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 reported financial results
for the fourth quarter and full-year of 2024.
“Pacira enters 2025 with a sharp focus on executing
our 5x30 strategy to accelerate our transition into an innovative
biopharmaceutical organization and therapeutic area leader in
musculoskeletal pain and adjacencies,” said Frank D. Lee, chief
executive officer of Pacira BioSciences. “The new year is off to a
strong start, highlighted by the recent implementation of NOPAIN,
which we believe will drive greater utilization of EXPAREL and
iovera° by significantly expanding patient access in outpatient
settings. We are confident in our ability to drive growth in our
base business and advance a novel pipeline of potentially
transformative assets, like PCRX-201.”
2024 Fourth Quarter and
Full-Year Financial Highlights
- Fourth quarter
revenues of $187.3 million and full-year revenues of $701.0
million.
- Fourth quarter GAAP
net income of $16.0 million or $0.35 per basic share and $0.34 per
diluted share and full-year GAAP net loss of $99.6 million or $2.15
per basic and diluted share.
- Fourth quarter
adjusted EBITDA of $62.5 million and full-year adjusted EBITDA of
$223.9 million.
- Initiated a share
repurchase program with $125.0 million remaining on
authorization.
See “Non-GAAP Financial Information” below.
Recent Business Highlights
- Launched
new Five-Year Plan (5x30) to Transition into an Innovative
Biopharmaceutical Organization. In January 2025, the
company announced its 5x30 plan to transition into an innovative
biopharmaceutical and therapeutic area leader in musculoskeletal
pain and adjacencies. With 5x30, the company intends to achieve the
following five key objectives by 2030: (i) deliver its products to
more than 3 million patients annually; (ii) grow product revenues
by a double-digit compounded annual growth rate; (iii) achieve a
five percentage point improvement in gross margins over 2024; (iv)
advance an innovative pipeline with at least five programs in
clinical development; and (v) establish five partnerships including
pipeline and commercial agreements.
- Strategic
Acquisition of Remaining Equity Stake of GQ Bio to Advance 5x30
Growth Strategy. In February 2025, Pacira announced it has
acquired the remaining 81 percent equity stake of GQ Bio
Therapeutics GmbH for approximately $32 million, net of working
capital and other transaction adjustments, to equity holders other
than Pacira. The net purchase price includes $18 million of cash
paid at closing, $8 million to be paid over three years pursuant to
a key employee holdback agreement and a post-closing indemnity
holdback of $6 million. The transaction brings to Pacira a novel,
high capacity, local delivery platform for genetic medicines; a
preclinical portfolio; and research and development talent. It also
builds upon Pacira’s previous investments in GQ Bio, as well as the
two companies’ partnership that was initiated in 2023 for the
development of a commercially scalable manufacturing process for
PCRX-201 and other products utilizing the platform. In addition,
the transaction is expected to provide near- and long-term
financial benefits with the elimination of future milestone
payments, including $4.5 million due at the initiation of a Phase 2
study of PCRX-201.
- Board of
Directors Updates. In January 2025, Laura Brege was
appointed Chair of the Board, following the retirement of former
Chair, Paul J. Hastings, and Andreas Wicki, PhD. These changes
align with Pacira’s ongoing commitment to Board refreshment. With
these changes, the Board is composed of nine directors, eight of
whom are independent and five of whom have joined since October
2023. Each director brings expertise in areas important to Pacira’s
business to support Pacira’s 5x30 growth-oriented plan including
executive leadership, mergers and acquisitions, research and
development, finance, operations, commercialization, manufacturing
and supply chain.
-
Strengthened Executive Leadership Team with Two Key
Appointments. In January 2025, Brendan Teehan was named
Chief Commercial Officer and Krys Corbett, Esq. was named Chief
Business Officer. Mr. Teehan brings extensive expertise in both
private and public companies across multiple large and rare disease
therapeutic categories and development stages. Ms. Corbett brings
more than 25 years of industry experience across business
development, strategic transactions, alliance management, and
product portfolio management.
- New iovera°
SmartTip Receives FDA 510k Clearance to Manage Chronic Low Back
Pain. In December 2024, the U.S. Food & Drug
Administration (FDA) approved a new iovera° Smart Tip designed to
access the medial branch nerves to manage chronic low back pain.
Chronic low back pain remains a pervasive health challenge in the
United States that impacts millions and often leads to poor quality
of life, disability, and persistent prescription opioid use.
- New Patent
Covering EXPAREL Composition. In December 2024, the
company announced the issuance of U.S. Patent No. 12,156,940 (the
‘940 patent). The ‘940 patent, entitled “Manufacturing of
Bupivacaine Multivesicular Liposomes” protects the chemical
composition of EXPAREL produced by the company’s enhanced
large-scale manufacturing process in San Diego. The company expects
the ‘940 patent to provide protection into July 2044, further
supporting the company’s confidence in the long-term exclusivity of
EXPAREL.
