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 second quarter
of 2024.
Second Quarter
2024 Financial Highlights
- Total revenues of $178.0
million
- Net product sales of $136.9 million
for EXPAREL, $30.7 million for ZILRETTA, and $5.7 million for
iovera°
- Net income of $18.9 million, or
$0.41 per share (basic) and $0.39 per share (diluted)
- Adjusted earnings before interest,
taxes, depreciation and amortization (EBITDA) of $62.1 million
See “Non-GAAP Financial Information” below.
“The first half of the year was marked by meaningful progress
towards our commercial, clinical, and business objectives. With a
focus on strong execution, we maintained solid sales across all
three of our opioid-sparing products, strengthened our balance
sheet, and realigned our leadership team to better position us for
long-term success,” said Frank D. Lee, chief executive officer of
Pacira BioSciences. “Looking ahead to the back half of the year, we
remain sharply focused on preparations to maximize the benefit of
separate EXPAREL reimbursement for outpatient procedures with the
implementation of NOPAIN in January 2025.”
“We have multiple initiatives underway to drive awareness around
the opioid-sparing benefits of EXPAREL ahead of NOPAIN. Recent
progress includes the publication of three robust real-world
studies that demonstrate the opioid-sparing and economic benefits
of EXPAREL and the launch of a national awareness and educational
campaign. We remain confident this important reimbursement
milestone will drive expanded EXPAREL utilization in outpatient
settings and drive accelerated topline growth in 2025 and beyond,”
continued Mr. Lee.
Recent Business Highlights
- Centers for Medicare and Medicaid Services (CMS)
propose new reimbursement for EXPAREL in all outpatient surgical
environments beginning January 1, 2025. In July 2024, CMS
issued its proposed Hospital Outpatient Prospective Payment System
and Ambulatory Surgical Center Payment System rule for 2025. In the
proposed rule, EXPAREL® (bupivacaine liposome injectable
suspension) is one of six covered non-opioids—two of which are
specific to ophthalmology— qualifying for separate Medicare
reimbursement in both the ambulatory surgical center (ASC) and
hospital outpatient (HOPD) settings. Pending finalization, this
policy would go into effect beginning January 1, 2025. The proposed
rule reflects impending implementation of the Non-Opioids Prevent
Addiction in the Nation (NOPAIN) Act, which mandates separate CMS
payment for qualifying non-opioid drugs and devices across the HOPD
and ASC settings. The law was passed as part of the Consolidated
Appropriations Act of 2023.
- $150 Million Share Repurchase Program. In May
2024, the company announced a new share repurchase program which
authorizes the company to repurchase up to an aggregate of $150
million of its outstanding common stock. Repurchases under the
program may be made at management’s discretion on the open market
or through privately negotiated transactions. The share repurchase
program may be suspended or discontinued at any time by the company
and has an expiration date of December 31, 2026. Concurrently with
the pricing of the offering of the 2029 Notes discussed below, the
company entered into separate privately negotiated agreements with
certain of the initial purchasers of the 2029 Notes or their
respective affiliates and/or certain other financial institutions
to repurchase 837,240 shares of its common stock for $25.0
million.
- Issuance of $287.5 million
aggregate principal amount of 2.125% convertible senior notes due
2029. In May 2024, Pacira issued $287.5 million in
aggregate principal amount of 2.125% convertible senior notes due
2029 (the 2029 Notes) in a private placement. Pacira used
approximately $191.0 million of the net proceeds to repurchase
$200.0 million aggregate principal amount of its outstanding 0.750%
convertible senior notes due 2025, approximately $26.7 million of
the net proceeds to fund the cost of entering into capped call
transactions associated with the issuance, and approximately $25.0
million of the net proceeds for the share repurchase referenced
above. Pacira intends to use the remainder of the net proceeds from
the offering for general corporate purposes, including working
capital and research and development expenditures.
Second Quarter
2024 Financial Results
- Total revenues were $178.0 million
in the second quarter of 2024, versus $169.5 million reported for
the second quarter of 2023.
- EXPAREL net product sales were
$136.9 million in the second quarter of 2024, versus $135.1 million
reported for the second quarter of 2023. Second quarter volume
growth of 3 percent was offset by contracted discounts and vial
mix. There were 63 selling days in the second quarter of 2024 and
64 selling days in the second quarter of 2023.
