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 first quarter
of 2024.
First Quarter
2024 Financial Highlights
- Total revenues
of $167.1 million
- Net product
sales of $132.4 million for EXPAREL, $25.8 million for ZILRETTA,
and $5.0 million for iovera°
- Net income of
$9.0 million, or $0.19 per share (basic and diluted)
- Adjusted
earnings before interest, taxes, depreciation and amortization
(EBITDA) of $44.6 million
See “Non-GAAP Financial Information” below.
“Sales are off to a solid start for all three of
our trusted, opioid-sparing products and we remain sharply focused
on driving accelerated growth in 2025 and beyond,” said Frank D.
Lee, chief executive officer of Pacira BioSciences. “We are pleased
with the progress we are making advancing the launch of EXPAREL in
two new lower extremity nerve block indications, and we are
receiving positive market receptivity across all sites of care. We
are also preparing for a significant growth catalyst ahead with the
implementation of separate Medicare reimbursement for EXPAREL at
average sales price plus 6 percent in outpatient settings beginning
in January 2025. We believe this important reimbursement milestone
will expand patient access to EXPAREL and drive greater utilization
in outpatient procedures.”
“Our confidence in Pacira’s future remains
steadfast and the $150 million stock buyback announced today
underscores our belief in our team, products, and growth outlook,”
added Mr. Lee.
Recent Business Highlights
- New $150
Million Share Repurchase Program. Today the company
announced its Board of Directors has approved a new share
repurchase program effective immediately, which authorizes the
company to purchase 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. The company expects to fund
the share repurchase program using a combination of existing cash
reserves and future cash flows.
- Positive
Efficacy and Safety Data of PCRX-201 (enekinragene
inzadenovec) Presented at OARSI 2024 World
Congress. In April 2024, investigators presented
encouraging preliminary results from a 72-patient study of PCRX-201
data at the Osteoarthritis Research Society International, or
OARSI, 2024 World Congress in Vienna, Austria. PCRX-201 is the
company’s novel, intra-articular helper-dependent adenovirus gene
therapy product candidate that codes for interleukin-1 receptor
antagonist (IL-1Ra), for the treatment of osteoarthritis of the
knee. The data showed that a single intra-articular injection of
PCRX-201 demonstrated sustained clinical effect as assessed by
patient-reported outcomes at all dose levels for at least one-year
post-injection. Importantly, PCRX-201 was shown to be
well-tolerated with a favorable safety profile. The company expects
to submit updated data demonstrating PCRX-201’s effectiveness
through two years for presentation at a medical meeting in the
Fall.
- PCRX-201
Granted Regenerative Medicine Advance Therapy (RMAT)
Designation. In March 2024, the company announced that the
U.S. Food and Drug Administration (FDA) has granted Regenerative
Medicine Advanced Therapy (RMAT) designation to PCRX-201. The
company’s RMAT application was supported by the preliminary safety
and efficacy findings from the company’s Phase 1 study.
- Three
New EXPAREL Patents. In March 2024, the United States
Patent and Trademark Office issued Patent No. 11,925,706 claiming
composition of matter, Patent No. 11,918,565 claiming method of use
as a sciatic nerve block in the popliteal fossa, and Patent No.
11,931,459 claiming method of use in pediatric patients. Each of
these EXPAREL patents are listed in the FDA’s “Approved Drug
Products with Therapeutic Equivalence Evaluations” (the “Orange
Book”). The ‘706 patent has an expiration date of January 22, 2041
and the ‘459 and ‘565 patents have expiration dates of March 17,
2042 and February 2, 2043, respectively.
First Quarter
2024 Financial Results
- Total revenues
were $167.1 million in the first quarter of 2024, versus $160.3
million reported for the first quarter of 2023.
- EXPAREL net
product sales were $132.4 million in the first quarter of 2024,
versus $130.4 million reported for the first quarter of 2023. First
quarter volume growth of 3 percent was offset by contracted
discounts and vial mix. There were 62 selling days in the first
quarter of 2024 and 63 selling days in the first quarter of
2023.
- ZILRETTA net
product sales were $25.8 million in the first quarter of 2024,
versus $24.3 million reported for the first quarter of 2023.
- First quarter
2024 iovera° net product sales were $5.0 million, versus $4.0
million reported for the first quarter of 2023.
- Sales of
bupivacaine liposome injectable suspension to third-party licensees
were $2.5 million in the first quarter of 2024, versus $0.7 million
reported for the first quarter of 2023.
- Total operating
expenses were $153.9 million in the first quarter of 2024, compared
to $163.4 million in the first quarter of 2023.
