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 third quarter
of 2023.
Third Quarter
2023 Financial Highlights
- Total revenues of $163.9
million
- Net product sales of $128.7 million
for EXPAREL, $28.8 million for ZILRETTA, and $5.3 million for
iovera°
- Net income of $10.9 million, or
$0.23 per share (basic and diluted)
- Adjusted EBITDA of $52.9
million
See “Non-GAAP Financial Information” below.
“Pacira continues to operate from a position of financial
strength with substantial revenues, improving gross margins, and
ongoing operating discipline, which have resulted in significantly
positive adjusted EBITDA of $53 million for the third quarter,”
said Dave Stack, chairman and chief executive officer of Pacira
BioSciences. “Our strong and durable cash flows, fueled by EXPAREL
exclusivity through 2041, leave us well positioned to self-fund our
growth and deliver multiple value-creating milestones in the coming
year including the anticipated launch of EXPAREL in two key lower
extremity nerve blocks. Looking ahead, we will continue to actively
manage operating expenses while deploying capital in a manner we
believe will maximize shareholder return and unlock the significant
untapped potential within our best-in-class opioid-sparing
commercial portfolio.”
Recent Business Highlights
- Four New Independent
Directors Appointed to Board of Directors. In October
2023, the company announced the appointments of Marcelo Bigal, MD,
PhD, Abraham Ceesay, Michael Yang, and Alethia Young, to its Board
of Directors. Each of the new directors adds diversity of
experience and background to the Pacira board of directors, while
also enhancing racial and gender diversity. Pacira now has 12
experienced directors, all with relevant industry experience.
- New Initiatives Supporting
the American Society of Anesthesiologists to Advance Education and
Enhance Patient Care. In October 2023, the American
Society of Anesthesiologists (ASA) and Pacira announced a new grant
from Pacira to the ASA Charitable Foundation to advance the medical
specialty of anesthesiology and pain medicine, facilitate
best-in-class clinician education and improve patient care. The
company has also joined ASA’s Industry Supporter Program to support
the Society’s more than 56,000 physician anesthesiologist members
to improve patient care and reduce reliance on opioids for the
treatment of postsurgical or chronic pain.
- Leadership Succession Plan. In September 2023,
the company announced that David Stack will retire from his role as
chairman and chief executive officer. To ensure a seamless
transition, Mr. Stack has committed to continuing in his current
role until a replacement is appointed by the Board of Directors
after which Mr. Stack will continue with the company in a
consulting role through August 2025.
Third Quarter
2023 Financial Results
- Total revenues were $163.9 million
in the third quarter of 2023, versus $167.5 million reported for
the third quarter of 2022.
- EXPAREL net product sales were
$128.7 million in the third quarter of 2023, versus $132.6 million
reported for the third quarter of 2022. Third quarter average daily
volume growth of 5 percent was offset by a lower net selling price
primarily due to the implementation of 340B Drug Pricing in October
2022 and other contracted relationships. There were 62 selling days
in the third quarter of 2023 and 64 selling days in the third
quarter of 2022.
- ZILRETTA net product sales were
$28.8 million in the third quarter of 2023, versus $26.5 million
reported for the third quarter of 2022.
- Third quarter 2023 iovera° net
product sales were $5.3 million, versus $4.5 million reported for
the third quarter of 2022.
- Sales of bupivacaine liposome
injectable suspension to third-party licensees were $0.9 million in
the third quarter of 2023, versus $3.0 million reported for the
third quarter of 2022.
- Total operating expenses were $146.2
million in both the third quarter of 2023 and 2022.
- Research and development (R&D)
expenses were $20.8 million in the third quarter of 2023, compared
to $19.4 million in the third quarter of 2022. R&D expenses
included $9.4 million and $7.2 million of product development and
manufacturing capacity expansion costs in the third quarters of
2023 and 2022, respectively.
- Selling, general and administrative
(SG&A) expenses were $67.9 million in the third quarter of
2023, compared to $61.3 million in the third quarter of 2022.
- GAAP net income was $10.9 million,
or $0.23 per share (basic and diluted) in the third quarter of
2023, compared to a net loss of $0.7 million, or $(0.02) per share
(basic and diluted) in the third quarter of 2022.
- Non-GAAP net income was $36.6
million, or $0.79 per share (basic) and $0.72 per share (diluted)
in the third quarter of 2023, compared to $29.9 million, or $0.65
per share (basic) and $0.59 per share (diluted), in the third
quarter of 2022.
- Adjusted EBITDA was $52.9 million in
the third quarter of 2023, compared to $55.2 million in the third
quarter of 2022.
