JAZZ
$140.92
Jazz Pharma Plc
$1.01
.72%
Earnings Details
1st Quarter March 2019
Tuesday, May 7, 2019 4:05:00 PM
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Summary

Jazz Pharmaceuticals Reaffirms

Jazz Pharma Plc (JAZZ) reported 1st Quarter March 2019 earnings of $3.27 per share on revenue of $508.2 million. The consensus earnings estimate was $2.83 per share on revenue of $471.0 million. Revenue grew 14.3% on a year-over-year basis.

The company said it continues to expect 2019 non-GAAP earnings of $14.30 to $15.00 per share on revenue of $2.05 billion to $2.13 billion. The current consensus earnings estimate is $14.60 per share on revenue of $2.08 billion for the year ending December 31, 2019.

Results
Reported Earnings
$3.27
Earnings Whisper
-
Consensus Estimate
$2.83
Reported Revenue
$508.2 Mil
Revenue Estimate
$471.0 Mil
Growth
Earnings Growth
Revenue Growth
Power Rating
Grade
Earnings Release

Jazz Pharmaceuticals Announces First Quarter 2019 Financial Results

DUBLIN, May 7, 2019 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the first quarter of 2019 and reaffirmed 2019 financial guidance.

"In the first quarter of 2019, we delivered strong top- and bottom-line growth and continued our efforts to bring innovative and life-changing medicines to patients, with FDA approval of Sunosi for EDS associated with narcolepsy or OSA, launch of Xyrem in pediatric narcolepsy and announcement of positive top-line results from our Phase 3 study of JZP-258," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "As the year progresses, we are continuing to invest in our business to support the successful launch of Sunosi in the U.S. and pre-launch activities in the EU, to generate data for our existing products and to fuel further advancement and diversification of our pipeline."

Financial Highlights













Three Months Ended
March 31,



(In thousands, except per share amounts and percentages)

2019


2018


Change

Total revenues

$

508,186



$

444,613



14

%

GAAP net income

$

85,201



$

45,991



85

%

Adjusted net income

$

213,173



$

182,371



17

%

GAAP EPS

$

1.47



$

0.75



96

%

Adjusted EPS

$

3.67



$

2.98



23

%

GAAP net income for the first quarter of 2019 was $85.2 million, or $1.47 per diluted share, compared to $46.0 million, or $0.75 per diluted share, for the first quarter of 2018.

Adjusted net income for the first quarter of 2019 was $213.2 million, or $3.67 per diluted share, compared to $182.4 million, or $2.98 per diluted share, for the first quarter of 2018. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Key Regulatory/R&D Updates 

In March 2019, the company announced that the U.S. Food and Drug Administration (FDA) approved Sunosi (solriamfetol) to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA. Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA for this indication and was approved with strengths of 75 mg and 150 mg for patients with narcolepsy and 37.5 mg, 75 mg, and 150 mg for patients with OSA.

In March 2019, the company announced positive top-line results from the global, double-blind, placebo-controlled, randomized-withdrawal, multi-center Phase 3 study evaluating the efficacy and safety of JZP-258 for the treatment of cataplexy and EDS in adult patients with narcolepsy. JZP-258 is a novel oxybate product candidate with a 92% reduction in sodium content compared to Xyrem.

In March 2019, positive results from DEFIFrance, an observational, multi-center, post-marketing study in adult and pediatric patients treated with defibrotide at hematopoietic stem cell transplant centers in France, were presented at the European Society for Blood and Marrow Transplant (EBMT) meeting.

Select 2019 Milestones




Programs


2019 Milestones*

Xyrem® (sodium oxybate) oral solution

Launched in March for the treatment of cataplexy or EDS in pediatric narcolepsy

JZP-258

Announced positive top-line results in March from the Phase 3 narcolepsy study


-

Expect to submit top-line results from the Phase 3 narcolepsy study to a fall medical meeting


-

Pre-New Drug Application (NDA) meeting with FDA


-

Goal to submit NDA as early as year-end

Sunosi™ (solriamfetol)

FDA approval on March 20 for EDS in narcolepsy or OSA


-

Drug Enforcement Administration (DEA) scheduling decision by late second quarter


-

Initiate Sunosi launch following DEA scheduling decision


-

Announce new Phase 3 development program mid-year


-

Obtain EU approval for EDS in narcolepsy or OSA as early as year-end

Vyxeos® (daunorubicin and cytarabine) liposome for injection

-

Presentation by Children's Oncology Group at the American Society of Clinical Oncology (relapsed/refractory pediatric acute myeloid leukemia (AML) study data)


