    100%+                  $       31,174       $     13,131                 100%+
Product development and
manufacturing capacity expansion     5,080             4,607                     10%                           10,073              9,309                   8%
Regulatory and other                 1,948             1,526                     28%                            3,662              3,578                   2%
Stock-based compensation             1,520             1,329                     14%                            2,978              2,435                  22%
Total research and development
expense                           $ 26,282          $ 12,573                    100%+                  $       47,887       $     28,453                  68%
 % of total revenues                    16  %              9  %                                                15   %             11   %

Total research and development expense increased over 100% and 68% in the three and six months ended June 30, 2022 versus 2021, respectively.


Clinical and preclinical development expense increased over 100% in each of the
three and six months ended June 30, 2022 versus 2021, due to the start-up of and
continued enrollment in two EXPAREL lower extremity nerve block trials in
bunionectomy and TKA and ongoing trials for the product candidates acquired as
part of the Flexion Acquisition.

Product development and manufacturing capacity expansion expense increased 10%
and 8% in the three and six months ended June 30, 2022 versus 2021,
respectively, mainly attributable to the significant scale-up of our EXPAREL
manufacturing capacity at our Science Center Campus in San Diego, California.
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Regulatory and other expense increased 28% and 2% in the three and six months
ended June 30, 2022 versus 2021, respectively, due to increased support of E.U.
EXPAREL pediatric submissions, partially offset by lower ongoing costs in 2022
related to our iovera° clinical data registry, as compared to start-up expenses
incurred in the first half of 2021.

Stock-based compensation increased 14% and 22% in the three and six months ended
June 30, 2022 versus 2021, respectively, primarily due to greater equity awards
outstanding for research and development personnel.

Selling, General and Administrative Expenses


Sales and marketing expenses primarily consist of compensation and benefits for
our sales force and personnel that support our sales, marketing, medical and
scientific affairs operations, payments to our marketing partners for the
promotion and sale of our products, expenses related to communicating the health
outcome benefits of our products, investments in provider-level market access
and patient reimbursement support and educational programs for our customers.
General and administrative expenses consist of compensation and benefits for
legal, finance, regulatory activities related to approved products and
indications, compliance, information technology, human resources, business
development, executive management and other supporting personnel. It also
includes professional fees for legal, audit, tax and consulting services.
Stock-based compensation expense relates to the costs of stock option grants,
RSU awards and our ESPP.

The following table provides information regarding our selling, general and administrative expenses during the periods indicated, including percent changes (dollar amounts in thousands):

                                        Three Months Ended                                                      Six Months Ended
                                             June 30,                                                               June 30,
                                      2022              2021            % Increase / (Decrease)              2022                2021            % Increase / (Decrease)
 Sales and marketing               $ 36,854          $ 28,259                     30%                   $       75,294       $     55,361                  36%
 General and administrative          19,603            14,887                     32%                           37,044             28,755              

29%

 Stock-based compensation             8,546             7,667                     11%                           16,925             15,219              

11%

Total selling, general and
administrative expense             $ 65,003          $ 50,813                     28%                   $      129,263       $     99,335                  30%
 % of total revenues                     38  %             37  %                                                39   %             39   %

Total selling, general and administrative expenses increased 28% and 30% in the three and six months ended June 30, 2022 versus 2021, respectively


Sales and marketing expenses increased 30% and 36% in the three and six months
ended June 30, 2022 versus 2021, respectively. The increases were driven by a
sales force expansion supporting iovera°, the addition of a sales force to
support ZILRETTA and fully staffing a contracted sales force in Europe. We are
continuing our marketing investment in EXPAREL and iovera°, which includes
educational initiatives and programs related to the impact of opioids and
postsurgical pain management and our national advocacy campaign designed to
educate patients about non-opioid treatment options. Additionally, we continue
our investment in clinician training in the use of EXPAREL and iovera° at our
PITT training facility in Tampa, Florida. The addition of ZILRETTA to our
commercial portfolio has increased our sales and marketing spend in 2022 as we
increased the size of our ZILRETTA and iovera° sales force, which is providing
clinicians with two unique OA treatment options to individualize patient care
and patient reimbursement support for ZILRETTA.