- Research and
development (R&D) expenses were $18.2 million in the first
quarter of 2024, compared to $17.1 million in the first quarter of
2023. R&D expenses included $7.4 million and $7.7 million of
product development and manufacturing capacity expansion costs in
the first quarters of 2024 and 2023, respectively.
- Selling, general
and administrative (SG&A) expenses were $72.0 million in the
first quarter of 2024, compared to $70.8 million in the first
quarter of 2023.
- GAAP net income
was $9.0 million, or $0.19 per share (basic and diluted) in the
first quarter of 2024, compared to a GAAP net loss of $19.5
million, or $(0.43) per share (basic and diluted) in the first
quarter of 2023.
- Non-GAAP net
income was $31.1 million, or $0.67 per share (basic) and $0.62 per
share (diluted) in the first quarter of 2024, compared to $24.3
million, or $0.53 per share (basic) and $0.49 per share (diluted),
in the first quarter of 2023.
- Adjusted EBITDA
was $44.6 million in the first quarter of 2024, compared to $41.9
million in the first quarter of 2023.
- Pacira ended the
first quarter of 2024 with cash, cash equivalents and
available-for-sale investments (“cash”) of $325.9 million. Cash
provided by operations was $49.1 million in the first quarter of
2024, compared to $19.1 million in the first quarter of 2023.
- Pacira had 46.5
million basic and 52.2 million diluted weighted average shares of
common stock outstanding in the first quarter of 2024.
- For non-GAAP
measures, Pacira had 52.2 million diluted weighted average shares
of common stock outstanding in the first 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, May 7, 2024, at 4:30 p.m.
ET. To participate in the conference call, dial 1-800-715-9871 and
provide the passcode 6363041. International callers may dial
1-646-307-1963 and use the same passcode. 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 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)
|
March 31,2024 |
|
December 31,2023 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
184,052 |
|
$ |
153,298 |
Short-term available-for-sale
investments |
|
141,838 |
|
|
125,283 |
Accounts receivable, net |
|
101,639 |
|
|
105,556 |
Inventories, net |
|
96,782 |
|
|
104,353 |
Prepaid expenses and other
current assets |
|
18,802 |
|
|
21,504 |
Total current assets |
|
543,113 |
|
|
509,994 |
Noncurrent available-for-sale
investments |
|
— |
|
|
2,410 |
Fixed assets, net |
|
171,804 |
|
|
173,927 |
Right-of-use assets, net |
|
58,626 |
|
|
61,020 |
Goodwill |
|
163,243 |
|
|
163,243 |
Intangible assets, net |
|
468,936 |
|
|
483,258 |
Deferred tax assets |
|
141,057 |
|
|
144,485 |
Investments and other
assets |
|
36,542 |
|
|
36,049 |
Total assets |
$ |
1,583,321 |
|
$ |
1,574,386 |
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
8,982 |
|
$ |
15,698 |
Accrued expenses |
|
66,818 |
|
|
64,243 |
Lease liabilities |
|
9,003 |
|
|
8,801 |
Current portion of convertible
senior notes, net |
|
8,641 |
|
|
8,641 |
Total current liabilities |
|
93,444 |
|
|
97,383 |
Convertible senior notes,
net |
|
399,210 |
|
|
398,594 |
Long-term debt, net |
|
112,477 |
|
|
115,202 |
Lease liabilities |
|
52,446 |
|
|
54,806 |
Contingent consideration |
|
20,892 |
|
|
24,698 |
Other liabilities |
|
12,690 |
|
|
13,573 |
Total stockholders’
equity |
|
892,162 |
|
|
870,130 |
Total liabilities and
stockholders’ equity |
$ |
1,583,321 |
|
$ |
1,574,386 |
|
Pacira BioSciences,
Inc.Condensed Consolidated Statements of
Operations(in thousands, except per share
amounts)(unaudited)
|
Three Months Ended |
|
March 31, |
|
2024 |
|
2023 |
Net product sales: |
|
|
|
EXPAREL |
$ |
132,430 |
|
|
$ |
130,408 |
|
ZILRETTA |
|
25,839 |
|
|
|
24,334 |
|
iovera° |
|
5,030 |
|
|
|
4,001 |
|
Bupivacaine liposome injectable suspension |
|
2,525 |
|
|
|
688 |
|
Total net product sales |
|
165,824 |
|
|
|
159,431 |
|
Royalty revenue |
|
1,293 |
|
|
|
910 |
|
Total revenues |
|
167,117 |
|
|
|
160,341 |
|
