Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its
commitment to non-opioid pain management and regenerative health
solutions, today reported financial results for the fourth quarter
and full-year of 2023.
“Now that I have spent several weeks working with the Pacira
team, I am even more enthusiastic to lead this great company as we
build upon an impressive foundation of success,” said Frank D. Lee,
chief executive officer of Pacira BioSciences. “Looking ahead, we
are sharply focused on driving long-term growth, furthering our
patient centric culture and establishing high standards for
operational excellence. Throughout 2024, we plan to advance the
launch of EXPAREL in two key lower extremity nerve blocks and
prepare for the significant catalyst ahead in NOPAIN. In parallel,
we are taking the necessary steps to reallocate our efforts and
resources to ensure the organization is best positioned for
sustainable success.We have the people, the purpose, and the
products to change the course of pain management and, hopefully, to
help save patients from the deadly effects of opioid
addiction.”
2023 Fourth Quarter and Full-Year
Financial Highlights
- Fourth quarter revenues of $181.2 million and full-year
revenues of $675.0 million.
- Fourth quarter GAAP net income of $24.9 million or $0.54 per
basic share and $0.50 per diluted share and full-year GAAP net
income of $42.0 million or $0.91 per basic share and $0.89 per
diluted share.
- Fourth quarter adjusted EBITDA of $65.4 million and full-year
adjusted EBITDA of $214.5 million.
See “Non-GAAP Financial Information” below.
Recent Business Highlights
- FDA Approval of New EXPAREL 200-liter Manufacturing
Suite. In February 2024, the U.S. Food and Drug
Administration (FDA) approved the company’s supplemental New Drug
Application (sNDA) for its 200-liter EXPAREL manufacturing suite in
San Diego, CA. The company expects to start selling commercial
product manufactured at this 200-liter suite later this year, which
will help drive a more favorable mix of commercial product sold and
benefit EXPAREL gross margins over time.
- Frank D. Lee Appointed as Chief Executive
Officer. In December 2023, the company’s Board of
Directors appointed Frank D. Lee as chief executive officer and a
member of the Board, 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. Prior to Forma, Mr. Lee spent 13 years at Genentech, a
member of the Roche Group, in a series of leadership positions of
increasing scope and responsibility for delivering transformative
medicines to patients.
- FDA Approval of Expanded EXPAREL Label to Include Two
Additional Nerve Block Indications. In November 2023, the
FDA approved the company’s sNDA to expand the EXPAREL label to
include administration in adults as an adductor canal block and a
sciatic nerve block in the popliteal fossa. The approval is
supported by a Phase 3 program data supporting EXPAREL as the first
and only single-dose product to safely demonstrate four days of
superiority versus bupivacaine. EXPAREL achieved statistical
significance in postsurgical pain, opioid consumption and
percentage of opioid-free patients (P<0.01).
- Two New EXPAREL Patents. In November 2023, the
United States Patent and Trademark Office issued Patent Nos.
11,819,574 and 11,819,575, claiming composition of EXPAREL prepared
by an enhanced manufacturing process and composition of matter for
EXPAREL, respectively. Each of these EXPAREL patents are listed in
the FDA’s “Approved Drug Products with Therapeutic Equivalence
Evaluations” (the “Orange Book”). These two patents are among the
ten Orange Book listed patents that are now listed for EXPAREL, all
with an expiration date of January 22, 2041.
Fourth Quarter 2023
Financial Results
- Total revenues were $181.2 million in the fourth quarter of
2023, a 5% increase over the $172.0 million reported for the fourth
quarter of 2022.
- EXPAREL net product sales were $143.9 million in the fourth
quarter of 2023, a 4% increase over the $138.0 million reported for
the fourth quarter of 2022.
- ZILRETTA net product sales were $28.7 million in the fourth
quarter of 2023, a 3% increase over the $28.0 million reported for
the fourth quarter of 2022.
- Fourth quarter 2023 iovera° net product sales were $6.0
million, a 32% increase over the $4.6 million reported in the
fourth quarter of 2022.
- Sales of bupivacaine liposome injectable suspension to
third-party licensees were $1.1 million in the fourth quarter of
2023, versus the $1.0 million reported for the fourth quarter of
2022.
