Jazz Pharmaceuticals Announces First Quarter 2023 Financial Results and Affirms 2023 Financial Guidance
- Net product sales of Xywav increased by 49% in 1Q23 compared to 1Q22.
- Net product sales of Epidiolex/Epidyolex increased by 20% in 1Q23 compared to 1Q22.
- Net product sales of Rylaze increased by 58% in 1Q23 compared to 1Q22.
- Jazz Pharmaceuticals is confident in the blockbuster potential of Epidiolex and expects continued strong demand.
- The company's enhanced pipeline is positioned to deliver at least three late-stage data readouts by the end of 2024.
- None.
Focus on commercial execution drove 1Q23 total revenues of
Continued adoption of Xywav®; net product sales increased
Confident in blockbuster potential of Epidiolex®; net product sales increased
Strong Rylaze® demand drove
Enhanced pipeline positioned to deliver at least three late-stage data readouts by the end of 2024
"This quarter, we once again delivered strong commercial results, advanced our efforts to unlock the tremendous potential of our pipeline and built on our record of driving operational excellence. On the commercial front, key products launched over the past several years are demonstrating impressive and durable performance with Xywav annualizing at more than
"Our enhanced pipeline is positioned to deliver at least three late-stage data readouts by the end of 2024, including JZP150 in post-traumatic stress disorder (PTSD), suvecaltamide in essential tremor (ET) and zanidatamab in first-line gastroesophageal adenocarcinoma (1L GEA)," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "These late-stage trials are exploring new therapies with the potential to transform the lives of patients affected by diseases where substantial unmet medical need remains."
Key Highlights
- Continued confidence that low-sodium Xywav will remain the oxybate of choice in 2023; already annualizing at more than
$1 billion - Epidiolex/Epidyolex continues to grow year-over-year with an expanding global prescriber base.
- Strong Rylaze demand drove net product sales of
$85.9 million - Pipeline positioned to deliver at least three late-stage data readouts by the end of 2024, including JZP150 in PTSD, suvecaltamide in ET and zanidatamab in 1L GEA.
- The Company will host a KOL investor webcast to review the HERIZON-BTC-01 trial data, which will be presented at the 2023 ASCO Annual Meeting.
- 1Q23 total revenues increased
10% to$892.8 million - On track to achieve full year revenue expectations; full year financial guidance affirmed.
Business Updates
Key Commercial Products
Oxybate (Xywav and Xyrem®):
- Total revenues for the combined oxybate business, including royalties from a high-sodium oxybate authorized generic (AG) in 1Q23, increased
6% to$458.0 million - Average active Jazz oxybate patients on therapy was approximately 17,400 in 1Q23, an increase of
5% compared to the same period in 2022.
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
- Xywav net product sales increased
49% to$277.8 million - Xywav is the Company's largest product by net product sales, annualizing at more than
$1 billion - There were approximately 11,050 active Xywav patients exiting 1Q23.
Xywav for Narcolepsy:
- There were approximately 9,050 narcolepsy patients taking Xywav exiting 1Q23.
- The benefits of reducing sodium intake resonate with patients and prescribers as the large majority of new-to-oxybate narcolepsy patients continue to be prescribed Xywav.
- FDA continues to recognize seven years of Orphan Drug Exclusivity (ODE), through July 2027, for Xywav in narcolepsy. FDA published its summary of clinical superiority findings stating that "Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem." Further, FDA stated that "the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated." For clarity, the authorized generics of Xyrem contain the exact same drug product as branded Xyrem.
- FDA has also recognized that the difference in sodium content between Xywav and Lumryz is likely to be clinically meaningful in all patients with narcolepsy and that Xywav is safer than Lumryz in all such patients. Lumryz is a branded, fixed-dose, high-sodium oxybate that has the same sodium content as Xyrem.
- Xywav is the only approved oxybate therapy that does not carry a warning and precaution related to high sodium intake.
Xywav for Idiopathic Hypersomnia (IH):
- There were approximately 2,000 IH patients taking Xywav exiting 1Q23.
