Document
false0001232524Jazz Pharmaceuticals plc 0001232524 2019-11-05 2019-11-05


 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
 
FORM 8-K
 
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
November 5, 2019
Date of Report (Date of earliest event reported)
 
 
JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter)
 
 
 
 
 
 
Ireland
 
001-33500
 
98-1032470
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File No.)
 
(IRS Employer
Identification No.)
Fifth Floor, Waterloo Exchange,
Waterloo Road, Dublin 4, Ireland D04 E5W7
(Address of principal executive offices, including zip code)

011-353-1-634-7800
(Registrant's telephone number, including area code)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Ordinary shares, nominal value $0.0001 per share
JAZZ
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  






Item 2.02. Results of Operations and Financial Condition.
On November 5, 2019, Jazz Pharmaceuticals plc (the “Company”) issued a press release (the “Press Release”) announcing financial results for the Company for the quarter ended September 30, 2019. A copy of the Press Release is furnished as Exhibit 99.1 to this current report.
The information in this Item 2.02 and in the Press Release furnished as Exhibit 99.1 to this current report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the Press Release furnished as Exhibit 99.1 to this current report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits.
(d)
Exhibits
Exhibit
Number
Description
 
 
99.1
104
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)







SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
 
 
JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY
 
 
 
 
By:
/s/ Neena M. Patil
 
Name:
Neena M. Patil
 
Title:
Senior Vice President and General Counsel

Date: November 5, 2019






Exhibit
Exhibit 99.1
http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=13182348&doc=8

JAZZ PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2019
FINANCIAL RESULTS

Total Revenues Increased 15% to $538 Million

GAAP Diluted EPS of $1.78; Adjusted Diluted EPS of $4.10

2019 Total Revenues Guidance Increased to $2.10-$2.18 Billion, an Increase of 11-15% Over 2018

2019 EPS Guidance Updated to $8.00-$9.00 on a GAAP Basis, an Increase of 10-23% Over 2018

2019 EPS Guidance Increased to $15.50-$16.15 on an Adjusted Basis, an Increase of 13-18% Over 2018

Positive JZP-258 Phase 3 Data Presented at the World Sleep Congress in September; Plan to Submit NDA in January 2020 and Redeem Priority Review Voucher

FDA Granted Fast Track Designation to JZP-458 for the Treatment of ALL/LBL

Acquired Cavion, Inc. and its Lead Product Candidate, a Potential Treatment for Essential Tremor, Broadening Company's Neuroscience Therapeutic Focus into Movement Disorders

DUBLIN, November 5, 2019 -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the third quarter of 2019 and updated 2019 financial guidance.
“In the third quarter, we delivered strong revenue and adjusted EPS growth ahead of our expectations. As a result, we are raising our revenue and adjusted EPS guidance for 2019,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.  “Following the recent presentation of the positive JZP-258 Phase 3 data at the World Sleep Congress, we are looking forward to submitting the NDA in January 2020 and plan to redeem our priority review voucher for this submission.  The quarter included our U.S. new product launch of Sunosi and execution on other key commercial, R&D and corporate development goals, further positioning us for long-term sustainable growth.”

“We made significant progress during the quarter, advancing multiple development programs and expanding our pipeline with the acquisition of Cavion, including JZP-385, a Phase 2 investigational candidate for the treatment of essential tremor,” said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development, of Jazz Pharmaceuticals.  “Importantly, given the urgent patient need, we finalized the protocol for the Phase 2/3 study of JZP-458, our recombinant Erwinia asparaginase, for acute lymphoblastic leukemia and one year after submitting our IND, we are working toward recruiting the first patient in this pivotal study." 


1


Financial Highlights
 
Three Months Ended
September 30,
 
 
 