- Total operating expenses were $148.1 million in the fourth
quarter of 2023, versus the $181.8 million reported for the fourth
quarter of 2022. Included in operating expenses in 2022 was a $26.1
million impairment of acquired in-process research and development
(IPR&D).
- Research and development (R&D) expenses were $19.5 million
in the fourth quarter of 2023, compared to $17.5 million in the
fourth quarter of 2022. The company’s R&D expenses included
$6.9 million and $7.3 million of product development and
manufacturing capacity expansion costs in the fourth quarters of
2023 and 2022, respectively.
- Selling, general and administrative (SG&A) expenses were
$65.8 million in the fourth quarter of 2023, compared to $64.0
million in the fourth quarter of 2022.
- GAAP net income was $24.9 million, or $0.54 per basic share and
$0.50 per diluted share in the fourth quarter of 2023, compared to
a GAAP net loss of $10.1 million, or $0.22 per basic and diluted
share in the fourth quarter of 2022.
- Non-GAAP net income was $45.1 million, or $0.97 per basic share
and $0.89 per diluted share in the fourth quarter of 2023, compared
to $37.0 million, or $0.81 per basic share and $0.73 per diluted
share in the fourth quarter of 2022.
- Adjusted EBITDA was $65.4 million in the fourth quarter of
2023, a 11% increase compared to $58.8 million in the fourth
quarter of 2022.
- Pacira ended the fourth quarter of 2023 with cash, cash
equivalents and available-for-sale investments (“cash”) of $281.0
million. Cash provided by operations was $47.6 million in the
fourth quarter of 2023, compared to $42.0 million in the fourth
quarter of 2022.
- Pacira had 46.4 million basic and 52.1 million diluted weighted
average shares of common stock outstanding in the fourth quarter of
2023.
- For non-GAAP measures, Pacira had 52.1 million and 51.9 million
diluted weighted average shares of common stock outstanding in the
fourth quarter of 2023 and 2022, respectively.
See “Non-GAAP Financial Information” below.
Full-Year 2023
Financial Results
- Total revenues were $675.0 million in 2023, a 1% increase over
the $666.8 million reported in 2022.
- EXPAREL net product sales were $538.1 million in 2023, a
nominal increase compared to the $536.9 million reported in 2022.
There were two less selling days in 2023 compared to 2022.
- ZILRETTA net product sales were $111.1 million in 2023, a 5%
increase over the $105.5 million reported in 2022.
- Full-year iovera° net product sales were $19.7 million, a 29%
increase over the $15.3 million reported in 2022.
- Full-year sales of bupivacaine liposome injectable suspension
to third-party licensees were $3.3 million in 2023, versus the $6.5
million reported in 2022.
- Total operating expenses were $587.3 million in 2023, compared
to $606.8 million in 2022.
- R&D expenses were $76.3 million in 2023, compared to $84.8
million in 2022. The company’s R&D expenses include $33.4
million and $24.6 million of product development and manufacturing
capacity expansion costs in 2023 and 2022, respectively.
- SG&A expenses were $269.4 million in 2023, compared to
$254.5 million in 2022.
- GAAP net income was $42.0 million, or $0.91 per basic share and
$0.89 per diluted share in 2023, compared to $15.9 million, or
$0.35 per basic share and $0.34 per diluted share in 2022.
- Non-GAAP net income was $142.0 million, or $3.07 per basic
share and $2.81 per diluted share in 2023, compared to $120.7
million, or $2.65 per basic share and $2.39 per diluted share in
2022.
- Adjusted EBITDA was $214.5 million in 2023, a 1% increase over
$212.7 million in 2022.
- Cash provided by operations was $154.6 million in 2023,
compared to $145.3 million in 2022.
- Pacira had 46.2 million basic and 52.0 million diluted weighted
average shares of common stock outstanding in 2023.
- For non-GAAP measures, Pacira had 52.0 million and 52.7 million
diluted weighted average shares of common stock outstanding in 2023
and 2022, respectively.
See “Non-GAAP Financial Information” below.