- Recent Jazz survey of sleep specialists indicates
70% anticipate increasing their prescribing of Xywav for IH over the next six months. - Xywav is the first and only treatment approved by FDA to treat the full condition of IH.
- FDA recognized ODE for IH extending regulatory exclusivity to August 2028.
Xyrem (sodium oxybate) oral solution:
- Xyrem net product sales decreased
28% to$178.1 million - Royalties from high-sodium oxybate AG were
$2.1 million
Epidiolex/Epidyolex (cannabidiol):
- Epidiolex/Epidyolex net product sales increased
20% to$188.9 million - A pivotal Phase 3 trial of Epidyolex for Dravet syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex in
Japan is enrolling patients. - Epidiolex/Epidyolex global prescriber base is increasing with multiple launches expected outside of the
U.S. this year. - Additional Epidiolex growth opportunities underscored by BECOME survey's caregiver reported outcomes beyond seizure control, and compelling data for use of Epidiolex in combination with clobazam.
- Epidyolex is launched and reimbursed in all five key European markets:
United Kingdom ,Germany ,Italy ,Spain andFrance .
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
- Rylaze net product sales increased
58% to$85.9 million - Continued strong demand for Rylaze reflects the significant unmet patient need for a high-quality, reliable supply of Erwinia asparaginase for patients with acute lymphoblastic leukemia.
- In May 2022, the Company completed the Marketing Authorization Application submission to European Medicines Agency for a Monday/Wednesday/Friday dosing schedule and intramuscular and intravenous administration for JZP458 (approved as Rylaze in the
U.S. ) with potential for approval in 2023. - The Company is also continuing to evaluate patient need in other geographies.
Zepzelca (lurbinectedin):
- Zepzelca net product sales increased
13% to$67.2 million - Zepzelca is the treatment of choice in second-line (2L) small cell lung cancer (SCLC) setting.
- Zepzelca development program highlights:
- The EMERGE-201 Phase 2 basket trial evaluating Zepzelca as monotherapy in select relapsed/refractory solid tumors is ongoing.
- Phase 3 trial in partnership with F. Hoffmann-La Roche Ltd (Roche) to evaluate 1L use of Zepzelca in combination with Tecentriq® (atezolizumab), compared to Tecentriq alone, as maintenance therapy in patients with extensive-stage SCLC after induction chemotherapy is ongoing. The Company expects complete enrollment in the trial by the end of 2023.
- The Company's partner, PharmaMar, is conducting the Phase 3 confirmatory trial, LAGOON, in 2L SCLC. If positive, this trial could confirm the benefit of Zepzelca in the treatment of SCLC when patients progress following 1L treatment with a platinum-based regimen.
Key Pipeline Highlights
Zanidatamab:
- Zanidatamab is a bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients.
- Initial focus is in biliary tract cancers (BTC) and GEA with potential to transform the current standard of care in multiple HER2-expressing cancers.
- Positive top-line data from the pivotal HERIZON-BTC-01 clinical trial has the potential to support regulatory submissions for zanidatamab as a monotherapy in patients with previously treated HER2-amplifed and expressing BTC.
- Data from the HERIZON-BTC-01 clinical trial will be presented at the 2023 ASCO Annual Meeting on Friday, June 2, 2023; the Company will host an investor webcast with Dr. Shubham Pant, M.D., MBBS, Professor in the Department of Gastrointestinal Medical Oncology with a joint appointment in the Department of the Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, to review the BTC data.
- In January 2023, the Company and Zymeworks announced the first overall survival data of
84% at 18 months from a Phase 2 trial of zanidatamab in combination with chemotherapy in 1L patients with HER2-expressing metastatic GEA. - The pivotal trial, HERIZON-GEA-01, evaluating zanidatamab in 1L GEA is ongoing and top-line data are expected in 2024.
JZP150:
- JZP150, a selective fatty acid amide hydrolase, or FAAH, inhibitor, is in clinical development for the potential treatment of PTSD.
- Patient enrollment is ongoing in a Phase 2 trial and top-line data readout is anticipated in late 2023.
