Jazz Pharmaceuticals Announces Third Quarter 2024 Financial Results
– 14% year-over-year revenue increase from combined key growth drivers:
Xywav®, Epidiolex® and Rylaze® –
– 2024 total revenue guidance affirmed at
– Zanidatamab 2L BTC PDUFA date of
– Plan to submit sNDA for Zepzelca® in 1L ES-SCLC in 1H25 –
"Jazz once again delivered record revenues of more than
Key Highlights
- Key growth drivers grew 14% combined year-over-year.
- Combination of Zepzelca and atezolizumab demonstrated statistically significant and clinically meaningful improvement in OS and PFS primary endpoints, demonstrating the potential of the regimen to delay disease progression in ES-SCLC and extend survival for patients.
- Zanidatamab:
- PDUFA date of
November 29 ; expect 2L BTC commercial launch in 4Q24, following approval. - Top-line PFS data from zanidatamab in Phase 3 1L GEA estimated to be 2Q25.
- Initiated a Phase 2 pan-tumor trial to evaluate HER2-positive solid tumors.
- PDUFA date of
- 2024 Financial Guidance:
- Affirming 2024 total revenue guidance of
$4.0 to$4.1 billion . - Affirming neuroscience revenue guidance of
$2.825 to$2.925 billion . - Lowering oncology revenue guidance to
$1.08 to$1.13 billion . - Lowering GAAP R&D expense guidance to
$862 to$908 million and non-GAAP R&D expense guidance to$790 to$830 million ,2 primarily driven by strategic pipeline prioritization. - Raising GAAP EPS guidance range to
$6.70 to$8.50 and non-GAAP EPS guidance range to$19.50 to$20.60 .2
- Affirming 2024 total revenue guidance of
1 |
Total Sleep revenue includes: Xywav, branded Xyrem and high-sodium oxybate authorized generic royalty revenues. |
2 |
See "Non-GAAP Financial Measures." |
Business Updates
Commercial Updates
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
- Xywav net product sales were
$388 .5 million in 3Q24, an increase of 17% compared to the same period in 2023. - There were approximately 400 net patient adds for a total of approximately 13,625 active Xywav patients exiting 3Q24 comprised of:
- Approximately 10,075 narcolepsy patients.
- Approximately 3,550 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.
- Presented top-line results from the Phase 4 DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial at the
Psych Congress 2024, which demonstrated efficacy and safety consistent with narcolepsy and IH Phase 3 data. The prospective trial assesses the effect of Xywav treatment on excessive daytime sleepiness, polysomnography parameters and functional outcomes in adults with narcolepsy or IH.
Xyrem® (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties:
- Xyrem net product sales were
$58.1 million in 3Q24, a decrease of 54% compared to the same period in 2023. - Royalties from high-sodium oxybate AGs were
$58 .2 million in 3Q24, an increase of$29 .2 million compared to the same period in 2023.
Epidiolex/Epidyolex (cannabidiol):
- Epidiolex/Epidyolex net product sales were
$251.6 million in 3Q24, an increase of 18% compared to the same period in 2023. - Outside of the U.S., Epidyolex is approved in more than 35 countries.
- Presented data at the
European Epilepsy Congress 2024 demonstrating clinically meaningful reductions in drop seizures in patients with Lennox-Gastaut syndrome and subgroup analyses from theBECOME Caregiver Survey showing most caregivers reported patient improvements in seizure and non-seizure outcomes. - Ongoing data generation of the seizure and non-seizure benefits of Epidiolex, including from the EpiCom study in tuberous sclerosis complex, to be presented at
American Epilepsy Society 2024.
Rylaze/Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
- Rylaze/Enrylaze net product sales were
$98 .8 million in 3Q24, a decrease of 6% compared to the same period in 2023. - There is a temporary impact to Rylaze revenue due to a recent update to pediatric acute lymphoblastic leukemia (ALL) protocols regarding timing of asparaginase administration. The Company does not expect this impact will affect ongoing demand and expects revenue will normalize by early 2025.