- ZILRETTA net product sales were
$30.7 million in the second quarter of 2024, versus $29.3 million
reported for the second quarter of 2023.
- Second quarter 2024 iovera° net
product sales were $5.7 million, versus $4.4 million reported for
the second quarter of 2023.
- Sales of bupivacaine liposome
injectable suspension to third-party licensees were $3.2 million in
the second quarter of 2024, versus $0.7 million reported for the
second quarter of 2023.
- Total operating expenses were $149.8
million in the second quarter of 2024, compared to $129.6 million
in the second quarter of 2023.
- Research and development (R&D)
expenses were $20.3 million in the second quarter of 2024, compared
to $18.8 million in the second quarter of 2023. R&D expenses
included $7.3 million and $9.3 million of product development and
manufacturing capacity expansion costs in the second quarters of
2024 and 2023, respectively.
- Selling, general and administrative
(SG&A) expenses were $68.1 million in the second quarter of
2024, compared to $64.9 million in the second quarter of 2023.
- GAAP net income was $18.9 million,
or $0.41 per share (basic) and $0.39 (diluted) in the second
quarter of 2024, compared to $25.8 million, or $0.56 per share
(basic) and $0.51 (diluted) in the second quarter of 2023.
- Non-GAAP net income was $44.2
million, or $0.96 per share (basic) and $0.89 per share (diluted)
in the second quarter of 2024, compared to $36.0 million, or $0.78
per share (basic) and $0.71 per share (diluted), in the second
quarter of 2023.
- Adjusted EBITDA was $62.1 million in
the second quarter of 2024, compared to $54.3 million in the second
quarter of 2023.
- Pacira ended the second quarter of
2024 with cash, cash equivalents and available-for-sale investments
(“cash”) of $404.2 million. Cash provided by operations was $53.2
million in the second quarter of 2024, compared to $43.5 million in
the second quarter of 2023.
- Pacira had 46.2 million basic and
50.5 million diluted weighted average shares of common stock
outstanding in the second quarter of 2024.
See “Non-GAAP Financial Information” below.
2024 Financial Guidance
Today the company is reiterating its 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, Tuesday, July 30, 2024, 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 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 non-opioid pain management options 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 “anticipate,” “believe,”
“can,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“project,” “should,” “will,” “would,” 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, plans with respect to the Non-Opioids
Prevent Addiction in the Nation (“NOPAIN”) Act and other statements
that are not historical facts. For this purpose, any statement that
is not a statement of historical fact should be considered a
forward-looking statement. We cannot assure you that our estimates,
assumptions and expectations will prove to have been correct.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including risks relating to, among others: 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; 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.
(Tables to Follow)
Pacira BioSciences, Inc.Condensed
Consolidated Balance Sheets(in
thousands)(unaudited) |
|
|
June 30,2024 |
|
December 31,2023 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
247,053 |
|
$ |
153,298 |
Short-term available-for-sale investments |
|