- Pacira ended the third quarter of
2023 with cash, cash equivalents and available-for-sale investments
(“cash”) of $235.2 million. Cash provided by operations was $44.4
million in the third quarter of 2023, compared to $42.7 million in
the third quarter of 2022.
- Pacira had 46.4 million basic and
52.1 million diluted weighted average shares of common stock
outstanding in the third quarter of 2023.
See “Non-GAAP Financial Information” below.
Financial Guidance
While the company remains confident in the business and its
long-term growth outlook, today it is revising its full-year
EXPAREL guidance to reflect an updated view of the remainder of the
year. Pacira now expects full-year EXPAREL net product sales of
$535 million to $540 million versus the company’s previously guided
range of $550 million to $560 million.
Pacira is reiterating the following full-year financial
guidance:
- ZILRETTA net product sales of $110
million to $115 million;
- iovera° net product sales of $17
million to $20 million;
- Non-GAAP gross margin of 73% to
74%;
- Non-GAAP R&D expense of $70
million to $80 million;
- Non-GAAP SG&A expense of $220
million to $230 million; and
- Stock-based compensation of $46 million to $49 million.
See “Non-GAAP Financial Information” below.
Today’s Conference Call and Webcast
Reminder
The Pacira management team will host a conference call to
discuss the company’s financial results and recent developments
today, Thursday, November 2, 2023, at 8:30 a.m. ET. For
listeners who wish to participate in the question-and-answer
session via telephone, please pre-register at
investor.pacira.com/upcoming-events. All registrants will receive
dial-in information and a PIN allowing them to access the live
call. In addition, a live audio of the conference call will be
available as a webcast. Interested parties can access the event
through the “Events” page on the Pacira website at
investor.pacira.com.
Non-GAAP Financial Information
This press release contains financial measures that do not
comply with U.S. generally accepted accounting principles (GAAP),
such as non-GAAP gross margin, non-GAAP cost of goods sold,
non-GAAP research and development (R&D) expense, non-GAAP
selling, general and administrative (SG&A) expense, non-GAAP
net income, non-GAAP net income per common share, non-GAAP weighted
average diluted common shares outstanding, EBITDA (earnings before
interest, taxes, depreciation and amortization) and adjusted
EBITDA, because these non-GAAP financial measures exclude the
impact of items that management believes affect comparability or
underlying business trends.
These measures supplement the company’s financial results
prepared in accordance with GAAP. Pacira management uses these
measures to better analyze its financial results, estimate its
future cost of goods sold, R&D expense and SG&A expense
outlook for 2023 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.
The company is also developing innovative interventions to address
debilitating conditions involving the sympathetic nervous system,
such as cardiac electrical storm, chronic pain, and spasticity.
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 for single-dose infiltration in patients 6
years of age and older to produce postsurgical local analgesia and
in adults as an interscalene brachial plexus nerve block to produce
postsurgical regional analgesia. Safety and efficacy have not been
established in other nerve blocks. 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 in the pivotal trials.
Additional information is available at www.EXPAREL.com.
Important Safety Information about EXPAREL for
Patients
EXPAREL should not be used in obstetrical paracervical block
anesthesia. In studies in adults where EXPAREL was injected into a
wound, the most common side effects were nausea, constipation, and
vomiting. In studies in adults where EXPAREL was injected near a
nerve, the most common side effects were nausea, fever, and
constipation. In the study where EXPAREL was given to children, the
most common side effects were nausea, vomiting, constipation, low
blood pressure, low number of red blood cells, muscle twitching,
blurred vision, itching, and rapid heartbeat. EXPAREL can cause a
temporary loss of feeling and/or loss of muscle movement. How much
and how long the loss of feeling and/or muscle movement depends on
where and how much of EXPAREL was injected and may last for up to 5
days. EXPAREL is not recommended to be used in patients younger
than 6 years old for injection into the wound, for patients younger
than 18 years old for injection near a nerve, and/or in pregnant
women. Tell your health care provider if you or your child has
liver disease, since this may affect how the active ingredient
(bupivacaine) in EXPAREL is eliminated from the body. EXPAREL
should not be injected into the spine, joints, or veins. The active
ingredient in EXPAREL can affect the nervous system and the
cardiovascular system; may cause an allergic reaction; may cause
damage if injected into the joints; and can cause a rare blood
disorder.