2024 Financial Guidance
Today the company is providing full-year 2024 financial guidance
as follows:
- Total revenue of $680 million to $705 million;
- Non-GAAP gross margin of 74% to 76%;
- Non-GAAP R&D expense of $70 million to $80 million;
- Non-GAAP SG&A expense of $245 million to $265 million;
and
- Stock-based compensation of $50 million to $55 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 29, 2024, at 8:30 a.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 gross margin, non-GAAP cost of goods sold,
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 diluted 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 2024 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 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. 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®
(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 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° 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.
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 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 integration
of our new chief executive officer; risks associated with
acquisitions, such as the risk that the acquired businesses will
not be integrated successfully, that such integration may be more
difficult, time-consuming or costly than expected or that the
expected benefits of the transaction will not occur; our
manufacturing and supply chain, global and U.S. economic conditions
(including inflation and rising interest rates), and our business,
including our revenues, financial condition, cash flow and results
of operations; the success of our sales and manufacturing efforts
in support of the commercialization of EXPAREL, ZILRETTA and
iovera°; the rate and degree of market acceptance of EXPAREL,
ZILRETTA and iovera°; the size and growth of the potential markets
for EXPAREL, ZILRETTA and iovera° and our ability to serve those
markets; our plans to expand the use of EXPAREL, ZILRETTA and
iovera° to additional indications and opportunities, and the timing
and success of any related clinical trials for EXPAREL, ZILRETTA
and iovera°; the commercial success of EXPAREL, ZILRETTA and
iovera°; the related timing and success of U.S. Food and Drug
Administration supplemental New Drug Applications and premarket
notification 510(k)s; the related timing and success of European
Medicines Agency Marketing Authorization Applications; our plans to
evaluate, develop and pursue additional product candidates
utilizing our proprietary multivesicular liposome (“pMVL”) drug
delivery technology; the approval of the commercialization of our
products in other jurisdictions; clinical trials in support of an
existing or potential pMVL-based product; our commercialization and
marketing capabilities; our ability to successfully complete
capital projects; the outcome of any litigation; the ability to
successfully integrate any future acquisitions into our existing
business; the recoverability of our deferred tax assets;
assumptions associated with contingent consideration payments; 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 31,2023 |
|
December 31,2022 |
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
153,298 |
|
|
$ |
104,139 |
|
Short-term available-for-sale investments |
|
|
125,283 |
|
|
|
184,512 |
|
Accounts receivable, net |
|
|
105,556 |
|
|
|
98,397 |
|
Inventories, net |
|
|
104,353 |
|
|
|
96,063 |
|
Prepaid expenses and other current assets |
|
|
21,504 |
|
|
|
15,223 |
|
Total current assets |
|
|