Operating expenses: |
|
|
|
Cost of goods sold |
|
47,416 |
|
|
|
49,020 |
|
Research and development |
|
18,238 |
|
|
|
17,140 |
|
Selling, general and administrative |
|
72,026 |
|
|
|
70,843 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
Contingent consideration (gains) charges, restructuring charges and
other |
|
1,903 |
|
|
|
12,107 |
|
Total operating expenses |
|
153,905 |
|
|
|
163,432 |
|
Income (loss) from
operations |
|
13,212 |
|
|
|
(3,091 |
) |
Other income (expense): |
|
|
|
Interest income |
|
3,903 |
|
|
|
3,142 |
|
Interest expense |
|
(3,316 |
) |
|
|
(9,589 |
) |
Loss on early extinguishment
of debt |
|
— |
|
|
|
(16,926 |
) |
Other, net |
|
(159 |
) |
|
|
(10 |
) |
Total other income (expense),
net |
|
428 |
|
|
|
(23,383 |
) |
Income (loss) before income
taxes |
|
13,640 |
|
|
|
(26,474 |
) |
Income tax (expense) benefit |
|
(4,661 |
) |
|
|
6,938 |
|
Net income (loss) |
$ |
8,979 |
|
|
$ |
(19,536 |
) |
|
|
|
|
Net income (loss) per
share: |
|
|
|
Basic and diluted net income (loss) per common share |
$ |
0.19 |
|
|
$ |
(0.43 |
) |
Weighted average common shares
outstanding: |
|
|
|
Basic |
|
46,499 |
|
|
|
45,949 |
|
Diluted |
|
52,193 |
|
|
|
45,949 |
|
|
Pacira BioSciences,
Inc.Reconciliation of GAAP to Non-GAAP Financial
Information(in thousands, except per share
amounts)(unaudited)
|
Three Months Ended |
|
March 31, |
|
2024 |
|
2023 |
GAAP net income (loss) |
$ |
8,979 |
|
|
$ |
(19,536 |
) |
|
|
|
|
Non-GAAP adjustments: |
|
|
|
Contingent consideration (gains) charges, restructuring charges and
other: |
|
|
|
Changes in the fair value of contingent consideration |
|
(3,806 |
) |
|
|
11,618 |
|
Restructuring charges (1) (2) |
|
3,300 |
|
|
|
— |
|
Acquisition-related fees (3) |
|
174 |
|
|
|
489 |
|
Step-up of acquired Flexion fixed assets and inventory to fair
value and other |
|
— |
|
|
|
2,107 |
|
Stock-based compensation |
|
13,151 |
|
|
|
11,990 |
|
CEO transition costs (4) |
|
277 |
|
|
|
— |
|
Loss on early extinguishment
of debt |
|
— |
|
|
|
16,926 |
|
Amortization of debt
discount |
|
24 |
|
|
|
675 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
Tax impact of non-GAAP
adjustments (5) |
|
(5,346 |
) |
|
|
(14,289 |
) |
Total non-GAAP
adjustments |
|
22,096 |
|
|
|
43,838 |
|
|
|
|
|
Non-GAAP net income |
$ |
31,075 |
|
|
$ |
24,302 |
|
|
|
|
|
GAAP basic and diluted net
income (loss) per common share |
$ |
0.19 |
|
|
$ |
(0.43 |
) |
|
|
|
|
GAAP net income (loss) used for
basic earnings per share |
$ |
8,979 |
|
|
$ |
(19,536 |
) |
Interest expense on convertible senior notes, net of tax |
|
1,029 |
|
|
|
— |
|
GAAP net income (loss) used for
diluted earnings per share |
$ |
10,008 |
|
|
$ |
(19,536 |
) |
|
|
|
|
Non-GAAP basic net income per
common share |
$ |
0.67 |
|
|
$ |
0.53 |
|
Non-GAAP diluted net income
per common share |
$ |
0.62 |
|
|
$ |
0.49 |
|
|
|
|
|
Non-GAAP net income |
$ |
31,075 |
|
|
$ |
24,302 |
|
Interest expense on convertible senior notes, net of tax (6) |
|
1,029 |
|
|
|
1,029 |
|
Non-GAAP net income used for
diluted earnings per share (6) |
$ |
32,104 |
|
|
$ |
25,331 |
|
|
|
|
|
Weighted average common shares
outstanding - basic |
|
46,499 |
|
|
|
45,949 |
|
Weighted average common shares
outstanding - diluted |
|
52,193 |
|
|
|
45,949 |
|
Non-GAAP Weighted average common
shares outstanding - basic |
|
46,499 |
|
|
|
45,949 |
|
Non-GAAP Weighted average common
shares outstanding - diluted (6) |
|
52,193 |
|
|
|
51,730 |
|
|
|
|
|
|
|
|
|
|
(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 $2.2 million of restructuring charges were
excluded from this line item as they are included in the
stock-based compensation line item. |
(3) For the three months ended March 31, 2024 and 2023,
acquisition-related fees 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 months ended
March 31, 2024, the GAAP effective income tax rate was
approximately 34% and the non-GAAP effective income tax rate was