- The Company received Fast Track Designation for JZP150 development in PTSD from FDA, underscoring the significant unmet medical needs of patients.
Suvecaltamide (JZP385):
- Suvecaltamide, a highly selective and state dependent modulator of T-type calcium channels, is in clinical development for the treatment of ET and Parkinson's disease tremor.
- Patient enrollment is ongoing in the Phase 2b ET trial and top-line data readout is anticipated in 1H24.
- A Phase 2 trial in patients with Parkinson's disease tremor is ongoing.
JZP441:
- JZP441, is a potent, highly selective oral orexin-2 receptor agonist designed to activate orexin signaling with the potential to be applicable in the treatment of narcolepsy, IH and other sleep disorders.
- A Phase 1 development program to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of JZP441 in sleep-deprived healthy volunteers is ongoing.
- The Company expects initial proof of concept in healthy volunteers in 2023.
JZP815:
- A Phase 1 trial evaluating JZP815 in patients with advanced or metastatic solid tumors with MAPK pathway alterations is ongoing.
- The pan-RAF inhibitor program is part of a novel class of next-generation precision oncology therapies that has the potential to benefit cancer patients with high unmet needs in multiple different solid tumors.
JZP898:
- JZP898 is an engineered IFNα cytokine pro-drug that is activated specifically within the tumor microenvironment where it can stimulate IFNα receptors on cancer-fighting immune effector cells.
- The Company expects to file an Investigational New Drug (IND) application for JZP898 in the
U.S. this year.
Financial Highlights
Three Months Ended | |||
(In thousands, except per share amounts) | 2023 | 2022 | |
Total revenues | $ 892,812 | $ 813,721 | |
GAAP net income | $ 69,420 | $ 1,647 | |
Non-GAAP adjusted net income | $ 285,261 | $ 261,934 | |
GAAP earnings per share | $ 1.04 | $ 0.03 | |
Non-GAAP adjusted EPS | $ 3.95 | $ 3.73 | |
GAAP net income for 1Q23 was
Non-GAAP adjusted net income for 1Q23 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 | |||
(In thousands) | 2023 | 2022 | |
Xywav | $ 277,761 | $ 186,080 | |
Xyrem | 178,130 | 247,497 | |
Total Oxybate | 455,891 | 433,577 | |
Epidiolex/Epidyolex | 188,909 | 157,893 | |
Sativex | 7,098 | 4,742 | |
Sunosi1 | — | 15,878 | |
Total Neuroscience | 651,898 | 612,090 | |
Rylaze | 85,927 | 54,220 | |
Zepzelca | 67,181 | 59,338 | |
Defitelio/defibrotide | 39,079 | 49,489 | |
Vyxeos | 36,700 | 33,757 | |
Total Oncology | 228,887 | 196,804 | |
Other | 3,434 | 943 | |
Product sales, net | 884,219 | 809,837 | |
High-sodium oxybate AG royalty revenue | 2,096 | — | |
Other royalty and contract revenues | 6,497 | 3,884 | |
Total revenues | $ 892,812 | $ 813,721 | |
___________________________ |
(1) Divestiture of Sunosi |
Total revenues increased
- Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was
$654.0 million $612.1 million 7% to$651.9 million - Oncology net product sales in 1Q23 increased
16% to$228.9 million 58% to$86.0 million
Operating Expenses and Effective Tax Rate
Three Months Ended | |||
(In thousands, except percentages) | 2023 | 2022 | |
GAAP: | |||
Cost of product sales | $ 128,644 | $ 115,284 | |
Gross margin | 85.5 % | 85.8 % | |
Selling, general and administrative | $ 297,917 | $ 308,813 | |
% of total revenues | 33.4 % | 38.0 % | |
Research and development | $ 189,410 | $ 129,981 | |
% of total revenues | 21.2 % | 16.0 % | |
Income tax expense (benefit)1 | $ (15,324) | $ 536 | |
Effective tax rate 1 | (27.8) % | 8.5 % | |
__________________________ | |
1. | The GAAP income tax benefit for 1Q23 increased as a result of the mix of pre-tax income and losses across tax jurisdictions, and increases in our patent box and foreign derived intangible income benefits. |
Three Months Ended | |||
(In thousands, except percentages) | 2023 | 2022 | |
Non-GAAP adjusted: | |||
Cost of product sales | $ 64,728 | $ 48,206 | |
Gross margin | 92.7 % | 94.0 % | |
Selling, general and administrative | $ 260,515 | $ 258,701 | |
% of total revenues | 29.2 % | 31.8 % | |
Research and development | $ 173,918 | $ 116,459 | |
% of total revenues | 19.5 % | 14.3 % | |
Income tax expense | $ 40,197 | $ 55,223 | |
Effective tax rate | 12.3 % | 17.2 % | |
Changes in operating expenses in 1Q23 over the prior year period are primarily due to the following:
- Cost of product sales increased in 1Q23 compared to the same period in 2022, on a GAAP and on a non-GAAP adjusted basis, primarily due to changes in product mix.