509,994 |
|
|
|
498,334 |
|
Noncurrent available-for-sale
investments |
|
|
2,410 |
|
|
|
37,209 |
|
Fixed assets, net |
|
|
173,927 |
|
|
|
183,512 |
|
Right-of-use assets, net |
|
|
61,020 |
|
|
|
70,877 |
|
Goodwill |
|
|
163,243 |
|
|
|
163,243 |
|
Intangible assets, net |
|
|
483,258 |
|
|
|
540,546 |
|
Deferred tax assets |
|
|
144,485 |
|
|
|
160,309 |
|
Investments and other
assets |
|
|
36,049 |
|
|
|
27,170 |
|
Total assets |
|
$ |
1,574,386 |
|
|
$ |
1,681,200 |
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
15,698 |
|
|
$ |
15,220 |
|
Accrued expenses |
|
|
64,243 |
|
|
|
89,785 |
|
Lease liabilities |
|
|
8,801 |
|
|
|
9,121 |
|
Current portion of convertible senior notes, net |
|
|
8,641 |
|
|
|
— |
|
Current portion of long-term debt, net |
|
|
— |
|
|
|
33,648 |
|
Total current liabilities |
|
|
97,383 |
|
|
|
147,774 |
|
Convertible senior notes,
net |
|
|
398,594 |
|
|
|
404,767 |
|
Long-term debt, net |
|
|
115,202 |
|
|
|
251,056 |
|
Lease liabilities |
|
|
54,806 |
|
|
|
64,802 |
|
Contingent consideration |
|
|
24,698 |
|
|
|
28,122 |
|
Other liabilities |
|
|
13,573 |
|
|
|
9,669 |
|
Total stockholders’
equity |
|
|
870,130 |
|
|
|
775,010 |
|
Total liabilities and stockholders’ equity |
|
$ |
1,574,386 |
|
|
$ |
1,681,200 |
|
Pacira BioSciences, Inc. |
Consolidated Statements of Operations |
(in thousands, except per share amounts) |
(unaudited) |
|
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net product sales: |
|
|
|
|
|
|
|
|
EXPAREL |
|
$ |
143,918 |
|
|
$ |
138,045 |
|
|
$ |
538,120 |
|
|
$ |
536,899 |
|
ZILRETTA |
|
|
28,705 |
|
|
|
27,971 |
|
|
|
111,098 |
|
|
|
105,517 |
|
iovera° |
|
|
6,040 |
|
|
|
4,564 |
|
|
|
19,685 |
|
|
|
15,258 |
|
Bupivacaine liposome injectable suspension |
|
|
1,101 |
|
|
|
1,007 |
|
|
|
3,342 |
|
|
|
6,476 |
|
Total net product sales |
|
|
179,764 |
|
|
|
171,587 |
|
|
|
672,245 |
|
|
|
664,150 |
|
Royalty revenue |
|
|
1,480 |
|
|
|
368 |
|
|
|
2,733 |
|
|
|
2,673 |
|
Total revenues |
|
|
181,244 |
|
|
|
171,955 |
|
|
|
674,978 |
|
|
|
666,823 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
47,692 |
|
|
|
61,916 |
|
|
|
184,669 |
|
|
|
199,295 |
|
Research and development |
|
|
19,463 |
|
|
|
17,505 |
|
|
|
76,257 |
|
|
|
84,797 |
|
Selling, general and administrative |
|
|
65,801 |
|
|
|
63,970 |
|
|
|
269,441 |
|
|
|
254,516 |
|
Amortization of acquired intangible assets |
|
|
14,322 |
|
|
|
14,322 |
|
|
|
57,288 |
|
|
|
57,288 |
|
Contingent consideration (gains) charges, acquisition-related
charges and other |
|
|
798 |
|
|
|
24,135 |
|
|
|
(352 |
) |
|
|
10,903 |
|
Total operating expenses |
|
|
148,076 |
|
|
|
181,848 |
|
|
|
587,303 |
|
|
|
606,799 |
|
Income (loss) from operations |
|
|
33,168 |
|
|
|
(9,893 |
) |
|
|
87,675 |
|
|
|
60,024 |
|
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
3,425 |
|
|
|
2,785 |
|
|
|
11,444 |
|
|
|
4,542 |
|
Interest expense |
|
|
(3,388 |
) |
|
|
(11,041 |
) |
|
|
(20,306 |
) |
|
|
(39,976 |
) |
Loss on early extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
(16,926 |
) |
|
|
— |
|
Other, net |
|
|
515 |
|
|
|
81 |
|
|
|
(186 |
) |
|
|
(11,288 |
) |
Total other income (expense) |
|
|
552 |
|
|
|
(8,175 |
) |
|
|
(25,974 |
) |
|
|
(46,722 |
) |
Income (loss) before income taxes |
|
|
33,720 |
|
|
|
(18,068 |
) |
|
|
61,701 |
|
|
|
13,302 |
|
Income tax (expense) benefit |
|
|
(8,850 |
) |
|
|
7,966 |
|
|
|
(19,746 |
) |
|
|
2,607 |
|
Net income (loss) |
|
$ |
24,870 |
|
|
$ |
(10,102 |
) |
|
$ |
41,955 |
|
|
$ |
15,909 |