General and administrative expenses increased 32% and 29% in the three and six
months ended June 30, 2022 versus 2021, respectively. The increases were driven
by administrative support costs as a result of the Flexion Acquisition in
November 2021, including transition expenses during integration, and additional
support for our expansion into European markets. The increase in the six months
ended June 30, 2022 also includes legal costs to support intellectual property
protection.

Stock-based compensation increased 11% in both the three and six months ended June 30, 2022 and 2021 primarily due to an increase in the number of equity awards outstanding for selling, general and administrative personnel.

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Amortization of Acquired Intangible Assets

The following table provides a summary of the amortization of acquired intangible assets during the periods indicated, including percent changes (dollar amounts in thousands):

                                       Three Months Ended                                                     Six Months Ended
                                            June 30,                                                              June 30,
                                      2022               2021           % Increase / (Decrease)             2022              2021           % Increase / (Decrease)
Amortization of acquired
intangible assets                $    14,322          $ 1,967                    100% +                 $  28,644          $ 3,933                    100% +


Amortization of acquired intangible assets increased substantially in the three
and six months ended June 30, 2022 versus 2021 due to the Flexion Acquisition.
We acquired a developed technology intangible asset for ZILRETTA for OA knee
pain, which is being amortized over a useful life of approximately ten years.
For more information, see Note 4, Flexion Acquisition, and Note 8, Goodwill and
Intangible Assets, to our condensed consolidated financial statements included
herein.

Acquisition-Related (Gains) Charges, Product Discontinuation and Other


The following table provides a summary of the costs related to the Flexion
Acquisition, MyoScience Acquisition, termination costs and other activities
during the periods indicated, including percent changes (dollar amounts in
thousands):

                                                  Three Months Ended                                                      Six Months Ended
                                                       June 30,                                                               June 30,
                                                 2022                2021           % Increase / (Decrease)             2022              2021           % Increase / (Decrease)
Acquisition-related (gains) charges, net   $     (18,058)         $   146                     N/A                   $ (13,721)         $  (981)                  (100)%+

Other                                                  -                -                     N/A                           -            3,000                    (100)%
Total acquisition-related (gains) charges,
product discontinuation and other          $     (18,058)         $   146                     N/A                   $ (13,721)         $ 2,019                     N/A


Total acquisition-related (gains) charges, product discontinuation and other
increased substantially in the three and six months ended June 30, 2022 versus
2021.

During the three and six months ended June 30, 2022, we recognized
acquisition-related gains, net of $18.1 million and $13.7 million, respectively.
These gains were primarily driven by reductions in acquisition contingent
consideration liabilities due to adjustments to near-term forecasts for the
applicable period during which the Flexion contingent consideration may be
achieved under the Merger Agreement and due to the reduced probability of
meeting the MyoScience contingent consideration milestones by December 31, 2023,
the expiration date for achieving the milestones. These gains were partially
offset by severance, legal fees, third-party services and other one-time charges
related to the Flexion Acquisition. For more information, see Note 10, Financial
Instruments, and Note 15, Acquisition-Related Charges, Product Discontinuation
and Other, to our condensed consolidated financial statements included herein.

In the three and six months ended June 30, 2021, as part of the MyoScience
Acquisition, we recognized acquisition-related charges of $0.1 million and gains
of $1.0 million, respectively, primarily related to changes in the fair value of
contingent consideration. See Note 10, Financial Instruments, to our condensed
consolidated financial statements included herein, for information regarding the
methods and key assumptions used in the fair value measurements of contingent
consideration.

In June 2018, we entered into an agreement with Nuance Biotech Co. Ltd. to
advance the development and commercialization of EXPAREL in China. In April
2021, we agreed to a mutual termination of the agreement due to the lack of a
viable regulatory pathway that adequately safeguards our intellectual property
against the risk of a generic product. Dissolution costs of $3.0 million were
included in other operating expenses in the condensed consolidated statements of
operations for the six months ended June 30, 2021.
             Pacira BioSciences, Inc. | Q2 2022 Form 10-Q | Page 43

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Other Income (Expense)

The following table provides information regarding other expense, net during the periods indicated, including percent changes (dollar amounts in thousands):