Nine Months Ended
September 30,
 
 
(In thousands, except per share amounts and percentages)
2019
 
2018
 
Change
 
2019
 
2018
 
Change
Total revenues
$
537,702

 
$
469,373

 
15
 %
 
$
1,580,021

 
$
1,414,465

 
12
%
GAAP net income
$
102,276

 
$
149,316

 
(32
)%
 
$
449,375

 
$
287,628

 
56
%
Adjusted net income
$
235,278

 
$
221,655

 
6
 %
 
$
680,988

 
$
618,662

 
10
%
GAAP EPS
$
1.78

 
$
2.41

 
(26
)%
 
$
7.80

 
$
4.68

 
67
%
Adjusted EPS
$
4.10

 
$
3.58

 
15
 %
 
$
11.81

 
$
10.06

 
17
%
GAAP net income for the third quarter of 2019 was $102.3 million, or $1.78 per diluted share, compared to $149.3 million, or $2.41 per diluted share, for the third quarter of 2018. GAAP net income and EPS for the third quarter of 2019 included the impact of acquired in-process research and development expense primarily related to the company's acquisition of Cavion, Inc. (Cavion).
Non-GAAP adjusted net income for the third quarter of 2019 was $235.3 million, or $4.10 per diluted share, compared to $221.7 million, or $3.58 per diluted share, for the third quarter of 2018. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Key Corporate and R&D Updates
In August 2019, the company acquired Cavion in a merger transaction. Under the terms of the agreement, the former Cavion shareholders received an upfront payment of $52.5 million and have the potential to receive additional payments of up to $260.0 million upon the achievement of certain clinical, regulatory and commercial milestones, for a total potential consideration of $312.5 million. Cavion’s lead molecule, CX-8998, now JZP-385, has been evaluated in a Phase 2 randomized, placebo-controlled clinical study and demonstrated proof-of-concept as a potential treatment for essential tremor.

In September 2019, the company presented positive results from the Phase 3 study of JZP-258, which demonstrate the efficacy of JZP-258 for the treatment of cataplexy and excessive daytime sleepiness (EDS) in adults with narcolepsy. The JZP-258 study met its primary and key secondary endpoints demonstrating highly statistically significant differences in weekly number of cataplexy attacks and Epworth Sleepiness Scale scores compared to placebo. JZP-258 is a novel oxybate formulation with a unique composition of cations resulting in 92% less sodium, or approximately 1 to 1.5 grams less sodium per night, than Xyrem® (sodium oxybate) oral solution.

In October 2019, the company announced that the first patient was enrolled in an exploratory Phase 2 clinical trial evaluating the ability of defibrotide to prevent neurotoxicity in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving chimeric antigen receptor t-cell (CAR T-cell) therapy.

In October 2019, U.S. Food and Drug Administration (FDA) granted Fast Track designation to JZP-458 for the treatment of acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL).

Today, the company announced that it expects to submit the JZP-258 New Drug Application (NDA) in January 2020 and plans to redeem its priority review voucher for this submission.

Today, the company announced that Mike Miller will retire from his role as Executive Vice President, U.S. Commercial effective March 31, 2020. Mr. Miller will continue as an employee of the company through June 30, 2020, to ensure a smooth transition to new leadership. The company plans to begin a search for Mr. Miller’s successor soon.

2



Select 2019 Milestones*
Xyrem® (sodium oxybate) oral solution
Launched for the treatment of cataplexy or EDS in pediatric narcolepsy in March
JZP-258
Announced positive top-line results from Phase 3 narcolepsy study in March
Received Orphan Drug Designation from FDA for idiopathic hypersomnia indication
Presented positive results from Phase 3 narcolepsy study at World Sleep Congress meeting in September
NDA submission as early as year-end (now intend to submit January 2020)
Sunosi® (solriamfetol)
Received FDA approval for EDS in narcolepsy or obstructive sleep apnea (OSA) in March
Received U.S. Drug Enforcement Agency scheduling decision in June
Launched in the U.S. in July
Identified EDS associated with Major Depressive Disorder as a new area of interest
Obtain EU approval for EDS in narcolepsy or OSA as early as year-end (now anticipate Committee for Medicinal Products for Human Use (CHMP) opinion November 2019; expect European Medicines Agency (EMA) decision early 2020)
Vyxeos® (daunorubicin and cytarabine) liposome for injection
Positive data presented by Children's Oncology Group (COG) in children and young adults with relapsed/refractory acute myeloid leukemia (AML) at American Society of Clinical Oncology (ASCO) in June
Activated sites for Phase 1 attenuated dose finding study of Vyxeos in higher risk myelodysplastic syndrome (MDS) through MD Anderson collaboration (FPI 2Q19)
Activated sites for Phase 1b study of low intensity therapy of Vyxeos in combination with venetoclax in first-line, unfit AML (FPI 4Q19)
Activated sites for Phase 3 study in adult patients with newly diagnosed standard- and high-risk AML through the AML Study Group, a cooperative group (FPI 3Q19)
Activated sites for Phase 2 study in patients with high-risk MDS through the European Myelodysplastic Syndromes Cooperative Group (FPI 3Q19)
Activate sites for Phase 1b master trial of Vyxeos in combination with various targeted agents in first-line, fit AML
Potential interim combination data results from studies conducted through MD Anderson collaboration
Activate sites in the COG Phase 3 study in newly diagnosed pediatric patients with AML
Activate sites for Phase 2 study in newly diagnosed, fit, older adults with high-risk AML
Activate sites for Phase 2 study in a broader age range of adults with high-risk AML
Defitelio® (defibrotide sodium) / defibrotide
Positive results from DEFIFrance study presented at European Society for Blood and Marrow Transplant meeting in March
Nippon Shinyaku Co., Ltd. received marketing authorization for Defitelio in Japan in June and launched in September
Activated sites for exploratory Phase 2 study in CAR T-cell therapy associated neurotoxicity (FPI 4Q19)
Completed enrollment in prevention of acute graft-vs-host disease Phase 2 study
Conduct interim analysis (IA) in the prevention of hepatic veno-occlusive disease (VOD) study (now expect to conduct 1H20)
x
Activate sites for Phase 2 study in transplant-associated thrombotic microangiopathy (activities discontinued)
JZP-458
FDA granted Fast Track designation to JZP-458 for the treatment of ALL/LBL
Activate sites for single-arm, pivotal Phase 2/3 clinical study in ALL/LBL
CombiPlex®
Continue Investigational New Drug enabling activities for a solid tumor combination; progress exploratory activities for other hematology/oncology candidates
* Milestones denoted as ü=completed, x=not completed, =milestones planned for 2019. FPI = First Patient In

