– Total revenues of $3.8
billion in 2023 and $1 billion
in 4Q23 –
– 27% year-over-year revenue increase from combined key growth
drivers: Xywav®, Epidiolex® and
Rylaze® –
– Oncology revenue surpassed $1
billion in 2023 –
– Multiple late-stage pipeline catalysts anticipated in 2024 –
– 2024 total revenue guidance reflects continued top-line growth
–
DUBLIN, Feb. 28,
2024 /PRNewswire/ -- Jazz Pharmaceuticals plc
(Nasdaq: JAZZ) today announced financial results for the full year
and fourth quarter of 2023 and provided guidance for 2024.
"2023 was a year of continued strong execution that delivered
top- and bottom-line growth and over $3.8
billion in total revenue. Sleep1 revenue exceeded
$1.9 billion, Oncology revenue
surpassed $1 billion and
Epidiolex remains on track to deliver on its blockbuster
potential, demonstrating our progress towards Vision 2025 targets.
We also meaningfully advanced our late-stage pipeline and are
pleased to note enrollment of the Phase 3 Zepzelca®
trial in first-line small cell lung cancer has been completed,"
said Bruce Cozadd, chairman and
chief executive officer of Jazz Pharmaceuticals. "Looking to 2024,
we expect double-digit percentage revenue growth across combined
key growth drivers: Xywav, Epidiolex and
Rylaze. We look forward to multiple near-term, late-stage
pipeline catalysts and anticipate completing the rolling BLA
submission for zanidatamab in second-line biliary tract cancer in
the first half of 2024. We expect our disciplined capital
allocation to enable investment in our key commercial growth
drivers for near-term growth, in our pipeline for long-term growth
and to provide flexibility for corporate development."
Key Highlights
- Achieved first $1 billion revenue
quarter.
- Key growth drivers:
- Xywav net product sales grew 33% year-over-year;
annualizing2 at $1.35
billion.
- Epidiolex/Epidyolex® net product sales grew
15% year-over-year; annualizing2 at over $900 million.
- Rylaze net product sales grew 40% year-over-year;
annualizing2 at over $400
million.
- Initiated zanidatamab 1L BTC confirmatory trial in 1Q24.
- Multiple near-term, late-stage pipeline catalysts anticipated:
- Completion of rolling BLA submission for accelerated
approval in 2L BTC in 1H24.
- Top-line PFS data from zanidatamab in Phase 3 1L GEA
targeted for late 2024.
- Suvecaltamide top-line data from Phase 2b trial in ET in late 1H24.
- Top-line data from Epidyolex Phase 3 trial in
Japan in 2H24.
- Top-line data from Zepzelca 1L SCLC Phase 3 trial
at the end of 2024 or early 2025.
- The Company will host a virtual zanidatamab R&D Day on
Tuesday, March 19, 2024.
- 2024 total revenue guidance of $4.0 to $4.2
billion, 7% top-line growth at the mid-point.
- Total revenue guidance is underpinned by expectations of
continued growth in net sales of Xywav in IH,
Epidiolex/Epidyolex, our Oncology therapeutic area, and
royalties on net sales of authorized generics of Xyrem®
offset by a continued decline in net sales of Xyrem.
_______________________
|
1 Total
Sleep revenue includes: Xywav, branded Xyrem and
high-sodium authorized generic royalty revenues.
|
2 Based on
4Q23 net product sales.
|
Business Updates
Key Commercial Products
Xywav (calcium, magnesium, potassium, and sodium
oxybates) oral solution:
- Xywav net product sales increased 33% to $1,273.0 million in 2023 and increased 20% to
$337.0 million in 4Q23 compared to
the same periods in 2022.
- As the only low-sodium oxybate and the only therapy approved to
treat IH, expect Xywav to remain the oxybate of choice.
- There were approximately 12,300 active Xywav patients
exiting 4Q23.
- Results from the real-world TENOR study were published in
Sleep Medicine. The most common reason cited for switching
to Xywav was long-term health benefits due to lower sodium
content of Xywav.
- A review of scientific evidence was published in Neurology
and Therapy showing oxybate regimens impart substantial and
highly similar medical benefit on subjective and objective measures
of sleep and daytime function regardless of dosing.
Xywav for Narcolepsy:
- There were approximately 9,525 narcolepsy patients
taking Xywav exiting 4Q23.
Xywav for Idiopathic Hypersomnia (IH):
- There were approximately 2,775 IH patients taking
Xywav exiting 4Q23.
Xyrem (sodium oxybate) oral solution:
- Xyrem net product sales decreased 44% to
$569.7 million in 2023 and
decreased 57% to $106.7 million in
4Q23 compared to the same periods in 2022.
High-Sodium Oxybate Authorized Generic (AG)
Royalties:
- Royalties from high-sodium oxybate AGs were $75.9 million in 2023 and $39.4 million in 4Q23.
- The Company expects high-sodium oxybate AG royalty revenue to
exceed $200 million in 2024, which
reflects an increase in the fixed-rate royalty structures of the AG
agreements in 2024.
Epidiolex/Epidyolex (cannabidiol):
- Epidiolex/Epidyolex net product sales increased 15% to
$845.5 million in 2023 and increased
16% to $240.6 million in 4Q23
compared to the same periods in 2022.
- Outside of the U.S., Epidyolex is approved in more than
35 countries with additional launches and reimbursement anticipated
through the end of 2024.
- Long-term and real-world data of treatment-resistant epilepsy
were presented at AES 2023:
- Data from long-term Expanded Access Program study
demonstrated Epidiolex was associated with a sustained
reduction in treatment-resistant, focal-onset seizures through 144
weeks.
- Interim results from the BECOME-TSC survey of caregivers
of patients with tuberous sclerosis complex (TSC) demonstrated
improved day-to-day function, cognition, language and communication
and emotional and social function in patients.
Rylaze/Enrylaze® (asparaginase
erwinia chrysanthemi (recombinant)-rywn):
- Rylaze net product sales increased 40% to $394.2 million in 2023 and increased 26% to
$101.7 million in 4Q23 compared to
the same periods in 2022.
- Initiated European rolling launch of Enrylaze (JZP458; a
recombinant Erwinia asparaginase or crisantaspase), marketed
as Rylaze in the U.S. and Canada, in 4Q23.
Zepzelca (lurbinectedin):
- Zepzelca net product sales increased 7% to $289.5 million in 2023 and increased 3% to
$74.0 million in 4Q23 compared to the
same periods in 2022.
- Enrollment in the Phase 3 trial evaluating first-line (1L) use
of Zepzelca in combination with Tecentriq®
(atezolizumab) in small cell lung cancer, in partnership with
Roche, is complete; expect top-line progression-free survival (PFS)
data readout at the end of 2024 or early 2025.
