Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in the
delivery of innovative, non-opioid pain therapies, today reported
financial results for the third quarter of 2024.
Third Quarter 2024 Financial Highlights
- Total revenues of $168.6 million
- Net product sales of $132.0 million for EXPAREL, $28.4 million
for ZILRETTA, and $5.7 million for iovera°
- Net loss of $143.5 million, or $3.11 per share (basic and
diluted)
- Adjusted earnings before interest, taxes, depreciation and
amortization (EBITDA) of $54.7 million
See “Non-GAAP Financial Information” below.
“2024 continues to be highlighted by important progress across
both our clinical pipeline and commercial portfolio of
best-in-class opioid-sparing products that delivered solid third
quarter sales,” said Frank D. Lee, chief executive officer of
Pacira BioSciences. “Looking at the remainder of the year, we
intend to build on this momentum by advancing our strategy for
long-term growth and value creation, which includes investing in a
best-practice commercial organization and innovative pipeline of
potentially transformational assets, such as PCRX-201.”
“The work we have completed this year positions us to enter 2025
from a new place of focus, commitment, and strategic strength. We
are confident the investments we are making will support and expand
our leadership in non-opioid pain management and ensure we are
positioned for sustainable success,” continued Mr. Lee.
Recent Business Highlights
- Final CMS Rule Issued for EXPAREL and iovera° in
Outpatient Settings. In November 2024, the CMS issued its
final Medicare Hospital Outpatient Prospective Payment System
(OPPS) and Medicare Ambulatory Surgical Center (ASC) Payment System
rule for 2025, which implements the Non-Opioids Prevent Addiction
in the Nation (NOPAIN) Act that mandates separate Medicare payment
for qualifying non-opioid drugs and devices. In the final rule, CMS
confirmed that both EXPAREL and iovera° qualify as eligible
non-opioid pain management products under the NOPAIN Act. Hospital
outpatient departments (HOPDs) and ASCs that use these products
will receive additional Medicare reimbursement beginning January 1,
2025.
- Shawn Cross Appointed as Chief Financial
Officer. In October 2024, the company appointed Shawn
Cross as Chief Financial Officer. Mr. Cross brings more than 25
years of experience as a biotechnology executive, board member and
investment banker. Most recently, Mr. Cross served in executive
positions of increasing responsibility at Applied Molecular
Transport, Inc. (AMT) where he was ultimately named Chief Executive
Officer to lead the company’s merger with Cyclo Therapeutics, Inc.,
where he currently serves on the Board of Directors. His
biopharmaceutical investment banking career includes senior
leadership roles at JMP Securities, Inc., Deutsche Bank Securities
Inc., and Wells Fargo Securities, LLC.
- New Product-Specific J-Code for EXPAREL. In
October 2024, the company announced that the Centers for Medicare
and Medicaid Services (CMS) established a permanent
product-specific Healthcare Common Procedure Coding System (HCPCS)
J-code for EXPAREL. The new J-code for EXPAREL, J0666, becomes
effective January 1, 2025, and will supersede the current C-code
(C9290), which has been in place since 2019. In addition to the
separate CMS reimbursement EXPAREL will receive in outpatient
settings with the implementation of NOPAIN in January 2025, this
new J-code will also provide reimbursement when EXPAREL is used in
the office setting and for office-based surgeries.
- Presentation of Two-year Safety and Efficacy Data
Following Local Administration of PCRX-201 for Moderate to Severe
Osteoarthritis of the Knee. In September 2024, Pacira
announced the upcoming presentation of new data in support of its
gene therapy candidate, PCRX-201. The data will be presented at the
American College of Rheumatology's annual ACR Converge meeting,
being held in Washington, D.C. The data will be presented on
Sunday, November 17 in a poster session taking place from 10:30AM
to 12:30PM ET by Stanley Cohen, MD, a board-certified
rheumatologist and Co-Medical Director of the Metroplex Clinical
Research Center in Dallas, TX.
Third Quarter 2024 Financial Results
- Total revenues were $168.6 million in the third quarter of
2024, versus $163.9 million reported for the third quarter of
2023.
- EXPAREL net product sales were $132.0 million in the third
quarter of 2024, versus $128.7 million reported for the third
quarter of 2023. Third quarter volume growth of 3 percent and a net
price increase of 1 percent was partially offset by a shift in vial
mix. There were the same number of selling days in the third
quarters of 2024 and 2023.