approximately 24%, with the difference from GAAP primarily due to
the impact of excluding both discrete tax expenses associated with
non-deductible stock-based compensation and tax expenses related to
executive compensation. For the three months ended March 31, 2023,
the GAAP effective income tax rate was approximately 26% and the
non-GAAP effective income tax rate was approximately 23%, with the
difference from GAAP primarily due to the impact of excluding tax
expenses related to non-U.S. valuation allowances and
non-deductible executive compensation. |
(6) For the three months ended March 31, 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 three months ended March 31,
2023, the $402.5 million aggregate principal 0.75% convertible
senior notes due 2025, or 2025 Notes, were excluded on a GAAP basis
as the impact to diluted net 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 ended March 31, 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
$1.0 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 |
|
March 31, |
|
2024 |
|
2023 |
Cost of goods sold
reconciliation: |
|
|
|
GAAP cost of goods sold |
$ |
47,416 |
|
|
$ |
49,020 |
|
Step-up of acquired Flexion fixed assets and inventory to fair
value and other |
|
— |
|
|
|
(2,107 |
) |
Stock-based compensation |
|
(1,128 |
) |
|
|
(1,724 |
) |
Non-GAAP cost of goods
sold |
$ |
46,288 |
|
|
$ |
45,189 |
|
|
|
|
|
Research and
development reconciliation: |
|
|
|
GAAP research and
development |
$ |
18,238 |
|
|
$ |
17,140 |
|
Stock-based compensation |
|
(1,803 |
) |
|
|
(1,875 |
) |
Non-GAAP research and
development |
$ |
16,435 |
|
|
$ |
15,265 |
|
|
|
|
|
Selling, general and
administrative reconciliation: |
|
|
|
GAAP selling, general and
administrative |
$ |
72,026 |
|
|
$ |
70,843 |
|
CEO transition costs |
|
(277 |
) |
|
|
— |
|
Stock-based compensation |
|
(7,985 |
) |
|
|
(8,391 |
) |
Non-GAAP selling, general and
administrative |
$ |
63,764 |
|
|
$ |
62,452 |
|
|
|
|
|
Weighted average
shares outstanding - diluted reconciliation: |
|
|
|
GAAP weighted average common
shares outstanding - diluted |
|
52,193 |
|
|
|
45,949 |
|
Dilutive common shares associated with the 2025 Notes (1) |
|
— |
|
|
|
5,608 |
|
Dilutive common shares associated with stock options and restricted
stock units |
|
— |
|
|
|
173 |
|
Non-GAAP weighted average
common shares outstanding - diluted |
|
52,193 |
|
|
|
51,730 |
|
|
(1) For the three months ended March 31, 2023, 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. |
|
Pacira BioSciences,
Inc.Reconciliation of GAAP Net Income (Loss) to
Adjusted EBITDA (Non-GAAP)(in
thousands)(unaudited)
|
Three Months Ended |
|
March 31, |
|
2024 |
|
2023 |
GAAP net income (loss) |
$ |
8,979 |
|
|
$ |
(19,536 |
) |
|
|
|
|
Interest
income |
|
(3,903 |
) |
|
|
(3,142 |
) |
Interest
expense (1) |
|
3,316 |
|
|
|
9,589 |
|
Income tax
expense (benefit) |
|
4,661 |
|
|
|
(6,938 |
) |
Depreciation expense |
|
4,104 |
|
|
|
5,280 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
EBITDA |
|
31,479 |
|
|
|
(425 |
) |
|
|
|
|
Other adjustments: |
|
|
|
Contingent consideration (gains) charges, restructuring charges and
other: |
|
|
|
Changes in the fair value of contingent consideration |
|
(3,806 |
) |
|
|
11,618 |
|
Restructuring charges (2) |
|
3,300 |
|
|
|
— |
|
Acquisition-related fees |
|
174 |
|
|
|
489 |
|
Step-up of acquired Flexion inventory to fair value and other |
|
— |
|
|
|
1,305 |
|
Stock-based compensation |
|
13,151 |
|
|
|
11,990 |
|
CEO transition costs |
|
277 |
|
|
|
— |
|
Loss on early extinguishment of debt |
|
— |
|
|
|
16,926 |
|
Adjusted EBITDA |
$ |
44,575 |
|
|
$ |
41,903 |
|
|
(1) Includes
amortization of debt discount and debt issuance costs. |
(2) Approximately
$2.2 million of restructuring charges were excluded from this line
item as they are included in the stock-based compensation line
item. |
|
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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