– 15% year-over-year revenue increase from
combined key growth drivers: Xywav®,
Epidiolex® and Rylaze® –
– Oncology revenues grew 10% year-over-year –
– Zanidatamab granted Priority Review by U.S. FDA for 2L BTC; PDUFA
date of November 29, 2024 –
– Near-term, late-stage pipeline catalysts anticipated through 2025
–
– Narrowing 2024 total revenue guidance to $4.0 to $4.1
billion –
– Affirming GAAP and non-GAAP adjusted net income guidance –
DUBLIN, July 31, 2024 /PRNewswire/ -- Jazz
Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial
results for the second quarter of 2024 and updated guidance for
2024.
"Jazz's record revenues of over $1
billion in the second quarter were driven by strong
execution and increased demand for our key growth drivers,
Xywav, Epidiolex and Rylaze. Our launch
preparations are well underway for zanidatamab, which was recently
granted Priority Review in BTC, and we are pleased to have
initiated the Phase 3 EmpowHER trial in HER2-positive breast cancer
in patients whose disease has progressed after T-DXd treatment,"
said Bruce Cozadd, chairman and
chief executive officer, Jazz Pharmaceuticals. "Based on
projections for the remainder of the year, we are narrowing and
maintaining the mid-point of our Neuroscience guidance and lowering
our Oncology guidance. Importantly, our Oncology guidance still
includes double-digit growth at the mid-point and we continue to
expect double-digit growth from our combined key growth drivers in
2024."
Key Highlights
- Key growth drivers:
- Xywav net product sales grew 13% year-over-year.
- Epidiolex/Epidyolex® net product sales
grew 22% year-over-year.
- Rylaze/Enrylaze® net product sales
grew 6% year-over-year.
- Zanidatamab:
- Granted Priority Review by U.S. FDA for 2L BTC; MAA validated
by EMA.
- Initiated Phase 3 EmpowHER trial in late-line HER2+ breast
cancer.
- Near-term, late-stage pipeline catalysts anticipated:
- Top-line data from Epidyolex Phase 3 trial in
Japan in 2H24.
- Top-line data from Zepzelca® 1L SCLC Phase 3
trial by the end of 2024.
- Top-line PFS data from zanidatamab in Phase 3 1L GEA estimated
to be 2Q25.
- 2024 Financial Guidance:
- Narrowing 2024 total revenue guidance range to $4.0 to $4.1
billion.
- Narrowing Neuroscience guidance to $2.825 to $2.925
billion.
- Lowering Oncology guidance to $1.10 to $1.15
billion.
- Affirming GAAP net income guidance of $385 to $530
million and non-GAAP adjusted net income guidance of
$1.275 to $1.350 billion.1
- Raising GAAP EPS guidance range by approximately $1.00 to $6.00 to
$8.00 and non-GAAP EPS guidance to
$19.20 to $20.30.1
- Vision 2025: The Company is no longer providing the Vision 2025
metrics; however, the priorities highlighted in Vision 2025 remain
the same:
- Achieving commercial excellence to drive a growing and
diversified revenue base;
- Reaching more patients and creating value for shareholders by
investing in our business and pipeline, including through corporate
development; and
- Maintaining disciplined capital allocation to generate
long-term sustainable growth and value.
____________________________
|
1 See
"Non-GAAP Financial Measures."
|
Business Updates
Key Commercial Products
Xywav (calcium, magnesium, potassium, and sodium
oxybates) oral solution:
- Xywav net product sales were $368.5 million in 2Q24, an increase of 13%
compared to the same period in 2023.
- There were approximately 13,225 active Xywav patients
exiting 2Q24 comprised of:
- Approximately 9,925 narcolepsy patients.
- Approximately 3,300 idiopathic hypersomnia (IH)
patients, with 250 net patient adds.
- As the only low-sodium oxybate and the only therapy approved to
treat IH, expect Xywav to remain the oxybate of choice.
- Expert recommendations for optimizing flexible and
individualized dosing regimens of low-sodium Xywav in
narcolepsy and IH were published in Neurology and Therapy.
Nearly 90% of HCPs surveyed felt the ability to adjust Xywav
dosing to accommodate routine changes was important or very
important and had a positive impact on their ability to provide
care.
- Data presented at SLEEP 2024 included two late-breaking posters
assessing the burden experienced by patients with IH. One poster
demonstrated substantial comorbidity and health-related
quality-of-life burdens for IH patients. Another poster reported
greater economic burden, including work productivity impairment,
compared to people living without IH.
Xyrem® (sodium oxybate) oral solution and
high-sodium oxybate authorized generic (AG) royalties:
- Xyrem net product sales were $62.2 million in 2Q24, a decrease of 61% compared
to the same period in 2023.
- Royalties from high-sodium oxybate AGs were $54.2 million in 2Q24, an increase of
$48.7 million compared to the same
period in 2023.
- The Company expects high-sodium oxybate AG royalty revenue to
exceed $200 million in 2024.