Zepzelca (lurbinectedin):
- Zepzelca net product sales were
$85 .8 million in 3Q24, an increase of 10% compared to the same period in 2023. - The Company announced statistically significant and clinically meaningful overall survival (OS) and progression-free survival (PFS) results from the Phase 3 clinical trial, conducted in partnership with Roche, evaluating Zepzelca in combination with Tecentriq® (atezolizumab) in first-line (1L) extensive-stage (ES) small cell lung cancer (SCLC). Based on positive results from the trial, the Company plans to submit a supplemental New Drug Application (sNDA) for Zepzelca in 1L ES-SCLC in the first half of 2025.
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 ofNovember 29, 2024 . If approved, zanidatamab would be the first HER2-targeted treatment specifically approved for biliary tract cancer (BTC) in theU.S. A confirmatory trial in 1L metastatic BTC is ongoing. - The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L gastroesophageal adenocarcinoma (GEA), is expected to read out in 2Q25.
- Data presented at ESMO 2024 demonstrated sustained clinical antitumor activity in HER2-positive metastatic GEA. Updated results from the Phase 2 trial included a confirmed objective response rate of 84%, duration of response of 18.7 months, median PFS of 15.2 months and a Kaplan-Meier–estimated OS of 59% at 30 months.
- 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 is enrolling patients.
- The Company initiated a Phase 2 DiscovHER-Pan-206 pan-tumor trial in HER2-positive solid tumors.
Senior Notes Offering and Concurrent Share Repurchases
In the third quarter of 2024, the Company completed a private placement of $1.0 billion aggregate principal amount of 3.125% exchangeable senior notes due 2030, or 2030 Notes. The Company intends to use a portion of the proceeds from the private placement to make a payment on the Term Loan B following the
Financial Highlights
Three Months Ended |
Nine Months Ended |
||||||
(In thousands, except per share amounts) |
2024 |
2023 |
2024 |
2023 |
|||
Total revenues |
$ 1,054,969 |
$ 972,140 |
$ 2,980,777 |
$ 2,822,269 |
|||
GAAP net income |
$ 215,055 |
$ 146,820 |
$ 369,005 |
$ 320,678 |
|||
Non-GAAP adjusted net income |
$ 416,924 |
$ 340,148 |
$ 963,866 |
$ 950,538 |
|||
GAAP earnings per share |
$ 3.42 |
$ 2.14 |
$ 5.63 |
$ 4.67 |
|||
Non-GAAP adjusted EPS |
$ 6.61 |
$ 4.84 |
$ 14.42 |
$ 13.29 |
GAAP net income for 3Q24 was
Non-GAAP adjusted net income for 3Q24 was
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.
Total Revenues
Three Months Ended |
Nine Months Ended |
||||||
(In thousands) |
2024 |
2023 |
2024 |
2023 |
|||
Xywav |
$ 388,466 |
$ 331,633 |
$ 1,072,238 |
$ 935,958 |
|||
Xyrem |
58,114 |
125,110 |
184,526 |
463,009 |
|||
Epidiolex/Epidyolex |
251,558 |
213,711 |
697,376 |
604,846 |
|||
Sativex |
4,586 |
4,627 |
13,704 |
14,531 |
|||
Total Neuroscience |
702,724 |
675,081 |
1,967,844 |
2,018,344 |
|||
Rylaze/Enrylaze |
98,780 |
104,859 |
309,359 |
292,479 |
|||
Zepzelca |
85,843 |
77,994 |
241,990 |
215,523 |
|||
Defitelio/defibrotide |
65,818 |
47,730 |
158,915 |
132,917 |
|||
Vyxeos |
34,313 |
29,827 |
109,348 |
100,583 |
|||
Total Oncology |
284,754 |
260,410 |
819,612 |
741,502 |
|||
Other |
2,229 |
2,907 |
8,497 |
9,758 |
|||
Product sales, net |
989,707 |
938,398 |
2,795,953 |
2,769,604 |
|||
High-sodium oxybate AG royalty revenue |
58,157 |
28,921 |
162,268 |
36,531 |
|||
Other royalty and contract revenues |
7,105 |
4,821 |
22,556 |
16,134 |
|||
Total revenues |
$ 1,054,969 |
$ 972,140 |
$ 2,980,777 |
$ 2,822,269 |
Total revenues increased 9% in 3Q24 compared to the same period in 2023.
Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was
Oncology net product sales were
Operating Expenses and Effective Tax Rate
Three Months Ended |
Nine Months Ended |
||||||
(In thousands, except percentages) |
2024 |
2023 |
2024 |
2023 |
|||
GAAP: |
|||||||
Cost of product sales |
$ 111,611 |
$ 102,153 |
$ 317,000 |
$ 328,334 |
|||
Gross margin |
88.7 % |
89.1 % |
88.7 % |
88.1 % |
|||
Selling, general and administrative |
$ 325,772 |
$ 308,310 |
$ 1,016,007 |
$ 947,071 |
|||
% of total revenues |
30.9 % |
31.7 % |
34.1 % |
33.6 % |
|||
Research and development |
$ 199,919 |
$ 234,402 |
$ 643,500 |
$ 633,050 |
|||
% of total revenues |
19.0 % |
24.1 % |
21.6 % |
22.4 % |
|||
Acquired in-process research and development |
$ — |
$ — |
$ 10,000 |
$ 1,000 |
|||
Income tax benefit1 |
$ (14,533) |
$ (47,176) |
$ (33,517) |
$ (86,823) |
|||
Effective tax rate 1 |
(7.2) % |
(47.4) % |
(9.9) % |
(36.7) % |
_________________________
1. |
The GAAP income tax benefit decreased in the three and nine months ended |
Three Months Ended |
Nine Months Ended |
||||||
(In thousands, except percentages) |
2024 |
2023 |
2024 |
2023 |
|||
Non-GAAP adjusted: |
|||||||
Cost of product sales |
$ 72,844 |
$ 67,119 |
$ 209,405 |
$ 197,841 |
|||
Gross margin |
92.6 % |
92.8 % |
92.5 % |
92.9 % |
|||
Selling, general and administrative |
$ 288,672 |
$ 273,042 |
$ 903,557 |
$ 810,428 |
|||
% of total revenues |
27.4 % |
28.1 % |
30.3 % |
28.7 % |
|||
Research and development |
$ 180,992 |
$ 217,767 |
$ 588,470 |
$ 583,704 |
|||
% of total revenues |
17.2 % |
22.4 % |
19.7 % |
20.7 % |
|||
Acquired in-process research and development |
$ — |
$ — |
$ 10,000 |
$ 1,000 |
|||
Income tax expense1 |
$ 41,683 |
$ 7,378 |
$ 130,999 |
$ 72,785 |
|||
Effective tax rate1 |
9.1 % |
2.1 % |
11.9 % |
7.1 % |
_________________________
1. |
The non-GAAP income tax expense increased in the three and nine months ended |
Changes in operating expenses in 3Q24 over the prior year period are primarily due to the following:
- Cost of product sales, on a GAAP basis, increased in 3Q24 compared to the same period in 2023, primarily due to higher product sales, net and higher acquisition accounting inventory fair value step-up expense. Cost of product sales, on a non-GAAP adjusted basis, increased in 3Q24 compared to the same period in 2023, primarily due to higher product sales, net.
- Selling, general and administrative (SG&A) expenses, on a GAAP and on a non-GAAP adjusted basis, increased in 3Q24 compared to the same period in 2023, primarily due to increased compensation-related expenses driven by higher headcount in support of our key growth drivers.
- Research and development (R&D) expenses, on a GAAP and on a non-GAAP adjusted basis, decreased in 3Q24 compared to the same period in 2023, primarily due to lower clinical program costs as a result of JZP150 costs incurred in 3Q23 and lower zanidatamab costs.