- PCRX-201 2-year Safety and
Efficacy Data Indicate Potential for Sustained Efficacy in Moderate
to Severe Osteoarthritis of the Knee. In November 2024,
the company reported new data demonstrating that its osteoarthritis
product candidate, PCRX-201 (enekinragene inzadenovec), provided
sustained improvements in knee pain, stiffness, and function for at
least two years following local administration, with a
well-tolerated safety profile. The data were presented at the
American College of Rheumatology’s annual ACR Convergence
meeting.
Fourth Quarter
2024 Financial Results
- Total revenues were
$187.3 million in the fourth quarter of 2024, a 3 percent increase
over the $181.2 million reported for the fourth quarter of
2023.
- EXPAREL net product
sales were $147.7 million in the fourth quarter of 2024, a 3
percent increase over the $143.9 million reported for the fourth
quarter of 2023.
- ZILRETTA net
product sales were $33.1 million in the fourth quarter of 2024, a
15 percent increase over the $28.7 million reported for the fourth
quarter of 2023.
- Fourth quarter 2024
iovera° net product sales were $6.5 million, a 7 percent increase
over the $6.0 million reported in the fourth quarter of 2023.
- Total operating
expenses were $162.5 million in the fourth quarter of 2024, versus
the $148.1 million reported for the fourth quarter of 2023.
- Research and
development (R&D) expenses were $23.9 million in the fourth
quarter of 2024, compared to $19.5 million in the fourth quarter of
2023. The company’s R&D expenses included $8.8 million and
$6.9 million of product development and manufacturing capacity
expansion costs in the fourth quarters of 2024 and 2023,
respectively.
- Selling, general
and administrative (SG&A) expenses were $79.6 million in the
fourth quarter of 2024, compared to $65.8 million in the fourth
quarter of 2023.
- GAAP net income was
$16.0 million, or $0.35 per basic share and $0.34 per diluted share
in the fourth quarter of 2024, compared to $24.9 million, or $0.54
per basic share and $0.50 per diluted share in the fourth quarter
of 2023.
- Non-GAAP net income
was $44.3 million, or $0.96 per basic share and $0.91 per diluted
share in the fourth quarter of 2024, compared to $45.1 million, or
$0.97 per basic share and $0.89 per diluted share in the fourth
quarter of 2023.
- Adjusted EBITDA was
$62.5 million in the fourth quarter of 2024, a 4 percent decrease
compared to $65.4 million in the fourth quarter of 2023.
- Pacira ended the
fourth quarter of 2024 with cash, cash equivalents and
available-for-sale investments (“cash”) of $484.6 million. Cash
provided by operations was $33.1 million in the fourth quarter of
2024, compared to $47.6 million in the fourth quarter of 2023.
- Pacira had 46.2
million basic and 49.0 million diluted weighted average shares of
common stock outstanding in the fourth quarter of 2024.
- For non-GAAP
measures, Pacira had 49.0 million and 52.1 million diluted weighted
average shares of common stock outstanding in the fourth quarters
of 2024 and 2023, respectively.
See “Non-GAAP Financial Information” below.
Full-Year 2024
Financial Results
- Total revenues were
$701.0 million in 2024, a 4 percent increase over the $675.0
million reported in 2023.
- EXPAREL net product
sales were $549.0 million in 2024, a 2 percent increase compared to
the $538.1 million reported in 2023.
- ZILRETTA net
product sales were $118.1 million in 2024, a 6 percent increase
over the $111.1 million reported in 2023.
- Full-year iovera°
net product sales were $22.8 million, a 16 percent increase over
the $19.7 million reported in 2023.
- Total operating
expenses were $774.3 million in 2024, compared to $587.3 million in
2023. Included within 2024 is a goodwill impairment of $163.2
million based upon an assessment that the fair value of goodwill
was less than its carrying value.
- R&D expenses
were $81.6 million in 2024, compared to $76.3 million in 2023. The
company’s R&D expenses include $30.8 million and $33.4 million
of product development and manufacturing capacity expansion costs
in 2024 and 2023, respectively.
- SG&A expenses
were $294.1 million in 2024, compared to $269.4 million in
2023.
- GAAP net loss was
$99.6 million, or $2.15 per basic and diluted share in 2024,
compared to GAAP net income of $42.0 million, or $0.91 per basic
share and $0.89 per diluted share in 2023. Included in GAAP net
loss in 2024 was a $163.2 million impairment of goodwill based upon
an assessment that the fair value of goodwill was less than its
carrying value.