- Selling, general and administrative (SG&A) expenses, on a GAAP basis, decreased in 1Q23 compared to the same period in 2022 primarily due to transaction and integration expenses related to the acquisition of GW Pharmaceuticals plc (GW) and Sunosi® (solriamfetol) related spend incurred in 1Q22, partially offset by increased investment in our priority programs. SG&A expenses, on a non-GAAP adjusted basis, were in line with the same period in 2022.
- Research and development (R&D) expenses increased in 1Q23 compared to the same period in 2022, on a GAAP and on a non-GAAP adjusted basis, primarily due to the inclusion of costs related to clinical programs for zanidatamab, as well as JZP815, JZP898 and JZP441, offset by a decrease in costs related to JZP458.
Cash Flow and Balance Sheet
As of March 31, 2023, cash and cash equivalents were
2023 Financial Guidance
The Company is affirming its full year 2023 financial guidance as follows:
(In millions) | Guidance | |
Revenues | ||
–Neuroscience (includes royalties from high-sodium oxybate AG) | ||
–Oncology |
(In millions, except per share amounts and percentages) | GAAP | Non-GAAP | |
Gross margin % | 89 % | ||
SG&A expenses | |||
SG&A expenses as % of total revenues | |||
R&D expenses | |||
R&D expenses as % of total revenues | |||
Effective tax rate | (32)% - (8)% | ||
Net income | |||
Net income per diluted share5 | |||
Weighted-average ordinary shares used in per share calculations5 | 75 | 75 |
___________________________ | |
1. | Excludes |
2. | Excludes |
3. | Excludes |
4. | Excludes |
5. | Diluted EPS calculations for 2023 include 9 million shares related to the assumed conversion of the Exchangeable Senior Notes and the associated interest expense 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 2023 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 2023 first quarter results.
Interested parties may register for the call in advance here or 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in
Non-GAAP Financial Measures
To supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with
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 2023 financial guidance and the Company's expectations related thereto and anticipated catalysts; the Company's expectations for total revenue growth in 2023 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 ex-
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 the Company's oxybate products, Zepzelca and other key marketed products; 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; the Company's failure to realize the expected benefits of its acquisition of GW, including the failure to realize the blockbuster potential of Epidiolex; 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
JAZZ PHARMACEUTICALS PLC | |||
Three Months Ended | |||
2023 | 2022 | ||
Revenues: | |||
Product sales, net | $ 884,219 | $ 809,837 | |
Royalties and contract revenues | 8,593 | 3,884 | |
Total revenues | 892,812 | 813,721 | |
Operating expenses: | |||
Cost of product sales (excluding amortization of acquired developed technologies) | 128,644 | 115,284 | |
Selling, general and administrative | 297,917 | 308,813 | |
Research and development | 189,410 | 129,981 | |
Intangible asset amortization | 149,786 | 172,094 | |
Acquired in-process research and development | 1,000 | — | |
Total operating expenses | 766,757 | 726,172 | |
Income from operations | 126,055 | 87,549 | |
Interest expense, net | (74,147) | (70,684) | |
Foreign exchange gain (loss) | 3,193 | (10,540) | |
Income before income tax expense (benefit) and equity in loss of investees | 55,101 | 6,325 | |
