Jazz Pharmaceuticals Announces First Quarter 2022 Financial Results and Raises 2022 Financial Guidance
"We're pleased to raise our top- and bottom-line guidance, driven by our continued execution and significant progress across commercial and R&D in the first quarter, which positions us well for the rest of the year and to achieve Vision 2025," said
"We've had a highly productive start to 2022 with the submission of two Rylaze Supplemental Biologics License Applications, the first patient enrolled in our Phase 2 basket trial for Zepzelca® and the first presentation of preclinical data for JZP815, an investigational, next-generation pan-RAF kinase inhibitor," said
- Robust early launch momentum in first full quarter of Xywav for IH
- Submitted a Rylaze Supplemental Biologics License Application (sBLA) for Monday/Wednesday/Friday (M/W/F) intramuscular (IM) dosing and an sBLA for intravenous (IV) administration; both are being reviewed under the Real-Time Oncology Review (RTOR) program
- First patient enrolled in Zepzelca EMERGE-201 Phase 2 basket trial
- Strengthened leadership in sleep medicine with addition of a potent, highly selective oral orexin-2 receptor agonist, JZP441 (DSP-0187)
- Expanded oncology pipeline with JZP898 (WTX-613), a differentiated, conditionally activated IFNα INDUKINE™ molecule
- Strategic divestiture of Sunosi® allows increased investment and sharpens focus on highest strategic priorities
- Growing and durable commercial franchises drove 1Q22 total revenues of
$813.7 million ; 34% increase compared to the same period in 2021 - Raising top- and bottom-line guidance; 2022 total revenue guidance increased to
$3.5 to$3.7 billion - Net leverage ratio of 3.9x1 as of
March 31, 2022 , demonstrating rapid deleveraging following the close of theGW Pharmaceuticals (GW) acquisition; on-track for target of less than 3.5x by the end of 2022 - Substantial revenue diversification continues as newer products continue to grow and the Company optimizes its commercial portfolio
1 |
On a non-GAAP adjusted basis. Non-GAAP net leverage ratio is a non-GAAP financial measure. For further information, see "Non-GAAP Financial Measures." |
- Net product sales for the combined oxybate business increased 6% to
$433.6 million in 1Q22 compared to the same period in 2021. - Average active oxybate patients on therapy was approximately 16,650 in 1Q22, an increase of approximately 6% compared to the same period in 2021.
- Xywav net product sales increased 147% to
$186.1 million in 1Q22 compared to the same period in 2021. - There were approximately 7,800 active Xywav patients exiting 1Q22.
- Xywav has broad patent protection to 2033.
- There were approximately 7,050 narcolepsy patients taking Xywav exiting 1Q22.
- The benefits of lowering sodium intake continues to resonate with patients and prescribers. In
June 2021 ,U.S. Food and Drug Administration (FDA) recognized seven years of Orphan Drug Exclusivity (ODE), throughJuly 2027 , for Xywav and 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."
- Positive early launch momentum with approximately 750 IH patients taking Xywav exiting 1Q22.
- The Company launched Xywav for IH in
November 2021 , with initial launch efforts focused on the approximately 37,000 currently diagnosed patients in theU.S. who are actively seeking healthcare. Healthcare providers are excited to have a treatment option with positive and compelling clinical trial results that address IH and not just its symptoms. - FDA recognized ODE for IH in
January 2022 , extending regulatory exclusivity toAugust 2028 .
- Xyrem net product sales decreased 26% to
$247.5 million in 1Q22 compared to the same period in 2021, reflecting the continued adoption of Xywav by patients with narcolepsy.
- Epidiolex/Epidyolex net product sales increased 6% to
$157.9 million in 1Q22 compared to the same period in 2021, on a proforma basis. - Epidiolex/Epidyolex net product sales in 4Q21 were favorably impacted by approximately
$18 million , due to a temporary increase in specialty pharmacy inventory levels at the end of 2021. The majority of this increase reversed in 1Q22, reducing 1Q22 revenues. - Excluding this impact, we saw double-digit percentage revenue growth in 1Q22 compared to 1Q21, and sequential growth in underlying demand, despite challenges posed by the Omicron variant.