- Non-GAAP net income
was $157.7 million, or $3.41 per basic share and $3.20 per diluted
share in 2024, compared to $142.0 million, or $3.07 per basic share
and $2.81 per diluted share in 2023.
- Adjusted EBITDA was
$223.9 million in 2024, a 4 percent increase over $214.5 million in
2023.
- Cash provided by
operations was $189.4 million in 2024, compared to $154.6 million
in 2023.
- Pacira had 46.2
million basic and diluted weighted average shares of common stock
outstanding in 2024.
- For non-GAAP
measures, Pacira had 50.2 million and 52.0 million diluted weighted
average shares of common stock outstanding in 2024 and 2023,
respectively.
See “Non-GAAP Financial Information” below.
2025 Financial
Guidance
Today the company is providing full-year 2025
financial guidance as follows:
- Total revenue of
$725 million to $765 million;
- Non-GAAP gross
margin of 76 to 78 percent;
- Non-GAAP R&D
expense of $90 million to $105 million;
- Non-GAAP SG&A
expense of $290 million to $320 million; and
- Stock-based
compensation of $56 million to $61 million.
See “Non-GAAP Financial Information” below.
Today’s Conference Call and Webcast
Reminder
The Pacira management team will host a conference
call to discuss the company’s financial results and recent
developments today, Thursday, February 27, 2025, at 4:30 p.m.
ET. For listeners who wish to participate in the
question-and-answer session via telephone, please pre-register at
investor.pacira.com/upcoming-events. All registrants will receive
dial-in information and a PIN allowing them to access the live
call. In addition, a live audio of the conference call will be
available as a webcast. Interested parties can access the event
through the “Events” page on the Pacira website at
investor.pacira.com.
Non-GAAP Financial Information
This press release contains financial measures that
do not comply with U.S. generally accepted accounting principles
(GAAP), such as non-GAAP cost of goods sold, non-GAAP gross margin,
non-GAAP research and development (R&D) expense, non-GAAP
selling, general and administrative (SG&A) expense, non-GAAP
net income, non-GAAP net income per common share, non-GAAP weighted
average common shares outstanding, EBITDA (earnings before
interest, taxes, depreciation and amortization) and adjusted
EBITDA, because these non-GAAP financial measures exclude the
impact of items that management believes affect comparability or
underlying business trends.
These measures supplement the company’s financial
results prepared in accordance with GAAP. Pacira management uses
these measures to better analyze its financial results, estimate
its future cost of goods sold, R&D expense and SG&A expense
outlook for 2025 and to help make managerial decisions. In
management’s opinion, these non-GAAP measures are useful to
investors and other users of the company’s financial statements by
providing greater transparency into the ongoing operating
performance of Pacira and its future outlook. Such measures should
not be deemed to be an alternative to GAAP requirements or a
measure of liquidity for Pacira. The non-GAAP measures presented
here are also unlikely to be comparable with non-GAAP disclosures
released by other companies. See the tables below for a
reconciliation of GAAP to non-GAAP measures.
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 iovera®º, 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 directors and executives, our intellectual property and patent
terms, the acquisition of GQ Bio and the anticipated benefits
thereof, our growth and future operating results and trends, our
strategy, plans, objectives, expectations (financial or otherwise)
and intentions, and 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, 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: the failure to
realize the anticipated benefits and synergies from the acquisition
of GQ Bio; the ability to successfully integrate GQ Bio into our
existing business; the commercial success of GQ Bio’s high-capacity
adenovirus gene therapy vector platform; future opportunities and
plans for GQ Bio and its product candidates, including uncertainty
of the expected financial performance of GQ Bio and its product
candidates; disruption from the acquisition of GQ Bio, making it
more difficult to conduct business as usual or maintain
relationships with customers, employees or suppliers; the
possibility that if we do not achieve the perceived benefits of the
transaction as rapidly or to the extent anticipated by financial
analysts or investors, the market price of our common stock could
decline; 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 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. 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.