Epidiolex/Epidyolex (cannabidiol):
- Epidiolex/Epidyolex net product sales were $247.1 million in 2Q24, an increase of 22%
compared to the same period in 2023.
- Outside of the U.S., Epidyolex is approved in more than
35 countries with additional launches and reimbursements
anticipated through the end of 2024.
- A plain language summary of the BECOME survey results was
published in Future Neurology. In addition to reporting an
85% reduction in the frequency of seizures, caregivers also
reported improvements in non-seizure benefits such as cognitive,
emotional and social functioning.
- Retrospective review of the validated REST-LGS questionnaire
was evaluated in a real-world setting and the majority of patients
who had not been previously diagnosed with Lennox-Gastaut syndrome
(LGS) were identified, highlighting the potential of the screening
tool to identify patients with LGS who may benefit from further
diagnostic evaluation.
Rylaze/Enrylaze (asparaginase erwinia
chrysanthemi (recombinant)-rywn):
- Rylaze/Enrylaze net product sales were $107.8 million in 2Q24, an increase of 6%
compared to the same period in 2023.
Zepzelca (lurbinectedin):
- Zepzelca net product sales were $81.0 million in 2Q24, an increase of 15%
compared to the same period in 2023.
- Enrollment in the Phase 3 trial evaluating first-line (1L) use
of Zepzelca in combination with Tecentriq®
(atezolizumab) in small cell lung cancer (SCLC), in partnership
with Roche, was completed in 1Q24.
- The Company expects top-line progression-free survival (PFS)
data readout by the end of 2024.
Key Pipeline Highlights
Zanidatamab:
- In 2Q24, the U.S. FDA accepted and granted Priority Review of
the Biologics License Application for zanidatamab with a target
action date of November 29, 2024. If
approved, zanidatamab would be the first HER2-targeted treatment
specifically approved for biliary tract cancer (BTC) in the U.S. A
confirmatory trial in 1L metastatic BTC is ongoing.
- The European Medicines Agency (EMA) validated the marketing
authorization application (MAA) for zanidatamab in second-line (2L)
BTC.
- Updated zanidatamab data from the HERIZON-BTC-01 trial were
presented at the ASCO Annual Meeting 2024, demonstrating a
confirmed objective response rate was maintained at 41.3%, median
duration of response increased by approximately two months to 14.9
months compared to findings reported in 2023, and a median overall
survival of 15.5 months in all patients with HER2+ BTC and 18.1
months in patients with immunohistochemistry (IHC) 3+ tumors.
- The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L
gastroesophageal adenocarcinoma (GEA), is ongoing and enrollment
remains on track. Based on an updated blinded assessment of
progression events, the Company estimates top-line PFS data will be
available in 2Q25. The Company continues to track events in the
trial relative to the initial protocol assumptions.
- The Company initiated the Phase 3 EmpowHER-BC-303 trial to
evaluate zanidatamab plus chemotherapy or trastuzumab plus
chemotherapy in patients with HER2-positive breast cancer whose
disease has progressed on previous trastuzumab deruxtecan (T-DXd)
treatment.
Suvecaltamide (JZP385):
- Announced top-line results from the Phase 2b trial of suvecaltamide in essential tremor did
not achieve statistical significance. The improvement in placebo
from baseline to week 12 exceeded the Company's expectations and
was higher than what was observed for placebo in the prior T-CALM
trial of suvecaltamide.
- A Phase 2 trial in patients with Parkinson's disease tremor
(PDT) is ongoing, with results expected 1Q25. The Company awaits
results from the PDT trial to determine next steps, if any, for the
program.
JZP441:
- Pending input from FDA, the Company is planning to initiate a
Phase 1b trial of JZP441 in type 1
narcolepsy patients in 2H24.
- Expect this trial will further the Company's understanding of
JZP441 and more broadly orexin agonism, providing key learnings
that could inform future development efforts.
Share Repurchases of Approximately $161 Million and New $500
Million Authorization
The Company resumed repurchases of its ordinary shares on the
open market in the second quarter of 2024 as part of the Company's
previously authorized and announced share repurchase program. Under
this share repurchase program, the Company was authorized to
repurchase its ordinary shares for up to an aggregate purchase
price of $1.5 billion, exclusive of
any brokerage commissions. As of June 30,
2024, a nominal amount remained outstanding under this
authorization, reflecting the purchase of shares worth
approximately $161 million during the
second quarter of 2024. The remaining amount will be utilized under
the newly authorized repurchase program described below.
On July 25, 2024, the Board of
Directors authorized a new share repurchase program with no
expiration date pursuant to which the Company may repurchase its
ordinary shares for up to an aggregate purchase price of
$500 million, exclusive of any
brokerage commissions. The timing and amount of repurchases under
the program will depend on a variety of factors, including the
amount and timing of corporate development transactions, repayment
of debt, restrictions under the Company's credit agreement,
corporate and regulatory requirements, market conditions and the
price of the Company's ordinary shares.