                                                  Three Months Ended                                                          Six Months Ended
                                                       June 30,                                                                   June 30,
                                                2022                  2021            % Increase / (Decrease)             2022                2021             % Increase / (Decrease)
 Interest income                         $        252              $    224                     13%                   $      523                 639                    (18)%
 Interest expense                              (8,833)               (7,023)                    26%                      (19,079)            (13,994)                    36%

 Other, net                                      (647)               (2,396)                   (73)%                        (771)             (2,554)                   (70)%
Total other expense, net                 $     (9,228)               (9,195)                     -%                   $  (19,327)            (15,909)                    21%


Total other expense, net increased nominally and 21% in the three and six months
ended June 30, 2022 versus 2021, respectively. The 26% and 36% increase in
interest expense during the three and six months ended June 30, 2022,
respectively, was due to the $375.0 million term loan B credit agreement (the
"Term Loan") entered into in December 2021. This increase was partially offset
by the absence of debt discount amortization associated with our convertible
notes in the current year due to adopting Accounting Standards Update, or ASU,
2020-06 in 2022, and the maturing of our 2.375% convertible senior notes due
2022, or 2022 Notes, on April 1, 2022. For additional information regarding the
adoption of ASU 2020-06, see Note 2, Summary of Significant Accounting Policies,
to our condensed consolidated financial statements herein.

Other, net in the prior year periods included a realized loss on the sale of an
equity investment in the amounts of $2.5 million and $2.6 million during the
three and six months ended June 30, 2021, respectively.

Income Tax Expense


The following table provides information regarding our income tax expense during
the periods indicated, including percent changes (dollar amounts in thousands):
                                            Three Months Ended                                                   Six Months Ended
                                                 June 30,                                                            June 30,
                                           2022              2021           % Increase / (Decrease)            2022             2021           % Increase / (Decrease)
 Income tax expense                    $   2,131          $ 6,567                    (68)%                  $ 2,597          $ 8,921                    (71)%
 Effective tax rate                           10  %            26  %                                              9  %            23  %


The effective tax rates were 10% and 9% for the three and six months ended
June 30, 2022, respectively. The effective tax rates were 26% and 23% for the
three and six months ended June 30, 2021, respectively. Income tax expense
represents the estimated annual effective tax rate applied to the year-to-date
domestic operating results adjusted for certain discrete tax items. The
effective tax rates for the three and six months ended June 30, 2022 include
benefits related to stock-based compensation, a first quarter SkyePharma
Holding, Inc., or Skyepharma, (now a subsidiary of Vectura Group plc), milestone
payment and a fair value adjustment for Flexion contingent consideration, offset
by non-deductible executive compensation costs and a valuation allowance against
non-U.S. results. The effective tax rates for the three and six months ended
June 30, 2021 include benefits related to stock-based compensation offset by
non-deductible executive compensation costs and valuation allowances recorded
against deductible capital losses and non-U.S. results.

Liquidity and Capital Resources


Since our inception in 2006, we have devoted most of our cash resources to
manufacturing, research and development and selling, general and administrative
activities related to the development and commercialization of EXPAREL. In
addition, we acquired ZILRETTA as part of the Flexion Acquisition in November
2021 and iovera° as part of the MyoScience Acquisition in April 2019. We are
primarily dependent on the commercial success of EXPAREL and ZILRETTA. We have
financed our operations primarily with the proceeds from the sale of convertible
senior notes and other debt, common stock, product sales and collaborative
licensing and milestone revenue. As of June 30, 2022, we had an accumulated
deficit of $138.0 million, cash and cash equivalents and short-term
available-for-sale investments of $316.4 million and working capital of $393.0
million.

We expect that our cash and available-for-sale investments on hand will be adequate to cover our short-term liquidity needs, and that we would be able to access other sources of financing should the need arise.


In March 2020, the Coronavirus Aid, Relief and Economic Security (CARES) Act was
signed into law in response to the COVID-19 pandemic. The CARES Act, among other
things, allows for certain measures to increase liquidity for businesses
             Pacira BioSciences, Inc. | Q2 2022 Form 10-Q | Page 44

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such as the deferral of employer payroll taxes, a tax credit for retaining
employees and other provisions. We benefited from the provision to defer the
payment of certain employer payroll taxes in the amount of $2.8 million for the
year ended December 31, 2020 and remitted $1.4 million in December 2021. The
remaining $1.4 million is due by December 31, 2022.

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