|
(Tables to Follow) |
|
Pacira BioSciences, Inc.Condensed
Consolidated Balance Sheets(in
thousands)(unaudited) |
|
|
December 31,2024 |
|
December 31,2023 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
276,774 |
|
$ |
153,298 |
Short-term available-for-sale investments |
|
207,841 |
|
|
125,283 |
Accounts receivable, net |
|
113,304 |
|
|
105,556 |
Inventories, net |
|
125,282 |
|
|
104,353 |
Prepaid expenses and other current assets |
|
21,929 |
|
|
21,504 |
Total current assets |
|
745,130 |
|
|
509,994 |
Noncurrent available-for-sale investments |
|
— |
|
|
2,410 |
Fixed assets, net |
|
167,169 |
|
|
173,927 |
Right-of-use assets, net |
|
49,222 |
|
|
61,020 |
Goodwill |
|
— |
|
|
163,243 |
Intangible assets, net |
|
425,970 |
|
|
483,258 |
Deferred tax assets |
|
130,376 |
|
|
144,485 |
Investments and other assets |
|
35,649 |
|
|
36,049 |
Total assets |
$ |
1,553,516 |
|
$ |
1,574,386 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
19,133 |
|
$ |
15,698 |
Accrued expenses |
|
80,124 |
|
|
64,243 |
Lease liabilities |
|
8,887 |
|
|
8,801 |
Current portion of convertible senior notes, net |
|
201,776 |
|
|
8,641 |
Total current liabilities |
|
309,920 |
|
|
97,383 |
Convertible senior notes, net |
|
279,334 |
|
|
398,594 |
Long-term debt, net |
|
104,211 |
|
|
115,202 |
Lease liabilities |
|
44,645 |
|
|
54,806 |
Contingent consideration |
|
20,241 |
|
|
24,698 |
Other liabilities |
|
16,817 |
|
|
13,573 |
Total stockholders’ equity |
|
778,348 |
|
|
870,130 |
Total liabilities and stockholders’ equity |
$ |
1,553,516 |
|
$ |
1,574,386 |
|
Pacira BioSciences, Inc.Consolidated
Statements of Operations(in thousands, except per
share amounts)(unaudited) |
|
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Net product sales: |
|
|
|
|
|
|
|
EXPAREL |
$ |
147,676 |
|
|
$ |
143,918 |
|
|
$ |
548,962 |
|
|
$ |
538,120 |
|
ZILRETTA |
|
33,123 |
|
|
|
28,705 |
|
|
|
118,089 |
|
|
|
111,098 |
|
iovera° |
|
6,454 |
|
|
|
6,040 |
|
|
|
22,813 |
|
|
|
19,685 |
|
Bupivacaine liposome injectable suspension |
|
— |
|
|
|
1,101 |
|
|
|
7,322 |
|
|
|
3,342 |
|
Total net product sales |
|
187,253 |
|
|
|
179,764 |
|
|
|
697,186 |
|
|
|
672,245 |
|
Royalty revenue |
|
— |
|
|
|
1,480 |
|
|
|
3,780 |
|
|
|
2,733 |
|
Total revenues |
|
187,253 |
|
|
|
181,244 |
|
|
|
700,966 |
|
|
|
674,978 |
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
|
39,886 |
|
|
|
47,692 |
|
|
|
170,428 |
|
|
|
184,669 |
|
Research and development |
|
23,897 |
|
|
|
19,463 |
|
|
|
81,577 |
|
|
|
76,257 |
|
Selling, general and administrative |
|
79,614 |
|
|
|
65,801 |
|
|
|
294,099 |
|
|
|
269,441 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
|
|
57,288 |
|
|
|
57,288 |
|
Goodwill impairment |
|
— |
|
|
|
— |
|
|
|
163,243 |
|
|
|
— |
|
Contingent consideration gains, restructuring charges and
other |
|
4,830 |
|
|
|
798 |
|
|
|
7,702 |
|
|
|
(352 |
) |
Total operating expenses |
|
162,549 |
|
|
|
148,076 |
|
|
|
774,337 |
|
|
|
587,303 |
|
Income (loss) from
operations |
|
24,704 |
|
|
|
33,168 |
|
|
|
(73,371 |
) |
|
|
87,675 |
|
Other
income (expense): |
|
|
|
|
|
|
|
Interest income |
|
5,555 |
|
|
|
3,425 |
|
|
|
19,689 |
|
|
|
11,444 |
|
Interest expense |
|
(4,680 |
) |
|
|
(3,388 |
) |
|
|
(16,569 |
) |
|
|
(20,306 |
) |
Gain (loss) on early extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
7,518 |
|
|
|
(16,926 |
) |
Other, net |
|
(53 |
) |
|
|
515 |
|
|
|
(373 |
) |
|
|
(186 |
) |
Total other income (expense) |
|
822 |
|
|
|
552 |
|
|
|
10,265 |
|
|
|
(25,974 |
) |
Income (loss) before income
taxes |
|
25,526 |
|
|
|
33,720 |
|
|
|
(63,106 |
) |
|
|
61,701 |
|
Income tax expense |
|
(9,485 |
) |
|
|
(8,850 |
) |
|
|
(36,454 |
) |
|
|
(19,746 |
) |
Net income (loss) |
$ |
16,041 |
|
|
$ |
24,870 |
|
|
$ |
(99,560 |
) |
|
$ |
41,955 |
|
|
|
|
|
|
|
|
|
Net income (loss) per
share: |
|
|
|
|
|
|
|
Basic net income (loss) per common share |
$ |
0.35 |
|
|
$ |
0.54 |
|
|
$ |
