Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its
commitment to non-opioid pain management and regenerative health
solutions, today announced that its Board of Directors (the
“Board”) has appointed Frank D. Lee as Chief Executive Officer and
a member of the Board, effective January 2, 2024. As previously
announced in September 2023, David Stack will retire from his roles
as Chief Executive Officer and Chairman of the Board, effective
January 1, 2024, and will remain with the company through August
2025 in an advisory capacity to help ensure a smooth transition. In
connection with Mr. Stack’s retirement, the Board has elected Paul
Hastings, Lead Independent Director, as Chair of the Board, also
effective January 2, 2024.
Mr. Lee brings more than three decades of global experience and
a strong track record of product development and commercial
leadership success across a wide range of therapeutic areas within
the biotech and pharmaceutical industry. Most recently he served as
Chief Executive Officer and member of the board of directors of
Forma Therapeutics from March 2019 through its acquisition by Novo
Nordisk in October 2022. During his tenure at Forma, Mr. Lee
transformed the company from an early-stage drug discovery company
into one focused on the clinical development of lead assets in rare
hematologic disorders and cancer.
“Following a comprehensive executive search process, we are
delighted to welcome Frank as our new CEO and are confident he is
the ideal leader for our next phase of growth and value creation,”
said Paul Hastings, Chair elect of Pacira BioSciences, Inc. “Frank
is a proven leader who has distinguished himself over the course of
his career as a disciplined executive with a focus on revenue
growth and cost management, having built successful patient-focused
organizations driving product growth to blockbuster and
multi-blockbuster status across a wide range of therapeutics areas
and treatment settings. He has a proven ability to forge
partnerships with key stakeholders and to deliver creative
solutions that provide value and improve patients’ lives. We
believe he has the relevant skills and experience to continue the
execution of our strategy to maximize shareholder return and unlock
the significant untapped potential within our best-in-class
opioid-sparing commercial portfolio.”
“I am excited to join Pacira to continue advancing the company’s
important mission to expand patient access to non-opioid pain
management,” said Mr. Lee. “The efforts that Dave and his team have
made establishing Pacira as a leader in opioid-sparing innovation
are exceptional and I am eager to work with the team to capitalize
on the significant opportunities ahead. I look forward to working
closely with Dave to ensure a smooth transition, and to partnering
with the entire Board and leadership team to build upon our strong
foundation and deliver value for all Pacira stakeholders.”
Mr. Hastings concluded, “On behalf of the entire Board, I want
to thank Dave for his visionary leadership and numerous
contributions to Pacira. As CEO for the last 16 years, Dave has
transformed Pacira into a leader in non-opioid pain management and
positioned the company for future success. We wish him the best in
his well-deserved retirement.”
Prior to Forma, Mr. Lee most recently served as Senior Vice
President, Global Product Strategy and Therapeutic Area Head for
Immunology, Ophthalmology and Infectious Diseases at Genentech, a
member of the Roche Group. At Genentech, he was responsible for
driving development and commercial strategy for a broad portfolio
of molecules in development and for global in-line product sales of
more than $11 billion. His 13-year career path at Genentech
included leadership positions of increasing scope and
responsibility for delivering transformative medicines to
patients.
Prior to joining Genentech, Mr. Lee spent approximately 13 years
across Novartis, Janssen and Eli Lilly in engineering,
manufacturing, sales/marketing and business development. Mr. Lee
received a bachelor’s degree in chemical engineering from
Vanderbilt University and an MBA in marketing and finance from the
Wharton Graduate School of Business. He currently serves as
executive chairman of the board of directors of privately held
Therini Bio, Inc. and chairman of the board of privately held
Catamaran Bio, Inc. He is also a member of the board of directors
of Bolt Biotherapeutics, Inc. (Nasdaq: BOLT).
On December 20, 2023, in connection with Mr. Lee’s appointment
as Chief Executive Officer, the Board approved the grant of
inducement awards to Mr. Lee. The awards were made pursuant to the
Pacira BioSciences, Inc. Amended and Restated 2014 Inducement Plan,
which was approved by the Board without stockholder approval
pursuant to, and in compliance with, Rule 5635(c)(4) of the Nasdaq
Listing Rules.
Mr. Lee’s inducement awards included (i) a non-qualified stock
option to purchase an aggregate of 692,512 shares of Pacira’s
common stock with an exercise price per share equal to the closing
price of Pacira’s common stock as reported on the Nasdaq Global
Select Market on January 3, 2024, and, subject to continued service
with Pacira as of each vesting date, such option will vest and
become exercisable as to 25% of the option shares on January 3,
2025, and vest as to the remaining shares in successive equal
quarterly installments over the subsequent three years, and (ii) a
restricted stock unit award for 99,520 shares of Pacira’s common
stock, subject to continued service with Pacira as of each vesting
date, to vest in four equal annual installments beginning on
January 2, 2025, in each case, pursuant to the terms and provisions
of the Inducement Plan.
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 [NTD: edits are to conform to
the earnings release FLS and also add protection for some of the
forward-looking statements in here]
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 new chief
executive officer, delivering value to stockholders, 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, 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; risks related to 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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