157,173 |
|
|
125,283 |
Accounts receivable, net |
|
104,779 |
|
|
105,556 |
Inventories, net |
|
103,438 |
|
|
104,353 |
Prepaid expenses and other current assets |
|
19,771 |
|
|
21,504 |
Total current assets |
|
632,214 |
|
|
509,994 |
Noncurrent available-for-sale
investments |
|
— |
|
|
2,410 |
Fixed assets, net |
|
168,850 |
|
|
173,927 |
Right-of-use assets, net |
|
56,264 |
|
|
61,020 |
Goodwill |
|
163,243 |
|
|
163,243 |
Intangible assets, net |
|
454,614 |
|
|
483,258 |
Deferred tax assets |
|
135,136 |
|
|
144,485 |
Investments and other
assets |
|
36,499 |
|
|
36,049 |
Total assets |
$ |
1,646,820 |
|
$ |
1,574,386 |
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
18,730 |
|
$ |
15,698 |
Accrued expenses |
|
64,811 |
|
|
64,243 |
Lease liabilities |
|
9,149 |
|
|
8,801 |
Current portion of convertible senior notes, net |
|
— |
|
|
8,641 |
Total current liabilities |
|
92,690 |
|
|
97,383 |
Convertible senior notes,
net |
|
479,549 |
|
|
398,594 |
Long-term debt, net |
|
109,751 |
|
|
115,202 |
Lease liabilities |
|
50,146 |
|
|
54,806 |
Contingent consideration |
|
22,401 |
|
|
24,698 |
Other liabilities |
|
13,005 |
|
|
13,573 |
Total stockholders’
equity |
|
879,278 |
|
|
870,130 |
Total liabilities and stockholders’ equity |
$ |
1,646,820 |
|
$ |
1,574,386 |
|
Pacira BioSciences, Inc.Condensed
Consolidated Statements of Operations(in
thousands, except per share
amounts)(unaudited) |
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Net product sales: |
|
|
|
|
|
|
|
EXPAREL |
$ |
136,852 |
|
|
$ |
135,127 |
|
|
$ |
269,282 |
|
|
$ |
265,535 |
|
ZILRETTA |
|
30,707 |
|
|
|
29,261 |
|
|
|
56,546 |
|
|
|
53,595 |
|
iovera° |
|
5,674 |
|
|
|
4,384 |
|
|
|
10,704 |
|
|
|
8,385 |
|
Bupivacaine liposome injectable suspension |
|
3,154 |
|
|
|
695 |
|
|
|
5,679 |
|
|
|
1,383 |
|
Total net product sales |
|
176,387 |
|
|
|
169,467 |
|
|
|
342,211 |
|
|
|
328,898 |
|
Royalty revenue |
|
1,636 |
|
|
|
— |
|
|
|
2,929 |
|
|
|
910 |
|
Total revenues |
|
178,023 |
|
|
|
169,467 |
|
|
|
345,140 |
|
|
|
329,808 |
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
|
44,262 |
|
|
|
48,207 |
|
|
|
91,678 |
|
|
|
97,227 |
|
Research and development |
|
20,338 |
|
|
|
18,824 |
|
|
|
38,576 |
|
|
|
35,964 |
|
Selling, general and administrative |
|
68,126 |
|
|
|
64,850 |
|
|
|
140,152 |
|
|
|
135,693 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
|
|
28,644 |
|
|
|
28,644 |
|
Contingent consideration charges (gains), restructuring charges and
other |
|
2,735 |
|
|
|
(16,613 |
) |
|
|
4,638 |
|
|
|
(4,506 |
) |
Total operating expenses |
|
149,783 |
|
|
|
129,590 |
|
|
|
303,688 |
|
|
|
293,022 |
|
Income from operations |
|
28,240 |
|
|
|
39,877 |
|
|
|
41,452 |
|
|
|
36,786 |
|
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
4,749 |
|
|
|
2,111 |
|
|
|
8,652 |
|
|
|
5,253 |
|
Interest expense |
|
(3,884 |
) |
|
|
(3,865 |
) |
|
|
(7,200 |
) |
|
|
(13,454 |
) |
Gain (loss) on early extinguishment of debt |
|
7,518 |
|
|
|
— |
|
|
|
7,518 |
|
|
|
(16,926 |
) |
Other, net |
|
(39 |
) |
|
|
(269 |
) |
|
|
(198 |
) |
|
|
(279 |
) |
Total other income (expense), net |
|
8,344 |
|
|
|
(2,023 |
) |
|
|
8,772 |
|
|
|
(25,406 |
) |
Income before income
taxes |
|
36,584 |
|
|
|
37,854 |
|
|
|
50,224 |
|
|
|
11,380 |
|
Income tax expense |
|
(17,698 |
) |
|
|
(12,091 |
) |
|
|
(22,359 |
) |
|
|
(5,153 |
) |
Net income |
$ |
18,886 |
|
|
$ |
25,763 |
|
|
$ |
27,865 |
|
|
$ |
6,227 |
|
|
|
|
|
|
|
|
|