- ZILRETTA net product sales were $28.4 million in the third
quarter of 2024, versus $28.8 million reported for the third
quarter of 2023.
- Third quarter 2024 iovera° net product sales were $5.7 million,
versus $5.3 million reported for the third quarter of 2023.
- Sales of bupivacaine liposome injectable suspension to
third-party licensees were $1.6 million in the third quarter of
2024, versus $0.9 million reported for the third quarter of
2023.
- Total operating expenses were $308.1 million in the third
quarter of 2024, compared to $146.2 million in the third quarter of
2023. The third quarter of 2024 includes a goodwill impairment of
$163.2 million based upon an assessment that the fair value of
goodwill is less than its carrying value.
- Research and development (R&D) expenses were $19.1 million
in the third quarter of 2024, compared to $20.8 million in the
third quarter of 2023. R&D expenses included $7.2 million and
$9.4 million of product development and manufacturing capacity
expansion costs in the third quarters of 2024 and 2023,
respectively.
- Selling, general and administrative (SG&A) expenses were
$74.3 million in the third quarter of 2024, compared to $67.9
million in the third quarter of 2023.
- GAAP net loss was $143.5 million, or $3.11 per share (basic and
diluted) in the third quarter of 2024, compared to GAAP net income
of $10.9 million, or $0.23 per share (basic and diluted) in the
third quarter of 2023. Included in GAAP net loss in the third
quarter of 2024 was a $163.2 million impairment of goodwill based
upon an assessment that the fair value of goodwill is less than its
carrying value.
- Non-GAAP net income was $38.2 million, or $0.83 per share
(basic) and $0.79 per share (diluted) in the third quarter of 2024,
compared to $36.6 million, or $0.79 per share (basic) and $0.72 per
share (diluted), in the third quarter of 2023.
- Adjusted EBITDA was $54.7 million in the third quarter of 2024,
compared to $52.9 million in the third quarter of 2023.
- Pacira ended the third quarter of 2024 with cash, cash
equivalents and available-for-sale investments (“cash”) of $453.8
million. Cash provided by operations was $53.9 million in the third
quarter of 2024, compared to $44.4 million in the third quarter of
2023.
- Pacira had 46.1 million basic and diluted weighted average
shares of common stock outstanding in the third quarter of
2024.
- For non-GAAP measures, Pacira had 49.0 million diluted weighted
average shares of common stock outstanding in the third 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, Wednesday, November 6, 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
goodwill impairment, 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.
Inducement Grants Under Nasdaq Listing Rule
5635(c)(4)
Pacira today announced the granting of inducement awards on
November 4, 2024 to 11 new employees under Pacira’s Amended and
Restated 2014 Inducement Plan as a material inducement to each
employee's entry into employment with the company. In accordance
with Nasdaq Listing Rule 5635(c)(4), the awards were approved by
the Compensation Committee of the Board of Directors.
4 employees received stock options to purchase an aggregate of
19,200 shares of Pacira common stock and 11 employees received
restricted stock units for an aggregate of 36,000 shares of Pacira
common stock.
The stock options have a 10-year term and a four-year vesting
schedule with 25 percent of the underlying shares vesting on the
first anniversary of the recipient’s first day of employment and in
successive equal quarterly installments over the 36 months
thereafter. The stock options have an exercise price of $16.45 per
share, the closing trading price of Pacira common stock on the
Nasdaq Global Select Market on the date of grant. Each restricted
stock unit represents the contingent right to receive one share of
Pacira common stock and the restricted stock unit awards vest
annually in four equal installments beginning on the first
anniversary of November 1, 2024.
Vesting of the equity awards is subject to the employee’s
continued employment with Pacira. Each equity award is also subject
to the terms and conditions of an award agreement.
About Pacira
Pacira delivers innovative, non-opioid pain therapies to
transform the lives of patients. Pacira has three commercial-stage
non-opioid treatments: EXPAREL® (bupivacaine liposome injectable
suspension), a long-acting local analgesic currently approved for
infiltration, fascial plane block, and as an interscalene brachial
plexus nerve block, an adductor canal nerve block, and a sciatic
nerve block in the popliteal fossa for postsurgical pain
management; ZILRETTA® (triamcinolone acetonide extended-release
injectable suspension), an extended-release, intra-articular
injection indicated for the management of osteoarthritis knee pain;
and 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. The company is also
advancing the development of PCRX-201, a novel locally administered
gene therapy with the potential to treat large prevalent diseases
like osteoarthritis. To learn more about Pacira, visit
www.pacira.com.