Cash Flow and Balance Sheet
As of
2024 Financial Guidance
The Company is updating its full year 2024 financial guidance as follows:
(In millions) |
|
|
|
Revenues |
|
|
|
–Neuroscience (includes royalties from high-sodium oxybate AG) |
|
|
|
–Oncology |
|
|
GAAP:
(In millions, except per share amounts and percentages) |
|
|
|
Gross margin % |
89 % |
89 % |
|
SG&A expenses |
|
|
|
SG&A expenses as % of total revenues |
33% - 35% |
33% - 36% |
|
R&D expenses |
|
|
|
R&D expenses as % of total revenues |
21% - 23% |
22% - 23% |
|
Effective tax rate |
(17)% - (2)% |
(22)% - (3)% |
|
Net income |
|
|
|
Net income per diluted share5 |
|
|
|
Weighted-average ordinary shares used in per share calculations |
66 |
67 |
Non-GAAP:
(In millions, except per share amounts and percentages) |
|
|
|
Gross margin % |
93%1,6 |
93 % |
|
SG&A expenses |
|
|
|
SG&A expenses as % of total revenues |
29% - 31% |
29% - 31% |
|
R&D expenses |
|
|
|
R&D expenses as % of total revenues |
19% - 21% |
20% - 21% |
|
Effective tax rate |
10% - 12%4,6 |
10% - 12% |
|
Net income |
|
|
|
Net income per diluted share5 |
|
|
|
Weighted-average ordinary shares used in per share calculations |
66 |
67 |
___________________________
1. |
Excludes |
2. |
Excludes |
3. |
Excludes |
4. |
Excludes 27%-14% from the GAAP effective tax rate of (17)%-(2)% 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 2.000% exchangeable senior notes due 2026, or the 2026 Notes, and the associated interest expense, net of tax, add-back to net income of |
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
Audio webcast/conference call:
Ireland Dial-In Number: +353 1800 943 926
Additional global dial-in numbers are available here.
Passcode: 5080203
Interested parties may access the live audio webcast via the Investors section of the
A replay of the webcast will be available via the Investors section of the
About Jazz Pharmaceuticals
Non-GAAP Financial Measures
To supplement
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.
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, including plans to submit a sNDA for Zepzelca in 1L ES-SCLC in the first half of 2025 and the anticipated launch of zanidatamab in 2L BTC; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof, including: top-line PFS data from a Phase 3 trial of zanidatamab in 1L GEA, plans to initiate a Phase 1b trial of JZP441 in type 1 narcolepsy patients; 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
|
|||||||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME |
|||||||
(In thousands, except per share amounts) |
|||||||
(Unaudited) |
|||||||
Three Months Ended |
Nine Months Ended |
||||||
2024 |
2023 |
2024 |
2023 |
||||
Revenues: |
|||||||
Product sales, net |
$ 989,707 |
$ 938,398 |
$ 2,795,953 |
$ 2,769,604 |
|||
Royalties and contract revenues |
65,262 |
33,742 |
184,824 |
52,665 |
|||
Total revenues |
1,054,969 |
972,140 |
2,980,777 |
2,822,269 |
|||
Operating expenses: |
|||||||
Cost of product sales (excluding amortization |
111,611 |
102,153 |
317,000 |
328,334 |
|||
Selling, general and administrative |
325,772 |
308,310 |
1,016,007 |
947,071 |
|||
Research and development |
199,919 |
234,402 |
643,500 |