3



Total Revenues

Three Months Ended
September 30,
 
Nine Months Ended
September 30,
(In thousands)
2019
 
2018
 
2019
 
2018
Xyrem® (sodium oxybate) oral solution
$
425,644

 
$
357,251

 
$
1,207,173

 
$
1,030,036

Erwinaze® / Erwinase® (asparaginase Erwinia chrysanthemi)
34,024

 
41,134

 
122,545

 
150,474

Defitelio® (defibrotide sodium) / defibrotide
37,604

 
36,177

 
125,159

 
111,736

Vyxeos® (daunorubicin and cytarabine) liposome for injection
29,581

 
21,038

 
89,886

 
75,217

Sunosi® (solriamfetol)
987

 

 
987

 

Other
4,481

 
9,597

 
13,325

 
34,676

Product sales, net
532,321

 
465,197

 
1,559,075

 
1,402,139

Royalties and contract revenues
5,381

 
4,176

 
20,946

 
12,326

Total revenues
$
537,702

 
$
469,373

 
$
1,580,021

 
$
1,414,465


Total revenues increased 15% in the third quarter of 2019 compared to the same period in 2018.
Xyrem net product sales increased 19% in the third quarter of 2019 compared to the same period in 2018.
Erwinaze/Erwinase net product sales decreased 17% in the third quarter of 2019 compared to the same period in 2018 due to ongoing supply and manufacturing issues at the sole manufacturer, resulting in limited product availability during the quarter. The company anticipates ongoing manufacturing issues and supply disruptions for the fourth quarter of 2019 and in 2020.
Defitelio/defibrotide net product sales increased 4% in the third quarter of 2019 compared to the same period in 2018. The company continues to expect inter-quarter variability in Defitelio net sales.
Vyxeos net product sales increased 41% in the third quarter of 2019 compared to the same period in 2018 primarily due to the ongoing EU launch. The company continues to implement its education and outreach initiatives while advancing a development program to support potential expanded uses of Vyxeos.
Sunosi net product sales were $1.0 million in the third quarter of 2019, following the U.S. launch in July 2019.


4



Operating Expenses
 
Three Months Ended
September 30,
 
Nine Months Ended
September 30,
(In thousands, except percentages)
2019
 
2018
 
2019
 
2018
GAAP:
 
 
 
 
 
 
 
Cost of product sales
$
31,400

 
$
26,574

 
$
92,582

 
$
95,207

Gross margin
94.1
%
 
94.3
%
 
94.1
 %
 
93.2
%
Selling, general and administrative
$
178,706

 
$
155,873

 
$
522,667

 
$
521,665

% of total revenues
33.2
%
 
33.2
%
 
33.1
 %
 
36.9
%
Research and development
$
79,855

 
$
51,160

 
$
202,344

 
$
169,959

% of total revenues
14.9
%
 
10.9
%
 
12.8
 %
 
12.0
%
Impairment charges
$

 
$

 
$

 
$
42,896

Acquired in-process research and development
$
51,775

 
$

 
$
109,975

 
$

Income tax provision (benefit)
$
10,903

 
$
19,348

 
$
(38,631
)
 