Key Pipeline Highlights
Zanidatamab:
- Initiated the zanidatamab rolling biologics license application
(BLA) submission in 4Q23 for accelerated approval in second-line
(2L) biliary tract cancer (BTC) and expect to complete the rolling
submission 1H24.
- Initiated confirmatory trial in 1L metastatic BTC, where there
remains unmet patient need, in 1Q24.
- The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L
gastroesophageal adenocarcinoma (GEA), is ongoing and the Company
is targeting top-line PFS data in late 2024. The Company increased
enrollment in the trial from 714 to 918 to improve statistical
power for overall survival analysis, while maintaining PFS top-line
readout.
- Data presented at SABCS in heavily pretreated patients with
HER2+/HR+ metastatic breast cancer demonstrated 67% PFS at six
months with a median PFS of 12 months.
- In addition to achieving clinically meaningful improvements,
data presented at the ASCO Gastrointestinal Cancers Symposium in
January 2024 demonstrated that
patients who responded to zanidatamab also reported improved
quality of life with less pain interference in the Phase
2b HERIZON-BTC-01 trial.
Suvecaltamide (JZP385):
- Patient enrollment is ongoing in the Phase 2b essential tremor (ET) trial; top-line data
readout is anticipated late 1H24.
- A Phase 2 trial in patients with Parkinson's disease tremor is
ongoing.
JZP898:
- Initiated a Phase 1 first-in-human clinical trial in solid
tumors in 4Q23.
Corporate Development
KRAS Inhibitor Program Agreement:
- In February 2024, the
Company acquired Redx Pharma's KRAS inhibitor program, which
includes G12D selective and pan-KRAS molecules, further expanding
Jazz's early-stage oncology pipeline.
Ion Channel Targets Agreement:
- In November 2023, the Company
and Autifony announced an exclusive global license and
collaboration agreement to discover and develop drug candidates for
two different ion channel targets associated with neurological
disorders.
Continued Repurchases under Previously Announced $1.5 Billion Share Repurchase Program
The Company continued repurchases of its ordinary shares on the
open market in the fourth quarter of 2023 as part of its previously
authorized and announced share repurchase program. As of
December 31, 2023, approximately
$161 million remained available and
authorized for share repurchases, after the purchase of
approximately $100 million of shares during the fourth quarter
of 2023. The timing and amount of repurchases under the program
will depend on a variety of factors, including the price of the
Company's ordinary shares, alternative investment opportunities,
restrictions under the Company's credit agreement, corporate and
regulatory requirements and market conditions.
Financial Highlights
|
Three Months
Ended
December
31,
|
|
Year
Ended
December
31,
|
(In thousands, except
per share amounts)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Total
revenues
|
$
1,011,935
|
|
$ 972,123
|
|
$
3,834,204
|
|
$
3,659,374
|
GAAP net income
(loss)
|
$
94,154
|
|
$
(240,724)
|
|
$ 414,832
|
|
$
(224,060)
|
Non-GAAP adjusted net
income (loss)
|
$ 345,286
|
|
$
(4,239)
|
|
$
1,295,824
|
|
$ 933,598
|
GAAP earnings (loss)
per share
|
$
1.42
|
|
$
(3.82)
|
|
$
6.10
|
|
$
(3.58)
|
Non-GAAP adjusted
EPS
|
$
5.02
|
|
$
(0.07)
|
|
$
18.29
|
|
$
13.20
|
GAAP net income for 2023 was $414.8 million, or $6.10 per diluted share, compared to a GAAP net
loss of $(224.1) million, or $(3.58) per diluted share, for 2022. GAAP net
income for 4Q23 was $94.2 million, or $1.42 per diluted share, compared to a GAAP net
loss of $(240.7) million, or $(3.82) per diluted share, for 4Q22.
Non-GAAP adjusted net income for 2023 was $1,295.8 million, or $18.29 per diluted share, compared to
$933.6 million, or $13.20 per diluted share, for 2022. Non-GAAP
adjusted net income for 4Q23 was $345.3 million, or $5.02 per diluted share, compared to a Non-GAAP
adjusted net loss of $(4.2) million, or $(0.07) per diluted share, for 4Q22.
Reconciliations of applicable GAAP reported to non-GAAP adjusted
information are included at the end of this press release.
Total Revenues
|
Three Months
Ended
December
31,
|
|
Year
Ended
December
31,
|
(In
thousands)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Xywav
|
$ 337,019
|
|
$ 281,384
|
|
$
1,272,977
|
|
$ 958,425
|
Xyrem
|
106,721
|
|
247,496
|
|
569,730
|
|
1,020,453
|
Epidiolex/Epidyolex
|
240,622
|
|
206,998
|
|
845,468
|
|
736,398
|
Sativex
|
5,137
|
|
4,721
|
|
19,668
|
|
16,825
|
Sunosi1
|
—
|
|
—
|
|
—
|
|
28,844
|
Total
Neuroscience
|
689,499
|
|
740,599
|
|
2,707,843
|
|
2,760,945
|
Rylaze
|
101,747
|
|
80,972
|
|
394,226
|
|
281,659
|
Zepzelca
|
74,010
|
|
71,969
|
|
289,533
|
|
269,912
|
Defitelio/defibrotide
|
51,083
|
|
40,653
|
|
184,000
|
|
194,290
|
Vyxeos
|
46,912
|
|
30,266
|
|
147,495
|
|
127,980
|
Total
Oncology
|
273,752
|
|
223,860
|
|
1,015,254
|
|
873,841
|
Other
|
4,088
|
|
3,067
|
|
13,846
|
|
6,643
|
Product sales,
net
|
967,339
|
|
967,526
|
|
3,736,943
|
|
3,641,429
|
High-sodium oxybate AG
royalty revenue
|
39,387
|
|
—
|
|
75,918
|
|
—
|
Other royalty and
contract revenues
|
5,209
|
|
4,597
|
|
21,343
|
|
17,945
|
Total
revenues
|
$
1,011,935
|
|
$ 972,123
|
|
$
3,834,204
|
|
$
3,659,374
|
___________________________
|
1. Divestiture of Sunosi U.S.
was completed in May 2022.
|
Total revenues increased 5% in 2023 and 4% in 4Q23 compared to
the same periods in 2022.
- Total neuroscience revenue, including high-sodium oxybate AG
royalty revenue, of $2,783.8 million
in 2023 and $728.9 million in 4Q23,
was broadly in line with the same periods in 2022 and included
increased Xywav and Epidiolex/Epidyolex net product
sales, offset by decreased Xyrem revenues, reflecting the
strong adoption of Xywav by existing Xyrem patients
and the impact of high-sodium oxybate competition. High-sodium
oxybate AG royalty revenue relates primarily to royalty revenue
received from Hikma Pharmaceuticals plc on net sales of a
high-sodium oxybate AG product.