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share: |
|
|
|
|
|
|
|
|
Basic net income (loss) per common share |
|
$ |
0.54 |
|
|
$ |
(0.22 |
) |
|
$ |
0.91 |
|
|
$ |
0.35 |
|
Diluted net income (loss) per common share (1) |
|
$ |
0.50 |
|
|
$ |
(0.22 |
) |
|
$ |
0.89 |
|
|
$ |
0.34 |
|
Weighted average common shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
|
46,437 |
|
|
|
45,882 |
|
|
|
46,222 |
|
|
|
45,521 |
|
Diluted (1) |
|
|
52,064 |
|
|
|
45,882 |
|
|
|
51,979 |
|
|
|
46,538 |
|
|
(1) Upon the adoption of Accounting Standards Update, or ASU,
2020-06 on January 1, 2022, diluted net income per common share was
calculated in consideration of the “if-converted” method associated
with the Company’s convertible senior notes. Refer to the
Reconciliation of GAAP to Non-GAAP Financial Information, filed
herein, for the inputs used in the computation. |
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, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
GAAP net income (loss) |
|
$ |
24,870 |
|
|
$ |
(10,102 |
) |
|
$ |
41,955 |
|
|
$ |
15,909 |
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
Contingent consideration (gains) charges, acquisition-related
charges and other: |
|
|
|
|
|
|
|
|
Severance-related expenses (1) |
|
|
— |
|
|
|
235 |
|
|
|
— |
|
|
|
4,494 |
|
Acquisition-related fees and expenses (2) |
|
|
375 |
|
|
|
848 |
|
|
|
1,963 |
|
|
|
6,751 |
|
Changes in the fair value of contingent consideration |
|
|
423 |
|
|
|
(6,082 |
) |
|
|
(3,424 |
) |
|
|
(29,476 |
) |
Restructuring charges (3) |
|
|
— |
|
|
|
— |
|
|
|
1,109 |
|
|
|
— |
|
Impairment of acquired IPR&D (4) |
|
|
— |
|
|
|
26,134 |
|
|
|
— |
|
|
|
26,134 |
|
Termination of license agreement (5) |
|
|
— |
|
|
|
3,000 |
|
|
|
— |
|
|
|
3,000 |
|
Amortization of acquired intangible assets |
|
|
14,322 |
|
|
|
14,322 |
|
|
|
57,288 |
|
|
|
57,288 |
|
Stock-based compensation |
|
|
12,420 |
|
|
|
12,677 |
|
|
|
47,895 |
|
|
|
48,092 |
|
Step-up of acquired Flexion fixed assets and inventory to fair
value |
|
|
— |
|
|
|
2,169 |
|
|
|
5,152 |
|
|
|
7,927 |
|
Loss on early extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
16,926 |
|
|
|
— |
|
Amortization of debt discount |
|
|
24 |
|
|
|
700 |
|
|
|
752 |
|
|
|
2,807 |
|
Accelerated depreciation |
|
|
— |
|
|
|
10,545 |
|
|
|
— |
|
|
|
10,545 |
|
Impairment on investment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
10,000 |
|
Tax impact of non-GAAP adjustments (6) |
|
|
(7,320 |
) |
|
|
(17,454 |
) |
|
|
(27,569 |
) |
|
|
(42,728 |
) |
Total Non-GAAP
adjustments |
|
|
20,244 |
|
|
|
47,094 |
|
|
|
100,092 |
|
|
|
104,834 |
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
|
$ |
45,114 |
|
|
$ |
36,992 |
|
|
$ |
142,047 |
|
|
$ |
120,743 |
|
|
|
|
|
|
|
|
|
|
GAAP basic net income (loss)
per common share |
|
$ |
0.54 |
|
|
$ |
(0.22 |
) |
|
$ |
0.91 |
|
|
$ |
0.35 |
|
GAAP diluted net income (loss)
per common share |
|
$ |
0.50 |
|
|
$ |
(0.22 |
) |
|
$ |
0.89 |
|
|
$ |
0.34 |
|
|
|
|
|
|
|
|
|
|
GAAP net income (loss) |
|
$ |
24,870 |
|
|
$ |
(10,102 |
) |
|
$ |
41,955 |
|
|
$ |
15,909 |
|
Interest expense on convertible senior notes, net of tax |
|
|
1,029 |
|
|
|
— |
|
|
|
4,114 |
|
|
|
— |
|
GAAP net income (loss) used
for diluted earnings per share |
|
$ |
25,899 |
|
|
$ |
(10,102 |
) |
|
$ |
46,069 |
|
|
$ |
15,909 |
|
|
|
|
|
|
|
|
|
|
Non-GAAP basic net income per
common share |
|
$ |
0.97 |
|
|
$ |
0.81 |
|
|
$ |
3.07 |
|
|
$ |
2.65 |
|
Non-GAAP diluted net income
per common share |
|
$ |
0.89 |
|
|
$ |