(2.15 |
) |
|
$ |
0.91 |
|
Diluted net income (loss) per common share |
$ |
0.34 |
|
|
$ |
0.50 |
|
|
$ |
(2.15 |
) |
|
$ |
0.89 |
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
46,171 |
|
|
|
46,437 |
|
|
|
46,245 |
|
|
|
46,222 |
|
Diluted |
|
49,036 |
|
|
|
52,064 |
|
|
|
46,245 |
|
|
|
51,979 |
|
|
Pacira BioSciences, Inc.Reconciliation of
GAAP to Non-GAAP Financial Information(in
thousands, except per share
amounts)(unaudited) |
|
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP net income (loss) |
$ |
16,041 |
|
|
$ |
24,870 |
|
|
$ |
(99,560 |
) |
|
$ |
41,955 |
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Contingent consideration gains, restructuring charges and
other: |
|
|
|
|
|
|
|
Changes in the fair value of contingent consideration |
|
1,084 |
|
|
|
423 |
|
|
|
(4,457 |
) |
|
|
(3,424 |
) |
Restructuring charges (1) (2) |
|
722 |
|
|
|
— |
|
|
|
4,929 |
|
|
|
1,109 |
|
Acquisition-related expenses (3) |
|
773 |
|
|
|
375 |
|
|
|
1,462 |
|
|
|
1,963 |
|
Loss on lease termination (4) |
|
2,165 |
|
|
|
— |
|
|
|
2,165 |
|
|
|
— |
|
Goodwill impairment (5) |
|
— |
|
|
|
— |
|
|
|
163,243 |
|
|
|
— |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
|
|
57,288 |
|
|
|
57,288 |
|
Step-up of acquired Flexion fixed assets and inventory to fair
value |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
5,152 |
|
Stock-based compensation |
|
12,266 |
|
|
|
12,420 |
|
|
|
51,171 |
|
|
|
47,895 |
|
Chief Executive Officer transition costs (6) |
|
98 |
|
|
|
— |
|
|
|
843 |
|
|
|
— |
|
(Gain) loss on early extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
(7,518 |
) |
|
|
16,926 |
|
Amortization of debt discount |
|
22 |
|
|
|
24 |
|
|
|
92 |
|
|
|
752 |
|
Tax impact of non-GAAP adjustments (7) |
|
(3,208 |
) |
|
|
(7,320 |
) |
|
|
(11,911 |
) |
|
|
(27,569 |
) |
Total Non-GAAP adjustments |
|
28,244 |
|
|
|
20,244 |
|
|
|
257,307 |
|
|
|
100,092 |
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
44,285 |
|
|
$ |
45,114 |
|
|
$ |
157,747 |
|
|
$ |
142,047 |
|
|
|
|
|
|
|
|
|
GAAP basic net income (loss) per common share |
$ |
0.35 |
|
|
$ |
0.54 |
|
|
$ |
(2.15 |
) |
|
$ |
0.91 |
|
GAAP diluted net income (loss) per common share |
$ |
0.34 |
|
|
$ |
0.50 |
|
|
$ |
(2.15 |
) |
|
$ |
0.89 |
|
|
|
|
|
|
|
|
|
GAAP net income (loss) |
$ |
16,041 |
|
|
$ |
24,870 |
|
|
$ |
(99,560 |
) |
|
$ |
41,955 |
|
Interest expense on convertible senior notes, net of tax |
|
518 |
|
|
|
1,029 |
|
|
|
— |
|
|
|
4,114 |
|
GAAP net income (loss) used for diluted earnings per share |
$ |
16,559 |
|
|
$ |
25,899 |
|
|
$ |
(99,560 |
) |
|
$ |
46,069 |
|
|
|
|
|
|
|
|
|
Non-GAAP basic net income per common share |
$ |
0.96 |
|
|
$ |
0.97 |
|
|
$ |
3.41 |
|
|
$ |
3.07 |
|
Non-GAAP diluted net income per common share |
$ |
0.91 |
|
|
$ |
0.89 |
|
|
$ |
3.20 |
|
|
$ |
2.81 |
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
44,285 |
|
|
$ |
45,114 |
|
|
$ |
157,747 |
|
|
$ |
142,047 |
|
Interest expense on convertible senior notes, net of tax (8) |
|
518 |
|
|
|
1,029 |
|
|
|
2,825 |
|
|
|
4,114 |
|
Non-GAAP net income used for diluted earnings per share (8) |
$ |
44,803 |
|
|
$ |
46,143 |
|
|
$ |
160,572 |
|
|
$ |
146,161 |
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic |
|
46,171 |
|
|
|
46,437 |
|
|
|
46,245 |
|
|
|
46,222 |
|
Weighted average common shares outstanding - diluted |
|
49,036 |
|
|
|
52,064 |
|
|
|
46,245 |
|
|
|
51,979 |
|
Non-GAAP weighted average common shares outstanding - diluted
(8) |
|
49,036 |
|
|
|
52,064 |
|
|
|
50,185 |
|
|
|
51,979 |
|
Pacira BioSciences, Inc.Reconciliation of
GAAP to Non-GAAP Financial Information
(continued)(unaudited) |
(1) In February 2024, we initiated a restructuring plan designed to
ensure we are well positioned for long-term growth. The
restructuring plan includes: (i) reshaping our executive team; (ii)
reallocating efforts and resources from our ex-U.S. and certain
early-stage development programs to our commercial portfolio in the