Term Loan B Repricing
The Company completed a repricing of the approximately
$2.7 billion outstanding balance of
its U.S. dollar term loans under its credit facility. The
applicable margin above the Term Secured Overnight Financing Rate
was reduced by 75 basis points (from 300 basis points to 225 basis
points) and the credit spread adjustment of approximately 11 basis
points has also been removed, resulting in anticipated interest
savings of approximately $23 million
on an annualized basis. All other terms are substantially
unchanged.
Irrevocable Election of Settlement Method for the 2.000%
Exchangeable Senior Notes due 2026
Jazz Investments I Limited (the "Issuer"), a subsidiary of Jazz
Pharmaceuticals, announced that it provided written notice to the
exchange agent, the trustee and the holders of its 2.000%
Exchangeable Senior Notes due 2026 (the "2026 notes") that it has
irrevocably elected to fix the settlement method for exchanges of
the 2026 notes to combination settlement with a specified cash
amount equal to or in excess of $1,000. As a result, an exchanging holder will
receive (i) up to $1,000 in cash per
$1,000 principal amount of 2026 notes
exchanged and (ii) cash, ordinary shares, or any combination
thereof, at the Issuer's election, in respect of the remainder, if
any, of its exchange obligation in excess of $1,000 per $1,000
principal amount of 2026 notes exchanged.
Financial Highlights
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
(In thousands, except
per share amounts)
|
2024
|
|
2023
|
|
2024
|
|
2023
|
Total
revenues
|
$
1,023,825
|
|
$ 957,317
|
|
$
1,925,808
|
|
$
1,850,129
|
GAAP net
income
|
$ 168,568
|
|
$ 104,438
|
|
$ 153,950
|
|
$ 173,858
|
Non-GAAP adjusted net
income
|
$ 364,727
|
|
$ 325,129
|
|
$ 546,942
|
|
$ 610,390
|
GAAP earnings per
share
|
$
2.49
|
|
$
1.52
|
|
$
2.35
|
|
$
2.55
|
Non-GAAP adjusted
EPS
|
$
5.30
|
|
$
4.51
|
|
$
7.98
|
|
$
8.46
|
GAAP net income for 2Q24 was $168.6 million, or $2.49 per diluted share, compared to $104.4 million, or $1.52 per diluted share, for 2Q23.
Non-GAAP adjusted net income for 2Q24 was $364.7 million, or $5.30 per diluted share, compared to $325.1 million, or $4.51 per diluted share, for 2Q23.
Reconciliations of applicable GAAP reported to non-GAAP adjusted
information are included at the end of this press release.
Total Revenues
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
(In
thousands)
|
2024
|
|
2023
|
|
2024
|
|
2023
|
Xywav
|
$ 368,472
|
|
$ 326,564
|
|
$ 683,772
|
|
$ 604,325
|
Xyrem
|
62,180
|
|
159,769
|
|
126,412
|
|
337,899
|
Epidiolex/Epidyolex
|
247,102
|
|
202,226
|
|
445,818
|
|
391,135
|
Sativex
|
6,383
|
|
2,806
|
|
9,118
|
|
9,904
|
Total
Neuroscience
|
684,137
|
|
691,365
|
|
1,265,120
|
|
1,343,263
|
Rylaze/Enrylaze
|
107,829
|
|
101,693
|
|
210,579
|
|
187,620
|
Zepzelca
|
81,047
|
|
70,348
|
|
156,147
|
|
137,529
|
Defitelio/defibrotide
|
45,421
|
|
46,108
|
|
93,097
|
|
85,187
|
Vyxeos
|
43,012
|
|
34,056
|
|
75,035
|
|
70,756
|
Total
Oncology
|
277,309
|
|
252,205
|
|
534,858
|
|
481,092
|
Other
|
2,698
|
|
3,417
|
|
6,268
|
|
6,851
|
Product sales,
net
|
964,144
|
|
946,987
|
|
1,806,246
|
|
1,831,206
|
High-sodium oxybate AG
royalty revenue
|
54,164
|
|
5,514
|
|
104,111
|
|
7,610
|
Other royalty and
contract revenues
|
5,517
|
|
4,816
|
|
15,451
|
|
11,313
|
Total
revenues
|
$
1,023,825
|
|
$ 957,317
|
|
$
1,925,808
|
|
$
1,850,129
|
Total revenues increased 7% in 2Q24 compared to the same period
in 2023.
Total neuroscience revenue, including high-sodium oxybate AG
royalty revenue, was $738.3 million in 2Q24, an increase of 6%
compared to $696.9 million in
2Q23, primarily due to increased high-sodium oxybate AG royalty
revenue and increased Epidiolex/Epidyolex and Xywav
net product sales, partially offset by decreased Xyrem
revenues.