0.73 |
|
|
$ |
2.81 |
|
|
$ |
2.39 |
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
|
$ |
45,114 |
|
|
$ |
36,992 |
|
|
$ |
142,047 |
|
|
$ |
120,743 |
|
Interest expense on convertible senior notes, net of
tax (7) |
|
|
1,029 |
|
|
|
1,034 |
|
|
|
4,114 |
|
|
|
5,061 |
|
Non-GAAP net income used for
diluted earnings per share (7) |
|
$ |
46,143 |
|
|
$ |
38,026 |
|
|
$ |
146,161 |
|
|
$ |
125,804 |
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding - basic |
|
|
46,437 |
|
|
|
45,882 |
|
|
|
46,222 |
|
|
|
45,521 |
|
Weighted average common shares
outstanding - diluted |
|
|
52,064 |
|
|
|
45,882 |
|
|
|
51,979 |
|
|
|
46,538 |
|
Non-GAAP weighted average
common shares outstanding - basic |
|
|
46,437 |
|
|
|
45,882 |
|
|
|
46,222 |
|
|
|
45,521 |
|
Non-GAAP weighted average
common shares outstanding - diluted (7) |
|
|
52,064 |
|
|
|
51,926 |
|
|
|
51,979 |
|
|
|
52,744 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) The
severance-related expenses in 2022 substantially relate to former
employees released in connection with the acquisition of Flexion
Therapeutics, Inc. (“Flexion”) in November 2021. |
(2) For the three
months and year ended December 31, 2023, acquisition-related fees
and expenses primarily related to vacant and underutilized leases
assumed from acquiring Flexion. For the three months and year ended
December 31, 2022, acquisition-related fees and expenses primarily
related to legal and other professional fees, third-party services
and other one-time charges associated with the Flexion
acquisition. |
(3) In June 2023,
the Company implemented a restructuring plan in an effort to
improve its operational efficiencies. The restructuring charges are
predominantly related to one-time employee termination benefits
through a reduction of headcount, such as severance and related
costs. |
(4) For the three
months and year ended December 31, 2022, an impairment of
$26.1 million for an IPR&D intangible asset related to
ZILRETTA for the treatment of osteoarthritis pain of the shoulder
was recognized based on the amount its previous carrying value of
$60.0 million exceeded its fair value of
$33.9 million. |
(5) The Company
recognized expense of $3.0 million in the three months and
year ended December 31, 2022 related to the termination of a
license agreement. |
(6) 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 and out of period tax
items. Both the GAAP and non-GAAP effective income tax rates for
the three months ended December 31, 2023 were 26%. The non-GAAP
effective income tax rate excludes costs related to discrete
non-deductible executive compensation, offset by excluding benefits
from discrete tax credits. The effective income tax rates for the
year ended December 31, 2023 were 32% and 25% for GAAP and
non-GAAP, 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. For the three months ended December 31, 2022,
the GAAP and non-GAAP effective income tax rates were 44% and 20%,
respectively. For the year ended December 31, 2022, the GAAP and
non-GAAP effective income tax rates were (20)% and 25%,
respectively. The differences from GAAP were primarily due to the
impact of excluding tax benefits related to acquisition items,
partially offset by excluding tax expenses for non-deductible
capital losses. |
(7) For 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 three months and year ended December
31, 2022, the $402.5 million convertible senior notes due 2025, or
2025 Notes, were excluded on a GAAP basis as the impact to diluted