Income tax expense (benefit) | (15,324) | 536 | |
Equity in loss of investees | 1,005 | 4,142 | |
Net income | $ 69,420 | $ 1,647 | |
Net income per ordinary share: | |||
Basic | $ 1.09 | $ 0.03 | |
Diluted | $ 1.04 | $ 0.03 | |
Weighted-average ordinary shares used in per share calculations - basic | 63,494 | 61,865 | |
Weighted-average ordinary shares used in per share calculations - diluted | 73,771 | 62,907 | |
JAZZ PHARMACEUTICALS PLC | |||
March 31, | December 31, | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 1,167,911 | $ 881,482 | |
Accounts receivable, net of allowances | 623,938 | 651,493 | |
Inventories | 674,778 | 714,061 | |
Prepaid expenses | 72,779 | 91,912 | |
Other current assets | 245,244 | 267,192 | |
Total current assets | 2,784,650 | 2,606,140 | |
Property, plant and equipment, net | 227,552 | 228,050 | |
Operating lease assets | 75,538 | 73,326 | |
Intangible assets, net | 5,764,209 | 5,794,437 | |
Goodwill | 1,723,444 | 1,692,662 | |
Deferred tax assets, net | 399,097 | 376,247 | |
Deferred financing costs | 8,559 | 9,254 | |
Other non-current assets | 64,076 | 55,139 | |
Total assets | $ 11,047,125 | $ 10,835,255 | |
LIABILITIES AND SHAREHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable | $ 125,454 | $ 90,758 | |
Accrued liabilities | 712,349 | 803,255 | |
Current portion of long-term debt | 31,000 | 31,000 | |
Income taxes payable | 40,095 | 7,717 | |
Deferred revenue | 4 | 463 | |
Total current liabilities | 908,902 | 933,193 | |
Long-term debt, less current portion | 5,689,662 | 5,693,341 | |
Operating lease liabilities, less current portion | 72,095 | 71,838 | |
Deferred tax liabilities, net | 932,247 | 944,337 | |
Other non-current liabilities | 109,178 | 106,812 | |
Total shareholders' equity | 3,335,041 | 3,085,734 | |
Total liabilities and shareholders' equity | $ 11,047,125 | $ 10,835,255 | |
JAZZ PHARMACEUTICALS PLC | |||
Three Months Ended | |||
2023 | 2022 | ||
Net cash provided by operating activities | $ 320,708 | $ 208,979 | |
Net cash used in investing activities | (4,822) | (37,292) | |
Net cash used in provided by financing activities | (29,788) | (270,811) | |
Effect of exchange rates on cash and cash equivalents | 331 | (1,489) | |
Net increase (decrease) in cash and cash equivalents | $ 286,429 | $ (100,613) | |
JAZZ PHARMACEUTICALS PLC | |||
Three Months Ended | |||
2023 | 2022 | ||
GAAP reported net income | $ 69,420 | $ 1,647 | |
Intangible asset amortization | 149,786 | 172,094 | |
Acquisition accounting inventory fair value step-up | 60,458 | 63,943 | |
Share-based compensation expense | 56,352 | 47,629 | |
Non-cash interest expense1 | 4,766 | 12,168 | |
Transaction and integration related expenses2 | — | 11,130 | |
Costs related to disposal of a business3 | — | 8,010 | |
Income tax effect of above adjustments | (55,521) | (54,687) | |
Non-GAAP adjusted net income | $ 285,261 | $ 261,934 | |
GAAP reported net income per diluted share4 | $ 1.04 | $ 0.03 | |
Non-GAAP adjusted net income per diluted share4 | $ 3.95 | $ 3.73 | |
Weighted-average ordinary shares used in diluted per share calculations - GAAP | 73,771 | 62,907 | |
Weighted-average ordinary shares used in diluted per share calculations - non-GAAP | 73,771 | 71,950 | |
________________________________________________ | |
Explanation of Adjustments and Certain Line Items: | |
1. | Non-cash interest expense associated with debt issuance costs. |
2. | Transaction and integration expenses related to the acquisition of GW. |