- Epidyolex is now commercially available and fully reimbursed in four of the five key European markets:
United Kingdom ,Germany ,Italy andSpain , with an anticipated launch inFrance in 2022. The Company has made significant progress on its European rollout with launches inSpain ,Italy andSwitzerland in 3Q21 andIreland andNorway in 1Q22. - The Company expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures (EMAS), the fourth target indication for Epidiolex, in 1H22.
- The Company continues to strengthen the durability of Epidiolex. Patent US 11,207,292 is Orange Book listed and extends through 2039. This patent covers the composition of the botanically derived cannabidiol (CBD) preparation used in Epidiolex and the treatment of indicated disorders using that CBD preparation.
- Zepzelca net product sales increased 9% to
$59.3 million in 1Q22 compared to the same period in 2021. - The Company is pleased to have established Zepzelca as the treatment of choice in the second-line small cell lung cancer (SCLC) setting after only eighteen months on the market.
- Zepzelca development program updates:
- In
March 2022 , the first patient was enrolled in the EMERGE-201 Phase 2 basket trial evaluating Zepzelca as monotherapy in select relapsed/refractory solid tumors. - Jazz and collaborator
F. Hoffmann-La Roche Ltd (Roche) have initiated a Phase 3 trial to evaluate first-line use of Zepzelca in combination with Tecentriq® (atezolizumab), compared to Tecentriq alone, as maintenance therapy in patients with extensive-stage SCLC after induction chemotherapy. The first patient was enrolled in the trial inNovember 2021 . - The Company's partner, PharmaMar, initiated a confirmatory trial, LAGOON, in second-line SCLC in
December 2021 . If positive, this trial could confirm the benefit of Zepzelca in the treatment of SCLC when patients progress following first-line treatment with a platinum-based regimen.
- Rylaze net product sales were
$54.2 million in 1Q22. - The continued strong launch of Rylaze reflects the significant unmet patient need for a high-quality, reliable supply of Erwinia asparaginase for patients with ALL.
- In
January 2022 , the Company completed the submission of an sBLA to FDA seeking approval for a M/W/F IM dosing schedule for Rylaze. InApril 2022 , the Company also completed the submission of an sBLA to FDA seeking approval for IV administration of Rylaze. Both submissions are being reviewed under the RTOR program. - The Company anticipates that data from the current development program will support regulatory filings in
Europe in mid-2022, including IV administration, with potential for approval in 2023. The Company is also working with a partner to advance the program for potential submission, approval and launch inJapan .
- On
May 4, 2022 , the Company and Sumitomo Pharma Co., Ltd. announced an exclusive license agreement for DSP-0187, now called JZP441, a potent, highly selective oral orexin-2 receptor agonist designed to activate orexin signaling. - Sumitomo Pharma initiated a Phase 1 clinical trial in
Japan inNovember 2021 to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers. - The collaboration will leverage the Company's substantial experience and leadership in sleep disorders to advance this therapy with the potential to improve patient care.
- Financial terms included a
$50 million upfront payment to Sumitomo Pharma, and Sumitomo Pharma is eligible to receive development, regulatory and commercial milestone payments of up to$1.09 billion . Pending approval, Sumitomo Pharma is eligible to receive a tiered, low double-digit royalty on the Company's future net sales of JZP441.
- On
April 7, 2022 , the Company and Werewolf Therapeutics entered into a licensing agreement under which the Company acquired exclusive global development and commercialization rights to Werewolf's investigational molecule, WTX-613, now called JZP898, a differentiated, conditionally activated IFNα INDUKINE™ molecule. - 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 aim of JZP898 is to minimize the severe toxicities that have been observed with systemically active recombinant IFNα therapy and maximize clinical benefit when administered as monotherapy or in combination with other agents.