net income (loss) per common share 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
three months and year ended December 31, 2022, 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 5.6 million
common shares in each period upon an assumed conversion and added
back $1.0 million and $4.1 million, respectively, of interest
expense, net of tax, to non-GAAP net income. The Company has the
option to settle its 2025 Notes in cash, shares of the Company’s
common stock or a combination of cash and shares of the Company’s
common stock.For the year ended December 31, 2022, the $160.0
million convertible senior notes due 2022, or 2022 Notes, were
excluded on a GAAP basis as the impact to diluted net income per
common share 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, 2022, non-GAAP adjustments to diluted weighted average
shares outstanding included the impact of the 2022 Notes, as if
they were converted on the first day of the period presented, which
resulted in adding an additional 0.6 million common shares upon an
assumed conversion and added back $1.0 million of interest expense,
net of tax, to net income. On April 1, 2022, the Company repaid the
principal portion of its 2022 Notes in cash.Prior year amounts were
reclassified to conform to the current year presentation. |
Pacira BioSciences, Inc. |
Reconciliation of GAAP to Non-GAAP Financial Information
(continued) |
(in thousands, except per share amounts) |
(unaudited) |
|
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Cost of goods sold
reconciliation: |
|
|
|
|
|
|
|
|
GAAP cost of goods sold |
|
$ |
47,692 |
|
|
$ |
61,916 |
|
|
$ |
184,669 |
|
|
$ |
199,295 |
|
Stock-based compensation |
|
|
(1,105 |
) |
|
|
(1,538 |
) |
|
|
(5,537 |
) |
|
|
(5,967 |
) |
Step-up of acquired Flexion fixed assets and inventory to fair
value |
|
|
— |
|
|
|
(2,169 |
) |
|
|
(5,152 |
) |
|
|
(7,927 |
) |
Accelerated depreciation |
|
|
— |
|
|
|
(10,545 |
) |
|
|
— |
|
|
|
(10,545 |
) |
Non-GAAP cost of goods
sold |
|
$ |
46,587 |
|
|
$ |
47,664 |
|
|
$ |
173,980 |
|
|
$ |
174,856 |
|
|
|
|
|
|
|
|
|
|
Research and
development reconciliation: |
|
|
|
|
|
|
|
|
GAAP research and
development |
|
$ |
19,463 |
|
|
$ |
17,505 |
|
|
$ |
76,257 |
|
|
$ |
84,797 |
|
Stock-based compensation |
|
|
(2,877 |
) |
|
|
(1,833 |
) |
|
|
(8,694 |
) |
|
|
(6,594 |
) |
Non-GAAP research and
development |
|
$ |
16,586 |
|
|
$ |
15,672 |
|
|
$ |
67,563 |
|
|
$ |
78,203 |
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative reconciliation: |
|
|
|
|
|
|
|
|
GAAP selling, general and
administrative |
|
$ |
65,801 |
|
|
$ |
63,970 |
|
|
$ |
269,441 |
|
|
$ |
254,516 |
|
Stock-based compensation |
|
|
(8,438 |
) |
|
|
(9,306 |
) |
|
|
(33,664 |
) |
|
|
(35,531 |
) |
Non-GAAP selling, general and
administrative |
|
$ |
57,363 |
|
|
$ |
54,664 |
|
|
$ |
235,777 |
|
|
$ |
218,985 |
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - diluted reconciliation: |
|
|
|
|
|
|
|
|
GAAP weighted average common
shares outstanding - diluted |
|
|
52,064 |
|
|
|
45,882 |
|
|
|
51,979 |
|
|
|
46,538 |
|
Dilutive common shares associated with the 2025 Notes (1) |
|
|
— |
|
|
|
5,608 |
|
|
|
— |
|
|
|
5,608 |
|
Dilutive common shares associated with the 2022 Notes (2) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
598 |
|
Dilutive common shares associated with stock options, restricted
stock units and ESPP (3) |
|
|
— |
|
|
|
436 |
|
|
|
— |
|
|
|
— |
|
Non-GAAP weighted average
common shares outstanding - diluted |
|
|
52,064 |
|
|
|
51,926 |