About ZILRETTA®
(triamcinolone acetonide extended-release injectable
suspension)
On October 6, 2017, ZILRETTA was approved by the U.S. Food and
Drug Administration as the first and only extended-release
intra-articular therapy for patients confronting osteoarthritis
(OA)- related knee pain. ZILRETTA employs proprietary microsphere
technology combining triamcinolone acetonide—a commonly
administered, short-acting corticosteroid—with a poly
lactic-co-glycolic acid (PLGA) matrix to provide extended pain
relief. The pivotal Phase 3 trial on which the approval of ZILRETTA
was based showed that ZILRETTA significantly reduced OA knee pain
for 12 weeks, with some people experiencing pain relief through
Week 16. Learn more at www.zilretta.com.
Indication and Select Important Safety Information for
ZILRETTA
Indication: ZILRETTA is indicated as an
intra-articular injection for the management of OA pain of the
knee. Limitation of Use: The efficacy and safety of repeat
administration of ZILRETTA have not been demonstrated.
Contraindication: ZILRETTA is contraindicated
in patients who are hypersensitive to triamcinolone acetonide,
corticosteroids or any components of the product.
Warnings and Precautions:
- Intra-articular Use Only: ZILRETTA has not
been evaluated and should not be administered by epidural,
intrathecal, intravenous, intraocular, intramuscular, intradermal,
or subcutaneous routes. ZILRETTA should not be considered safe for
epidural or intrathecal administration.
- Serious Neurologic Adverse Reactions with Epidural and
Intrathecal Administration: Serious neurologic events have
been reported following epidural or intrathecal corticosteroid
administration. Corticosteroids are not approved for this use.
- Hypersensitivity reactions: Serious reactions
have been reported with triamcinolone acetonide injection.
Institute appropriate care if an anaphylactic reaction occurs.
- Joint infection and damage: A marked increase
in joint pain, joint swelling, restricted motion, fever and malaise
may suggest septic arthritis. If this occurs, conduct appropriate
evaluation and if confirmed, institute appropriate antimicrobial
treatment.
Adverse Reactions: The most commonly reported
adverse reactions (incidence ≥1%) in clinical studies included
sinusitis, cough, and contusions.
Please see ZILRETTALabel.com for full Prescribing
Information.
About iovera°®
The iovera° system uses the body’s natural response to cold to
treat peripheral nerves and immediately reduce pain without the use
of drugs. Treated nerves are temporarily stopped from sending pain
signals for a period of time, followed by a restoration of
function. Treatment with iovera° works by applying targeted cold to
a peripheral nerve. A precise cold zone is formed under the skin
that is cold enough to immediately prevent the nerve from sending
pain signals without causing damage to surrounding structures. The
effect on the nerve is temporary, providing pain relief until the
nerve regenerates and function is restored. Treatment with iovera°
does not include injection of any substance, opioid, or any other
drug. The effect is immediate and can last up to 90 days. The
iovera° system is not indicated for treatment of central nervous
system tissue. Additional information is available at
www.iovera.com.
Indication and Select Important Safety Information for
iovera°®
Indication: iovera° applies freezing cold to
peripheral nerve tissue to block and/or relieve pain for up to 90
days. It should not be used to treat central nervous system
tissue.
Important Safety Information
- Do not receive treatment with iovera° if you experience
hypersensitivity to cold or have open and/or infected wounds near
the treatment site.
- You may experience bruising, swelling, inflammation and/or
redness, local pain and/or tenderness, and altered feeling at the
site of application.
- In treatment area(s), you may experience damage to the skin,
skin darkening or lightening, and dimples in the skin.
- You may experience a temporary loss of your ability to use your
muscles normally outside of the treatment area.
- Talk to your doctor before receiving treatment with
iovera°.
Forward-Looking Statements
Any statements in this press release about Pacira’s future
expectations, plans, trends, outlook, projections and prospects,
and other statements containing the words “believes,”
“anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,”
“will,” “would,” “could,” “can” and similar expressions, constitute
forward-looking statements within the meaning of Section 21E of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”),
and the Private Securities Litigation Reform Act of 1995,
including, without limitation, statements related to our growth and
future operating results and trends, our strategy, plans,
objectives, expectations (financial or otherwise) and intentions,
future financial results and growth potential, including our plans
with respect to the repayment of our indebtedness, anticipated
product portfolio, development programs, patent terms, development
of products, strategic alliances and intellectual property and
other statements that are not historical facts. For this purpose,
any statement that is not a statement of historical fact should be
considered a forward-looking statement. We cannot assure you that
our estimates, assumptions and expectations will prove to have been
correct. Actual results may differ materially from those indicated
by such forward-looking statements as a result of various important
factors, including risks relating to, among others: the successful
transition of our chief executive officer and chairman; 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; the lingering impact of the COVID-19 pandemic on elective
surgeries, 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 an EXPAREL capacity expansion project in San
Diego, California; our ability to successfully complete a ZILRETTA
capital project in Swindon, England; the outcome of any litigation;
the ability to successfully integrate any future acquisitions into
our existing business; the recoverability of our deferred tax
assets; assumptions associated with contingent consideration
payments; and factors discussed in the “Risk Factors” of our most
recent Annual Report on Form 10-K and in other filings that we
periodically make with the Securities and Exchange Commission (the
“SEC”). In addition, the forward-looking statements included in
this press release represent our views as of the date of this press
release. Important factors could cause actual results to differ
materially from those indicated or implied by forward-looking
statements, and as such we anticipate that subsequent events and
developments will cause our views to change. Except as required by
applicable law, we undertake no intention or obligation to update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise, and readers should not
rely on these forward-looking statements as representing our views
as of any date subsequent to the date of this press release.
These forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause our actual
results, levels of activity, performance or achievements to differ
materially from those expressed or implied by these statements.
These factors include the matters discussed and referenced in the
“Risk Factors” of our most recent Annual Report on Form 10-K and in
other filings that we periodically make with the SEC.
Investor Contact:Susan Mesco, (973)
451-4030susan.mesco@pacira.com
Media Contact:Amber Sears, (973)
254-3587amber.sears@pacira.com
(Tables to Follow)
Pacira BioSciences,
Inc.Condensed Consolidated Balance
Sheets(in
thousands)(unaudited)
|
September 30,2023 |
|
December 31,2022 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
99,119 |
|
$ |
104,139 |
Short-term available-for-sale
investments |
|
136,069 |
|
|
184,512 |
Accounts receivable, net |
|
96,956 |
|
|
98,397 |
Inventories, net |
|
96,520 |
|
|
96,063 |
Prepaid expenses and other
current assets |
|
18,591 |
|
|
15,223 |
Total current assets |
|
447,255 |
|
|
498,334 |
Noncurrent available-for-sale
investments |
|
— |
|
|
37,209 |
Fixed assets, net |
|
175,783 |
|
|
183,512 |
Right-of-use assets, net |
|
63,394 |
|
|
70,877 |
Goodwill |
|
163,243 |
|
|
163,243 |
Intangible assets, net |
|
497,580 |
|
|
540,546 |
Deferred tax assets |
|
151,660 |
|
|
160,309 |
Investments and other
assets |
|
35,547 |
|
|
27,170 |
Total assets |
$ |
1,534,462 |
|
$ |
1,681,200 |
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
16,511 |
|
$ |
15,220 |
Accrued expenses |
|
59,884 |
|
|
89,785 |
Lease liabilities |
|
8,625 |
|
|
9,121 |
Current portion of convertible
senior notes, net |
|
8,641 |
|
|
— |
Current portion of long-term debt, net |
|
— |
|
|
33,648 |
Total current liabilities |
|
93,661 |
|
|
147,774 |
Convertible senior notes,
net |
|
397,976 |
|
|
404,767 |
Long-term debt, net |
|
117,965 |
|
|
251,056 |
Lease liabilities |
|
57,089 |
|
|
64,802 |
Contingent consideration |
|
24,275 |
|
|
28,122 |
Other liabilities |
|
11,945 |
|
|
9,669 |
Total stockholders’
equity |
|
831,551 |
|
|
775,010 |
Total liabilities and
stockholders’ equity |
$ |
1,534,462 |
|
$ |
1,681,200 |
|
|
|
|
|
|
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, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net product sales: |
|
|
|
|
|
|
|
EXPAREL |
$ |
128,667 |
|
|
$ |
132,642 |
|
|
$ |
394,202 |
|
|
$ |
398,854 |
|
ZILRETTA |
|
28,798 |
|
|
|
26,494 |
|
|
|
82,393 |
|
|
|
77,546 |
|
iovera° |
|
5,260 |
|
|
|
4,467 |
|
|
|
13,645 |
|
|
|
10,694 |
|
Bupivacaine liposome injectable suspension |
|
858 |
|
|
|
2,957 |
|
|
|
2,241 |
|
|
|
5,469 |
|
Total net product sales |
|
163,583 |
|
|
|
166,560 |
|
|
|
492,481 |
|
|
|
492,563 |
|
Royalty revenue |
|
343 |
|
|
|
906 |
|
|
|
1,253 |
|
|
|
2,305 |
|
Total revenues |
|
163,926 |
|
|
|
167,466 |
|
|
|
493,734 |
|
|
|
494,868 |
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
|
39,750 |
|
|
|
50,678 |
|
|
|
136,977 |
|
|
|
137,379 |
|
Research and development |
|
20,830 |
|
|
|
19,405 |
|
|
|
56,794 |
|
|
|
67,292 |
|
Selling, general and administrative |
|
67,947 |
|
|
|
61,283 |
|
|
|
203,640 |
|
|
|
190,546 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
|
|
42,966 |
|
|
|
42,966 |
|
Contingent consideration charges (gains), restructuring charges and
other |
|
3,356 |
|
|
|
489 |
|
|
|
(1,150 |
) |
|
|
(13,232 |
) |
Total operating expenses |
|
146,205 |
|
|
|
146,177 |
|
|
|
439,227 |
|
|
|
424,951 |
|
Income from operations |
|
17,721 |
|
|
|
21,289 |
|
|
|
54,507 |
|
|
|
69,917 |
|
Other (expense) income: |
|
|
|
|
|
|
|
Interest income |
|
2,766 |
|
|
|
1,234 |
|
|
|
8,019 |
|
|
|
1,757 |
|
Interest expense |
|
(3,464 |
) |
|
|
(9,856 |
) |
|
|
(16,918 |
) |
|
|
(28,935 |
) |
Loss on early extinguishment
of debt |
|
— |
|
|