- Oncology net product sales increased 16% in 2023 and 22% in
4Q23 compared to the same periods in 2022, primarily driven by the
continued growth in Rylaze product sales, which increased
40% to $394.2 million in 2023 and
increased 26% to $101.7 million in
4Q23 compared to the same periods in 2022.
Operating Expenses and Effective Tax Rate
|
Three Months
Ended
December
31,
|
|
Year
Ended
December
31,
|
(In thousands, except
percentages)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
GAAP:
|
|
|
|
|
|
|
|
Cost of product
sales
|
$ 107,243
|
|
$ 167,364
|
|
$ 435,577
|
|
$ 540,517
|
Gross
margin
|
88.9 %
|
|
82.7 %
|
|
88.3 %
|
|
85.2 %
|
Selling, general and
administrative
|
$ 396,034
|
|
$ 383,203
|
|
$
1,343,105
|
|
$
1,416,967
|
% of total
revenues
|
39.1 %
|
|
39.4 %
|
|
35.0 %
|
|
38.7 %
|
Research and
development
|
$ 216,608
|
|
$ 172,555
|
|
$ 849,658
|
|
$ 590,453
|
% of total
revenues
|
21.4 %
|
|
17.8 %
|
|
22.2 %
|
|
16.1 %
|
Acquired in-process
research and development
|
$
18,000
|
|
$ 375,000
|
|
$
19,000
|
|
$ 444,148
|
Intangible asset
impairment charge
|
$
—
|
|
$
—
|
|
$
—
|
|
$ 133,648
|
Income tax
benefit
|
$
(33,089)
|
|
$
(100,042)
|
|
$
(119,912)
|
|
$
(158,645)
|
Effective tax rate
1
|
(53.8) %
|
|
29.4 %
|
|
(40.2) %
|
|
42.6 %
|
_________________________
|
1.
|
The GAAP effective tax
rate decreased for the three months and the year ended December 31,
2023 compared to the same periods in 2022, primarily due to the
impact of payments made for acquired in-process research and
development (IPR&D) in 2022. The year ended December 31, 2022
was also impacted by the recognition of the nabiximols impairment
charge, partially offset by the change in income mix across
jurisdictions.
|
|
Three Months
Ended
December
31,
|
|
Year
Ended
December
31,
|
(In thousands, except
percentages)
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Non-GAAP
adjusted:
|
|
|
|
|
|
|
|
Cost of product
sales
|
$
71,238
|
|
$
93,386
|
|
$ 269,079
|
|
$ 251,941
|
Gross
margin
|
92.6 %
|
|
90.3 %
|
|
92.8 %
|
|
93.1 %
|
Selling, general and
administrative
|
$ 300,520
|
|
$ 319,763
|
|
$
1,110,948
|
|
$
1,134,703
|
% of total
revenues
|
29.7 %
|
|
32.9 %
|
|
29.0 %
|
|
31.0 %
|
Research and
development
|
$ 201,107
|
|
$ 160,105
|
|
$ 784,811
|
|
$ 521,085
|
% of total
revenues
|
19.9 %
|
|
16.5 %
|
|
20.5 %
|
|
14.2 %
|
Acquired in-process
research and development
|
$
18,000
|
|
$ 375,000
|
|
$
19,000
|
|
$ 444,148
|
Income tax expense
(benefit)
|
$
20,475
|
|
$
(43,301)
|
|
$
93,260
|
|
$
94,695
|
Effective tax
rate1
|
5.6 %
|
|
92.6 %
|
|
6.7 %
|
|
9.1 %
|
_________________________
|
1.
|
The non-GAAP effective
tax rate decreased for the three months ended December 31, 2023
compared to the same period in 2022, primarily due to the impact of
payments made for acquired IPR&D in 2022.
|
Changes in operating expenses in 2023 and 4Q23 over the prior
year periods are primarily due to the following:
- Cost of product sales decreased in 2023 and 4Q23 compared to
the same periods in 2022, on a GAAP basis, primarily due to lower
acquisition accounting inventory fair value step-up expense and the
impact of an expense in 2022 for past royalties payable under a
settlement agreement with Otsuka Pharmaceutical Co., Ltd, or the
Otsuka past royalty expense, partially offset by changes in product
mix. Cost of product sales, on a non-GAAP adjusted basis, increased
in 2023 compared to the same period in 2022 primarily due to
changes in product mix, partially offset by the Otsuka past royalty
expense and decreased in 4Q23 compared to the same period in 2022
primarily due to the Otsuka past royalty expense, partially offset
by changes in product mix.
- Selling, general and administrative (SG&A) expenses, on a
GAAP basis, decreased in 2023 compared to the same period in 2022,
primarily due to the loss on disposal of Sunosi, restructuring
costs and GW related integration costs incurred in 2022, together
with a reduction in costs related to program terminations,
partially offset by an impairment of facility assets in 2023.
SG&A expenses, on a GAAP and on a non-GAAP adjusted basis, in
2023 included lower compensation-related expenses compared to 2022.
SG&A expenses, on a GAAP basis, increased in 4Q23 compared to
the same period in 2022, primarily due to an impairment of facility
assets in 4Q23, offset by costs related to program terminations
incurred in 2022. SG&A expenses, on a GAAP and on a non-GAAP
adjusted basis, in 4Q23 included lower compensation-related and
litigation expenses compared to 4Q22.
- Research and development (R&D) expenses increased in 2023
and 4Q23 compared to the same periods in 2022, on a GAAP and on a
non-GAAP adjusted basis, primarily due to the inclusion of costs
related to zanidatamab, as well as our other key pipeline
programs.
- Acquired IPR&D expense in 4Q23 and 2023, on a GAAP and on a
non-GAAP adjusted basis, primarily related to an upfront payment
made in connection with our licensing and collaboration agreement
with Autifony Therapeutics Limited. Acquired IPR&D expense in
4Q22, on a GAAP and on a non-GAAP adjusted basis, related to
payments of $375.0 million to
Zymeworks Inc., in connection with our licensing and collaboration
agreement. Acquired IPR&D expense in 2022, on a GAAP and on a
non-GAAP adjusted basis, also included upfront payments of
$50.0 million to Sumitomo Pharma Co.,
Ltd in relation to our licensing agreement and $15.0 million to Werewolf Therapeutics, Inc., in
connection with our licensing and collaboration agreement.
- The intangible asset impairment charge in 2022, on a GAAP
basis, related to the discontinuation of our nabiximols
program.
Cash Flow and Balance Sheet
As of December 31, 2023, cash, cash equivalents and
investments were $1.6 billion,
and the outstanding principal balance of the Company's long-term
debt was $5.8 billion. In
addition, the Company had undrawn borrowing capacity under a
revolving credit facility of $500.0
million. For the year ended December 31, 2023, the
Company generated $1,092.0 million of cash from operations
reflecting strong business performance and continued financial
discipline.