Net income per share: |
|
|
|
|
|
|
|
Basic net income per common share |
$ |
0.41 |
|
|
$ |
0.56 |
|
|
$ |
0.60 |
|
|
$ |
0.14 |
|
Diluted net income per common share(1) |
$ |
0.39 |
|
|
$ |
0.51 |
|
|
$ |
0.58 |
|
|
$ |
0.13 |
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
46,174 |
|
|
|
46,088 |
|
|
|
46,337 |
|
|
|
46,019 |
|
Diluted(1) |
|
50,539 |
|
|
|
52,054 |
|
|
|
51,366 |
|
|
|
46,285 |
|
(1) 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 included 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 |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP net income |
$ |
18,886 |
|
|
$ |
25,763 |
|
|
$ |
27,865 |
|
|
$ |
6,227 |
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Contingent consideration charges (gains), restructuring charges and
other: |
|
|
|
|
|
|
|
Changes in the fair value of contingent consideration |
|
1,509 |
|
|
|
(18,258 |
) |
|
|
(2,297 |
) |
|
|
(6,640 |
) |
Restructuring charges(1) (2) |
|
504 |
|
|
|
936 |
|
|
|
3,804 |
|
|
|
936 |
|
Acquisition-related expenses(3) |
|
230 |
|
|
|
709 |
|
|
|
404 |
|
|
|
1,198 |
|
Step-up of acquired Flexion Therapeutics, Inc. fixed assets and
inventory to fair value and other |
|
— |
|
|
|
1,727 |
|
|
|
— |
|
|
|
3,834 |
|
Stock-based compensation |
|
12,524 |
|
|
|
10,955 |
|
|
|
25,675 |
|
|
|
22,945 |
|
Chief Executive Officer transition costs(4) |
|
294 |
|
|
|
— |
|
|
|
571 |
|
|
|
— |
|
(Gain) loss on early extinguishment of debt |
|
(7,518 |
) |
|
|
— |
|
|
|
(7,518 |
) |
|
|
16,926 |
|
Amortization of debt discount |
|
23 |
|
|
|
28 |
|
|
|
47 |
|
|
|
703 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
|
|
28,644 |
|
|
|
28,644 |
|
Tax impact of non-GAAP adjustments(5) |
|
3,456 |
|
|
|
(182 |
) |
|
|
(1,890 |
) |
|
|
(14,471 |
) |
Total non-GAAP adjustments |
|
25,344 |
|
|
|
10,237 |
|
|
|
47,440 |
|
|
|
54,075 |
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
44,230 |
|
|
$ |
36,000 |
|
|
$ |
75,305 |
|
|
$ |
60,302 |
|
|
|
|
|
|
|
|
|
GAAP basic net income per
common share |
$ |
0.41 |
|
|
$ |
0.56 |
|
|
$ |
0.60 |
|
|
$ |
0.14 |
|
GAAP diluted net income per
common share |
$ |
0.39 |
|
|
$ |
0.51 |
|
|
$ |
0.58 |
|
|
$ |
0.13 |
|
|
|
|
|
|
|
|
|
GAAP net income used for basic
earnings per share |
$ |
18,886 |
|
|
$ |
25,763 |
|
|
$ |
27,865 |
|
|
$ |
6,227 |
|
Interest expense on convertible senior notes, net of tax |
|
762 |
|
|
|
1,029 |
|
|
|
1,790 |
|
|
|
— |
|
GAAP net income used for
diluted earnings per share |
$ |
19,648 |
|
|
$ |
26,792 |
|
|
$ |
29,655 |
|
|
$ |
6,227 |
|
|
|
|
|
|
|
|
|
Non-GAAP basic net income per
common share |
$ |
0.96 |
|
|
$ |
0.78 |
|
|
$ |
1.63 |
|
|
$ |
1.31 |
|
Non-GAAP diluted net income
per common share |
$ |
0.89 |
|
|
$ |
0.71 |
|
|
$ |
1.50 |
|
|
$ |
1.20 |
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
44,230 |
|
|
$ |
36,000 |
|
|
$ |
75,305 |
|
|
$ |
60,302 |
|
Interest expense on
convertible senior notes, net of tax(6) |
|
762 |
|
|
|
1,029 |
|
|
|
1,790 |
|
|
|
2,057 |
|
Non-GAAP net income used for
diluted earnings per share(6) |
$ |
44,992 |
|
|
$ |
37,029 |
|
|
$ |
77,095 |
|
|
$ |
62,359 |
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding - basic |
|
46,174 |
|
|
|
46,088 |
|
|
|
46,337 |
|
|
|
46,019 |
|
Weighted average common shares
outstanding - diluted |
|
50,539 |
|
|
|
52,054 |
|
|
|
51,366 |
|
|
|
46,285 |
|
Non-GAAP weighted average
common shares outstanding - basic |
|
46,174 |
|
|
|
46,088 |
|
|
|
46,337 |
|
|
|
46,019 |
|