-

Potential interim combination data results from MD Anderson collaboration


-

Finalized protocol for Phase 1/2 study (low-dose Vyxeos in combination with venetoclax); patient enrollment is expected to begin in the second half of the year

Defitelio® (defibrotide sodium) / defibrotide

Presentation of positive results from DEFIFrance study at EBMT in March


-

Conduct interim analysis of the Phase 3 study for prevention of hepatic veno-occlusive disease (VOD)


-

Complete enrollment in prevention of acute graft-vs-host disease Phase 2 study


-

Initiate exploratory Phase 2 study in chimeric antigen receptor t-cell therapy associated neurotoxicity


-

Initiate Phase 2 study in transplant-associated thrombotic microangiopathy

Asparaginase

-

Provide informational update on early-stage recombinant crisantaspase program later this year

CombiPlex®

-

Continue Investigational New Drug enabling activities for one solid tumor combination and progress exploratory activities for other hematology/oncology candidates


* Milestones denoted as • have been completed; all other milestones are planned or expected in 2019.

Other Developments

In March 2019, the company launched Xyrem to treat cataplexy and EDS in pediatric narcolepsy patients following receipt of FDA approval in October 2018 after completing implementation of the Risk Evaluation and Mitigation Strategy to include pediatric patients and their caregivers.

In April 2019, the company announced the finalization of the settlement agreement with the U.S. Department of Justice (DOJ) related to the company's support of charitable organizations that provide financial assistance to Medicare patients. In 2018, the company had announced an agreement in principle and recorded a total expense of $58.2 million related to this matter, including related interest. Under the settlement agreement, in April 2019, the company paid $57.0 million plus interest and entered into a five-year corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.

Total Revenues










Three Months Ended
March 31,

(In thousands)

2019


2018

Xyrem® (sodium oxybate) oral solution

$

368,317



$

316,777


Erwinaze® / Erwinase® (asparaginase Erwinia chrysanthemi)

60,899



50,627


Defitelio® (defibrotide sodium) / defibrotide

41,500



35,061


Vyxeos® (daunorubicin and cytarabine) liposome for injection

28,943



26,228


Other

3,672



12,154


Product sales, net

503,331



440,847


Royalties and contract revenues

4,855



3,766


Total revenues

$

508,186



$

444,613


Total revenues increased 14% in the first quarter of 2019 compared to the same period in 2018.

Xyrem net product sales increased 16% in the first quarter of 2019 compared to the same period in 2018.

Erwinaze/Erwinase net product sales increased 20% in the first quarter of 2019 due to an increase in product availability compared to the same period in 2018. The company continues to expect supply disruptions throughout 2019 which will cause inter-quarter variability in Erwinaze net sales.

Defitelio/defibrotide net product sales increased 18% in the first quarter of 2019 compared to the same period in 2018 due to increased use by transplant centers that treat adult and pediatric patients. VOD is an ultra-rare disease and, as a result, the company continues to expect inter-quarter variability in Defitelio net sales.

Vyxeos net product sales increased 10% in the first quarter of 2019 compared to the same period in 2018 primarily due to the rolling launch in the EU initiated in September 2018. The company continues its education and outreach initiatives and its efforts to generate data to support Vyxeos' potential use across broader patient populations in AML and other hematological malignancies.

Operating Expenses










Three Months Ended
March 31,

(In thousands, except percentages)

2019


2018

GAAP:




Cost of product sales

$

33,506



$

33,919


Gross margin

93.3

%


92.3

%

Selling, general and administrative

$

167,947



$

207,213


% of total revenues

33.0

%


46.6

%

Research and development

$

60,105



$

62,667


% of total revenues

11.8

%


14.1

%

Acquired in-process research and development

$

56,000



$


Income tax provision

$

29,116



$

19,146


Effective tax rate

25.3

%


29.2

%











Three Months Ended
March 31,

(In thousands, except percentages)

2019


2018

Non-GAAP adjusted:




Cost of product sales

$

31,847



$

32,225


Gross margin

93.7

%


92.7

%

Selling, general and administrative

$

147,577



$

131,979


% of total revenues

29.0

%


29.7

%

Research and development

$

54,582



$

47,292


% of total revenues

10.7

%


10.6

%

Income tax provision

$

52,714



$

38,693


Effective tax rate

19.8

%


17.5

%

Operating expenses changed over the prior year period primarily due to the following:

  • Selling, general and administrative (SG&A) expenses on a GAAP basis decreased in the first quarter of 2019 compared to the same period in 2018 primarily due to a $57.0 million loss contingency recorded in 2018 related to the DOJ matter described above. SG&A expenses on a GAAP basis, excluding the impact of the loss contingency, and on a non-GAAP adjusted basis increased in the first quarter of 2019 compared to the same period in 2018 primarily due to higher expenses related to the planned launch of Sunosi in the U.S. and an increase in headcount and compensation-related expenses to support expansion of the business.
  • Research and development (R&D) expenses on a GAAP basis decreased in the first quarter of 2019 compared to the same period in 2018 primarily due to milestone payments of $11.0 million related to FDA acceptance for filing of the company's solriamfetol NDA recorded in 2018. R&D expenses on a GAAP basis, excluding the impact of milestone payments, and on a non-GAAP adjusted basis increased in the first quarter of 2019 compared to the same period in 2018 primarily due to expenses related to the company's pre-clinical and clinical development programs, including partner programs, regulatory activities and related headcount increases to support these efforts.

Cash Flow and Balance Sheet

As of March 31, 2019, cash, cash equivalents and investments were $832.5 million and the outstanding principal balance of the company's long-term debt was $1.8 billion. During the first quarter of 2019, the company generated $202.3 million of cash from operations, made an upfront payment of $56.0 million to Codiak BioSciences, Inc. under a collaboration agreement and used $111.2 million to repurchase shares.

In the first quarter of 2019, the company repurchased approximately 858,000 ordinary shares under the company's share repurchase program at an average cost of $129.66 per ordinary share. As of March 31, 2019, the remaining amount authorized for share repurchases was $267.9 million.

2019 Financial Guidance

Jazz Pharmaceuticals is reaffirming its full year 2019 financial guidance as follows (in millions, except per share amounts and percentages):

Revenues1


$2,050 - $2,130


Total net product sales1


$2,035 - $2,110


-Xyrem net sales


$1,530 - $1,570


-Erwinaze/Erwinase net sales


$160 - $195


-Defitelio/defibrotide net sales


$155 - $180


-Vyxeos net sales


$120 - $150


GAAP gross margin %


94%


Non-GAAP adjusted gross margin %2,6


94%


GAAP SG&A expenses


$702 - $740


Non-GAAP adjusted SG&A expenses3,6


$620 - $650


GAAP R&D expenses


$257 - $326


GAAP Acquired in-process research and development expenses


$56


Non-GAAP adjusted R&D expenses4,6


$235 - $265


GAAP effective tax rate


17% - 21%


Non-GAAP adjusted effective tax rate5,6


17% - 19%


GAAP net income per diluted share


$6.80 - $8.50


Non-GAAP adjusted net income per diluted share6


$14.30 - $15.00


____________________________



1.

Includes minimal net sales contribution from Sunosi in the U.S., assuming launch in mid-2019.



2.

Excludes $6-$8 million of share-based compensation expense from estimated GAAP gross margin.



3.

Excludes $82-$90 million of share-based compensation expense from estimated GAAP SG&A expenses.



4.

Excludes $0-$34 million of milestone payments and $22-$27 million of share-based compensation expense from estimated GAAP R&D expenses.



5.

Excludes the income tax effect of adjustments between GAAP reported and non-GAAP adjusted net income.



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 2019 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. EDT (9:30 p.m. IST) to provide a business and financial update and discuss its 2019 first quarter results. The live webcast may be accessed from the Investors section of the company's website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 6667859.

A replay of the conference call will be available through May 14, 2019 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 6667859. An archived version of the webcast will be available for at least one week in the Investors section of the company's website at www.jazzpharmaceuticals.com.

About Jazz Pharmaceuticals plc

Jazz Pharmaceuticals plc (Nasdaq: JAZZ), a global biopharmaceutical company, is dedicated to developing life-changing medicines for people with limited or no options. As a leader in sleep medicine and with a growing hematology/oncology portfolio, Jazz has a diverse portfolio of products and product candidates in development, and is focused on transforming biopharmaceutical discoveries into novel medicines. Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Defitelio® (defibrotide sodium) and Vyxeos® (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Erwinase®, Defitelio® (defibrotide) and Vyxeos® 44 mg/100 mg powder for concentrate for solution for infusion in countries outside the U.S. For country-specific product information, please visit https://www.jazzpharma.com/medicines. For more information, please visit www.jazzpharmaceuticals.com and follow us on Twitter at @JazzPharma.