U.S. market; and (iii) reprioritizing investments to focus on
commercial readiness for the implementation of separate Medicare
reimbursement for EXPAREL at average sales price plus 6 percent in
outpatient settings and iovera° at up to an additional $255.85 when
providers administer iovera° in ASC and HOPD settings as of January
2025 and broader commercial initiatives in key areas, such as
strategic national accounts, marketing and market access and
reimbursement. The charges related to employee termination
benefits, severance, and, to a lesser extent, other
employment-related termination costs. |
(2) Approximately $0.1 million and $3.6 million of
restructuring charges were excluded from this line item as they are
included in the stock-based compensation line item for the three
months and year ended December 31, 2024, respectively. |
(3) Acquisition-related expenses related to vacant and
underutilized leases assumed from the acquisition of Flexion
Therapeutics, Inc. (“Flexion”). |
(4) Represents a loss during both the three months and year ended
December 31, 2024 associated with exiting a training center lease
in Houston, Texas. |
(5) During the three months ended September 30, 2024, the FDA
approved a generic competitor to EXPAREL and a U.S. District Court
ruled that one of our patents was not valid. Due to these events
and a subsequent decrease in our common stock price, it was
determined these qualitative factors indicated it was more likely
than not that the fair value of goodwill may be less than its
carrying value. Accordingly, we performed a quantitative assessment
through a discounted cash flow model (or income approach), which
resulted in the carrying value of the Company exceeding its fair
value by more than the goodwill balance. As a result, the goodwill
balance of $163.2 million was fully impaired during the three
months ended September 30, 2024. |
(6) We appointed a new chief executive officer (“CEO”) effective
January 2, 2024. CEO transition costs include compensation costs
related to the transition of the former CEO who remains an advisor
to the Company in a consulting capacity. |
(7) The tax impact of non-GAAP adjustments is computed by: (i)
applying the statutory tax rate to the income or expense adjusted
items; (ii) applying a zero-tax rate to adjusted items where a
valuation allowance exists; and (iii) excluding discrete tax
benefits and expenses, primarily associated with tax deductible and
non-deductible stock-based compensation.For the three months and
year ended December 31, 2024, the GAAP effective income tax
rates were approximately 37% and (58)%, respectively, and the
non-GAAP effective income tax rates for the three months and year
ended December 31, 2024 were approximately 22% and 23%,
respectively, with the difference from GAAP primarily related to
the impact of excluding discrete tax expense for non-deductible
goodwill impairment charges and non-deductible stock-based
compensation, mainly related to expired stock options. The three
months ended December 31, 2024 also reflected a difference from
GAAP related to excluding discrete tax expense for non-deductible
executive compensation and other non-deductible expenses. For the
three months and year ended December 31, 2023, the GAAP effective
income tax rates were approximately 26% and 32%, respectively. The
non-GAAP effective income tax rates for the three months and year
ended December 31, 2023 were 26% and 25%, respectively. The
difference from GAAP is due to the impact of excluding costs of
discrete non-deductible executive and equity compensation,
partially offset by excluding benefits from discrete tax
credits. |
(8) For the three months ended December 31, 2024 and the three
months and year ended December 31, 2023, there were no non-GAAP
adjustments when calculating the diluted weighted average common
shares outstanding or the interest expense add back under the