2024 Financial Guidance
Jazz Pharmaceutical's full year 2024 financial guidance is as
follows:
(In
millions)
|
|
|
Guidance
|
Revenues
|
|
|
$4,000 -
$4,200
|
–Neuroscience
(includes royalties from high-sodium
oxybate AG)
|
|
|
$2,800 -
$2,950
|
–Oncology
|
|
|
$1,120 -
$1,220
|
|
(In millions, except
per share amounts and percentages)
|
GAAP
|
|
Non-GAAP
|
Gross margin
%
|
89 %
|
|
93%1,6
|
SG&A
expenses
|
$1,346 -
$1,426
|
|
$1,170 -
$1,2302,6
|
SG&A expenses
as % of total revenues
|
32% -
36%
|
|
28% -
31%
|
R&D
expenses
|
$877 - $935
|
|
$800 -
$8503,6
|
R&D expenses as
% of total revenues
|
21% -
23%
|
|
19% -
21%
|
Effective tax
rate
|
(22)% - (3)%
|
|
10% -
13%4,6
|
Net income
|
$385 - $530
|
|
$1,275 -
$1,3506
|
Net income per diluted
share5
|
$5.80 -
$7.70
|
|
$18.15 -
$19.356
|
Weighted-average
ordinary shares used in per share
calculations5
|
71
|
|
71
|
___________________________
|
1.
|
Excludes $125-$145
million of amortization of acquisition-related inventory fair value
step-up and $17-$19 million of share-based compensation
expense.
|
2.
|
Excludes $176-$196
million of share-based compensation expense.
|
3.
|
Excludes
$77-$85 million of share-based compensation
expense.
|
4.
|
Excludes 32%-16% from
the GAAP effective tax rate of (22)%-(3)% relating to the income
tax effect of adjustments between GAAP net income and non-GAAP
adjusted net income, resulting in a non-GAAP adjusted effective tax
rate of 10%-13%.
|
5.
|
Diluted EPS
calculations for 2024 include an estimated 6.4 million shares
related to the assumed conversion of the 2.00% exchangeable senior
notes due 2026, or the 2026 Notes, and the associated interest
expense add-back to net income of $20 million and
$18 million, on a GAAP and on a non-GAAP adjusted basis,
respectively, under the "if converted" method.
|
6.
|
See "Non-GAAP Financial
Measures" below. Reconciliations of non-GAAP adjusted guidance
measures are included above and in the table titled "Reconciliation
of GAAP to non-GAAP Adjusted 2024 Net Income Guidance" at the end
of this press release.
|
Conference Call Details
Jazz Pharmaceuticals will host an investor conference call and
live audio webcast today at 4:30 p.m.
ET (9:30 p.m. GMT) to provide
a business and financial update and discuss its 2023 full year and
4Q23 results and 2024 guidance.
Audio webcast/conference call:
U.S. Dial-In Number: +1
888 350 4423
Ireland Dial-In Number: +353 1800 943 926
Additional global dial-in numbers are available here.
Passcode: 6907242
Interested parties may access the live audio webcast via the
Investors section of the Jazz Pharmaceuticals website at
www.jazzpharmaceuticals.com. To ensure a timely connection, it is
recommended that participants register at least 15 minutes prior to
the scheduled webcast.
A replay of the webcast will be available via the Investors
section of the Jazz Pharmaceuticals website at
www.jazzpharmaceuticals.com.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global
biopharmaceutical company whose purpose is to innovate to transform
the lives of patients and their families. We are dedicated to
developing life-changing medicines for people with serious diseases
— often with limited or no therapeutic options. We have a diverse
portfolio of marketed medicines, including leading therapies for
sleep disorders and epilepsy, and a growing portfolio of cancer
treatments. Our patient-focused and science-driven approach powers
pioneering research and development advancements across our robust
pipeline of innovative therapeutics in oncology and neuroscience.
Jazz is headquartered in Dublin,
Ireland with research and development laboratories,
manufacturing facilities and employees in multiple countries
committed to serving patients worldwide. Please visit
www.jazzpharmaceuticals.com for more information.
Non-GAAP Financial Measures
To supplement Jazz Pharmaceuticals' financial results and
guidance presented in accordance with U.S. generally accepted
accounting principles (GAAP), the Company uses certain non-GAAP
(also referred to as adjusted or non-GAAP adjusted) financial
measures in this press release and the accompanying tables. In
particular, the Company presents non-GAAP adjusted net income (and
the related per share measure) and its line item components, as
well as certain non-GAAP adjusted financial measures derived
therefrom, including non-GAAP adjusted gross margin percentage and
non-GAAP adjusted effective tax rate. Non-GAAP adjusted net income
(and the related per share measure) and its line item components
exclude from GAAP reported net income (loss) (and the related per
share measure) and its line item components certain items, as
detailed in the reconciliation tables that follow, and in the case
of non-GAAP adjusted net income (and the related per share
measure), adjust for the income tax effect of the non-GAAP
adjustments. In this regard, the components of non-GAAP adjusted
net income, including non-GAAP adjusted cost of product sales,
SG&A expenses and R&D expenses, are income statement line
items prepared on the same basis as, and therefore components of,
the overall non-GAAP adjusted net income measure.
The Company believes that each of these non-GAAP financial
measures provides useful supplementary information to, and
facilitates additional analysis by, investors and analysts and that
each of these non-GAAP financial measures, when considered together
with the Company's financial information prepared in accordance
with GAAP, can enhance investors' and analysts' ability to
meaningfully compare the Company's results from period to period,
to its forward-looking guidance, and to identify operating trends
in the Company's business. In addition, these non-GAAP financial
measures are regularly used by investors and analysts to model and
track the Company's financial performance. Jazz Pharmaceuticals'
management also regularly uses these non-GAAP financial measures
internally to understand, manage and evaluate the Company's
business and to make operating decisions, and compensation of
executives is based in part on certain of these non-GAAP financial
measures. Because these non-GAAP financial measures are important
internal measurements for Jazz Pharmaceuticals' management, the
Company also believes that these non-GAAP financial measures are
useful to investors and analysts since these measures allow for
greater transparency with respect to key financial metrics the
Company uses in assessing its own operating performance and making
operating decisions. These non-GAAP financial measures are not
meant to be considered in isolation or as a substitute for
comparable GAAP measures; should be read in conjunction with the
Company's consolidated financial statements prepared in accordance
with GAAP; have no standardized meaning prescribed by GAAP; and are
not prepared under any comprehensive set of accounting rules or
principles in the reconciliation tables that follow. In addition,
from time to time in the future there may be other items that the
Company may exclude for purposes of its non-GAAP financial
measures; and the Company has ceased, and may in the future cease,
to exclude items that it has historically excluded for purposes of
its non-GAAP financial measures. Likewise, the Company may
determine to modify the nature of its adjustments to arrive at its
non-GAAP financial measures. Because of the non-standardized
definitions of non-GAAP financial measures, the non-GAAP financial
measures as used by Jazz Pharmaceuticals in this press release and
the accompanying tables have limits in their usefulness to
investors and may be calculated differently from, and therefore may
not be directly comparable to, similarly titled measures used by
other companies.
Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to: the Company's
growth prospects and future financial and operating results,
including the Company's 2024 financial guidance and the Company's
expectations related thereto and anticipated catalysts; the
Company's expectations for total revenue and Oncology revenue
growth in 2024 and anticipated product sales; expectations of
continued growth in net sales of Xywav, Epidiolex/Epidyolex and the
oncology portfolio; the blockbuster potential of
Epidiolex/Epidyolex and its significant additional growth
opportunities; the Company's expectations to executing multiple
Epidyolex launches through 2024; expectations with respect to
royalties from AGs; the Company's ability to achieve Vision 2025
and the Company's progress related thereto; the Company's
development, regulatory and commercialization strategy; the
Company's advancement of pipeline programs and the timing of
development activities, regulatory activities and submissions
related thereto, including the ability to deliver multiple
late-stage data readouts by the end of 2025, expectations to
complete a rolling BLA submission for zanidatamab for BTC in the
first half of 2024 and top line data from a Phase 3 trial of
Epidyolex for Dravet syndrome, Lennox-Gastaut syndrome and TSC in
Japan in the second half of 2024;
the Company's expectations with respect to its products and product
candidates and the potential of the Company's products and product
candidates and the potential regulatory path related thereto;
expectations that Xywav will remain the oxybate of choice; the
Company's capital allocation and corporate development strategy;
the potential successful future development, manufacturing,
regulatory and commercialization activities; the Company's
expectation of meaningful growth as part of its Vision 2025;
growing and diversifying the Company's revenue, investing in its
pipeline of novel therapies, and delivering innovative therapies
for patients and the potential benefits of such therapies; the
Company's ability to realize the commercial potential of its
products; the Company's net product sales and goals for net product
sales from new and acquired products; the Company's views and
expectations relating to its patent portfolio, including with
respect to expected patent protection, as well as expectations with
respect to exclusivity; planned or anticipated clinical trial
events, including with respect to initiations, enrollment and data
read-outs, and the anticipated timing thereof; the Company's
clinical trials confirming clinical benefit or enabling regulatory
submissions; planned or anticipated regulatory submissions and
filings, and the anticipated timing thereof; potential regulatory
approvals; the timing and amount of repurchases of the Company's
ordinary shares; and other statements that are not historical
facts. These forward-looking statements are based on the Company's
current plans, objectives, estimates, expectations and intentions
and inherently involve significant risks and uncertainties.
Actual results and the timing of events could differ materially
from those anticipated in such forward- looking statements as a
result of these risks and uncertainties, which include, without
limitation, risks and uncertainties associated with: maintaining or
increasing sales of and revenue from Xywav, Rylaze and
Epidiolex/Epidyolex and other marketed products; Epidiolex
realizing its blockbuster potential; the introduction of new
products into the U.S. market that compete with, or otherwise
disrupt the market for the Company's products and product
candidates; effectively launching and commercializing the Company's
other products and product candidates; the successful completion of
development and regulatory activities with respect to the Company's
product candidates, obtaining and maintaining adequate coverage and
reimbursement for the Company's products; the time-consuming and
uncertain regulatory approval process, including the risk that the
Company's current and/or planned regulatory submissions may not be
submitted, accepted or approved by applicable regulatory
authorities in a timely manner or at all; the costly and
time-consuming pharmaceutical product development and the
uncertainty of clinical success, including risks related to failure
or delays in successfully initiating or completing clinical trials
and assessing patients; global economic, financial, and healthcare
system disruptions and the current and potential future negative
impacts to the Company's business operations and financial results;
geopolitical events, including the conflict between Russia and Ukraine and related sanctions; macroeconomic
conditions, including global financial markets, rising interest
rates and inflation and recent and potential banking disruptions;
regulatory initiatives and changes in tax laws; market volatility;
protecting and enhancing the Company's intellectual property rights
and the Company's commercial success being dependent upon the
Company obtaining, maintaining and defending intellectual property
protection and exclusivity for its products and product candidates;
delays or problems in the supply or manufacture of the Company's
products and product candidates; complying with applicable U.S. and
non-U.S. regulatory requirements, including those governing the
research, development, manufacturing and distribution of controlled
substances; government investigations, legal proceedings and other
actions; identifying and consummating corporate development
transactions, financing these transactions and successfully
integrating acquired product candidates, products and businesses;
the Company's ability to realize the anticipated benefits of its
corporate development transactions and its collaborations and
license agreements with third parties; the sufficiency of the
Company's cash flows and capital resources; the Company's ability
to achieve targeted or expected future financial performance and
results and the uncertainty of future tax, accounting and other
provisions and estimates; the Company's ability to meet its
projected long-term goals and objectives, including as part of
Vision 2025, in the time periods that the Company anticipates, or
at all, and the inherent uncertainty and significant judgments and
assumptions underlying the Company's long-term goals and
objectives; fluctuations in the market price and trading volume of
the Company's ordinary shares; restrictions on repurchases of
capital stock; the timing and availability of alternative
investment opportunities; and other risks and uncertainties
affecting the Company, including those described from time to time
under the caption "Risk Factors" and elsewhere in Jazz
Pharmaceuticals' Securities and Exchange Commission filings and
reports, including the Company's Annual Report on Form 10-K
for the year ended December 31, 2022
as supplemented by its Quarterly Report on Form 10-Q for the
quarter ended June 30, 2023, and
future filings and reports by the Company including the Company's
Annual Report on Form 10-K for the year ended December 31, 2023. Other risks and uncertainties
of which the Company is not currently aware may also affect the
Company's forward-looking statements and may cause actual results
and the timing of events to differ materially from those
anticipated.