Oncology net product sales were $277.3 million in 2Q24, an increase of 10%
compared to the same period in 2023, and included higher net
product sales from Zepzelca and Rylaze/Enrylaze,
which increased 15% and 6% to $81.0
million and $107.8 million,
respectively.
Operating Expenses and Effective Tax Rate
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
(In thousands, except
percentages)
|
2024
|
|
2023
|
|
2024
|
|
2023
|
GAAP:
|
|
|
|
|
|
|
|
Cost of product
sales
|
$ 109,902
|
|
$
97,537
|
|
$ 205,389
|
|
$ 226,181
|
Gross
margin
|
88.6 %
|
|
89.7 %
|
|
88.6 %
|
|
87.6 %
|
Selling, general and
administrative
|
$ 338,523
|
|
$ 340,844
|
|
$ 690,235
|
|
$ 638,761
|
% of total
revenues
|
33.1 %
|
|
35.6 %
|
|
35.8 %
|
|
34.5 %
|
Research and
development
|
$ 220,734
|
|
$ 209,238
|
|
$ 443,581
|
|
$ 398,648
|
% of total
revenues
|
21.6 %
|
|
21.9 %
|
|
23.0 %
|
|
21.5 %
|
Acquired in-process
research and development
|
$
—
|
|
$
—
|
|
$
10,000
|
|
$
1,000
|
Income tax
benefit1
|
$
(30,653)
|
|
$
(24,323)
|
|
$
(18,984)
|
|
$
(39,647)
|
Effective tax rate
1
|
(22.2) %
|
|
(29.7) %
|
|
(13.9) %
|
|
(29.0) %
|
_________________________
|
1.
|
The GAAP income tax
benefit decreased in the six months ended June 30, 2024, compared
to the same period in 2023, due to the change in income mix across
our jurisdictions and the impact of tax shortfalls from share-based
compensation.
|
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
(In thousands, except
percentages)
|
2024
|
|
2023
|
|
2024
|
|
2023
|
Non-GAAP
adjusted:
|
|
|
|
|
|
|
|
Cost of product
sales
|
$
72,413
|
|
$
65,994
|
|
$ 136,561
|
|
$ 130,722
|
Gross
margin
|
92.5 %
|
|
93.0 %
|
|
92.4 %
|
|
92.9 %
|
Selling, general and
administrative
|
$ 303,386
|
|
$ 276,871
|
|
$ 614,885
|
|
$ 537,386
|
% of total
revenues
|
29.6 %
|
|
28.9 %
|
|
31.9 %
|
|
29.0 %
|
Research and
development
|
$ 203,463
|
|
$ 192,019
|
|
$ 407,478
|
|
$ 365,937
|
% of total
revenues
|
19.9 %
|
|
20.1 %
|
|
21.2 %
|
|
19.8 %
|
Acquired in-process
research and development
|
$
—
|
|
$
—
|
|
$
10,000
|
|
$
1,000
|
Income tax
expense1
|
$
23,520
|
|
$
25,210
|
|
$
89,316
|
|
$
65,407
|
Effective tax
rate1
|
6.1 %
|
|
7.2 %
|
|
14.0 %
|
|
9.6 %
|
_________________________
|
1.
|
The non-GAAP income tax
expense increased in the six months ended June 30, 2024, compared
to the same period in 2023, due to the change in income mix across
our jurisdictions and the impact of tax shortfalls from share-based
compensation.
|
Changes in operating expenses in 2Q24 over the prior year period
are primarily due to the following:
- Cost of product sales on a GAAP basis increased in 2Q24
compared to the same period in 2023 due to higher acquisition
accounting inventory fair value step-up expense and changes in
product mix. Cost of product sales on a non-GAAP adjusted basis
increased in 2Q24 compared to the same period in 2023, due to
changes in product mix.
- Selling, general and administrative (SG&A) expenses on a
GAAP basis decreased in 2Q24 compared to the same period in 2023
primarily due to costs related to program terminations incurred in
2Q23. SG&A expenses on a GAAP and on a non-GAAP adjusted basis
included increased investment in our priority programs in 2Q24 as
compared to the same period in 2023.
- Research and development (R&D) expenses on a GAAP and on a
non-GAAP adjusted basis increased in 2Q24 compared to the same
period in 2023 primarily due to higher costs related to
zanidatamab, as well as our other key pipeline programs.
Cash Flow and Balance Sheet
As of June 30, 2024, cash, cash
equivalents and investments were $2.0
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 six months ended
June 30, 2024, the Company generated
$598.6 million of cash from
operations reflecting strong business performance and continued
financial discipline.