$
75,018

Effective tax rate
9.5
%
 
11.4
%
 
(9.3
)%
 
20.6
%
 
Three Months Ended
September 30,
 
Nine Months Ended
September 30,
(In thousands, except percentages)
2019
 
2018
 
2019
 
2018
Non-GAAP adjusted:
 
 
 
 
 
 
 
Cost of product sales
$
29,415

 
$
25,049

 
$
87,230

 
$
90,185

Gross margin
94.5
%
 
94.6
%
 
94.4
%
 
93.6
%
Selling, general and administrative
$
158,404

 
$
136,895

 
$
461,310

 
$
406,580

% of total revenues
29.5
%
 
29.2
%
 
29.2
%
 
28.7
%
Research and development
$
73,357

 
$
46,560

 
$
184,427

 
$
145,275

% of total revenues
13.6
%
 
9.9
%
 
11.7
%
 
10.3
%
Acquired in-process research and development
$
3,500

 
$

 
$
5,700

 
$

Income tax provision
$
29,655

 
$
30,266

 
$
134,396

 
$
119,295

Effective tax rate
11.2
%
 
12.0
%
 
16.4
%
 
16.1
%
Operating expenses changed over the prior year period primarily due to the following:
Selling, general and administrative (SG&A) expenses increased in the third quarter of 2019 compared to the same period in 2018 on a GAAP and on a non-GAAP adjusted basis primarily due to expenses related to the expansion of the company's business, including the U.S. launch of Sunosi.
Research and development (R&D) expenses increased in the third quarter of 2019 on a GAAP and on a non-GAAP adjusted basis primarily due to expenses related to the company's expanding pre-clinical and clinical development programs and support of its partner programs, including a milestone of $11.0 million payable to Pfenex, Inc. under a license and option agreement to develop and commercialize multiple early stage hematology product candidates.


5



Cash Flow and Balance Sheet
As of September 30, 2019, cash, cash equivalents and investments were $1.1 billion, and the outstanding principal balance of the company’s long-term debt was $1.8 billion. During the nine months ended September 30, 2019, the company generated $688.6 million of cash from operations, used $191.1 million to repurchase shares under the company's share repurchase program, made milestone payments totaling $80.5 million related to Sunosi, and made upfront payments of $52.5 million to acquire Cavion, Inc. and $56.0 million to Codiak BioSciences, Inc. (Codiak) under a collaboration agreement.
In the nine months ended September 30, 2019, the company repurchased approximately 1.5 million ordinary shares under the company's share repurchase program at an average cost of $131.48 per ordinary share. As of September 30, 2019, the remaining amount authorized for share repurchases was $188.1 million. In October 2019, the company's board of directors increased the share repurchase program by $500 million.

2019 Financial Guidance
Jazz Pharmaceuticals is updating its full year 2019 financial guidance as follows (in millions, except per share amounts and percentages):
Revenues1
$2,100 - $2,180
Total net product sales1
$2,080 - $2,155
-Xyrem net sales
$1,600 - $1,640
-Erwinaze/Erwinase net sales
$160 - $195
-Defitelio/defibrotide net sales
$160 - $180
-Vyxeos net sales
$120 - $135
GAAP gross margin %
94%
Non-GAAP adjusted gross margin %2,8
94%
GAAP SG&A expenses
$712 - $740
Non-GAAP adjusted SG&A expenses3,8
$630 - $650
GAAP R&D expenses
$267 - $292
GAAP Acquired in-process research and development expenses
$110
Non-GAAP adjusted R&D expenses4,8
$245 - $265
GAAP effective tax rate5
(9%) - (6%)
Non-GAAP adjusted effective tax rate6,8
14% - 16%
GAAP net income per diluted share7
$8.00 - $9.00
Non-GAAP adjusted net income per diluted share8
$15.50 - $16.15
____________________________

1.
Includes minimal net sales contribution from Sunosi in the U.S.
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 $22-$27 million of share-based compensation expense from estimated GAAP R&D expenses.
5.
Includes an income tax benefit of $112.3 million related to an intra-entity intellectual property asset transfer.
6.
Excludes the income tax effect of adjustments between GAAP reported and non-GAAP adjusted net income and the income tax benefit related to an intra-entity intellectual property asset transfer.
7.
Includes expected intangible asset amortization of $111 million in the fourth quarter of 2019 as a result of the Company’s notification to the FDA of its intention to redeem its priority review voucher for the planned NDA submission for JZP-258.
8.
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.