“if-converted” method.For the year ended December 31, 2024, the
0.75% convertible senior notes due 2025, or 2025 Notes, were
excluded from diluted net income per common share on a GAAP basis
as the impact would have been antidilutive. These potential
securities resulted in a dilutive impact on diluted net income per
common share reported on a non-GAAP basis. For the year ended
December 31, 2024, non-GAAP adjustments to diluted weighted average
shares outstanding included the impact of the 2025 Notes as if they
converted on the first day of the period presented, which resulted
in an additional 3.8 million common shares upon an assumed
conversion and added back $2.8 million of interest expense, net of
tax, to non-GAAP net income. We have the option to settle its 2025
Notes in cash, shares of our common stock or a combination of cash
and shares of our common stock. |
|
Pacira BioSciences, Inc.Reconciliation of
GAAP to Non-GAAP Financial Information
(continued)(in thousands, except
percentages)(unaudited) |
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Cost of goods sold reconciliation: |
|
|
|
|
|
|
|
GAAP cost of goods sold |
$ |
39,886 |
|
|
$ |
47,692 |
|
|
$ |
170,428 |
|
|
$ |
184,669 |
|
Stock-based compensation |
|
(1,435 |
) |
|
|
(1,105 |
) |
|
|
(5,331 |
) |
|
|
(5,537 |
) |
Step-up of acquired Flexion fixed assets and inventory to fair
value |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(5,152 |
) |
Non-GAAP cost of goods sold |
$ |
38,451 |
|
|
$ |
46,587 |
|
|
$ |
165,097 |
|
|
$ |
173,980 |
|
|
|
|
|
|
|
|
|
Gross margin reconciliation: |
|
|
|
|
|
|
|
GAAP total revenues |
$ |
187,253 |
|
|
$ |
181,244 |
|
|
$ |
700,966 |
|
|
$ |
674,978 |
|
GAAP gross margin |
$ |
147,367 |
|
|
$ |
133,552 |
|
|
$ |
530,538 |
|
|
$ |
490,309 |
|
GAAP gross margin percentage |
|
79 |
% |
|
|
74 |
% |
|
|
76 |
% |
|
|
73 |
% |
Adjustments to GAAP gross margin: |
|
|
|
|
|
|
|
Stock-based compensation |
$ |
1,435 |
|
|
$ |
1,105 |
|
|
$ |
5,331 |
|
|
$ |
5,537 |
|
Step-up of acquired Flexion fixed assets and inventory to fair
value and other |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
5,152 |
|
Non-GAAP gross margin |
$ |
148,802 |
|
|
$ |
134,657 |
|
|
$ |
535,869 |
|
|
$ |
500,998 |
|
Non-GAAP gross margin percentage |
|
79 |
% |
|
|
74 |
% |
|
|
76 |
% |
|
|
74 |
% |
|
|
|
|
|
|
|
|
Research and development reconciliation: |
|
|
|
|
|
|
|
GAAP research and development |
$ |
23,897 |
|
|
$ |
19,463 |
|
|
$ |
81,577 |
|
|
$ |
76,257 |
|
Stock-based compensation |
|
(1,859 |
) |
|
|
(2,877 |
) |
|
|
(7,381 |
) |
|
|
(8,694 |
) |
Non-GAAP research and development |
$ |
22,038 |
|
|
$ |
16,586 |
|
|
$ |
74,196 |
|
|
$ |
67,563 |
|
|
|
|
|
|
|
|
|
Selling, general and administrative
reconciliation: |
|
|
|
|
|
|
|
GAAP selling, general and administrative |
$ |
79,614 |
|
|
$ |
65,801 |
|
|
$ |
294,099 |
|
|
$ |
269,441 |
|
Stock-based compensation |
|
(8,887 |
) |
|
|
(8,438 |
) |
|
|
(34,857 |
) |
|
|
(33,664 |
) |
Chief Executive Officer transition costs |
|
(98 |
) |
|
|
— |
|
|
|
(843 |
) |
|
|
— |
|
Non-GAAP selling, general and administrative |
$ |
70,629 |
|
|
$ |
57,363 |
|
|
$ |
258,399 |
|
|
$ |
235,777 |
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding - diluted
reconciliation: |
|
|
|
|
|
|
|
GAAP weighted average common shares outstanding - diluted |
|
49,036 |
|
|
|
52,064 |
|
|
|
46,245 |
|
|
|
51,979 |
|
Dilutive common shares associated with the 2025 Notes (1) |
|
— |
|
|
|
— |
|
|
|
3,843 |
|
|
|
— |
|
Dilutive common shares associated with stock options, restricted
stock units and ESPP (2) |
|
— |
|
|
|
— |
|
|
|
97 |
|
|
|
— |
|
Non-GAAP weighted average common shares outstanding - diluted |
|
49,036 |
|
|
|
52,064 |
|
|
|
50,185 |
|
|
|
51,979 |
|
(1) For the year ended December 31, 2024, potential common shares
of the 2025 Notes were excluded from diluted net loss per common
share on a GAAP basis because they would have been antidilutive.