2024 Financial Guidance
The Company is updating its full year 2024 financial guidance as
follows:
(In
millions)
|
July 31,
2024
|
|
May 1,
2024
|
Revenues
|
$4,000 -
$4,100
|
|
$4,000 -
$4,200
|
–Neuroscience
(includes royalties from high-sodium oxybate AG)
|
$2,825 -
$2,925
|
|
$2,800 -
$2,950
|
–Oncology
|
$1,100 -
$1,150
|
|
$1,120 -
$1,220
|
|
GAAP:
|
|
(In millions, except
per share amounts and percentages)
|
July 31,
2024
|
|
May 1,
2024
|
Gross margin
%
|
89 %
|
|
89 %
|
SG&A
expenses
|
$1,366 -
$1,426
|
|
$1,346 -
$1,426
|
SG&A expenses
as % of total revenues
|
33% -
36%
|
|
32% -
36%
|
R&D
expenses
|
$887 - $935
|
|
$877 - $935
|
R&D expenses as
% of total revenues
|
22% -
23%
|
|
21% -
23%
|
Effective tax
rate
|
(22)% - (3)%
|
|
(22)% - (3)%
|
Net income
|
$385 - $530
|
|
$385 - $530
|
Net income per diluted
share5
|
$6.00 -
$8.00
|
|
$5.80 -
$7.70
|
Weighted-average
ordinary shares used in per share calculations
|
67
|
|
71
|
|
Non-GAAP:
|
|
(In millions, except
per share amounts and percentages)
|
July 31,
2024
|
|
May 1,
2024
|
Gross margin
%
|
93%1,6
|
|
93 %
|
SG&A
expenses
|
$1,190 -
$1,2302,6
|
|
$1,170 -
$1,230
|
SG&A expenses
as % of total revenues
|
29% -
31%
|
|
28% -
31%
|
R&D
expenses
|
$810 -
$8503,6
|
|
$800 - $850
|
R&D expenses as
% of total revenues
|
20% -
21%
|
|
19% -
21%
|
Effective tax
rate
|
10% -
12%4,6
|
|
10% - 13%
|
Net income
|
$1,275 -
$1,3506
|
|
$1,275 -
$1,350
|
Net income per diluted
share5
|
$19.20 -
$20.306
|
|
$18.15 -
$19.35
|
Weighted-average
ordinary shares used in per share calculations
|
67
|
|
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%-15% 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%-12%.
|
5.
|
Diluted EPS
calculations for 2024 include an estimated 3.5 million shares
related to the assumed conversion of the 2026 Notes, and the
associated interest expense, net of tax, add-back to net income of
$11 million and $10 million, on a GAAP and on a non-GAAP adjusted
basis, respectively, under the "if converted" method. In July 2024,
we made the irrevocable election to net share settle our 2026
Notes. This election is expected to increase our full-year net
income per diluted share guidance by $0.10 to $0.20 per share, on a
GAAP basis, and $0.65 to $0.75 per share, on a non-GAAP adjusted
basis, as a result of an estimated decrease in the weighted-average
outstanding shares of 2.9 million shares.
|
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. IST) to provide
a business and financial update and discuss its 2024 second quarter
results.
Audio webcast/conference call:
U.S. Dial-In Number: +1
800 715 9871
Ireland Dial-In Number: +353 1800 943 926
Additional global dial-in numbers are available here.
Passcode: 9124647
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 (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;
expectations that Xywav will remain the oxybate of choice;
expectations of high-sodium oxybate AG royalty revenue in 2024; the
ability to generate long-term sustainable growth and value; the
Company's advancement of pipeline programs and the timing of
development activities, regulatory activities and submissions
related thereto; planned or anticipated clinical trial events,
including with respect to initiations, enrollment and data
read-outs, and the anticipated timing thereof, including:
expectations of near-term, late-stage pipeline catalysts through
2025, top-line data from a Phase 2 trial of suvecaltamide in PDT,
top-line PFS data from a Phase 3 trial of zanidatamab in 1L GEA,
top-line data from a Phase 3 trial of Epidyolex in DS, LGS and TSC
in Japan and top-line PFS data
from a Phase 3 trial of Zepzelca in 1L SCLC; and the Company's
development, regulatory and commercialization strategy, including
the Company's expectations to executing multiple Epidyolex launches
through 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; the Company's capital allocation and corporate
development strategy; the potential successful future development,