|
|
|
51,979 |
|
|
|
52,744 |
|
|
(1) For the three
months and year ended December 31, 2022, potential common shares of
the 2025 Notes were excluded from diluted net income (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, 2022, potential common shares of the 2022 Notes
were excluded from diluted net income 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. |
(3) For the three
months ended December 31, 2022, potential common shares associated
with stock options, restricted stock units and the Company’s
employee stock purchase plan were excluded from diluted net income
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. |
Pacira BioSciences, Inc. |
Reconciliation of GAAP Net (Loss) Income to Adjusted EBITDA
(Non-GAAP) |
(in thousands) |
(unaudited) |
|
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
GAAP net income (loss) |
|
$ |
24,870 |
|
|
$ |
(10,102 |
) |
|
$ |
41,955 |
|
|
$ |
15,909 |
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
(3,425 |
) |
|
|
(2,785 |
) |
|
|
(11,444 |
) |
|
|
(4,542 |
) |
Interest expense (1) |
|
|
3,388 |
|
|
|
11,041 |
|
|
|
20,306 |
|
|
|
39,976 |
|
Income tax expense (benefit) |
|
|
8,850 |
|
|
|
(7,966 |
) |
|
|
19,746 |
|
|
|
(2,607 |
) |
Depreciation expense |
|
|
4,163 |
|
|
|
16,083 |
|
|
|
18,286 |
|
|
|
34,213 |
|
Amortization of acquired intangible assets |
|
|
14,322 |
|
|
|
14,322 |
|
|
|
57,288 |
|
|
|
57,288 |
|
EBITDA |
|
|
52,168 |
|
|
|
20,593 |
|
|
|
146,137 |
|
|
|
140,237 |
|
|
|
|
|
|
|
|
|
|
Other adjustments: |
|
|
|
|
|
|
|
|
Contingent consideration (gains) charges, acquisition-related
charges and other: |
|
|
|
|
|
|
|
|
Severance-related expenses |
|
|
— |
|
|
|
235 |
|
|
|
— |
|
|
|
4,494 |
|
Acquisition-related fees and expenses (2) |
|
|
375 |
|
|
|
848 |
|
|
|
1,963 |
|
|
|
5,546 |
|
Changes in the fair value of contingent consideration |
|
|
423 |
|
|
|
(6,082 |
) |
|
|
(3,424 |
) |
|
|
(29,476 |
) |
Restructuring charges |
|
|
— |
|
|
|
— |
|
|
|
1,109 |
|
|
|
— |
|
Impairment of acquired IPR&D |
|
|
— |
|
|
|
26,134 |
|
|
|
— |
|
|
|
26,134 |
|
Termination of license agreement |
|
|
— |
|
|
|
3,000 |
|
|
|
— |
|
|
|
3,000 |
|
Stock-based compensation |
|
|
12,420 |
|
|
|
12,677 |
|
|
|
47,895 |
|
|
|
48,092 |
|
Step-up of acquired Flexion inventory to fair value |
|
|
— |
|
|
|
1,366 |
|
|
|
3,884 |
|
|
|
4,719 |
|
Loss on early extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
16,926 |
|
|
|
— |
|
Impairment on investment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
10,000 |
|
Adjusted EBITDA |
|
$ |
65,386 |
|
|
$ |
58,771 |
|
|
$ |
214,490 |
|
|
$ |
212,746 |
|
|
(1) Includes
amortization of debt discount and debt issuance costs. |
(2) For the year
ended December 31, 2022, excludes any depreciation expense included
in EBITDA above. |
Pacira BioSciences, Inc. |
Reconciliation of GAAP to Non-GAAP 2024 Financial
Guidance |
(dollars in millions) |
|
GAAP to Non-GAAP Guidance |
|
GAAP |
|
Impact of GAAPto
Non-GAAPAdjustments (1) |
|
Non-GAAP |
Total revenues |
|
$680 to $705 |
|
— |
|
$680 to $705 |
Gross margin |
|
73% to 75% |
|
Approximately 1% |
|
74% to 76% |
Research and development
expense |
|
$78 to $90 |
|
$8 to $10 |
|
$70 to $80 |
Selling, general and
administrative expense |
|
$280 to $310 |
|
$35 to $45 |
|
$245 to $265 |
Stock-based compensation |
|
$50 to $55 |
|
— |
|
— |
|
(1) The full-year
impact of GAAP to Non-GAAP adjustments primarily 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
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