About EXPAREL® (bupivacaine liposome injectable
suspension)
EXPAREL is indicated to produce postsurgical local analgesia via
infiltration in patients aged 6 years and older, and postsurgical
regional analgesia via an interscalene brachial plexus block in
adults, a sciatic nerve block in the popliteal fossa in adults, and
an adductor canal block in adults. The safety and effectiveness of
EXPAREL have not been established to produce postsurgical regional
analgesia via other nerve blocks besides an interscalene brachial
plexus nerve block, a sciatic nerve block in the popliteal fossa,
or an adductor canal block. The product combines bupivacaine with
multivesicular liposomes, a proven product delivery technology that
delivers medication over a desired time period. EXPAREL represents
the first and only multivesicular liposome local anesthetic that
can be utilized in the peri- or postsurgical setting. By utilizing
the multivesicular liposome platform, a single dose of EXPAREL
delivers bupivacaine over time, providing significant reductions in
cumulative pain scores with up to a 78 percent decrease in opioid
consumption; the clinical benefit of the opioid reduction was not
demonstrated. Additional information is available at
www.EXPAREL.com.
Important Safety Information about EXPAREL for
Patients
EXPAREL should not be used in obstetrical paracervical block
anesthesia. In studies in adults where EXPAREL was injected into a
wound, the most common side effects were nausea, constipation, and
vomiting. In studies in adults where EXPAREL was injected near a
nerve, the most common side effects were nausea, fever, and
constipation. In the study where EXPAREL was given to children, the
most common side effects were nausea, vomiting, constipation, low
blood pressure, low number of red blood cells, muscle twitching,
blurred vision, itching, and rapid heartbeat. EXPAREL can cause a
temporary loss of feeling and/or loss of muscle movement. How much
and how long the loss of feeling and/or muscle movement depends on
where and how much of EXPAREL was injected and may last for up to 5
days. EXPAREL is not recommended to be used in patients younger
than 6 years old for injection into the wound, for patients younger
than 18 years old, for injection near a nerve, and/or in pregnant
women. Tell your health care provider if you or your child has
liver disease, since this may affect how the active ingredient
(bupivacaine) in EXPAREL is eliminated from the body. EXPAREL
should not be injected into the spine, joints, or veins. The active
ingredient in EXPAREL can affect the nervous system and the
cardiovascular system; may cause an allergic reaction; may cause
damage if injected into the joints; and can cause a rare blood
disorder.
About ZILRETTA® (triamcinolone acetonide
extended-release injectable suspension)
On October 6, 2017, ZILRETTA was approved by the U.S. Food and
Drug Administration as the first and only extended-release
intra-articular therapy for patients confronting osteoarthritis
(OA)- related knee pain. ZILRETTA employs proprietary microsphere
technology combining triamcinolone acetonide—a commonly
administered, short-acting corticosteroid—with a poly
lactic-co-glycolic acid (PLGA) matrix to provide extended pain
relief. The pivotal Phase 3 trial on which the approval of ZILRETTA
was based showed that ZILRETTA significantly reduced OA knee pain
for 12 weeks, with some people experiencing pain relief through
Week 16. Learn more at www.zilretta.com.
Indication and Select Important Safety Information for
ZILRETTA
Indication: ZILRETTA is indicated as an
intra-articular injection for the management of OA pain of the
knee. Limitation of Use: The efficacy and safety of repeat
administration of ZILRETTA have not been demonstrated.
Contraindication: ZILRETTA is contraindicated
in patients who are hypersensitive to triamcinolone acetonide,
corticosteroids or any components of the product.
Warnings and Precautions:
- Intra-articular Use Only: ZILRETTA has not
been evaluated and should not be administered by epidural,
intrathecal, intravenous, intraocular, intramuscular, intradermal,
or subcutaneous routes. ZILRETTA should not be considered safe for
epidural or intrathecal administration.
- Serious Neurologic Adverse Reactions with Epidural and
Intrathecal Administration: Serious neurologic events have
been reported following epidural or intrathecal corticosteroid
administration. Corticosteroids are not approved for this use.
- Hypersensitivity reactions: Serious reactions
have been reported with triamcinolone acetonide injection.
