- 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 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
[https://c212.net/c/link/?t=0&l=en&o=4222264-1&h=3787854447&u=https%3A%2
F%2Flink.springer.com%2Farticle%2F10.1007%2Fs40120-024-00607-8&a=Neurolo
gy+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
[https://c212.net/c/link/?t=0&l=en&o=4222264-1&h=2682636627&u=https%3A%2
F%2Finvestor.jazzpharma.com%2Fnews-releases%2Fnews-release-details%2Fjaz
z-pharmaceuticals-showcases-pioneering-research-sleep&a=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
[https://c212.net/c/link/?t=0&l=en&o=4222264-1&h=1420831610&u=https%3A%2
F%2Fwww.tandfonline.com%2Fdoi%2Fepdf%2F10.2217%2Ffnl-2023-0033&a=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
[https://c212.net/c/link/?t=0&l=en&o=4222264-1&h=2276752994&u=https%3A%2
F%2Fonlinelibrary.wiley.com%2Fdoi%2F10.1002%2Fepi4.12952&a=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
[https://c212.net/c/link/?t=0&l=en&o=4222264-1&h=899484861&u=https%3A%2F
%2Finvestor.jazzpharma.com%2Fnews-releases%2Fnews-release-details%2Fjazz
-pharmaceuticals-presents-overall-survival-and-longer-follow&a=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 Six Months Ended June 30, 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 Six Months Ended June 30, 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 Six Months Ended June 30, 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 Six Months Ended June 30, 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 expense(1) $23,520 $25,210 $89,316 $65,407 Effective tax rate(1) 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 [https://c212.net/c/link/?t=0&l=en&o=4222264-1&h=3623260891&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4211818-1%26h%3D3468243657%26u%3Dhttps%253A%252F%252Fevents.q4irportal.com%252Fcustom%252Faccess%252F2324%252F%26a%3Dhere&a=here].
Passcode: 9124647
Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com [https://c212.net/c/link/?t=0&l=en&o=4222264-1&h=82233876&u=https%3A%2F%2Fwww.jazzpharma.com%2F&a=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 [https://c212.net/c/link/?t=0&l=en&o=4222264-1&h=82233876&u=https%3A%2F%2Fwww.jazzpharma.com%2F&a=www.jazzpharmaceuticals.com].
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc 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 [https://c212.net/c/link/?t=0&l=en&o=4222264-1&h=82233876&u=https%3A%2F%2Fwww.jazzpharma.com%2F&a=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 Six Months Ended June 30, 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, December 31, 2024 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 Six Months Ended June 30, June 30, 2024 2023 2024 2023 Net Diluted Net Diluted Net Diluted Net Diluted Income EPS(1) Income EPS(1) Income EPS(1) Income EPS(1) 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 costs(2) - 23,488 0.32 23,488 0.32 Non-cash interest expense(3) 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 Notes(1) - (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-GAAP(1) 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 Gross Selling, Research Intangible Interest Income tax product margin general and and asset expense, expense sales administrative development amortization net (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 Gross Selling, Research Intangible Interest Income tax product margin general and and asset expense, expense sales administrative development amortization net (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 Gross Selling, Research Intangible Acquired Interest Income tax product margin general and and asset IPR&D expense, expense sales administrative development amortization net (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 Gross Selling, Research Intangible Acquired Interest Income tax product margin general and and asset IPR&D expense, expense sales administrative development amortization net (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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