- Jazz expects to file an Investigational New Drug (IND) application in the
U.S. in 2023. - Financial terms included a
$15 million upfront payment to Werewolf, and Werewolf is eligible to receive development, regulatory and commercial milestone payments of up to$1.26 billion . Pending approval, Werewolf is eligible to receive a tiered, mid-single-digit percentage royalty on the net sales.
- On
March 28, 2022 , Jazz entered into a definitive agreement to divest Sunosi to Axsome Therapeutics. - The Company will receive an upfront payment of
$53 million , a high single-digit royalty on Axsome'sU.S. net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome'sU.S. net sales of Sunosi in future indications. - The Company and Axsome are committed to ensuring that patients receive uninterrupted access to Sunosi throughout the transition.
- The companies expect the
U.S. transaction to close in the second quarter of 2022 and the ex-U.S. transaction close to occur within 60 days following the close of theU.S. transaction.
- There are currently three ongoing Phase 3 trials in multiple sclerosis (MS)-related spasticity. The Company anticipates data from its first Phase 3 trial, NCT04657666, in 2Q22; supportive findings may enable a New Drug Application submission to FDA in 2022.
- Suvecaltamide, a highly selective modulator of T-type calcium channels, is in clinical development for the treatment of essential tremor.
- The Company initiated a Phase 2b trial in 4Q21 and announced that the first patient was enrolled in
December 2021 . Top-line data read-out is anticipated in 1H24.
- JZP150, a selective fatty acid amide hydrolase, or FAAH, inhibitor, is in clinical development for the potential treatment of post-traumatic stress disorder (PTSD).
- The Company initiated a Phase 2 trial in 4Q21 and announced that the first patient was enrolled in
December 2021 . Top-line data read-out is anticipated in late 2023. - The Company received Fast Track Designation for JZP150 development in PTSD from FDA in 4Q21, underscoring the significant unmet medical needs of patients.
- JZP815 is an investigational, preclinical stage pan-RAF kinase inhibitor that targets specific components of the mitogen-activated protein kinase (MAPK) pathway, which when activated by oncogenic mutations, can be a frequent driver of human cancer.
- 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.
- The Company, together with our preclinical collaboration partner, Redx Pharma, presented its first preclinical data in a poster at the
American Association for Cancer Research Annual Meeting inApril 2022 . - JZP815 inhibited tumor growth in several RAS- and BRAF-mutated solid tumor models, and demonstrated enhanced activity when combined with other MAPK pathway inhibitors.
- The Company plans to submit an IND for JZP815 this year.
Sunosi® (solriamfetol):
- Sunosi net product sales increased by 37% to
$15.9 million in 1Q22 compared to the same period in 2021.
Vyxeos® (daunorubicin and cytarabine) liposome for injection:
- Vyxeos net product sales increased 2% to
$33.8 million in 1Q22 compared to the same period in 2021.
Defitelio® (defibrotide sodium) / defibrotide:
- Defitelio/defibrotide net product sales of
$49.5 million in 1Q22 were consistent with the same period in 2021.