Institute appropriate care if an anaphylactic reaction occurs.
- Joint infection and damage: A marked increase
in joint pain, joint swelling, restricted motion, fever and malaise
may suggest septic arthritis. If this occurs, conduct appropriate
evaluation and if confirmed, institute appropriate antimicrobial
treatment.
Adverse Reactions: The most commonly reported
adverse reactions (incidence ≥1%) in clinical studies included
sinusitis, cough, and contusions.
Please see ZILRETTALabel.com for full Prescribing
Information.
About iovera°®
The iovera° system 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
future outlook, our intellectual property and patent terms, 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,
development of products, strategic alliances, 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;
assumptions used for estimated future cash flows associated with
determining the fair value of the Company; the anticipated funding
or benefits of our share repurchase program; and factors discussed
in the “Risk Factors” of our most recent Annual Report on Form 10-K
and in other filings that we periodically make with the Securities
and Exchange Commission (the “SEC”). In addition, the
forward-looking statements included in this press release represent
our views as of the date of this press release. Important factors
could cause actual results to differ materially from those
indicated or implied by forward-looking statements, and as such we
anticipate that subsequent events and developments will cause our
views to change. Except as required by applicable law, we undertake
no intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, and readers should not rely on these forward-looking
statements as representing our views as of any date subsequent to
the date of this press release.
(Tables to Follow)
Pacira BioSciences,
Inc.Condensed Consolidated Balance
Sheets(in
thousands)(unaudited)
|
September 30, 2024 |
|
December 31, 2023 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
245,965 |
|
$ |
153,298 |
Short-term available-for-sale investments |
|
207,845 |
|
|
125,283 |
Accounts receivable, net |
|
100,653 |
|
|
105,556 |
Inventories, net |
|
111,865 |
|
|
104,353 |
Prepaid expenses and other current assets |
|
23,641 |
|
|
21,504 |
Total
current assets |
|
689,969 |
|
|
509,994 |
Noncurrent available-for-sale
investments |
|
— |
|
|
2,410 |
Fixed assets, net |
|
166,852 |
|
|
173,927 |
Right-of-use assets, net |
|
53,830 |
|
|
61,020 |
Goodwill |
|
— |
|
|
163,243 |
Intangible assets, net |
|
440,292 |
|
|
483,258 |
Deferred tax assets |
|
134,022 |
|
|
144,485 |
Investments and other
assets |
|
36,726 |
|
|
36,049 |
Total
assets |
$ |
1,521,691 |
|
$ |
1,574,386 |
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
19,367 |
|
$ |
15,698 |
Accrued expenses |
|
76,377 |
|
|
64,243 |
Lease
liabilities |
|
9,191 |
|
|
8,801 |
Current portion of convertible senior notes, net |
|
201,466 |
|
|
8,641 |
Total
current liabilities |
|
306,401 |
|
|
97,383 |
Convertible senior notes,
net |
|
278,867 |
|
|
398,594 |
Long-term debt, net |
|
107,024 |
|
|
115,202 |
Lease liabilities |
|
47,875 |
|
|
54,806 |
Contingent consideration |
|
19,157 |
|
|
24,698 |
Other liabilities |
|
12,784 |
|
|
13,573 |
Total stockholders’
equity |
|
749,583 |
|
|
870,130 |
Total