JAZZ PHARMACEUTICALS
PLC
CONDENSED
CONSOLIDATED STATEMENTS OF INCOME (LOSS)
(In thousands,
except per share amounts)
(Unaudited)
|
|
|
Three Months
Ended
December
31,
|
|
Year
Ended
December
31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
967,339
|
|
$
967,526
|
|
$
3,736,943
|
|
$
3,641,429
|
Royalties and contract
revenues
|
44,596
|
|
4,597
|
|
97,261
|
|
17,945
|
Total
revenues
|
1,011,935
|
|
972,123
|
|
3,834,204
|
|
3,659,374
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of product sales
(excluding amortization of acquired developed
technologies)
|
107,243
|
|
167,364
|
|
435,577
|
|
540,517
|
Selling, general and
administrative
|
396,034
|
|
383,203
|
|
1,343,105
|
|
1,416,967
|
Research and
development
|
216,608
|
|
172,555
|
|
849,658
|
|
590,453
|
Intangible asset
amortization
|
151,553
|
|
137,387
|
|
608,284
|
|
599,169
|
Acquired in-process
research and development
|
18,000
|
|
375,000
|
|
19,000
|
|
444,148
|
Intangible asset
impairment charge
|
—
|
|
—
|
|
—
|
|
133,648
|
Total operating
expenses
|
889,438
|
|
1,235,509
|
|
3,255,624
|
|
3,724,902
|
Income (loss) from
operations
|
122,497
|
|
(263,386)
|
|
578,580
|
|
(65,528)
|
Interest expense,
net
|
(70,324)
|
|
(74,125)
|
|
(289,438)
|
|
(288,242)
|
Foreign exchange gain
(loss)
|
9,353
|
|
(2,482)
|
|
8,787
|
|
(19,014)
|
Income (loss) before
income tax benefit and equity in loss of investees
|
61,526
|
|
(339,993)
|
|
297,929
|
|
(372,784)
|
Income tax
benefit
|
(33,089)
|
|
(100,042)
|
|
(119,912)
|
|
(158,645)
|
Equity in loss of
investees
|
461
|
|
773
|
|
3,009
|
|
9,921
|
Net income
(loss)
|
$
94,154
|
|
$ (240,724)
|
|
$
414,832
|
|
$ (224,060)
|
|
|
|
|
|
|
|
|
Net income (loss) per
ordinary share:
|
|
|
|
|
|
|
|
Basic
|
$
1.50
|
|
$
(3.82)
|
|
$
6.55
|
|
$
(3.58)
|
Diluted
|
$
1.42
|
|
$
(3.82)
|
|
$
6.10
|
|
$
(3.58)
|
Weighted-average
ordinary shares used in per share calculations - basic
|
62,578
|
|
63,052
|
|
63,291
|
|
62,539
|
Weighted-average
ordinary shares used in per share calculations - diluted
|
69,673
|
|
63,052
|
|
72,066
|
|
62,539
|
JAZZ PHARMACEUTICALS
PLC
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands)
(Unaudited)
|
|
|
December 31,
2023
|
|
December 31,
2022
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$ 1,506,310
|
|
$
881,482
|
Investments
|
120,000
|
|
—
|
Accounts receivable,
net of allowances
|
705,794
|
|
651,493
|
Inventories
|
597,039
|
|
714,061
|
Prepaid
expenses
|
185,476
|
|
91,912
|
Other current
assets
|
320,809
|
|
267,192
|
Total current
assets
|
3,435,428
|
|
2,606,140
|
Property, plant and
equipment, net
|
169,646
|
|
228,050
|
Operating lease
assets
|
65,340
|
|
73,326
|
Intangible assets,
net
|
5,418,039
|
|
5,794,437
|
Goodwill
|
1,753,130
|
|
1,692,662
|
Deferred tax assets,
net
|
477,834
|
|
376,247
|
Deferred financing
costs
|
6,478
|
|
9,254
|
Other non-current
assets
|
67,464
|
|
55,139
|
Total assets
|
$
11,393,359
|
|
$
10,835,255
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
102,750
|
|
$
90,758
|
Accrued
liabilities
|
793,914
|
|
803,255
|
Current portion of
long-term debt
|
604,954
|
|
31,000
|
Income taxes
payable
|
35,074
|
|
7,717
|
Deferred
revenue
|
—
|
|
463
|
Total current
liabilities
|
1,536,692
|
|
933,193
|
Long-term debt, less
current portion
|
5,107,988
|
|
5,693,341
|
Operating lease
liabilities, less current portion
|
59,225
|
|
71,838
|
Deferred tax
liabilities, net
|
847,706
|
|
944,337
|
Other non-current
liabilities
|
104,751
|
|
106,812
|
Total shareholders'
equity
|
3,736,997
|
|
3,085,734
|
Total liabilities and
shareholders' equity
|
$
11,393,359
|
|
$
10,835,255
|
JAZZ PHARMACEUTICALS
PLC
SUMMARY OF CASH
FLOWS
(In
thousands)
(Unaudited)
|
|
|
Year
Ended
December
31,
|
|
2023
|
|
2022
|
Net cash provided by
operating activities
|
$ 1,092,007
|
|
$ 1,271,977
|
Net cash used in
investing activities
|
(163,062)
|
|
(446,230)
|
Net cash used in
financing activities
|
(305,254)
|
|
(529,491)
|
Effect of exchange
rates on cash and cash equivalents
|
1,137
|
|
(6,222)
|
Net increase in cash
and cash equivalents
|
$
624,828
|
|
$
290,034
|
JAZZ
PHARMACEUTICALS PLC
RECONCILIATIONS OF
GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
(In thousands,
except per share amounts)
(Unaudited)
|
|
|
Three Months
Ended
December
31,
|
|
Year
Ended
December
31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
Net
Income
|
|
Diluted
EPS
|
|
Net Loss
|
|
Diluted
EPS
|
|
Net
Income
|
|
Diluted
EPS
|
|
Net
Income
(Loss)
|
|
Diluted
EPS
|
GAAP
reported1
|
$
94,154
|
|
$
1.42
|
|
$
(240,724)
|
|
$
(3.82)
|
|
$ 414,832
|
|
$
6.10
|
|
$
(224,060)
|
|
$
(3.58)
|
Intangible asset
amortization
|
151,553
|
|
2.18
|
|
137,387
|
|
2.18
|
|
608,284
|
|
8.44
|
|
599,169
|
|
8.25
|
Share-based
compensation
expense
|
52,941
|
|
0.76
|
|
61,767
|
|
0.98
|
|
226,841
|
|
3.15
|
|
218,194
|
|
3.01
|
Acquisition
accounting
inventory fair value step-up
|
32,352
|
|
0.46
|
|
70,203
|
|
1.11
|
|
151,446
|
|
2.10
|
|
273,392
|
|
3.77
|
Restructuring and
other costs2
|
61,727
|
|
0.89
|
|
19,681
|
|
0.31
|
|
85,215
|
|
1.18
|
|
77,306
|
|
1.06
|
Non-cash interest
expense3
|
6,123
|
|
0.09
|
|
5,971
|
|
0.10
|
|
22,378
|
|
0.31
|
|
37,973
|
|
0.52
|
Intangible asset
impairment
charge4
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
133,648
|
|
1.84
|
(Income) costs related
to
disposal of a business5
|
—
|
|
—
|
|
(1,783)
|
|
(0.03)
|
|
—
|
|
—
|
|
47,756
|
|
0.66
|
Transaction and
integration
related expenses6
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
23,560
|
|
0.32
|
Income tax effect of
above
adjustments
|
(53,564)
|
|
(0.77)
|
|
(56,741)
|
|
(0.90)
|
|
(213,172)
|
|
(2.95)
|
|
(253,340)
|
|
(3.49)
|
Effect of assumed
conversion
of Exchangeable Senior
Notes
|
—
|
|
(0.01)
|
|
—
|
|
—
|
|
—
|
|
(0.04)
|
|
—
|
|
0.84
|
Non-GAAP
adjusted1
|
$
345,286
|
|
$
5.02
|
|
$ (4,239)
|
|
$
(0.07)
|
|
$ 1,295,824
|
|
$
18.29
|
|
$
933,598
|
|
$ 13.20
|
Weighted-average
ordinary
shares used in diluted per
share calculations - GAAP
|
69,673
|
|
|
|
63,052
|
|
|
|
72,066
|
|
|
|
62,539
|
|
|
Dilutive effect of
Exchangeable Senior Notes1
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
9,044
|
|
|
Dilutive effect of
employee
equity incentive and purchase
plans
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,025
|
|
|
Weighted-average
ordinary
shares used in diluted per share
calculations - non-GAAP
|
69,673
|
|
|
|
63,052
|
|
|
|
72,066
|
|
|
|
72,608
|
|
|
________________________________________________
|
Explanation of
Adjustments and Certain Line Items:
|
|
1.