Financial Highlights |
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Three Months Ended |
|||
(In thousands, except per share amounts) |
2022 |
2021 |
|
Total revenues |
$ 813,721 |
$ 607,581 |
|
GAAP net income |
$ 1,647 |
$ 121,832 |
|
Adjusted net income |
$ 261,934 |
$ 228,819 |
|
GAAP EPS |
$ 0.03 |
$ 2.09 |
|
Adjusted EPS1,2 |
$ 3.73 |
$ 3.92 |
1. |
Adjusted EPS in 1Q22 was impacted by |
||
2. |
The Company adopted ASU No. 2020-06, "Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's Own Equity", (ASU 2020-06) on |
GAAP net income in 1Q22 was
Total Revenues |
|||
Three Months Ended |
|||
(In thousands) |
2022 |
2021 |
|
Xyrem |
$ 247,497 |
$ 335,550 |
|
Xywav |
186,080 |
75,416 |
|
Total Oxybate |
433,577 |
410,966 |
|
Epidiolex/Epidyolex1 |
157,893 |
— |
|
Sunosi |
15,878 |
11,606 |
|
Sativex® (nabiximols)1 |
4,742 |
— |
|
Total Neuroscience |
612,090 |
422,572 |
|
Zepzelca |
59,338 |
54,334 |
|
Rylaze |
54,220 |
— |
|
Vyxeos |
33,757 |
33,155 |
|
Defitelio/defibrotide |
49,489 |
49,619 |
|
Erwinaze/Erwinase |
— |
41,068 |
|
Total Oncology |
196,804 |
178,176 |
|
Other |
943 |
2,783 |
|
Product sales, net |
809,837 |
603,531 |
|
Royalties and contract revenues |
3,884 |
4,050 |
|
Total revenues |
$ 813,721 |
$ 607,581 |
1. |
Net product sales for Epidiolex/Epidyolex and Sativex are included from the acquisition of GW on |
Total revenues increased 34% in 1Q22 compared to the same period in 2021.
- Neuroscience net product sales in 1Q22 increased 45% to
$612.1 million compared to the same period in 2021 primarily driven by Epidiolex/Epidyolex net product sales in the first quarter of 2022 of$157.9 million following the acquisition of GW. In 1Q22, oxybate net product sales increased 6% to$433.6 million . - Oncology net product sales in 1Q22 increased 10% to
$196.8 million compared to the same period in 2021 primarily driven by Rylaze net product sales in 1Q22 of$54.2 million following product launch inJuly 2021 , partially offset by Erwinaze/Erwinase net product sales in 1Q21 of$41.1 million .
Operating Expenses and Effective Tax Rate |
|||
Three Months Ended |
|||
(In thousands, except percentages) |
2022 |
2021 |
|
GAAP: |
|||
Cost of product sales |
$ 115,284 |
$ 40,189 |
|
Gross margin |
85.8% |
93.3% |
|
Selling, general and administrative |
$ 308,813 |
$ 260,508 |
|
% of total revenues |
38.0% |
42.9% |
|
Research and development |
$ 129,981 |
$ 76,573 |
|
% of total revenues |
16.0% |
12.6% |
|
Income tax expense |
$ 536 |
$ 18,019 |
|
Effective tax rate |
8.5% |
13.3% |
|
Three Months Ended |
|||
(In thousands, except percentages) |
2022 |
2021 |
|
Non-GAAP adjusted: |
|||
Cost of product sales |
$ 48,206 |
$ 38,193 |
|
Gross margin |
94.0% |
93.7% |
|
Selling, general and administrative |
$ 258,701 |
$ 228,400 |
|
% of total revenues |
31.8% |
37.6% |
|
Research and development |
$ 116,459 |
$ 67,930 |
|
% of total revenues |
14.3% |
11.2% |
|
Income tax expense |
$ 55,223 |
$ 37,659 |
|
Effective tax rate |
17.2% |
14.4% |
Operating expenses increased over the prior year period primarily due to the following:
- Cost of product sales increased in 1Q22 compared to the same period in 2021, on a GAAP and on a non-GAAP adjusted basis, due to increased net product sales as a result of the acquisition of GW. In addition, acquisition accounting inventory fair value step-up expense of
$63.9 million in 1Q22 impacted GAAP cost of product sales. - Selling, general and administrative (SG&A) expenses increased in 1Q22 compared to the same period in 2021, on a GAAP and on a non-GAAP adjusted basis, primarily due to an increase in compensation-related expenses driven by higher headcount as a result of the acquisition of GW.