liabilities and stockholders’ equity |
$ |
1,521,691 |
|
$ |
1,574,386 |
|
|
|
|
|
|
Pacira BioSciences,
Inc.Condensed Consolidated Statements of
Operations(in thousands, except per share
amounts)(unaudited)
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Net product sales: |
|
|
|
|
|
|
|
EXPAREL |
$ |
132,004 |
|
|
$ |
128,667 |
|
|
$ |
401,286 |
|
|
$ |
394,202 |
|
ZILRETTA |
|
28,420 |
|
|
|
28,798 |
|
|
|
84,966 |
|
|
|
82,393 |
|
iovera° |
|
5,655 |
|
|
|
5,260 |
|
|
|
16,359 |
|
|
|
13,645 |
|
Bupivacaine liposome injectable suspension |
|
1,643 |
|
|
|
858 |
|
|
|
7,322 |
|
|
|
2,241 |
|
Total net product sales |
|
167,722 |
|
|
|
163,583 |
|
|
|
509,933 |
|
|
|
492,481 |
|
Royalty revenue |
|
851 |
|
|
|
343 |
|
|
|
3,780 |
|
|
|
1,253 |
|
Total revenues |
|
168,573 |
|
|
|
163,926 |
|
|
|
513,713 |
|
|
|
493,734 |
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
|
38,864 |
|
|
|
39,750 |
|
|
|
130,542 |
|
|
|
136,977 |
|
Research and development |
|
19,104 |
|
|
|
20,830 |
|
|
|
57,680 |
|
|
|
56,794 |
|
Selling, general and administrative |
|
74,333 |
|
|
|
67,947 |
|
|
|
214,485 |
|
|
|
203,640 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
|
|
42,966 |
|
|
|
42,966 |
|
Goodwill impairment |
|
163,243 |
|
|
|
— |
|
|
|
163,243 |
|
|
|
— |
|
Contingent consideration (gains) charges, restructuring charges and
other |
|
(1,766 |
) |
|
|
3,356 |
|
|
|
2,872 |
|
|
|
(1,150 |
) |
Total
operating expenses |
|
308,100 |
|
|
|
146,205 |
|
|
|
611,788 |
|
|
|
439,227 |
|
(Loss) income from
operations |
|
(139,527 |
) |
|
|
17,721 |
|
|
|
(98,075 |
) |
|
|
54,507 |
|
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
5,482 |
|
|
|
2,766 |
|
|
|
14,134 |
|
|
|
8,019 |
|
Interest expense |
|
(4,689 |
) |
|
|
(3,464 |
) |
|
|
(11,889 |
) |
|
|
(16,918 |
) |
Gain (loss) on early extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
7,518 |
|
|
|
(16,926 |
) |
Other, net |
|
(122 |
) |
|
|
(422 |
) |
|
|
(320 |
) |
|
|
(701 |
) |
Total other
income (expense), net |
|
671 |
|
|
|
(1,120 |
) |
|
|
9,443 |
|
|
|
(26,526 |
) |
(Loss) income before income
taxes |
|
(138,856 |
) |
|
|
16,601 |
|
|
|
(88,632 |
) |
|
|
27,981 |
|
Income tax expense |
|
(4,610 |
) |
|
|
(5,743 |
) |
|
|
(26,969 |
) |
|
|
(10,896 |
) |
Net (loss) income |
$ |
(143,466 |
) |
|
$ |
10,858 |
|
|
$ |
(115,601 |
) |
|
$ |
17,085 |
|
|
|
|
|
|
|
|
|
Net (loss) income per common
share: |
|
|
|
|
|
|
|
Basic and diluted net (loss) income per common share |
$ |
(3.11 |
) |
|
$ |
0.23 |
|
|
$ |
(2.50 |
) |
|
$ |
0.37 |
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
46,134 |
|
|
|
46,416 |
|
|
|
46,269 |
|
|
|
46,151 |
|
Diluted |
|
46,134 |
|
|
|
52,067 |
|
|
|
46,269 |
|
|
|
46,343 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pacira BioSciences,
Inc.Reconciliation of GAAP to Non-GAAP Financial
Information(in thousands, except per share
amounts)(unaudited)
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP net (loss) income |
$ |
(143,466 |
) |
|
$ |
10,858 |
|
|
$ |
(115,601 |
) |
|
$ |
17,085 |
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Contingent consideration (gains) charges, restructuring charges and
other: |
|
|
|
|
|
|
|
Changes in the fair value of contingent consideration |
|
(3,244 |
) |
|
|
2,793 |
|
|
|
(5,541 |
) |
|
|
(3,847 |
) |
Restructuring charges(1) (2) |