633,050 |
|||
Intangible asset amortization |
157,457 |
154,883 |
468,410 |
456,731 |
|||
Acquired in-process research and development |
— |
— |
10,000 |
1,000 |
|||
Total operating expenses |
794,759 |
799,748 |
2,454,917 |
2,366,186 |
|||
Income from operations |
260,210 |
172,392 |
525,860 |
456,083 |
|||
Interest expense, net |
(58,702) |
(71,497) |
(186,841) |
(219,114) |
|||
Foreign exchange loss |
(701) |
(1,377) |
(1,887) |
(566) |
|||
Income before income tax benefit and equity in loss |
200,807 |
99,518 |
337,132 |
236,403 |
|||
Income tax benefit |
(14,533) |
(47,176) |
(33,517) |
(86,823) |
|||
Equity in loss (gain) of investees |
285 |
(126) |
1,644 |
2,548 |
|||
Net income |
$ 215,055 |
$ 146,820 |
$ 369,005 |
$ 320,678 |
|||
Net income per ordinary share: |
|||||||
Basic |
$ 3.50 |
$ 2.33 |
$ 5.93 |
$ 5.05 |
|||
Diluted |
$ 3.42 |
$ 2.14 |
$ 5.63 |
$ 4.67 |
|||
Weighted-average ordinary shares used in per share |
61,414 |
63,114 |
62,275 |
63,532 |
|||
Weighted-average ordinary shares used in per share |
63,174 |
71,293 |
67,511 |
72,866 |
|
|||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||
(In thousands) |
|||
(Unaudited) |
|||
|
|
||
ASSETS |
|||
Current assets: |
|||
Cash and cash equivalents |
$ 2,218,135 |
$ 1,506,310 |
|
Investments |
400,000 |
120,000 |
|
Accounts receivable, net of allowances |
723,639 |
705,794 |
|
Inventories |
539,302 |
597,039 |
|
Prepaid expenses |
155,132 |
185,476 |
|
Other current assets |
354,215 |
320,809 |
|
Total current assets |
4,390,423 |
3,435,428 |
|
Property, plant and equipment, net |
176,422 |
169,646 |
|
Operating lease assets |
77,164 |
65,340 |
|
Intangible assets, net |
5,144,217 |
5,418,039 |
|
|
1,804,646 |
1,753,130 |
|
Deferred tax assets, net |
583,218 |
477,834 |
|
Deferred financing costs |
4,395 |
6,478 |
|
Other non-current assets |
75,231 |
67,464 |
|
Total assets |
$ 12,255,716 |
$ 11,393,359 |
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|||
Current liabilities: |
|||
Accounts payable |
$ 85,425 |
$ 102,750 |
|
Accrued liabilities |
858,578 |
793,914 |
|
Current portion of long-term debt |
31,000 |
604,954 |
|
Income taxes payable |
54,974 |
35,074 |
|
Total current liabilities |
1,029,977 |
1,536,692 |
|
Long-term debt, less current portion |
6,080,802 |
5,107,988 |
|
Operating lease liabilities, less current portion |
71,115 |
59,225 |
|
Deferred tax liabilities, net |
791,784 |
847,706 |
|
Other non-current liabilities |
110,971 |
104,751 |
|
Total shareholders' equity |
4,171,067 |
3,736,997 |
|
Total liabilities and shareholders' equity |
$ 12,255,716 |
$ 11,393,359 |
|
|||
SUMMARY OF CASH FLOWS |
|||
(In thousands) |
|||
(Unaudited) |
|||
Nine Months Ended |
|||
2024 |
2023 |
||
Net cash provided by operating activities |
$ 997,328 |
$ 924,668 |
|
Net cash used in investing activities |
(314,908) |
(264,860) |
|
Net cash provided by (used in) financing activities |
28,791 |
(204,948) |
|
Effect of exchange rates on cash and cash equivalents |
614 |
(652) |
|
Net increase in cash and cash equivalents |
$ 711,825 |
$ 454,208 |
|
|||||||||||||||
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION |
|||||||||||||||