- Research and development (R&D) expenses increased in 1Q22 compared to the same period in 2021, on a GAAP and on a non-GAAP adjusted basis, primarily due to the addition of costs related to clinical programs for Epidiolex, nabiximols and cannabinoids, an increase in costs related to JZP150 and suvecaltamide (JZP385) and an increase in compensation-related expenses due to higher headcount primarily driven by the acquisition of GW.
As of
The Company is raising its full year 2022 financial guidance as follows:
(In millions) |
|
|
|
Revenues |
|
|
|
–Neuroscience (includes potential Xyrem authorized generic royalties) |
|
|
|
–Oncology |
|
|
GAAP: |
|||
(In millions, except per share amounts and percentages) |
|
|
|
Gross margin % |
84% |
83% |
|
SG&A expenses |
|
|
|
SG&A expenses as % of total revenues |
35% - 40% |
35% - 40% |
|
R&D expenses |
|
|
|
R&D expenses as % of total revenues |
17% - 19% |
17% - 19% |
|
Acquired in-process research and development expenses |
|
- |
|
Effective tax rate |
(117)% - (30)% |
(116)% - (32)% |
|
Net income |
|
|
|
Net income per diluted share5 |
|
|
|
Weighted-average ordinary shares used in per share calculations |
63 - 72 |
72 |
Non-GAAP: |
|||
(In millions, except per share amounts and percentages) |
|
|
|
Gross margin % |
93%1,6 |
92% |
|
SG&A expenses |
|
|
|
SG&A expenses as % of total revenues |
29% - 32% |
31% - 34% |
|
R&D expenses |
|
|
|
R&D expenses as % of total revenues |
15% - 17% |
15% - 17% |
|
Acquired in-process research and development expenses |
|
- |
|
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 |
72 |
72 |
1. |
Excludes |
2. |
Excludes |
3. |
Excludes |
4. |
Excludes the income tax effect of adjustments between GAAP net income and non-GAAP adjusted net income. |
5. |
Non-GAAP adjusted EPS guidance for 2022 reflects dilution 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 2022 Net Income Guidance" at the end of this press release. |
A replay of the conference call will be available through
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 and to its forward-looking guidance, to identify operating trends in the Company's business and to understand the Company's ability to delever. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the Company's financial performance.
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 2022 financial guidance and the Company's expectations related thereto; the proposed divestiture of Sunosi to Axsome, the anticipated upfront payment and royalties to be received by Jazz in connection therewith and the other anticipated benefits thereof; statements related to DSP-0187's potential application for the treatment of sleep disorders; the potential successful future development, manufacturing, regulatory and commercialization activities; potential future payments by
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: Jazz's and Axsome's ability to complete the proposed divestiture of Sunosi on the proposed terms or on the anticipated timeline, or at all, including risks and uncertainties related to the expiration or securing early termination of the applicable waiting period under the HSR act; 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; 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, including the risk that the Company's sBLA seeking approval for a revised dosing label for Rylaze may not be approved by FDA 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 such as those being experienced, and expected to continue to be experienced, by the Company as a result of the effects of the COVID-19 pandemic; the Company's failure to realize the expected benefits of its acquisition of