|
— |
|
|
|
(16,926 |
) |
|
|
— |
|
Other, net |
|
(422 |
) |
|
|
(10,598 |
) |
|
|
(701 |
) |
|
|
(11,369 |
) |
Total other expense, net |
|
(1,120 |
) |
|
|
(19,220 |
) |
|
|
(26,526 |
) |
|
|
(38,547 |
) |
Income before income
taxes |
|
16,601 |
|
|
|
2,069 |
|
|
|
27,981 |
|
|
|
31,370 |
|
Income tax expense |
|
(5,743 |
) |
|
|
(2,762 |
) |
|
|
(10,896 |
) |
|
|
(5,359 |
) |
Net income (loss) |
$ |
10,858 |
|
|
$ |
(693 |
) |
|
$ |
17,085 |
|
|
$ |
26,011 |
|
|
|
|
|
|
|
|
|
Net income (loss) per
share: |
|
|
|
|
|
|
|
Basic net income (loss) per common share |
$ |
0.23 |
|
|
$ |
(0.02 |
) |
|
$ |
0.37 |
|
|
$ |
0.57 |
|
Diluted net income (loss) per
common share(1) |
$ |
0.23 |
|
|
$ |
(0.02 |
) |
|
$ |
0.37 |
|
|
$ |
0.56 |
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
46,416 |
|
|
|
45,831 |
|
|
|
46,151 |
|
|
|
45,400 |
|
Diluted(1) |
|
52,067 |
|
|
|
45,831 |
|
|
|
46,343 |
|
|
|
52,220 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Upon adoption of
Accounting Standards Update, or ASU, 2020-06 on January 1, 2022,
diluted net income per common share was calculated using the
“if-converted” method associated with the Company’s convertible
senior notes. For the three months ended September 30, 2023 and the
nine months ended September 30, 2022, GAAP diluted net income per
common share includes 5.6 million shares, from an assumed
conversion of the convertible senior notes and the associated
interest expense add-backs to GAAP net income of $1.0 million in
the three months ended September 30, 2023 and $3.1 million in the
nine months ended September 30, 2022. |
|
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, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
GAAP net income (loss) |
$ |
10,858 |
|
|
$ |
(693 |
) |
|
$ |
17,085 |
|
|
$ |
26,011 |
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Contingent consideration charges (gains), restructuring charges and
other: |
|
|
|
|
|
|
|
Severance-related expenses(1) |
|
— |
|
|
|
194 |
|
|
|
— |
|
|
|
4,259 |
|
Acquisition-related fees and expenses(2) |
|
390 |
|
|
|
1,338 |
|
|
|
1,588 |
|
|
|
5,903 |
|
Changes in the fair value of contingent consideration |
|
2,793 |
|
|
|
(1,043 |
) |
|
|
(3,847 |
) |
|
|
(23,394 |
) |
Restructuring charges(3) |
|
173 |
|
|
|
— |
|
|
|
1,109 |
|
|
|
— |
|
Step-up of acquired Flexion fixed assets and inventory to fair
value and other |
|
1,318 |
|
|
|
1,973 |
|
|
|
5,152 |
|
|
|
5,758 |
|
Stock-based compensation |
|
12,530 |
|
|
|
12,682 |
|
|
|
35,475 |
|
|
|
35,415 |
|
Loss on early extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
16,926 |
|
|
|
— |
|
Amortization of debt discount |
|
25 |
|
|
|
695 |
|
|
|
728 |
|
|
|
2,107 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
|
|
42,966 |
|
|
|
42,966 |
|
Impairment on investment |
|
— |
|
|
|
10,000 |
|
|
|
— |
|
|
|
10,000 |
|
Tax impact of non-GAAP adjustments(4) |
|
(5,778 |
) |
|
|
(9,618 |
) |
|
|
(20,249 |
) |
|
|
(25,274 |
) |
Total non-GAAP adjustments |
|
25,773 |
|
|
|
30,543 |
|
|
|
79,848 |
|
|
|
57,740 |
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
36,631 |
|
|
$ |
29,850 |
|
|
$ |
96,933 |
|
|
$ |
83,751 |
|
|
|
|
|
|
|
|
|
GAAP basic net income (loss)
per common share |
$ |
0.23 |
|
|
$ |
(0.02 |
) |
|
$ |
0.37 |
|
|
$ |
0.57 |
|
GAAP diluted net income (loss)
per common share |
$ |
0.23 |
|
|
$ |
(0.02 |
) |
|
$ |
0.37 |
|
|
$ |
0.56 |
|
|
|
|
|
|
|
|
|
GAAP net income (loss) |
$ |
10,858 |
|
|
$ |
(693 |
) |
|
$ |
17,085 |
|
|
$ |
26,011 |
|
Interest expense on convertible senior notes, net of tax |
|
1,029 |
|
|
|
— |
|
|
|
— |
|
|
|
3,112 |
|
GAAP net income (loss) used
for diluted earnings per share |
$ |
11,887 |
|
|
$ |
(693 |
) |
|
$ |
17,085 |
|
|
$ |
29,123 |
|
|
|
|
|
|
|
|
|
Non-GAAP basic net income per