Non-GAAP weighted average
common shares outstanding - diluted(6) |
|
50,539 |
|
|
|
52,054 |
|
|
|
51,366 |
|
|
|
51,892 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pacira BioSciences, Inc.Reconciliation of
GAAP to Non-GAAP Financial Information
(continued)(in
thousands)(unaudited) |
(1) In February
2024, the Company initiated a restructuring plan to ensure it is
well positioned for long-term growth. The restructuring plan
includes: (i) reshaping the Company’s executive team; (ii)
reallocating efforts and resources from the Company’s ex-U.S. and
certain early-stage development programs to its 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 beginning in 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
$0.5 million and $2.7 million of restructuring charges were
excluded from this line item as they are included in the
stock-based compensation line item for the three and six months
ended June 30, 2024, respectively. |
|
(3)
Acquisition-related expenses related to vacant and underutilized
leases assumed from the acquisition of Flexion Therapeutics, Inc.
(“Flexion”). |
|
(4) The Company
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 employed by the
Company in an advisory role. |
|
(5) 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 and six
months ended June 30, 2024, the GAAP effective income tax
rates were approximately 48% and 45%, respectively, and the
non-GAAP effective income tax rate for both the three and six
months ended June 30, 2024 was approximately 24% with the
difference from GAAP primarily relating to the impact of excluding
both discrete tax expenses associated with non-deductible
stock-based compensation, primarily related to expired stock
options, and non-deductible tax expenses related to executive
compensation.For the three and six months ended June 30, 2023, the
GAAP effective income tax rates were approximately 32% and 45%,
respectively, and the non-GAAP effective income tax rate for both
the three and six months ended June 30, 2023 was approximately 25%
with the difference from GAAP primarily relating to the impact of
excluding discrete tax expenses associated with non-deductible
stock-based compensation and tax expenses related to executive
compensation. |
|
(6) For the three
months ended June 30, 2023 and the three and six months ended June
30, 2024, 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 six months
ended June 30, 2023, the then-outstanding $402.5 million aggregate
principal 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 six months ended
June 30, 2023, 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 upon an assumed
conversion and added back $2.1 million 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.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)(unaudited) |
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Cost of goods sold
reconciliation: |
|
|
|
|
|
|
|
GAAP cost of goods sold |
$ |
44,262 |
|
|
$ |
48,207 |
|
|
$ |
91,678 |
|
|
$ |
97,227 |
|
Step-up of acquired Flexion fixed assets and inventory to fair
value and other |
|
— |
|
|
|
(1,727 |
) |
|
|
— |
|
|
|
(3,834 |
) |
Stock-based compensation |
|
(1,259 |
) |
|
|
(1,436 |
) |
|
|
(2,387 |
) |
|
|
(3,160 |
) |
Non-GAAP cost of goods
sold |
$ |
43,003 |
|
|
$ |
45,044 |
|
|
$ |
89,291 |
|
|
$ |
90,233 |
|
|
|
|
|
|
|
|
|
Research and
development reconciliation: |
|
|
|
|
|
|
|
GAAP research and
development |
$ |
20,338 |
|
|
$ |
18,824 |
|
|
$ |
38,576 |
|
|
$ |