|
403 |
|
|
|
173 |
|
|
|
4,207 |
|
|
|
1,109 |
|
Acquisition-related expenses(3) |
|
285 |
|
|
|
390 |
|
|
|
689 |
|
|
|
1,588 |
|
Goodwill impairment(4) |
|
163,243 |
|
|
|
— |
|
|
|
163,243 |
|
|
|
— |
|
Step-up of acquired Flexion Therapeutics, Inc. fixed assets and
inventory to fair value and other |
|
— |
|
|
|
1,318 |
|
|
|
— |
|
|
|
5,152 |
|
Stock-based compensation |
|
13,230 |
|
|
|
12,530 |
|
|
|
38,905 |
|
|
|
35,475 |
|
Chief Executive Officer transition costs(5) |
|
174 |
|
|
|
— |
|
|
|
745 |
|
|
|
— |
|
(Gain) loss on early
extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
(7,518 |
) |
|
|
16,926 |
|
Amortization of debt
discount |
|
23 |
|
|
|
25 |
|
|
|
70 |
|
|
|
728 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
|
|
42,966 |
|
|
|
42,966 |
|
Tax impact of non-GAAP
adjustments(6) |
|
(6,813 |
) |
|
|
(5,778 |
) |
|
|
(8,703 |
) |
|
|
(20,249 |
) |
Total non-GAAP
adjustments |
|
181,623 |
|
|
|
25,773 |
|
|
|
229,063 |
|
|
|
79,848 |
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
38,157 |
|
|
$ |
36,631 |
|
|
$ |
113,462 |
|
|
$ |
96,933 |
|
|
|
|
|
|
|
|
|
GAAP basic and diluted net
(loss) income per common share |
$ |
(3.11 |
) |
|
$ |
0.23 |
|
|
$ |
(2.50 |
) |
|
$ |
0.37 |
|
|
|
|
|
|
|
|
|
GAAP net (loss) income used for
basic earnings per common share |
$ |
(143,466 |
) |
|
$ |
10,858 |
|
|
$ |
(115,601 |
) |
|
$ |
17,085 |
|
Interest expense on convertible
senior notes, net of tax |
|
— |
|
|
|
1,029 |
|
|
|
— |
|
|
|
— |
|
GAAP net (loss) income used for
diluted earnings per common share |
$ |
(143,466 |
) |
|
$ |
11,887 |
|
|
$ |
(115,601 |
) |
|
$ |
17,085 |
|
|
|
|
|
|
|
|
|
Non-GAAP basic net income per
common share |
$ |
0.83 |
|
|
$ |
0.79 |
|
|
$ |
2.45 |
|
|
$ |
2.10 |
|
Non-GAAP diluted net income
per common share |
$ |
0.79 |
|
|
$ |
0.72 |
|
|
$ |
2.29 |
|
|
$ |
1.93 |
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
38,157 |
|
|
$ |
36,631 |
|
|
$ |
113,462 |
|
|
$ |
96,933 |
|
Interest expense on convertible
senior notes, net of tax(7) |
|
518 |
|
|
|
1,029 |
|
|
|
2,308 |
|
|
|
3,086 |
|
Non-GAAP net income used for
diluted earnings per common share(7) |
$ |
38,675 |
|
|
$ |
37,660 |
|
|
$ |
115,770 |
|
|
$ |
100,019 |
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding - basic |
|
46,134 |
|
|
|
46,416 |
|
|
|
46,269 |
|
|
|
46,151 |
|
Weighted average common shares
outstanding - diluted |
|
46,134 |
|
|
|
52,067 |
|
|
|
46,269 |
|
|
|
46,343 |
|
Non-GAAP weighted average common
shares outstanding - basic |
|
46,134 |
|
|
|
46,416 |
|
|
|
46,269 |
|
|
|
46,151 |
|
Non-GAAP weighted average common
shares outstanding - diluted(7) |
|
48,971 |
|
|
|
52,067 |
|
|
|
50,568 |
|
|
|
51,951 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pacira BioSciences, Inc.Reconciliation of
GAAP to Non-GAAP Financial Information
(continued)(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
$0.8 million and $3.5 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 nine months
ended September 30, 2024, respectively. |
(3)
Acquisition-related expenses related to vacant and underutilized
leases assumed from the acquisition of Flexion Therapeutics, Inc.
(“Flexion”). |
(4) During the three
months ended September 30, 2024, the United States Food and Drug
Administration approved a generic competitor to EXPAREL and a U.S.