JAZZ PHARMACEUTICALS PLC |
|||
Three Months Ended |
|||
2022 |
2021 |
||
Revenues: |
|||
Product sales, net |
$ 809,837 |
$ 603,531 |
|
Royalties and contract revenues |
3,884 |
4,050 |
|
Total revenues |
813,721 |
607,581 |
|
Operating expenses: |
|||
Cost of product sales (excluding amortization of acquired developed technologies) |
115,284 |
40,189 |
|
Selling, general and administrative |
308,813 |
260,508 |
|
Research and development |
129,981 |
76,573 |
|
Intangible asset amortization |
172,094 |
68,192 |
|
Total operating expenses |
726,172 |
445,462 |
|
Income from operations |
87,549 |
162,119 |
|
Interest expense, net |
(70,684) |
(27,376) |
|
Foreign exchange loss (gain) |
(10,540) |
943 |
|
Income before income tax expense and equity in loss (gain) of investees |
6,325 |
135,686 |
|
Income tax expense |
536 |
18,019 |
|
Equity in loss (gain) of investees |
4,142 |
(4,165) |
|
Net income |
$ 1,647 |
$ 121,832 |
|
Net income per ordinary share: |
|||
Basic |
$ 0.03 |
$ 2.16 |
|
Diluted |
$ 0.03 |
$ 2.09 |
|
Weighted-average ordinary shares used in per share calculations - basic |
61,865 |
56,468 |
|
Weighted-average ordinary shares used in per share calculations - diluted |
62,907 |
58,393 |
JAZZ PHARMACEUTICALS PLC |
|||
The following unaudited pro forma information represents the net product sales for the three months ended |
|||
Three Months Ended |
|||
2022 |
2021 |
||
Xyrem |
$ 247,497 |
$ 335,550 |
|
Xywav |
186,080 |
75,416 |
|
Total Oxybate |
433,577 |
410,966 |
|
Epidiolex/Epidyolex |
157,893 |
148,261 |
|
Sunosi |
15,878 |
11,606 |
|
Sativex® (nabiximols) |
4,742 |
4,181 |
|
Total Neuroscience |
612,090 |
575,014 |
|
Zepzelca |
59,338 |
54,334 |
|
Rylaze |
54,220 |
— |
|
Vyxeos |
33,757 |
33,155 |
|
Defitelio/defibrotide |
49,489 |
49,619 |
|
Erwinaze/Erwinase |
— |
41,068 |
|
Total Oncology |
196,804 |
178,176 |
|
Other |
943 |
2,783 |
|
Product sales, net |
$ 809,837 |
$ 755,973 |
JAZZ PHARMACEUTICALS PLC |
|||
|
|
||
ASSETS |
|||
Current assets: |
|||
Cash and cash equivalents |
$ 490,835 |
$ 591,448 |
|
Accounts receivable, net of allowances |
572,392 |
563,360 |
|
Inventories |
985,454 |
1,072,721 |
|
Prepaid expenses |
117,399 |
131,413 |
|
Other current assets |
243,888 |
252,392 |
|
Assets held for sale |
90,888 |
— |
|
Total current assets |
2,500,856 |
2,611,334 |
|
Property, plant and equipment, net |
257,632 |
256,837 |
|
Operating lease assets |
83,412 |
86,586 |
|
Intangible assets, net |
6,783,057 |
7,152,328 |
|
|
1,782,444 |
1,827,609 |
|
Deferred tax assets, net |
314,672 |
311,103 |
|
Deferred financing costs |
11,336 |
12,029 |
|
Other non-current assets |
35,508 |
40,813 |
|
Total assets |
$ 11,768,917 |
$ 12,298,639 |
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|||
Current liabilities: |
|||
Accounts payable |
$ 73,336 |
$ 100,298 |
|
Accrued liabilities |
604,710 |
666,304 |
|
Current portion of long-term debt |
31,000 |
31,000 |
|
Income taxes payable |
26,677 |
9,608 |
|
Deferred revenue |
1,686 |
2,093 |
|
Total current liabilities |
737,409 |
809,303 |
|
Deferred revenue, non-current |
347 |
463 |
|
Long-term debt, less current portion |
5,992,868 |
6,018,943 |
|