35,964 |
|
Stock-based compensation |
|
(1,925 |
) |
|
|
(1,722 |
) |
|
|
(3,728 |
) |
|
|
(3,597 |
) |
Non-GAAP research and
development |
$ |
18,413 |
|
|
$ |
17,102 |
|
|
$ |
34,848 |
|
|
$ |
32,367 |
|
|
|
|
|
|
|
|
|
Selling, general and
administrative reconciliation: |
|
|
|
|
|
|
|
GAAP selling, general and
administrative |
$ |
68,126 |
|
|
$ |
64,850 |
|
|
$ |
140,152 |
|
|
$ |
135,693 |
|
CEO transition costs |
|
(294 |
) |
|
|
— |
|
|
|
(571 |
) |
|
|
— |
|
Stock-based compensation |
|
(8,848 |
) |
|
|
(7,797 |
) |
|
|
(16,833 |
) |
|
|
(16,188 |
) |
Non-GAAP selling, general and
administrative |
$ |
58,984 |
|
|
$ |
57,053 |
|
|
$ |
122,748 |
|
|
$ |
119,505 |
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - diluted reconciliation: |
|
|
|
|
|
|
|
GAAP weighted average common
shares outstanding - diluted |
|
50,539 |
|
|
|
52,054 |
|
|
|
51,366 |
|
|
|
46,285 |
|
Dilutive common shares associated with the 2025 Notes(1) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
5,607 |
|
Non-GAAP weighted average
common shares outstanding - diluted |
|
50,539 |
|
|
|
52,054 |
|
|
|
51,366 |
|
|
|
51,892 |
|
(1) For the six
months ended June 30, 2023, potential common shares of the 2025
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. |
Pacira BioSciences, Inc. |
|
Reconciliation of GAAP Net Income to Adjusted EBITDA
(Non-GAAP)(in
thousands)(unaudited) |
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP net income |
$ |
18,886 |
|
|
$ |
25,763 |
|
|
$ |
27,865 |
|
|
$ |
6,227 |
|
|
|
|
|
|
|
|
|
Interest income |
|
(4,749 |
) |
|
|
(2,111 |
) |
|
|
(8,652 |
) |
|
|
(5,253 |
) |
Interest expense (1) |
|
3,884 |
|
|
|
3,865 |
|
|
|
7,200 |
|
|
|
13,454 |
|
Income tax expense |
|
17,698 |
|
|
|
12,091 |
|
|
|
22,359 |
|
|
|
5,153 |
|
Depreciation expense |
|
4,541 |
|
|
|
4,732 |
|
|
|
8,645 |
|
|
|
10,012 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
|
|
28,644 |
|
|
|
28,644 |
|
EBITDA |
|
54,582 |
|
|
|
58,662 |
|
|
|
86,061 |
|
|
|
58,237 |
|
|
|
|
|
|
|
|
|
Other adjustments: |
|
|
|
|
|
|
|
Contingent consideration charges (gains), restructuring charges and
other: |
|
|
|
|
|
|
|
Changes in the fair value of contingent consideration |
|
1,509 |
|
|
|
(18,258 |
) |
|
|
(2,297 |
) |
|
|
(6,640 |
) |
Restructuring charges (2) |
|
504 |
|
|
|
936 |
|
|
|
3,804 |
|
|
|
936 |
|
Acquisition-related expenses |
|
230 |
|
|
|
709 |
|
|
|
404 |
|
|
|
1,198 |
|
Step-up of acquired Flexion inventory to fair value and other |
|
— |
|
|
|
1,261 |
|
|
|
— |
|
|
|
2,566 |
|
Stock-based compensation |
|
12,524 |
|
|
|
10,955 |
|
|
|
25,675 |
|
|
|
22,945 |
|
CEO transition costs |
|
294 |
|
|
|
— |
|
|
|
571 |
|
|
|
— |
|
(Gain) loss on early extinguishment of debt |
|
(7,518 |
) |
|
|
— |
|
|
|
(7,518 |
) |
|
|
16,926 |
|
Adjusted EBITDA |
$ |
62,125 |
|
|
$ |
54,265 |
|
|
$ |
106,700 |
|
|
$ |
96,168 |
|
|
(1) Includes
amortization of debt discount and debt issuance costs. |
(2) Approximately
$0.5 million and $2.7 million of restructuring charges were
excluded from this line item as they are included in the
stock-based compensation line item for the three and six months
ended June 30, 2024, respectively. |
|
Pacira BioSciences, Inc.Reconciliation of
GAAP to Non-GAAP 2024 Financial
Guidance(dollars in millions) |
|
GAAP to Non-GAAP Guidance |
|
GAAP |
|
Impact of GAAP to Non-GAAP Adjustments
(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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