common share |
$ |
0.79 |
|
|
$ |
0.65 |
|
|
$ |
2.10 |
|
|
$ |
1.84 |
|
Non-GAAP diluted net income
per common share(5) |
$ |
0.72 |
|
|
$ |
0.59 |
|
|
$ |
1.93 |
|
|
$ |
1.66 |
|
|
|
|
|
|
|
|
|
Non-GAAP net income |
$ |
36,631 |
|
|
$ |
29,850 |
|
|
$ |
96,933 |
|
|
$ |
83,751 |
|
Interest expense on convertible senior notes, net of tax(5) |
|
1,029 |
|
|
|
1,034 |
|
|
|
3,086 |
|
|
|
4,027 |
|
Non-GAAP net income used for
diluted earnings per share(5) |
$ |
37,660 |
|
|
$ |
30,884 |
|
|
$ |
100,019 |
|
|
$ |
87,778 |
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding - basic |
|
46,416 |
|
|
|
45,831 |
|
|
|
46,151 |
|
|
|
45,400 |
|
Weighted average common shares
outstanding - diluted |
|
52,067 |
|
|
|
45,831 |
|
|
|
46,343 |
|
|
|
52,220 |
|
Non-GAAP Weighted average
common shares outstanding - basic |
|
46,416 |
|
|
|
45,831 |
|
|
|
46,151 |
|
|
|
45,400 |
|
Non-GAAP Weighted average
common shares outstanding - diluted(5) |
|
52,067 |
|
|
|
52,135 |
|
|
|
51,951 |
|
|
|
53,017 |
|
|
(1) The
severance-related expenses in 2022 substantially relates to former
employees released in connection with the acquisition of Flexion
Therapeutics, Inc. (“Flexion”) in November 2021. |
(2) For the three
and nine months ended September 30, 2023, acquisition-related fees
and expenses primarily related to vacant and underutilized leases
assumed from acquiring Flexion. For the three and nine months ended
September 30, 2022, acquisition-related fees and expenses primarily
related to legal and other professional fees, third-party services
and other one-time charges associated with the Flexion
acquisition. |
(3) In June 2023,
the Company implemented a restructuring plan in an effort to
improve its operational efficiencies. The restructuring charges are
predominantly related to one-time employee termination benefits
through a reduction of headcount, such as severance and related
costs. |
(4) 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,
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. For the three and nine
months ended September 30, 2022, the GAAP effective income tax
rates were approximately 133% and 17%, respectively, and the
non-GAAP effective income tax rates were approximately 29% and 27%,
respectively, with the difference from GAAP primarily due to the
impact of excluding tax expenses related non-U.S. valuation
allowances, non-deductible capital loss and executive compensation
and excluding tax benefits related to acquisition items. The
non-GAAP effective income tax rate for the nine months ended
September 30, 2022 also excludes discrete tax benefits associated
with deductible stock-based compensation. |
(5) 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 months ended September 30, 2022
and nine months ended September 30, 2023, the $402.5 million
convertible senior notes due 2025, or 2025 Notes, were excluded on
a GAAP basis as the impact to diluted net income (loss) per common
share would have been antidilutive. These potential securities
resulted in a dilutive impact on diluted net income per common
share reported on a non-GAAP basis.For the three months ended
September 30, 2022 and 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
5.6 million of common shares in each period upon an assumed
conversion and added back $1.0 million and $3.1 million,
respectively, of interest expense, net of tax, to non-GAAP net
income. The Company has the option to settle its 2025 Notes in
cash, shares of the Company's common stock or a combination of cash
and shares of the Company's common stock.For the nine months ended
September 30, 2022, the $160.0 million convertible senior notes due
2022, or 2022 Notes, were excluded on a GAAP basis as the impact to
diluted net income per common share would have been antidilutive.