(In thousands, except per share amounts) |
|||||||||||||||
(Unaudited) |
|||||||||||||||
Three Months Ended |
Nine Months Ended |
||||||||||||||
2024 |
2023 |
2024 |
2023 |
||||||||||||
Net |
Diluted |
Net |
Diluted |
Net |
Diluted |
Net |
Diluted |
||||||||
GAAP reported |
$ 215,055 |
$ 3.42 |
$ 146,820 |
$ 2.14 |
$ 369,005 |
$ 5.63 |
$ 320,678 |
$ 4.67 |
|||||||
Intangible asset amortization |
157,457 |
2.49 |
154,883 |
2.17 |
468,410 |
6.94 |
456,731 |
6.27 |
|||||||
Share-based compensation |
59,760 |
0.95 |
56,115 |
0.79 |
177,855 |
2.63 |
173,900 |
2.39 |
|||||||
Acquisition accounting |
35,034 |
0.55 |
30,822 |
0.43 |
97,220 |
1.44 |
119,094 |
1.63 |
|||||||
Other costs2 |
— |
— |
— |
— |
— |
— |
23,488 |
0.32 |
|||||||
Non-cash interest expense3 |
5,834 |
0.09 |
6,062 |
0.09 |
15,892 |
0.24 |
16,255 |
0.23 |
|||||||
Income tax effect of above |
(56,216) |
(0.89) |
(54,554) |
(0.77) |
(164,516) |
(2.44) |
(159,608) |
(2.19) |
|||||||
Effect of assumed conversion |
— |
— |
— |
(0.01) |
— |
(0.02) |
— |
(0.03) |
|||||||
Non-GAAP adjusted |
$ 416,924 |
$ 6.61 |
$ 340,148 |
$ 4.84 |
$ 963,866 |
$ 14.42 |
$ 950,538 |
$ 13.29 |
|||||||
Weighted-average ordinary |
63,174 |
71,293 |
67,511 |
72,866 |
________________________________________________
Explanation of Adjustments and Certain Line Items: |
|
1. |
Diluted EPS was calculated using the "if-converted" method in relation to the 2024 Notes and the 2026 Notes, which we refer to collectively as the Exchangeable Senior Notes. In |
2. |
Costs related to program terminations. |
3. |
Non-cash interest expense associated with debt issuance costs. |
|
|||||||||||||
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION |
|||||||||||||
CERTAIN LINE ITEMS - FOR THE THREE MONTHS ENDED |
|||||||||||||
(In thousands, except percentages) |
|||||||||||||
(Unaudited) |
|||||||||||||
Three months ended |
|||||||||||||
Cost of |
Gross |
Selling, |
Research |
Intangible |
Interest |
Income tax |
|||||||
GAAP Reported |
|
88.7 % |
$ 325,772 |
$ 199,919 |
|
$ 58,702 |
$ (14,533) |
||||||
Non-GAAP Adjustments: |
|||||||||||||
Intangible asset amortization |
— |
— |
— |
— |
(157,457) |
— |
— |
||||||
Share-based compensation expense |
(3,733) |
0.4 |
(37,100) |
(18,927) |
— |
— |
— |
||||||
Acquisition accounting inventory fair value |
(35,034) |
3.5 |
— |
— |
— |
— |
— |
||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
(5,834) |
— |
||||||
Income tax effect of above adjustments |
— |
— |
— |
— |
— |
— |
56,216 |
||||||
Total of non-GAAP adjustments |
(38,767) |
3.9 |
(37,100) |
(18,927) |
(157,457) |
(5,834) |
56,216 |
||||||
Non-GAAP Adjusted |
$ 72,844 |
92.6 % |
$ 288,672 |
$ 180,992 |
$ — |
$ 52,868 |
$ 41,683 |
||||||
Three months ended |
|||||||||||||
Cost of |
Gross |
Selling, |
Research |
Intangible |
Interest |
Income |
|||||||
GAAP Reported |
|
89.1 % |
$ 308,310 |
$ 234,402 |
|
$ 71,497 |
$ (47,176) |
||||||
Non-GAAP Adjustments: |
|||||||||||||
Intangible asset amortization |
— |
— |
— |
— |
(154,883) |
— |
— |
||||||
Share-based compensation expense |
(4,212) |
0.5 |
(35,268) |
(16,635) |
— |
— |
— |
||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
(6,062) |
— |
||||||