Operating lease liabilities, less current portion |
83,078 |
87,200 |
|
Deferred tax liabilities, net |
1,222,084 |
1,300,541 |
|
Other non-current liabilities |
124,644 |
116,998 |
|
Total shareholders' equity |
3,608,487 |
3,965,191 |
|
Total liabilities and shareholders' equity |
$ 11,768,917 |
$ 12,298,639 |
|
|||
Three Months Ended |
|||
2022 |
2021 |
||
Net cash provided by operating activities |
$ 208,979 |
$ 284,997 |
|
Net cash (used in) provided by investing activities |
(37,292) |
737,132 |
|
Net cash (used in) provided by financing activities |
(270,811) |
18,276 |
|
Effect of exchange rates on cash and cash equivalents |
(1,489) |
(641) |
|
Net increase (decrease) in cash and cash equivalents |
$ (100,613) |
$ 1,039,764 |
|
|||
Three Months Ended |
|||
2022 |
2021 |
||
GAAP reported net income |
$ 1,647 |
$ 121,832 |
|
Intangible asset amortization |
172,094 |
68,192 |
|
Share-based compensation expense |
47,629 |
34,485 |
|
Transaction and integration related expenses1 |
11,130 |
8,262 |
|
Non-cash interest expense2 |
12,168 |
15,688 |
|
Acquisition accounting inventory fair value step-up |
63,943 |
— |
|
Costs related to disposal of a business3 |
8,010 |
— |
|
Income tax effect of above adjustments |
(54,687) |
(19,640) |
|
Non-GAAP adjusted net income |
$ 261,934 |
$ 228,819 |
|
GAAP reported net income per diluted share |
$ 0.03 |
$ 2.09 |
|
Non-GAAP adjusted net income per diluted share 4 |
$ 3.73 |
$ 3.92 |
|
Weighted-average ordinary shares used in diluted per share calculations - GAAP |
62,907 |
58,393 |
|
Weighted-average ordinary shares used in diluted per share calculations - non-GAAP |
71,950 |
58,393 |
Explanation of Adjustments and Certain Line Items: |
|
1. |
Transaction and integration expenses related to the acquisition of GW. |
2. |
Non-cash interest expense associated with debt discount and debt issuance costs. |
3. |
Costs related to disposal of Sunosi to Axsome and associated restructuring. |
4. |
Diluted EPS in 1Q22 was calculated using the "if-converted" method in relation to the Exchangeable Senior Notes. As such, non-GAAP adjusted net income per diluted share includes 9.0 million shares related to the assumed conversion of the Exchangeable Senior Notes and the associated interest expense add-back to net income of |
JAZZ PHARMACEUTICALS PLC |
|||||||||||||||
Three months ended |
|||||||||||||||
Cost of product sales |
Gross margin |
Selling, general and administrative |
Research and development |
Intangible asset amortization |
Interest expense, net |
Income tax provision |
Effective tax rate |
||||||||
GAAP Reported |
$ 115,284 |
85.8 % |
$ 308,813 |
$ 129,981 |
$ 172,094 |
$ 70,684 |
$ 536 |
8.5 % |
|||||||
Non-GAAP Adjustments: |
|||||||||||||||
Intangible asset amortization |
— |
— |
— |
— |
(172,094) |
— |
— |
— |
|||||||
Share-based compensation expense |
(2,816) |
0.3 |
(32,514) |
(12,299) |
— |
— |
— |
— |
|||||||
Costs related to the disposal of a business |
— |
— |
(8,010) |
— |
— |
— |
— |
— |
|||||||
Transaction and integration related expenses |
(319) |
— |
(9,588) |
(1,223) |
— |
— |
— |
— |
|||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
(12,168) |
— |
— |
|||||||
Acquisition accounting inventory fair value step-up |
(63,943) |
7.9 |
— |
— |
— |
— |
— |
— |
|||||||
Income tax effect of above adjustments |
— |
— |
— |
— |
— |
— |
54,687 |
8.7 |
|||||||
Total of non-GAAP adjustments |