manufacturing, regulatory and commercialization activities; 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; 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; 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; 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, 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; 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, 2023, as supplemented by our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, and future filings and reports by
the Company. 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
(In thousands,
except per share amounts)
(Unaudited)
|
|
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
964,144
|
|
$
946,987
|
|
$
1,806,246
|
|
$
1,831,206
|
Royalties and contract
revenues
|
59,681
|
|
10,330
|
|
119,562
|
|
18,923
|
Total
revenues
|
1,023,825
|
|
957,317
|
|
1,925,808
|
|
1,850,129
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of product sales
(excluding amortization of acquired developed
technologies)
|
109,902
|
|
97,537
|
|
205,389
|
|
226,181
|
Selling, general and
administrative
|
338,523
|
|
340,844
|
|
690,235
|
|
638,761
|
Research and
development
|
220,734
|
|
209,238
|
|
443,581
|
|
398,648
|
Intangible asset
amortization
|
155,223
|
|
152,062
|
|
310,953
|
|
301,848
|
Acquired in-process
research and development
|
—
|
|
—
|
|
10,000
|
|
1,000
|
Total operating
expenses
|
824,382
|
|
799,681
|
|
1,660,158
|
|
1,566,438
|
Income from
operations
|
199,443
|
|
157,636
|
|
265,650
|
|
283,691
|
Interest expense,
net
|
(62,023)
|
|
(73,470)
|
|
(128,139)
|
|
(147,617)
|
Foreign exchange gain
(loss)
|
507
|
|
(2,382)
|
|
(1,186)
|
|
811
|
Income before income
tax benefit and equity in loss of investees
|
137,927
|
|
81,784
|
|
136,325
|
|
136,885
|
Income tax
benefit
|
(30,653)
|
|
(24,323)
|
|
(18,984)
|
|
(39,647)
|
Equity in loss of
investees
|
12
|
|
1,669
|
|
1,359
|
|
2,674
|
Net income
|
$
168,568
|
|
$
104,438
|
|
$
153,950
|
|
$
173,858
|
|
|
|
|
|
|
|
|
Net income per ordinary
share:
|
|
|
|
|
|
|
|
Basic
|
$
2.68
|
|
$
1.63
|
|
$
2.45
|
|
$
2.73
|
Diluted
|
$
2.49
|
|
$
1.52
|
|
$
2.35
|
|
$
2.55
|
Weighted-average
ordinary shares used in per share calculations - basic
|
62,882
|
|
63,991
|
|
62,710
|
|
63,744
|
Weighted-average
ordinary shares used in per share calculations - diluted
|
69,625
|
|
73,540
|
|
69,684
|
|
73,657
|
JAZZ PHARMACEUTICALS
PLC
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands)
(Unaudited)
|
|
|
June 30,
2024
|
|
December 31,
2023
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$ 1,355,802
|
|
$ 1,506,310
|
Investments
|
625,000
|
|
120,000
|
Accounts receivable,
net of allowances
|
698,037
|
|
705,794
|
Inventories
|
542,555
|
|
597,039
|
Prepaid
expenses
|
134,421
|
|
185,476
|
Other current
assets
|
325,851
|
|
320,809
|
Total current
assets
|
3,681,666
|
|
3,435,428
|
Property, plant and
equipment, net
|
169,281
|
|
169,646
|
Operating lease
assets
|
73,145
|
|
65,340
|
Intangible assets,
net
|
5,079,462
|
|
5,418,039
|
Goodwill
|
1,735,931
|
|
1,753,130
|
Deferred tax assets,
net
|
545,222
|
|
477,834
|
Deferred financing
costs
|
5,736
|
|
6,478
|
Other non-current
assets
|
71,425
|
|
67,464
|
Total assets
|
$
11,361,868
|
|
$
11,393,359
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
97,096
|
|
$
102,750
|
Accrued
liabilities
|
800,993
|
|
793,914
|
Current portion of
long-term debt
|
605,798
|
|
604,954
|
Income taxes
payable
|
52,138
|
|
35,074
|
Total current
liabilities
|
1,556,025
|
|
1,536,692
|
Long-term debt, less
current portion
|
5,100,983
|
|
5,107,988
|
Operating lease
liabilities, less current portion
|
67,617
|
|
59,225
|
Deferred tax
liabilities, net
|
775,228
|
|
847,706
|
Other non-current
liabilities
|
99,416
|
|
104,751
|
Total shareholders'
equity
|
3,762,599
|
|
3,736,997
|
Total liabilities and
shareholders' equity
|
$
11,361,868
|
|
$
11,393,359
|
JAZZ PHARMACEUTICALS
PLC
SUMMARY OF CASH
FLOWS
(In
thousands)
(Unaudited)
|
|
|
Six Months
Ended
June
30,
|
|
2024
|
|
2023
|
Net cash provided by
operating activities
|
$
598,581
|
|
$
617,473
|
Net cash used in
investing activities
|
(528,995)
|
|
(90,561)
|
Net cash used in
financing activities
|
(217,637)
|
|
(126,455)
|
Effect of exchange
rates on cash and cash equivalents
|
(2,457)
|
|
365
|
Net increase (decrease)
in cash and cash equivalents