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 reported GAAP 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 non-GAAP adjustments. In this regard, the components of non-GAAP adjusted net income, including non-GAAP cost of product sales, non-GAAP SG&A expenses and non-GAAP 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. In particular, the company believes 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, 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 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.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 

This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' future financial and operating results, including its 2019 financial guidance, the company's planned or expected 2019 milestones and the timing thereof, the company's continuing investments to support a successful launch of Sunosi in the U.S. and EU pre-launch activities, to generate data for its existing products and to fuel further advancement and diversification of its pipeline, the company's expectations of further Erwinaze supply disruptions and inter-quarter variability in Erwinaze and Defitelio net sales, the company's plans to generate data to support existing products, including Vyxeos' potential use across broader patient populations in AML and other hematological malignancies, 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 Xyrem; effectively commercializing the company's other products and product candidates, including the risk of a potential delay in the commercial launch of Sunosi in the U.S. due to the DEA scheduling review or otherwise; the time-consuming and uncertain regulatory approval process, including the risk that the company's regulatory submissions, including the Sunosi marketing authorization application in the EU, may not be approved by applicable regulatory authorities in a timely manner or at all; costly and time-consuming pharmaceutical product development and the uncertainty of clinical success, including risks related to failure or delays in initiating or completing clinical trials; protecting and enhancing the company's intellectual property rights; 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; government investigations and other actions; obtaining and maintaining adequate coverage and reimbursement for the company's products; identifying and acquiring, in-licensing or developing additional products or product candidates, financing these transactions and successfully integrating acquired businesses; the ability to achieve expected future financial performance and results and the uncertainty of future tax and other provisions and estimates; 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 plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company's Annual Report on Form 10-K for the year ended December 31, 2018 and future filings and reports by the company, including the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2019. 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
March 31,


2019


2018

Revenues:




Product sales, net

$

503,331



$

440,847


Royalties and contract revenues

4,855



3,766


Total revenues

508,186



444,613


Operating expenses:




Cost of product sales (excluding amortization of intangible assets)

33,506



33,919


Selling, general and administrative

167,947



207,213


Research and development

60,105



62,667


Intangible asset amortization

56,885



53,007


Acquired in-process research and development

56,000




Total operating expenses

374,443



356,806


Income from operations

133,743



87,807


Interest expense, net

(17,922)



(20,605)


Foreign exchange loss

(611)



(1,728)


Income before income tax provision and equity in loss of investees

115,210



65,474


Income tax provision

29,116



19,146


Equity in loss of investees

893



337


Net income

$

85,201



$

45,991






Net income per ordinary share:




Basic

$

1.49



$

0.77


Diluted

$

1.47



$

0.75


Weighted-average ordinary shares used in per share calculations - basic

57,206



59,928


Weighted-average ordinary shares used in per share calculations - diluted

58,081



61,178


 

JAZZ PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)










March 31,
2019


December 31,
2018

ASSETS




Current assets:




Cash and cash equivalents

$

547,466



$

309,622


Investments

285,000



515,000


Accounts receivable, net of allowances

320,485



263,838


Inventories

60,707



52,956


Prepaid expenses

28,974



25,017


Other current assets

62,985



67,572


Total current assets

1,305,617



1,234,005


Property, plant and equipment, net

113,006



200,358


Operating lease assets

147,365




Intangible assets, net

2,679,393



2,731,334


Goodwill

919,972



927,630


Deferred tax assets, net

65,090



57,879


Deferred financing costs

9,056



9,589


Other non-current assets

40,736



42,696


Total assets

$

5,280,235



$

5,203,491


LIABILITIES AND SHAREHOLDERS' EQUITY




Current liabilities:




Accounts payable

$

42,669



$

40,602


Accrued liabilities

292,390



264,887


Current portion of long-term debt

33,387



33,387


Income taxes payable

40,833



1,197


Deferred revenue

4,720



5,414


Total current liabilities

413,999



345,487


Deferred revenue, non-current

8,401



9,581


Long-term debt, less current portion

1,565,277



1,563,025


Operating lease liabilities, less current portion

154,066




Deferred tax liabilities, net

296,148



309,097


Other non-current liabilities

111,897



218,879


Total shareholders' equity

2,730,447



2,757,422


Total liabilities and shareholders' equity

$

5,280,235



$

5,203,491


 

JAZZ PHARMACEUTICALS PLC

SUMMARY OF CASH FLOWS

(In thousands)

(Unaudited)










Three Months Ended
March 31,


2019


2018

Net cash provided by operating activities

$

202,253



$

167,359


Net cash provided by (used in) investing activities

166,052



(52,149)


Net cash used in financing activities

(130,349)



(47,575)


Effect of exchange rates on cash and cash equivalents

(112)



(501)


Net increase in cash and cash equivalents

$

237,844



$

67,134


 