(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 % |
|||||||
Three months ended |
|||||||||||||||
Cost of product sales |
Gross margin |
Selling, general and administrative |
Research and development |
Intangible asset amortization |
Interest expense, net |
Income tax provision |
Effective tax rate |
||||||||
GAAP Reported |
$ 40,189 |
93.3 % |
$ 260,508 |
$ 76,573 |
$ 68,192 |
$ 27,376 |
$ 18,019 |
13.3 % |
|||||||
Non-GAAP Adjustments: |
|||||||||||||||
Intangible asset amortization |
— |
— |
— |
— |
(68,192) |
— |
— |
— |
|||||||
Share-based compensation expense |
(1,996) |
0.4 |
(23,846) |
(8,643) |
— |
— |
— |
— |
|||||||
Transaction and integration related costs |
— |
— |
(8,262) |
— |
— |
— |
— |
— |
|||||||
Non-cash interest expense |
— |
— |
— |
— |
— |
(15,688) |
— |
— |
|||||||
Income tax effect of above adjustments |
— |
— |
— |
— |
— |
— |
19,640 |
1.1 |
|||||||
Total of non-GAAP adjustments |
(1,996) |
0.4 |
(32,108) |
(8,643) |
(68,192) |
(15,688) |
19,640 |
1.1 |
|||||||
Non-GAAP Adjusted |
$ 38,193 |
93.7 % |
$ 228,400 |
$ 67,930 |
$ — |
$ 11,688 |
$ 37,659 |
14.4 % |
JAZZ PHARMACEUTICALS PLC |
|
The following table provides a reconciliation of the Company's pro forma GAAP net loss to pro forma non-GAAP Adjusted EBITDA (calculated in accordance with the Credit Agreement) for the last twelve months, or LTM, ended |
|
LTM Ended |
|
Pro forma GAAP net loss2 |
$ (618,763) |
Interest expense, net |
322,158 |
Income tax expense |
199,555 |
Depreciation and amortization |
660,535 |
Pro forma non-GAAP EBITDA |
563,485 |
Transaction and integration related expenses |
406,866 |
Share-based compensation expense |
184,988 |
Acquisition accounting inventory fair value step-up |
287,028 |
Expected cost synergies3 |
35,000 |
Upfront and milestone payments |
15,000 |
Costs relating to the disposal of a business |
8,010 |
Other |
(35,075) |
Pro forma non-GAAP Adjusted EBITDA1 |
$ 1,465,302 |
At 2022 |
|
Calculation of Net Debt: |
|
Total GAAP debt |
$ 6,151,750 |
Cash and cash equivalents |
(490,835) |
Net Debt |
$ 5,660,915 |
Calculation of Pro Forma Non-GAAP Net Leverage Ratio: |
|
Pro forma non-GAAP Net Leverage Ratio |
3.9 |
1. |
Pro forma non-GAAP Adjusted EBITDA is calculated in accordance with the definition of Consolidated Adjusted EBITDA as set out in the Credit Agreement. |
||
2. |
Pro forma net loss is derived from the GAAP financial statements of the Company and GW for the LTM ended |
||
3. |
Expected cost synergies of |
JAZZ PHARMACEUTICALS PLC |
|
GAAP net income |
|
Intangible asset amortization |
620 - 660 |
Acquisition accounting inventory fair value step-up |
305 - 340 |
Share-based compensation expense |
220 - 250 |
Transaction and integration related expenses |
35 - 45 |
Costs related to disposal of a business |
40 - 50 |
Non-cash interest expense |
45 - 55 |
Income tax effect of above adjustments |
(215) - (235) |
Non-GAAP adjusted net income |
|
GAAP net income per diluted share |
|
Non-GAAP adjusted net income per diluted share1 |
|
Weighted-average ordinary shares used in per share calculations - GAAP |
63 - 72 |
Weighted-average ordinary shares used in per share calculations - non-GAAP |
72 |
1. |
Non-GAAP adjusted EPS guidance for 2022 reflects dilution of |
Contacts:
Investors:
Vice President, Head, Investor Relations
InvestorInfo@jazzpharma.com
Media:
Head of
CorporateAffairsMediaInfo@jazzpharma.com
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