|
$
(150,508)
|
|
$
400,822
|
JAZZ PHARMACEUTICALS
PLC
RECONCILIATIONS OF
GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
(In thousands,
except per share amounts)
(Unaudited)
|
|
|
Three Months
Ended
June
30,
|
|
Six Months
Ended
June
30,
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
|
Net
Income
|
|
Diluted
EPS1
|
|
Net
Income
|
|
Diluted
EPS1
|
|
Net
Income
|
|
Diluted
EPS1
|
|
Net
Income
|
|
Diluted
EPS1
|
GAAP
reported
|
$
168,568
|
|
$
2.49
|
|
$
104,438
|
|
$
1.52
|
|
$
153,950
|
|
$
2.35
|
|
$
173,858
|
|
$
2.55
|
Intangible asset
amortization
|
155,223
|
|
2.23
|
|
152,062
|
|
2.07
|
|
310,953
|
|
4.46
|
|
301,848
|
|
4.10
|
Share-based
compensation expense
|
56,654
|
|
0.81
|
|
61,433
|
|
0.84
|
|
118,095
|
|
1.69
|
|
117,785
|
|
1.60
|
Acquisition accounting
inventory fair value step-up
|
33,243
|
|
0.48
|
|
27,814
|
|
0.38
|
|
62,186
|
|
0.89
|
|
88,272
|
|
1.20
|
Other
costs2
|
—
|
|
—
|
|
23,488
|
|
0.32
|
|
—
|
|
—
|
|
23,488
|
|
0.32
|
Non-cash interest
expense3
|
5,212
|
|
0.07
|
|
5,427
|
|
0.07
|
|
10,058
|
|
0.14
|
|
10,193
|
|
0.14
|
Income tax effect of
above adjustments
|
(54,173)
|
|
(0.77)
|
|
(49,533)
|
|
(0.67)
|
|
(108,300)
|
|
(1.54)
|
|
(105,054)
|
|
(1.43)
|
Effect of assumed
conversion of Exchangeable Senior Notes1
|
—
|
|
(0.01)
|
|
—
|
|
(0.02)
|
|
—
|
|
(0.01)
|
|
—
|
|
(0.02)
|
Non-GAAP
adjusted
|
$
364,727
|
|
$
5.30
|
|
$
325,129
|
|
$
4.51
|
|
$
546,942
|
|
$ 7.98
|
|
$
610,390
|
|
$
8.46
|
Weighted-average
ordinary shares used in diluted per share calculations - GAAP and
non-GAAP1
|
69,625
|
|
|
|
73,540
|
|
|
|
69,684
|
|
|
|
73,657
|
|
|
________________________________________________
|
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 exchange 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 three and six months ended June 30, 2023. Net income
per diluted share, on a GAAP and non-GAAP adjusted basis, for the
three and six months ended June 30, 2024 included 6.4 million
shares related to the assumed conversion of the 2026 Notes and the
associated interest expense, net of tax, add-back to GAAP reported
net income of $4.9 million and $9.7 million, respectively, and the
associated interest expense, net of tax, add-back to non-GAAP
adjusted net income of $4.4 million and $8.8 million, respectively.
Net income per diluted share, on a GAAP and non-GAAP adjusted
basis, for the three and six months ended June 30, 2023 included
9.0 million shares related to the assumed conversion of the
Exchangeable Senior Notes and the associated interest expense, net
of tax, add-back to GAAP reported net income of $7.1 million and
$14.0 million, respectively, and the associated interest expense,
net of tax, add-back to non-GAAP adjusted net income of $6.3
million and $12.6 million, respectively.
|
2.
|
Costs related to
program terminations.
|
3.
|
Non-cash interest
expense associated with debt issuance costs.
|
JAZZ PHARMACEUTICALS
PLC
RECONCILIATIONS OF
GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
CERTAIN LINE ITEMS -
FOR THE THREE MONTHS ENDED JUNE 30, 2024 and 2023
(In thousands,
except percentages)
(Unaudited)
|
|
|
Three months ended
June 30, 2024
|
|
Cost of
product
sales
|
|
Gross
margin
|
|
Selling,
general and
administrative
|
|
Research
and
development
|
|
Intangible
asset
amortization
|
|
Interest
expense,
net
|
|
Income tax
expense
(benefit)
|
GAAP
Reported
|
$
109,902
|
|
88.6 %
|
|
$
338,523
|
|
$
220,734
|
|
$
155,223
|
|
$
62,023
|
|
$
(30,653)
|
Non-GAAP
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
—
|
|
—
|
|
—
|
|
(155,223)
|
|
—
|
|
—
|
Share-based
compensation expense
|
(4,246)
|
|
0.4
|
|
(35,137)
|
|
(17,271)
|
|
—
|
|
—
|
|
—
|
Acquisition accounting
inventory fair value step-up
|
(33,243)
|
|
3.5
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Non-cash interest
expense
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(5,212)
|
|
—
|
Income tax effect of
above adjustments
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
54,173
|
Total of
non-GAAP adjustments
|
(37,489)
|
|
3.9
|
|
(35,137)
|
|
(17,271)
|
|
(155,223)
|
|
(5,212)
|
|
54,173
|
Non-GAAP
Adjusted
|
$
72,413
|
|
92.5 %
|
|
$
