Jazz Pharmaceuticals Announces Full Year and Fourth Quarter 2023 Financial Results and Provides 2024 Financial Guidance
- 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. Sleep(1) 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; annualizing(2) at
$1.35 billion.
-- Epidiolex/Epidyolex(®) net product sales grew 15% year-over-year;
annualizing(2) at over $900 million.
-- Rylaze net product sales grew 40% year-over-year; annualizing(2) 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 Year Ended
December 31, 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 Year Ended
December 31, 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
Sunosi(1) 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 Year Ended
December 31, 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 Year Ended
December 31, 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 rate(1) 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 Year Ended
December 31, 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, December 31,
2023 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
Year Ended
December 31,
December 31,
2023 2022 2023 2022
Net Diluted Net Loss Diluted Net Diluted Net Diluted
Income EPS EPS Income EPS Income EPS
(Loss)
GAAP reported(1) $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 52,941 0.76 61,767 0.98 226,841 3.15 218,194 3.01
expense
Acquisition accounting 32,352 0.46 70,203 1.11 151,446 2.10 273,392 3.77
inventory fair value step-up
Restructuring and other costs(2) 61,727 0.89 19,681 0.31 85,215 1.18 77,306 1.06
Non-cash interest expense(3) 6,123 0.09 5,971 0.10 22,378 0.31 37,973 0.52
Intangible asset impairment - 133,648 1.84
charge4
(Income) costs related to - (1,783) (0.03) 47,756 0.66
disposal of a business5
Transaction and integration - 23,560 0.32
related expenses6
Income tax effect of above (53,564) (0.77) (56,741) (0.90) (213,172) (2.95) (253,340) (3.49)
adjustments
Effect of assumed conversion - (0.01) (0.04) 0.84
of Exchangeable Senior
Notes
Non-GAAP adjusted(1) $345,286 $5.02 $(4,239) $(0.07) $1,295,824 $18.29 $933,598 $13.20
Weighted-average ordinary 69,673 63,052 72,066 62,539
shares used in diluted per
share calculations - GAAP
Dilutive effect of - 9,044
Exchangeable Senior Notes(1)
Dilutive effect of employee - 1,025
equity incentive and purchase
plans
Weighted-average ordinary 69,673 63,052 72,066 72,608
shares used in diluted per share
calculations - non-GAAP
________________________________________________
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 Gross Selling, Research Intangible Interest Income tax Effective
product margin general and and asset expense, net expense tax
rate(1)
sales administrative development amortization (benefit)
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 (3,653) 0.4 (33,787) (15,501)
expense
Acquisition accounting inventory (32,352) 3.3
fair value step-up
Restructuring and other costs (61,727)
Non-cash interest expense (6,123)
Income tax effect of above 53,564 59.4
adjustments
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 Gross Selling, Research Intangible Acquired Interest Income tax Effective
product margin general and and asset IPR&D expense, benefit tax
rate(1)
sales administrative development amortization net
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 (137,387)
amortization
Share-based (3,835) 0.4 (43,875) (14,057)
compensation expense
Income related to the 1,783
disposal of a business
Restructuring and other 60 (21,348) 1,607
costs
Non-cash interest expense (5,971)
Acquisition accounting (70,203) 7.2
inventory fair value step-up
Income tax effect of above 56,741 63.2
adjustments
Total of non-GAAP (73,978) 7.6 (63,440) (12,450) (137,387) (5,971) 56,741 63.2
adjustments
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 Gross Selling, Research Intangible Acquired Interest Income tax Effective
product margin general and and asset IPR&D expense, expense tax
rate(1)
sales administrative development amortization net (benefit)
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 - (608,284)
amortization
Share-based (15,052) 0.4 (146,942) (64,847)
compensation expense
Restructuring and other - (85,215)
costs
Non-cash interest expense - (22,378)
Acquisition accounting (151,446) 4.1
inventory fair value step-up
Income tax effect of above - 213,172 46.9
adjustments
Total of non-GAAP (166,498) 4.5 (232,157) (64,847) (608,284) (22,378) 213,172 46.9
adjustments
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 Gross Selling, Research Intangible Acquired Intangible Interest Income tax Effective
product margin general and and asset IPR&D asset expense, expense tax
rate(1)
sales administrative development amortization impairment net (benefit)
charge
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 (599,169)
amortization
Share-based (12,416) 0.3 (148,726) (57,052)
compensation
expense
Intangible asset (133,648)
impairment
charge
Costs related to (47,756)
the disposal of a
business
Restructuring and (2,299) 0.1 (64,723) (10,284)
other costs
Transaction and (469) (21,059) (2,032)
integration
related costs
Non-cash interest (37,973)
expense
Acquisition (273,392) 7.5
accounting
inventory fair
value step-up
Income tax effect 253,340 (33.5)
of above
adjustments
Total of non- (288,576) 7.9 (282,264) (69,368) (599,169) (133,648) (37,973) 253,340 (33.5)
GAAP
adjustments
Non-GAAP $251,941 93.1 % $1,134,703 $521,085
$ - $444,148
$ - $250,269 $94,695 9.1 %
Adjusted
__________________________
(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 D
ILUTED 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 71
non-GAAP
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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SOURCE Jazz Pharmaceuticals plc