|
Diluted EPS was
calculated using the "if-converted" method in relation to the 1.50%
exchangeable senior notes due 2024, or the 2024 Notes and the 2026
Notes, which we refer to collectively as the Exchangeable Senior
Notes. In August 2023, we made an irrevocable election to fix
the settlement method for exchanges of the 2024 Notes to a
combination of cash and ordinary shares of the Company with a
specified cash amount per $1,000 principal amount of the 2024 Notes
of $1,000. As a result, the assumed issuance of ordinary
shares upon exchange of the 2024 Notes has only been included in
the calculation of diluted net income per ordinary share, on a GAAP
and on a non-GAAP adjusted basis, in the year ended December 31,
2023 up to the date the irrevocable election was made. GAAP
reported net income per diluted share for the three months and year
ended December 31, 2023 included 6.4 million shares and 8.0 million
shares, respectively, related to the assumed conversion of the
Exchangeable Senior Notes and the associated interest expense
add-back to GAAP net income of $4.9 million and $24.9 million,
respectively. There was no impact on GAAP reported net loss per
diluted share for the three months and year ended December 31,
2022, as the Exchangeable Senior Notes were anti-dilutive.
Non-GAAP adjusted net income per diluted share for the three months
and year ended December 31, 2023 included 6.4 million shares and
8.0 million shares, respectively, related to the assumed conversion
of the Exchangeable Senior Notes and the associated interest
expense add-back to non-GAAP adjusted net income of $4.4 million
and $22.2 million, respectively. There was no impact on
non-GAAP adjusted net loss per diluted share for the three months
ended December 31, 2022, as the Exchangeable Senior Notes were
anti-dilutive. Non-GAAP adjusted net income per diluted share
for the year ended December 31, 2022 included 9.0 million shares
related to the assumed conversion of the Exchangeable Senior Notes
and the associated interest expense add-back to non-GAAP adjusted
net income of $25.2 million.
|
2.
|
Includes costs related
to the impairment of facility assets, program terminations and
restructuring.
|
3.
|
Non-cash interest
expense associated with debt issuance costs.
|
4.
|
Intangible asset
impairment charge related to the IPR&D asset impairment
following the discontinuation of our nabiximols program.
|
5.
|
Loss on disposal of
Sunosi to Axsome Therapeutics Inc. and associated costs.
|
6.
|
Transaction and
integration expenses related to the acquisition of GW
Pharmaceuticals plc.
|
JAZZ PHARMACEUTICALS
PLC
RECONCILIATIONS OF
GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
CERTAIN LINE ITEMS -
FOR THE THREE MONTHS ENDED DECEMBER 31, 2023 and
2022
(In thousands,
except percentages)
(Unaudited)
|
|
|
|
Three months ended
December 31, 2023
|
|
|
Cost of
product
sales
|
|
Gross
margin
|
|
Selling,
general and
administrative
|
|
Research
and
development
|
|
Intangible
asset
amortization
|
|
Interest
expense, net
|
|
Income tax
expense
(benefit)
|
|
Effective
tax rate(1)
|
GAAP
Reported
|
|
$
107,243
|
|
88.9 %
|
|
$
396,034
|
|
$
216,608
|
|
$
151,553
|
|
$
70,324
|
|
$
(33,089)
|
|
(53.8) %
|
Non-GAAP
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(151,553)
|
|
—
|
|
—
|
|
—
|
Share-based
compensation
expense
|
|
(3,653)
|
|
0.4
|
|
(33,787)
|
|
(15,501)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition accounting
inventory
fair value step-up
|
|
(32,352)
|
|
3.3
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Restructuring and
other costs
|
|
—
|
|
—
|
|
(61,727)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Non-cash interest
expense
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(6,123)
|
|
—
|
|
—
|
Income tax effect of
above
adjustments
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
53,564
|
|
59.4
|
Total of non-GAAP
adjustments
|
|
(36,005)
|
|
3.7
|
|
(95,514)
|
|
(15,501)
|
|
(151,553)
|
|
(6,123)
|
|
53,564
|
|
59.4
|
Non-GAAP
Adjusted
|
|
$
71,238
|
|
92.6 %
|
|
$
300,520
|
|
$
201,107
|
|
$
—
|
|
$
64,201
|
|
$
20,475
|
|
5.6 %
|
|
|
Three months ended
December 31, 2022
|
|
Cost of
product
sales
|
|
Gross
margin
|
|
Selling,
general and
administrative
|
|
Research
and
development
|
|
Intangible
asset
amortization
|
|
Acquired
IPR&D
|
|
Interest
expense,
net
|
|
Income tax
benefit
|
|
Effective
tax rate(1)
|
GAAP
Reported
|
$
167,364
|
|
82.7 %
|
|
$
383,203
|
|
$
172,555
|
|
$
137,387
|
|
$
375,000
|
|
$
74,125
|
|
$
(100,042)
|
|
29.4 %
|
Non-GAAP
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
—
|
|
—
|
|
—
|
|
(137,387)
|
|
—
|
|
—
|
|
—
|
|
—
|
Share-based
compensation expense
|
(3,835)
|
|
0.4
|
|
(43,875)
|
|
(14,057)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Income related to
the
disposal of a business
|
—
|
|
—
|
|
1,783
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Restructuring and
other
costs
|
60
|
|
—
|
|
(21,348)
|
|
1,607
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Non-cash interest
expense
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(5,971)
|
|
—
|
|
—
|
Acquisition
accounting
inventory fair value step-up
|
(70,203)
|
|
7.2
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Income tax effect of
above
adjustments
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
56,741
|
|
63.2
|
Total of non-GAAP
adjustments
|
(73,978)
|
|
7.6
|
|
(63,440)
|
|
(12,450)
|
|
(137,387)
|
|
—
|
|
(5,971)
|
|
56,741
|
|
63.2
|
Non-GAAP
Adjusted
|
$
93,386
|
|
90.3 %
|
|
$
319,763
|
|
$
160,105
|
|
$
—
|
|
$ 375,000
|
|
$
68,154
|
|
$ (43,301)
|
|
92.6 %
|
|
|
|
|
|
|
|
|
|
|
|
1.