JAZZ PHARMACEUTICALS PLC

RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION

(In thousands, except per share amounts)

(Unaudited)










Three Months Ended
March 31,


2019


2018

GAAP reported net income

$

85,201



$

45,991


Intangible asset amortization

56,885



53,007


Share-based compensation expense

27,552



24,303


Loss contingency



57,000


Upfront and milestone payments

56,000



11,000


Non-cash interest expense

11,133



10,617


Income tax effect of above adjustments

(23,598)



(19,547)


Non-GAAP adjusted net income

$

213,173



$

182,371






GAAP reported net income per diluted share

$

1.47



$

0.75


Non-GAAP adjusted net income per diluted share

$

3.67



$

2.98


Weighted-average ordinary shares used in diluted per share calculations

58,081



61,178


 

JAZZ PHARMACEUTICALS PLC

RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION

CERTAIN LINE ITEMS AND OTHER INFORMATION

(In thousands, except per share amounts and percentages)

(Unaudited)


























Three Months Ended


March 31, 2019


March 31, 2018


GAAP
Reported


Adjustments


Non-GAAP
Adjusted


GAAP
Reported


Adjustments


Non-GAAP
Adjusted

Total revenues

$

508,186



$



$

508,186



$

444,613



$



$

444,613


Cost of product sales (excluding amortization of intangible assets)

33,506



(1,659)


(a) 

31,847



33,919



(1,694)


(a) 

32,225


Selling, general and administrative

167,947



(20,370)


(b) 

147,577



207,213



(75,234)


(b) 

131,979


Research and development

60,105



(5,523)


(c) 

54,582



62,667



(15,375)


(c) 

47,292


Intangible asset amortization

56,885



(56,885)





53,007



(53,007)




Acquired in-process research and development

56,000



(56,000)










Interest expense, net

17,922



(11,133)


(d) 

6,789



20,605



(10,617)


(d) 

9,988


Foreign exchange loss

611





611



1,728





1,728


Income before income tax provision and equity in loss of investees

115,210



151,570


(e) 

266,780



65,474



155,927


(e) 

221,401


Income tax provision

29,116



23,598


(f) 

52,714



19,146



19,547


(f) 

38,693


Effective tax rate (g)

25.3

%




19.8

%


29.2

%




17.5

%

Equity in loss of investees

893





893



337





337


Net income

$

85,201



$

127,972


(h) 

$

213,173



$

45,991



$

136,380


(h) 

$

182,371


Net income per diluted share

$

1.47





$

3.67



$

0.75





$

2.98


_____________________________

Explanation of Adjustments and Certain Line Items (in thousands):



(a)

Share-based compensation expense of $1,659 and $1,694 for the three months ended March 31, 2019 and 2018, respectively.



(b)

Share-based compensation expense of $20,370 and $18,234 and loss contingency of $0 and $57,000 for the three months ended March 31, 2019 and 2018, respectively.



(c)

Share-based compensation expense of $5,523 and $4,375 and upfront and milestone payments of $0 and $11,000 for the three months ended March 31, 2019 and 2018, respectively.



(d)

Non-cash interest expense associated with debt discount and debt issuance costs for the respective three-month period.



(e)

Sum of adjustments (a) through (d) plus the adjustments for intangible asset amortization and acquired in-process research and development, as applicable, for the respective three-month period.



(f)

Income tax adjustments related to the income tax effect of adjustments between GAAP reported and non-GAAP adjusted net income for the respective three-month period.



(g)

Income tax provision divided by income before income tax provision and equity in loss of investees for the respective three-month period.



(h)

Net of adjustments (e) and (f) for the respective three-month period.

 

JAZZ PHARMACEUTICALS PLC

RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2019 NET INCOME GUIDANCE

(In millions, except per share amounts)

(Unaudited)



GAAP net income

$395 - $495

Intangible asset amortization*

240 - 260

Share-based compensation expense

110 - 125

Upfront and milestone payments

56 - 90

Non-cash interest expense

40 - 50

Income tax effect of adjustments

(75) - (95)

Non-GAAP adjusted net income

$835 - $875



GAAP net income per diluted share

$6.80 - $8.50

Non-GAAP adjusted net income per diluted share 

$14.30 - $15.00



Weighted-average ordinary shares used in per share calculations

58

____________________________

* Updated May 7, 2019.

 

Jazz Pharmaceuticals Logo (PRNewsFoto/Jazz Pharmaceuticals plc) (PRNewsFoto/Jazz Pharmaceuticals plc)

 

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SOURCE Jazz Pharmaceuticals plc