Acquisition accounting inventory fair value |
(30,822) |
3.2 |
— |
— |
— |
— |
— |
||||||
Income tax effect of above adjustments |
— |
— |
— |
— |
— |
— |
54,554 |
||||||
Total of non-GAAP adjustments |
(35,034) |
3.7 |
(35,268) |
(16,635) |
(154,883) |
(6,062) |
54,554 |
||||||
Non-GAAP Adjusted |
$ 67,119 |
92.8 % |
$ 273,042 |
$ 217,767 |
$ — |
$ 65,435 |
$ 7,378 |
|
|||||||||||||||
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION |
|||||||||||||||
CERTAIN LINE ITEMS - FOR THE NINE MONTHS ENDED |
|||||||||||||||
(In thousands, except percentages) |
|||||||||||||||
(Unaudited) |
|||||||||||||||
Nine months ended |
|||||||||||||||
Cost of |
Gross |
Selling, |
Research |
Intangible |
Acquired |
Interest |
Income tax |
||||||||
GAAP Reported |
|
88.7 % |
|
$ 643,500 |
|
$ 10,000 |
$ 186,841 |
$ (33,517) |
|||||||
Non-GAAP Adjustments: |
|||||||||||||||
Intangible asset amortization |
— |
— |
— |
— |
(468,410) |
— |
— |
— |
|||||||
Share-based compensation expense |
(10,375) |
0.4 |
(112,450) |
(55,030) |
— |
— |
— |
— |
|||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
— |
(15,892) |
— |
|||||||
Acquisition accounting inventory fair |
(97,220) |
3.4 |
— |
— |
— |
— |
— |
— |
|||||||
Income tax effect of above |
— |
— |
— |
— |
— |
— |
— |
164,516 |
|||||||
Total of non-GAAP adjustments |
(107,595) |
3.8 |
(112,450) |
(55,030) |
(468,410) |
— |
(15,892) |
164,516 |
|||||||
Non-GAAP Adjusted |
|
92.5 % |
$ 903,557 |
$ 588,470 |
$ — |
$ 10,000 |
$ 170,949 |
|
|||||||
Nine months ended |
|||||||||||||||
Cost of |
Gross |
Selling, |
Research |
Intangible |
Acquired |
Interest |
Income tax |
||||||||
GAAP Reported |
|
88.1 % |
$ 947,071 |
$ 633,050 |
$ 456,731 |
$ 1,000 |
$ 219,114 |
$ (86,823) |
|||||||
Non-GAAP Adjustments: |
|||||||||||||||
Intangible asset amortization |
— |
— |
— |
— |
(456,731) |
— |
— |
— |
|||||||
Share-based compensation expense |
(11,399) |
0.4 |
(113,155) |
(49,346) |
— |
— |
— |
— |
|||||||
Other costs |
— |
— |
(23,488) |
— |
— |
— |
— |
— |
|||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
— |
(16,255) |
— |
|||||||
Acquisition accounting inventory fair |
(119,094) |
4.4 |
— |
— |
— |
— |
— |
— |
|||||||
Income tax effect of above adjustments |
— |
— |
— |
— |
— |
— |
— |
159,608 |
|||||||
Total of non-GAAP adjustments |
(130,493) |
4.8 |
(136,643) |
(49,346) |
(456,731) |
— |
(16,255) |
159,608 |
|||||||
Non-GAAP Adjusted |
|
92.9 % |
$ 810,428 |
$ 583,704 |
$ — |
$ 1,000 |
$ 202,859 |
$ 72,785 |
|
|||
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 |
|
|
|
Intangible asset amortization |
605 - 645 |
9.10 - 9.85 |
|
Acquisition accounting inventory fair value step-up |
125 - 145 |
1.90 - 2.20 |
|
Share-based compensation expense |
235 - 255 |
3.55 - 3.90 |
|
Non-cash interest expense |
20 - 30 |
0.30 - 0.45 |
|
Income tax effect of above adjustments |
(210) - (220) |
(3.15) - (3.35) |
|
Non-GAAP guidance |
|
|
|
Weighted-average ordinary shares used in per share calculations - GAAP and |
66 |
Contacts:
Investors:
Vice President, Head, Investor Relations
InvestorInfo@jazzpharma.com
Media:
Head of
CorporateAffairsMediaInfo@jazzpharma.com
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