|
The GAAP and non-GAAP
effective tax rate decreased in the three months ended December 31,
2023 compared to the same period in 2022, primarily due to the
impact of payments made for acquired IPR&D in 2022.
|
JAZZ PHARMACEUTICALS
PLC
RECONCILIATIONS OF
GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
CERTAIN LINE ITEMS -
FOR THE YEAR ENDED DECEMBER 31, 2023 and 2022
(In thousands,
except percentages)
(Unaudited)
|
|
|
Year ended December
31, 2023
|
|
Cost of
product
sales
|
|
Gross
margin
|
|
Selling,
general and
administrative
|
|
Research
and
development
|
|
Intangible
asset
amortization
|
|
Acquired
IPR&D
|
|
Interest
expense,
net
|
|
Income tax
expense
(benefit)
|
|
Effective
tax rate(1)
|
GAAP
Reported
|
$
435,577
|
|
88.3 %
|
|
$
1,343,105
|
|
$
849,658
|
|
$
608,284
|
|
$
19,000
|
|
$
289,438
|
|
$
(119,912)
|
|
(40.2) %
|
Non-GAAP
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
—
|
|
—
|
|
—
|
|
(608,284)
|
|
—
|
|
—
|
|
—
|
|
—
|
Share-based
compensation expense
|
(15,052)
|
|
0.4
|
|
(146,942)
|
|
(64,847)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Restructuring and
other
costs
|
—
|
|
—
|
|
(85,215)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Non-cash interest
expense
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(22,378)
|
|
—
|
|
—
|
Acquisition
accounting
inventory fair value step-up
|
(151,446)
|
|
4.1
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Income tax effect of
above
adjustments
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
213,172
|
|
46.9
|
Total of non-GAAP
adjustments
|
(166,498)
|
|
4.5
|
|
(232,157)
|
|
(64,847)
|
|
(608,284)
|
|
—
|
|
(22,378)
|
|
213,172
|
|
46.9
|
Non-GAAP
Adjusted
|
$
269,079
|
|
92.8 %
|
|
$ 1,110,948
|
|
$
784,811
|
|
$
—
|
|
$
19,000
|
|
$ 267,060
|
|
$
93,260
|
|
6.7 %
|
|
Year ended December
31, 2022
|
|
Cost of
product
sales
|
|
Gross
margin
|
|
Selling,
general and
administrative
|
|
Research
and
development
|
|
Intangible
asset
amortization
|
|
Acquired
IPR&D
|
|
Intangible
asset
impairment
charge
|
|
Interest
expense,
net
|
|
Income tax
expense
(benefit)
|
|
Effective
tax rate(1)
|
GAAP
Reported
|
$
540,517
|
|
85.2 %
|
|
$
1,416,967
|
|
$
590,453
|
|
$
599,169
|
|
$
444,148
|
|
$
133,648
|
|
$
288,242
|
|
$
(158,645)
|
|
42.6 %
|
Non-GAAP
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
—
|
|
—
|
|
—
|
|
(599,169)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Share-based
compensation
expense
|
(12,416)
|
|
0.3
|
|
(148,726)
|
|
(57,052)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Intangible asset
impairment
charge
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(133,648)
|
|
—
|
|
—
|
|
—
|
Costs related to
the disposal of a
business
|
—
|
|
—
|
|
(47,756)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Restructuring and
other costs
|
(2,299)
|
|
0.1
|
|
(64,723)
|
|
(10,284)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Transaction and
integration
related costs
|
(469)
|
|
—
|
|
(21,059)
|
|
(2,032)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Non-cash interest
expense
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(37,973)
|
|
—
|
|
—
|
Acquisition
accounting
inventory fair
value step-up
|
(273,392)
|
|
7.5
|
|
—
|
|
—
|
|
—
|
|
—
|
|
|
|
—
|
|
—
|
|
—
|
Income tax effect
of above
adjustments
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
253,340
|
|
(33.5)
|
Total of non-
GAAP
adjustments
|
(288,576)
|
|
7.9
|
|
(282,264)
|
|
(69,368)
|
|
(599,169)
|
|
—
|
|
(133,648)
|
|
(37,973)
|
|
253,340
|
|
(33.5)
|
Non-GAAP
Adjusted
|
$ 251,941
|
|
93.1 %
|
|
$
1,134,703
|
|
$
521,085
|
|
$
—
|
|
$
444,148
|
|
$
—
|
|
$ 250,269
|
|
$
94,695
|
|
9.1 %
|
__________________________
|
(1)
|
The GAAP effective tax
rate decreased in the year ended December 31, 2023 compared to the
same period in 2022, primarily due to the impact of payments made
for acquired IPR&D in 2022 and the nabiximols impairment
charge, which was recognized in 2022, partially offset mix of
pre-tax income and losses across tax jurisdictions.
|
JAZZ PHARMACEUTICALS
PLC
RECONCILIATION OF
GAAP TO NON-GAAP ADJUSTED 2024 NET INCOME AND DILUTED EPS
GUIDANCE
(In millions, except
per share amounts)
(Unaudited)
|
|
|
Net
Income
|
|
Diluted
EPS
|
GAAP
guidance
|
$385 -
$530
|
|
$5.80 -
$7.70
|
Intangible asset
amortization
|
605 - 645
|
|
8.55 - 9.15
|
Acquisition accounting
inventory fair value step-up
|
125 - 145
|
|
1.75 - 2.05
|
Share-based
compensation expense
|
270 - 300
|
|
3.80 - 4.25
|
Non-cash interest
expense
|
20 - 30
|
|
0.30 - 0.40
|
Income tax effect of
above adjustments
|
(205) -
(225)
|
|
(2.90) -
(3.20)
|
Effect of assumed
conversion of 2026 Notes
|
-
|
|
(0.05)
|
Non-GAAP
guidance
|
$1,275 -
$1,350
|
|
$18.15 -
$19.35
|
|
|
|
|
Weighted-average
ordinary shares used in per share calculations - GAAP and
non-GAAP
|
71
|
|
|
Contacts:
Investors:
Andrea N.
Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
InvestorInfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717
Media:
Kristin
Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 637 2141
U.S. +1 215 867 4948
View original content to download
multimedia:https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-full-year-and-fourth-quarter-2023-financial-results-and-provides-2024-financial-guidance-302074577.html
SOURCE Jazz Pharmaceuticals plc