District Court ruled that one of our patents was not valid. Due to
these events and a subsequent decrease in our common stock price,
it was determined these qualitative factors indicated it was more
likely than not that the fair value of goodwill may be less than
its carrying value. Accordingly, we performed a quantitative
assessment through a discounted cash flow model (or income
approach), which resulted in the carrying value of the Company
exceeding its fair value by more than the goodwill balance. As a
result, the goodwill balance of $163.2 million was fully
impaired during the three months ended September 30, 2024. |
(5) 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 an advisor to the
Company in a consulting capacity. |
(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. For the three and nine months ended
September 30, 2024, the GAAP effective income tax rates were
approximately (3)% and (30)%, respectively, and the non-GAAP
effective income tax rates for the three and nine months ended
September 30, 2024 were approximately 23% and 24%,
respectively, with the difference from GAAP primarily related to
the impact of excluding discrete tax expense related to
non-deductible goodwill impairment charges. The nine months ended
September 30, 2024 also reflected a difference from GAAP related to
excluding discrete tax expense for non-deductible stock-based
compensation, mainly related to expired stock options. For the
three and nine months ended September 30, 2023, the GAAP effective
income tax rates were approximately 35% and 39%, respectively, and
the non-GAAP effective income tax rates for both periods was
approximately 24%, with the difference from GAAP primarily due to
the impact of excluding discrete tax expenses associated with
non-deductible stock-based compensation and tax expenses related to
executive compensation. |
(7) For the three
months ended September 30, 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 and nine months ended
September 30, 2024 and the nine months ended September 30, 2023,
the 0.75% convertible senior notes due 2025, or 2025 Notes, were
excluded from diluted net income per common share on a GAAP basis
as the impact would have been antidilutive. These potential
securities resulted in a dilutive impact on diluted net income per
common share reported on a non-GAAP basis. For the three and nine
months ended September 30, 2024 and the nine months ended September
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 2.8 million, 4.2 million and 5.6 million common
shares, respectively, upon an assumed conversion and added back
$0.5 million, $2.3 million and $3.1 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. |
|
Pacira BioSciences, Inc.Reconciliation of
GAAP to Non-GAAP Financial Information
(continued)(in thousands, except
percentages)(unaudited)
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Cost of goods sold
reconciliation: |
|
|
|
|
|
|
|
GAAP cost of goods sold |
$ |
38,864 |
|
|
$ |
39,750 |
|
|
$ |
130,542 |
|
|
$ |
136,977 |
|
Step-up of acquired Flexion fixed assets and inventory to fair
value and other |
|
— |
|
|
|
(1,318 |
) |
|
|
— |
|
|
|
(5,152 |
) |
Stock-based compensation |
|
(1,509 |
) |
|
|
(1,272 |
) |
|
|
(3,896 |
) |
|
|
(4,432 |
) |
Non-GAAP cost of goods
sold |
$ |
37,355 |
|
|
$ |
37,160 |
|
|
$ |
126,646 |
|
|
$ |
127,393 |
|
|
|
|
|
|
|
|
|
Gross margin
reconciliation: |
|
|
|
|
|
|
|
Total revenues |
$ |
168,573 |
|
|
$ |
163,926 |
|
|
$ |
513,713 |
|
|
$ |
493,734 |
|
GAAP gross margin |
$ |
129,709 |
|
|
$ |
124,176 |
|
|
$ |
383,171 |
|
|
$ |
356,757 |
|
GAAP gross margin
percentage |
|
77 |
% |
|
|
76 |
% |
|
|
75 |
% |
|
|
72 |
% |
Adjustments to GAAP gross
margin: |
|
|
|
|
|
|
|
Step-up of acquired Flexion fixed assets and inventory to fair
value and other |
|
— |
|
|
|
1,318 |
|
|
|
— |
|
|
|
5,152 |
|
Stock-based compensation |
|
1,509 |
|
|
|
1,272 |
|
|
|
3,896 |
|
|
|
4,432 |
|