These potential securities resulted in a dilutive impact on diluted
net income per common share reported on a non-GAAP basis.For the
nine months ended September 30, 2022, non-GAAP adjustments to
diluted weighted average shares outstanding included the impact of
the 2022 Notes, as if they were converted on the first day of the
period presented, which resulted in adding an additional 0.8
million of common shares upon an assumed conversion and added back
$0.9 million of interest expense, net of tax, to net income. On
April 1, 2022, the Company repaid the principal portion of its 2022
Notes in cash.Prior year amounts may have been 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 |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Cost of goods sold
reconciliation: |
|
|
|
|
|
|
|
GAAP cost of goods sold |
$ |
39,750 |
|
|
$ |
50,678 |
|
|
$ |
136,977 |
|
|
$ |
137,379 |
|
Step-up of acquired Flexion fixed assets and inventory to fair
value and other |
|
(1,318 |
) |
|
|
(1,973 |
) |
|
|
(5,152 |
) |
|
|
(5,758 |
) |
Stock-based compensation |
|
(1,272 |
) |
|
|
(1,599 |
) |
|
|
(4,432 |
) |
|
|
(4,429 |
) |
Non-GAAP cost of goods
sold |
$ |
37,160 |
|
|
$ |
47,106 |
|
|
$ |
127,393 |
|
|
$ |
127,192 |
|
|
|
|
|
|
|
|
|
Research and
development reconciliation: |
|
|
|
|
|
|
|
GAAP research and
development |
$ |
20,830 |
|
|
$ |
19,405 |
|
|
$ |
56,794 |
|
|
$ |
67,292 |
|
Stock-based compensation |
|
(2,220 |
) |
|
|
(1,783 |
) |
|
|
(5,817 |
) |
|
|
(4,761 |
) |
Non-GAAP research and
development |
$ |
18,610 |
|
|
$ |
17,622 |
|
|
$ |
50,977 |
|
|
$ |
62,531 |
|
|
|
|
|
|
|
|
|
Selling, general and
administrative reconciliation: |
|
|
|
|
|
|
|
GAAP selling, general and
administrative |
$ |
67,947 |
|
|
$ |
61,283 |
|
|
$ |
203,640 |
|
|
$ |
190,546 |
|
Stock-based compensation |
|
(9,038 |
) |
|
|
(9,300 |
) |
|
|
(25,226 |
) |
|
|
(26,225 |
) |
Non-GAAP selling, general and
administrative |
$ |
58,909 |
|
|
$ |
51,983 |
|
|
$ |
178,414 |
|
|
$ |
164,321 |
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding - diluted reconciliation: |
|
|
|
|
|
|
|
GAAP weighted average common
shares outstanding - diluted |
|
52,067 |
|
|
|
45,831 |
|
|
|
46,343 |
|
|
|
52,220 |
|
Dilutive common shares associated with the 2025 Notes(1) |
|
— |
|
|
|
5,608 |
|
|
|
5,608 |
|
|
|
— |
|
Dilutive common shares associated with the 2022 Notes(2) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
797 |
|
Dilutive common shares associated with stock options and restricted
stock units |
|
— |
|
|
|
696 |
|
|
|
— |
|
|
|
— |
|
Non-GAAP weighted average
common shares outstanding - diluted |
|
52,067 |
|
|
|
52,135 |
|
|
|
51,951 |
|
|
|
53,017 |
|
|
(1) For the three
months ended September 30, 2022 and nine months ended September 30,
2023, potential common shares of the 2025 Notes were excluded from
diluted net income (loss) per common share on a GAAP basis because
they would have been antidilutive. These potential securities
resulted in a dilutive impact on diluted net income per common
share reported on a non-GAAP basis. |
(2) For the nine
months ended September 30, 2022, potential common shares of the