3. | Costs related to disposal of Sunosi to Axsome and associated restructuring. |
4. | Diluted EPS was calculated using the "if-converted" method in relation to the Exchangeable Senior Notes. GAAP reported net income per diluted share for the three months ended March 31, 2023 includes 9.0 million shares related to the assumed conversion of the Exchangeable Senior Notes and the associated interest expense add-back to GAAP net income of |
JAZZ PHARMACEUTICALS PLC | |||||||||||||||||
Three months ended March 31, 2023 | |||||||||||||||||
Cost of | Gross | Selling, | Research | Intangible | Acquired | Interest | Income tax | Effective | |||||||||
GAAP Reported | 85.5 % | $ 297,917 | $ 189,410 | $ 149,786 | $ 1,000 | (27.8) % | |||||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Intangible asset | — | — | — | — | (149,786) | — | — | — | — | ||||||||
Share-based | (3,458) | 0.4 | (37,402) | (15,492) | — | — | — | — | — | ||||||||
Acquisition accounting | (60,458) | 6.8 | — | — | — | — | — | — | — | ||||||||
Non-cash interest | — | — | — | — | — | — | (4,766) | — | — | ||||||||
Income tax effect of | — | — | — | — | — | — | — | 55,521 | 40.1 | ||||||||
Total of non-GAAP | (63,916) | 7.2 | (37,402) | (15,492) | (149,786) | — | (4,766) | 55,521 | 40.1 | ||||||||
Non-GAAP Adjusted | $ 64,728 | 92.7 % | $ 260,515 | $ 173,918 | $ — | $ 1,000 | $ 40,197 | 12.3 % | |||||||||
Three months ended March 31, 2022 | |||||||||||||||
Cost of | Gross | Selling, general | Research and | Intangible | Interest | Income tax | Effective | ||||||||
GAAP Reported | 85.8 % | $ 308,813 | $ 129,981 | $ 172,094 | $ 70,684 | $ 536 | 8.5 % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||
Intangible asset amortization | — | — | — | — | (172,094) | — | — | — | |||||||
Share-based compensation | (2,816) | 0.3 | (32,514) | (12,299) | — | — | — | — | |||||||
Costs related to the disposal of a | — | — | (8,010) | — | — | — | — | — | |||||||
Transaction and integration | (319) | — | (9,588) | (1,223) | — | — | — | — | |||||||
Non-cash interest expense | — | — | — | — | — | (12,168) | — | — | |||||||
Acquisition accounting | (63,943) | 7.9 | — | — | — | — | — | — | |||||||
Income tax effect of above | — | — | — | — | — | — | 54,687 | 8.7 | |||||||
Total of non-GAAP | (67,078) | 8.2 | (50,112) | (13,522) | (172,094) | (12,168) | 54,687 | 8.7 | |||||||
Non-GAAP Adjusted | $ 48,206 | 94.0 % | $ 258,701 | $ 116,459 | $ — | $ 58,516 | $ 55,223 | 17.2 % | |||||||
__________________________ | |
(1) | The GAAP effective tax rates were derived from the income tax benefit, which increased as a result of the mix of pre-tax income and losses across tax jurisdictions, and increases in our patent box and foreign derived intangible income benefits. |
JAZZ PHARMACEUTICALS PLC | |
GAAP net income | |
Intangible asset amortization | 555 - 595 |
Acquisition accounting inventory fair value step-up | 135 - 155 |
Share-based compensation expense | 230 - 260 |
Non-cash interest expense | 20 - 30 |
Income tax effect of above adjustments | (190) - (210) |
Non-GAAP adjusted net income | |
GAAP net income per diluted share | |
Non-GAAP adjusted net income per diluted share | |
Weighted-average ordinary shares used in per share calculations - GAAP and non-GAAP | 75 |
Contacts:
Investors:
Andrea N. Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
InvestorInfo@jazzpharma.com
Media:
Kristin Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
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SOURCE Jazz Pharmaceuticals plc
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