Non-GAAP gross margin |
$ |
131,218 |
|
|
$ |
126,766 |
|
|
$ |
387,067 |
|
|
$ |
366,341 |
|
Non-GAAP gross margin
percentage |
|
78 |
% |
|
|
77 |
% |
|
|
75 |
% |
|
|
74 |
% |
|
|
|
|
|
|
|
|
Research and
development reconciliation: |
|
|
|
|
|
|
|
GAAP research and
development |
$ |
19,104 |
|
|
$ |
20,830 |
|
|
$ |
57,680 |
|
|
$ |
56,794 |
|
Stock-based compensation |
|
(1,794 |
) |
|
|
(2,220 |
) |
|
|
(5,522 |
) |
|
|
(5,817 |
) |
Non-GAAP research and
development |
$ |
17,310 |
|
|
$ |
18,610 |
|
|
$ |
52,158 |
|
|
$ |
50,977 |
|
|
|
|
|
|
|
|
|
Selling, general and
administrative reconciliation: |
|
|
|
|
|
|
|
GAAP selling, general and
administrative |
$ |
74,333 |
|
|
$ |
67,947 |
|
|
$ |
214,485 |
|
|
$ |
203,640 |
|
CEO transition costs |
|
(174 |
) |
|
|
— |
|
|
|
(745 |
) |
|
|
— |
|
Stock-based compensation |
|
(9,137 |
) |
|
|
(9,038 |
) |
|
|
(25,970 |
) |
|
|
(25,226 |
) |
Non-GAAP selling, general and
administrative |
$ |
65,022 |
|
|
$ |
58,909 |
|
|
$ |
187,770 |
|
|
$ |
178,414 |
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding - diluted reconciliation: |
|
|
|
|
|
|
|
GAAP weighted average common
shares outstanding - diluted |
|
46,134 |
|
|
|
52,067 |
|
|
|
46,269 |
|
|
|
46,343 |
|
Dilutive common shares associated with the 2025 Notes(1) |
|
2,821 |
|
|
|
— |
|
|
|
4,184 |
|
|
|
5,608 |
|
Dilutive common shares associated with stock options,
restricted stock units and employee stock purchase plan |
|
16 |
|
|
|
— |
|
|
|
115 |
|
|
|
— |
|
Non-GAAP weighted average
common shares outstanding - diluted |
|
48,971 |
|
|
|
52,067 |
|
|
|
50,568 |
|
|
|
51,951 |
|
(1) For the three
and nine months ended September 30, 2024 and the nine months ended
September 30, 2023, potential common shares of the 2025 Notes were
excluded from diluted net (loss) 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 |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP net (loss) income |
$ |
(143,466 |
) |
|
$ |
10,858 |
|
|
$ |
(115,601 |
) |
|
$ |
17,085 |
|
|
|
|
|
|
|
|
|
Interest
income |
|
(5,482 |
) |
|
|
(2,766 |
) |
|
|
(14,134 |
) |
|
|
(8,019 |
) |
Interest expense
(1) |
|
4,689 |
|
|
|
3,464 |
|
|
|
11,889 |
|
|
|
16,918 |
|
Income tax
expense |
|
4,610 |
|
|
|
5,743 |
|
|
|
26,969 |
|
|
|
10,896 |
|
Depreciation
expense |
|
5,931 |
|
|
|
4,111 |
|
|
|
14,576 |
|
|
|
14,123 |
|
Amortization of
acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
|
|
42,966 |
|
|
|
42,966 |
|
EBITDA |
|
(119,396 |
) |
|
|
35,732 |
|
|
|
(33,335 |
) |
|
|
93,969 |
|
|
|
|
|
|
|
|
|
Other adjustments: |
|
|
|
|
|
|
|
Contingent consideration (gains) charges, restructuring charges and
other: |
|
|
|
|
|
|
|
Changes in the fair value of contingent consideration |
|
(3,244 |
) |
|
|
2,793 |
|
|
|
(5,541 |
) |
|
|
(3,847 |
) |
Restructuring charges (2) |
|
403 |
|
|
|
173 |
|
|
|
4,207 |
|
|
|
1,109 |
|
Acquisition-related expenses |
|
285 |
|
|
|
390 |
|
|
|
689 |
|
|
|
1,588 |
|
Goodwill impairment |
|
163,243 |
|
|
|
— |
|
|
|
163,243 |
|
|
|
— |
|
Step-up of acquired Flexion inventory to fair value and other |
|
— |
|
|
|
1,318 |
|
|
|
— |
|
|
|
3,884 |
|
Stock-based compensation |
|
13,230 |
|
|
|
12,530 |
|
|
|
38,905 |
|
|
|
35,475 |
|
CEO transition costs |
|
174 |
|
|
|
— |
|
|
|
745 |
|
|
|
— |
|
(Gain) loss on early extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
(7,518 |
) |
|
|
16,926 |
|
Adjusted EBITDA |
$ |
54,695 |
|
|
$ |
52,936 |
|
|
$ |
161,395 |
|
|
$ |
149,104 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes amortization of debt discount and debt issuance
costs.(2) Approximately $0.8 million and $3.5 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 nine months ended September 30, 2024, respectively.
Pacira BioSciences,
Inc.Reconciliation of GAAP to Non-GAAP 2024
Financial Guidance(dollars in
millions)
GAAP to Non-GAAP Financial 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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