2022 Notes were excluded from diluted net income per common share
on a GAAP basis because they would have been antidilutive. These
potential securities resulted in a dilutive impact on diluted net
income per common share reported on a non-GAAP basis. |
|
Pacira BioSciences,
Inc.Reconciliation of GAAP Net Income to Adjusted
EBITDA (Non-GAAP)(in
thousands)(unaudited)
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
GAAP net income |
$ |
10,858 |
|
|
$ |
(693 |
) |
|
$ |
17,085 |
|
|
$ |
26,011 |
|
|
|
|
|
|
|
|
|
Interest income |
|
(2,766 |
) |
|
|
(1,234 |
) |
|
|
(8,019 |
) |
|
|
(1,757 |
) |
Interest expense(1) |
|
3,464 |
|
|
|
9,856 |
|
|
|
16,918 |
|
|
|
28,935 |
|
Income tax expense |
|
5,743 |
|
|
|
2,762 |
|
|
|
10,896 |
|
|
|
5,359 |
|
Depreciation expense |
|
4,111 |
|
|
|
5,878 |
|
|
|
14,123 |
|
|
|
18,130 |
|
Amortization of acquired intangible assets |
|
14,322 |
|
|
|
14,322 |
|
|
|
42,966 |
|
|
|
42,966 |
|
EBITDA |
|
35,732 |
|
|
|
30,891 |
|
|
|
93,969 |
|
|
|
119,644 |
|
|
|
|
|
|
|
|
|
Other adjustments: |
|
|
|
|
|
|
|
Contingent consideration charges (gains), restructuring charges and
other: |
|
|
|
|
|
|
|
Severance-related expenses |
|
— |
|
|
|
194 |
|
|
|
— |
|
|
|
4,259 |
|
Acquisition-related fees and expenses(2) |
|
390 |
|
|
|
1,338 |
|
|
|
1,588 |
|
|
|
4,698 |
|
Changes in the fair value of contingent consideration |
|
2,793 |
|
|
|
(1,043 |
) |
|
|
(3,847 |
) |
|
|
(23,394 |
) |
Restructuring charges |
|
173 |
|
|
|
— |
|
|
|
1,109 |
|
|
|
— |
|
Step-up of acquired Flexion inventory to fair value and other |
|
1,318 |
|
|
|
1,172 |
|
|
|
3,884 |
|
|
|
3,353 |
|
Stock-based compensation |
|
12,530 |
|
|
|
12,682 |
|
|
|
35,475 |
|
|
|
35,415 |
|
Loss on early extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
16,926 |
|
|
|
— |
|
Impairment on investment |
|
— |
|
|
|
10,000 |
|
|
|
— |
|
|
|
10,000 |
|
Adjusted EBITDA |
$ |
52,936 |
|
|
$ |
55,234 |
|
|
$ |
149,104 |
|
|
$ |
153,975 |
|
(1) Includes amortization of debt discount and debt issuance
costs(2) For the three and nine months ended September 30, 2022,
excludes any depreciation expense included in EBITDA above
Pacira BioSciences,
Inc.Reconciliation of GAAP to Non-GAAP 2023
Financial Guidance(dollars in
millions)
GAAP to Non-GAAP Guidance |
|
GAAP |
|
Full-year Impact of GAAP to Non-GAAP Adjustments
(1) |
|
Non-GAAP |
EXPAREL net product sales |
|
$535 to $540 |
|
— |
|
— |
ZILRETTA net product
sales |
|
$110 to $115 |
|
— |
|
— |
iovera° net product sales |
|
$17 to $20 |
|
— |
|
— |
Gross margin |
|
71% to 72% |
|
Approximately 2% |
|
73% to 74% |
Research and development
expense |
|
$77 to $88 |
|
$7 to $8 |
|
$70 to $80 |
Selling, general and
administrative expense |
|
$252 to $264 |
|
$32 to $34 |
|
$220 to $230 |
Stock-based compensation |
|
$46 to $49 |
|
— |
|
— |
(1) The full-year impact of GAAP to Non-GAAP adjustments
primarily relates to stock-based compensation and also includes the
step-up of acquired Flexion fixed assets and inventory to fair
value from the acquisition of Flexion Therapeutics, Inc., and other
costs.
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