303,386
|
|
$
203,463
|
|
$
—
|
|
$
56,811
|
|
$
23,520
|
|
|
Three months ended
June 30, 2023
|
|
Cost of
product
sales
|
|
Gross
margin
|
|
Selling,
general and
administrative
|
|
Research
and
development
|
|
Intangible
asset
amortization
|
|
Interest
expense,
net
|
|
Income tax
expense
(benefit)
|
GAAP
Reported
|
$
97,537
|
|
89.7 %
|
|
$
340,844
|
|
$
209,238
|
|
$
152,062
|
|
$
73,470
|
|
$
(24,323)
|
Non-GAAP
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
—
|
|
—
|
|
—
|
|
(152,062)
|
|
—
|
|
—
|
Share-based
compensation expense
|
(3,729)
|
|
0.3
|
|
(40,485)
|
|
(17,219)
|
|
—
|
|
—
|
|
—
|
Other costs
|
—
|
|
—
|
|
(23,488)
|
|
—
|
|
—
|
|
—
|
|
—
|
Non-cash interest
expense
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(5,427)
|
|
—
|
Acquisition accounting
inventory fair value step-up
|
(27,814)
|
|
3.0
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Income tax effect of
above adjustments
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
49,533
|
Total of
non-GAAP adjustments
|
(31,543)
|
|
3.3
|
|
(63,973)
|
|
(17,219)
|
|
(152,062)
|
|
(5,427)
|
|
49,533
|
Non-GAAP
Adjusted
|
$
65,994
|
|
93.0 %
|
|
$
276,871
|
|
$
192,019
|
|
$
—
|
|
$
68,043
|
|
$
25,210
|
JAZZ PHARMACEUTICALS
PLC
RECONCILIATIONS OF
GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
CERTAIN LINE ITEMS -
FOR THE SIX MONTHS ENDED JUNE 30, 2024 and 2023
(In thousands,
except percentages)
(Unaudited)
|
|
|
Six months ended
June 30, 2024
|
|
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)
|
GAAP
Reported
|
$
205,389
|
|
88.6 %
|
|
$
690,235
|
|
$
443,581
|
|
$
310,953
|
|
$
10,000
|
|
$
128,139
|
|
$
(18,984)
|
Non-GAAP
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
—
|
|
—
|
|
—
|
|
(310,953)
|
|
—
|
|
—
|
|
—
|
Share-based
compensation expense
|
(6,642)
|
|
0.4
|
|
(75,350)
|
|
(36,103)
|
|
—
|
|
—
|
|
—
|
|
—
|
Non-cash interest
expense
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(10,058)
|
|
—
|
Acquisition accounting
inventory fair value step-up
|
(62,186)
|
|
3.4
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Income tax effect of
above adjustments
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
108,300
|
Total of
non-GAAP adjustments
|
(68,828)
|
|
3.8
|
|
(75,350)
|
|
(36,103)
|
|
(310,953)
|
|
—
|
|
(10,058)
|
|
108,300
|
Non-GAAP
Adjusted
|
$
136,561
|
|
92.4 %
|
|
$
614,885
|
|
$
407,478
|
|
$
—
|
|
$
10,000
|
|
$ 118,081
|
|
$
89,316
|
|
|
Six months ended
June 30, 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)
|
GAAP
Reported
|
$
226,181
|
|
87.6 %
|
|
$ 638,761
|
|
$
398,648
|
|
$
301,848
|
|
$
1,000
|
|
$
147,617
|
|
$
(39,647)
|
Non-GAAP
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
—
|
|
—
|
|
—
|
|
(301,848)
|
|
—
|
|
—
|
|
—
|
Share-based
compensation expense
|
(7,187)
|
|
0.4
|
|
(77,887)
|
|
(32,711)
|
|
—
|
|
—
|
|
—
|
|
—
|
Other costs
|
—
|
|
—
|
|
(23,488)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Non-cash interest
expense
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(10,193)
|
|
—
|
Acquisition accounting
inventory fair value step-up
|
(88,272)
|
|
4.9
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Income tax effect of
above adjustments
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
105,054
|
Total of
non-GAAP adjustments
|
(95,459)
|
|
5.3
|
|
(101,375)
|
|
(32,711)
|
|
(301,848)
|
|
—
|
|
(10,193)
|
|
105,054
|
Non-GAAP
Adjusted
|
$ 130,722
|
|
92.9 %
|
|
$ 537,386
|
|
$
365,937
|
|
$
—
|
|
$
1,000
|
|
$
137,424
|
|
$
65,407
|
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
|
|
$6.00 -
$8.00
|
Intangible asset
amortization
|
605 - 645
|
|
8.95 - 9.70
|
Acquisition accounting
inventory fair value step-up
|
125 - 145
|
|
1.85 - 2.20
|
Share-based
compensation expense
|
270 - 300
|
|
4.00 - 4.50
|
Non-cash interest
expense
|
20 - 30
|
|
0.30 - 0.45
|
Income tax effect of
above adjustments
|
(205) -
(225)
|
|
(3.05) -
(3.40)
|
Non-GAAP
guidance
|
$1,275 -
$1,350
|
|
$19.20 -
$20.30
|
|
|
|
|
Weighted-average
ordinary shares used in per share calculations - GAAP and
non-GAAP
|
67
|
|
|
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
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