These potential securities resulted in a dilutive impact on diluted
net income per common share reported on a non-GAAP basis. |
(2) For the year ended December 31, 2024, potential common shares
associated with stock options, restricted stock units and ESPP were
excluded from diluted net loss per common share on a GAAP basis
because they would have been antidilutive. These potential shares
resulted in a dilutive impact on diluted net income per common
share reported on a non-GAAP basis. |
|
Pacira BioSciences, Inc.Reconciliation of
GAAP Net Income (Loss) to Adjusted EBITDA
(Non-GAAP)(in
thousands)(unaudited) |
|
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP net income (loss) |
$ |
16,041 |
|
|
$ |
24,870 |
|
|
$ |
(99,560 |
) |
|
$ |
41,955 |
|
|
|
|
|
|
|
|
|
Interest income |
|
(5,555 |
) |
|
|
(3,425 |
) |
|
|
(19,689 |
) |
|
|
(11,444 |
) |
Interest expense (1) |
|
4,680 |
|
|
|
3,388 |
|
|
|
16,569 |
|
|
|
20,306 |
|
Income tax expense |
|
9,485 |
|
|
|
8,850 |
|
|
|
36,454 |
|
|
|
19,746 |
|
Depreciation expense |
|
6,921 |
|
|
|
4,163 |
|
|
|
21,497 |
|
|
|
18,286 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
|
|
57,288 |
|
|
|
57,288 |
|
EBITDA |
|
45,894 |
|
|
|
52,168 |
|
|
|
12,559 |
|
|
|
146,137 |
|
|
|
|
|
|
|
|
|
Other adjustments: |
|
|
|
|
|
|
|
Contingent consideration gains, restructuring charges and
other: |
|
|
|
|
|
|
|
Changes in the fair value of contingent consideration |
|
1,084 |
|
|
|
423 |
|
|
|
(4,457 |
) |
|
|
(3,424 |
) |
Restructuring charges (2) (3) |
|
181 |
|
|
|
— |
|
|
|
4,388 |
|
|
|
1,109 |
|
Acquisition-related fees and expenses |
|
773 |
|
|
|
375 |
|
|
|
1,462 |
|
|
|
1,963 |
|
Loss on lease termination |
|
2,165 |
|
|
|
— |
|
|
|
2,165 |
|
|
|
— |
|
Goodwill impairment |
|
— |
|
|
|
— |
|
|
|
163,243 |
|
|
|
— |
|
Stock-based compensation |
|
12,266 |
|
|
|
12,420 |
|
|
|
51,171 |
|
|
|
47,895 |
|
CEO transition costs |
|
98 |
|
|
|
— |
|
|
|
843 |
|
|
|
— |
|
Step-up of acquired Flexion inventory to fair value |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
3,884 |
|
(Gain) loss on early extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
(7,518 |
) |
|
|
16,926 |
|
Adjusted EBITDA |
$ |
62,461 |
|
|
$ |
65,386 |
|
|
$ |
223,856 |
|
|
$ |
214,490 |
|
(1) Includes amortization of debt discount and debt issuance
costs.(2) Approximately $0.1 million and $3.6 million of
restructuring charges were excluded from this line item for the
three months and year ended December 31, 2024, respectively, as
they are included in the stock-based compensation line item.(3)
Approximately $0.5 million of depreciation expense was excluded
from this line item for both the three months and year ended
December 31, 2024 as they are included in the depreciation expense
line item. |
|
Pacira BioSciences, Inc.Reconciliation of
GAAP to Non-GAAP 2025 Financial
Guidance(dollars in millions) |
|
GAAP to Non-GAAP Guidance |
|
GAAP |
|
Impact of GAAP to Non-GAAP Adjustments
(1) |
|
Non-GAAP |
Total revenues |
|
$725 to $765 |
|
— |
|
$725 to $765 |
Gross margin |
|
75% to 77% |
|
Approximately 1% |
|
76% to 78% |
Research and development expense |
|
$98 to $115 |
|
$8 to $10 |
|
$90 to $105 |
Selling, general and administrative expense |
|
$331 to $366 |
|
$41 to $46 |
|
$290 to $320 |
Stock-based compensation |
|
$56 to $61 |
|
— |
|
— |
(1) The full-year impact of GAAP to Non-GAAP adjustments relates to
stock-based compensation. |
Investor Contact:
Susan Mesco, (973) 451-4030
susan.mesco@pacira.com
Media Contact:
Sara Marino, (973) 370-5430
sara.marino@pacira.com
Grafico Azioni Pacira BioSciences (NASDAQ:PCRX)
Storico
Da Feb 2025 a Mar 2025
Grafico Azioni Pacira BioSciences (NASDAQ:PCRX)
Storico
Da Mar 2024 a Mar 2025