6



Conference Call Details
Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EST (9:30 p.m. GMT) to provide a business and financial update and discuss its 2019 third 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 9398898.
A replay of the conference call will be available through November 12, 2019 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 9398898. 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 Sunosi® (solriamfetol), Xyrem® (sodium oxybate) oral solution, Defitelio® (defibrotide sodium), Erwinaze® (asparaginase Erwinia chrysanthemi) and Vyxeos® (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Defitelio® (defibrotide), Erwinase® and Vyxeos® liposomal 44 mg/100 mg powder for concentrate for solution for infusion in countries outside the U.S. For country-specific product information, please visit 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 and, as applicable, the income tax benefit related to an intra-entity intellectual property asset transfer and the impact of the U.S. Tax Cuts and Job Act (U.S. Tax Act). 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

7



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 planned submission of an NDA for JZP-258 (with the redemption of a priority review voucher in connection with the submission) and the timing thereof, the company's potential for long-term sustainable growth, the company’s plans to advance its Vyxeos clinical development program and to initiate a pivotal Phase 2/3 study of JZP-458 for the treatment of ALL, the therapeutic potential of the company’s product candidates, including JZP-258, JZP-458, JZP-385, as well as defibrotide in the prevention of CAR T-cell therapy associated neurotoxicity in patients with relapsed or refractory DLBCL receiving axicabtagene ciloleucel, the company's expectations of Erwinaze supply disruptions in 2019 and 2020, the company’s expectations of inter-quarter variability in Defitelio net sales, potential expanded uses of Vyxeos, 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 with respect to the recent commercial launch of Sunosi in the U.S. and potential launch in the EU; the time-consuming and uncertain regulatory approval process, including the risk that the company’s current and planned regulatory submissions, including the Sunosi marketing authorization application in the EU and the planned JZP-258 NDA, may not be submitted, accepted or 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 successfully 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; the company’s ability to maintain rights to its products and product candidates, including Erwinaze; 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 company’s ability to realize the anticipated benefits of its collaborations with third parties for the development of product candidates; the company’s ability to achieve expected future financial performance and results and the

8



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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 and future filings and reports by the company, including the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 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.

9



JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(In thousands, except per share amounts)
(Unaudited)

 
Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2019
 
2018
 
2019
 
2018
Revenues:
 
 
 
 
 
 
 
Product sales, net
$
532,321

 
$
465,197

 
$
1,559,075

 
$
1,402,139

Royalties and contract revenues
5,381

 
4,176

 
20,946

 
12,326

Total revenues
537,702

 
469,373

 
1,580,021

 
1,414,465

Operating expenses:
 
 
 
 
 
 
 
Cost of product sales (excluding amortization of intangible assets)
31,400

 
26,574

 
92,582

 
95,207

Selling, general and administrative
178,706

 
155,873

 
522,667

 
521,665

Research and development
79,855

 
51,160

 
202,344

 
169,959

Intangible asset amortization
62,863

 
46,989

 
181,324

 
154,955

Impairment charges

 

 

 
42,896

Acquired in-process research and development
51,775

 

 
109,975

 

Total operating expenses
404,599

 
280,596

 
1,108,892

 
984,682

Income from operations
133,103

 
188,777

 
471,129

 
429,783

Interest expense, net
(17,861
)
 
(18,920
)
 
(54,017
)
 
(59,171
)
Foreign exchange loss
(1,033
)
 
(756
)
 
(3,577
)
 
(5,181
)
Loss on extinguishment and modification of debt

 

 

 
(1,425
)
Income before income tax provision (benefit) and equity in loss of investees
114,209

 
169,101

 
413,535

 
364,006

Income tax provision (benefit)
10,903

 
19,348

 
(38,631
)
 
75,018

Equity in loss of investees
1,030

 
437

 
2,791

 
1,360

Net income
$
102,276

 
$
149,316

 
$
449,375

 
$
287,628

 
 
 
 
 
 
 
 
Net income per ordinary share:
 
 
 
 
 
 
 
Basic
$
1.80

 
$
2.47

 
$
7.90

 
$
4.78

Diluted
$
1.78

 
$
2.41

 
$
7.80

 
$
4.68

Weighted-average ordinary shares used in per share calculations - basic
56,674

 
60,476

 
56,860

 
60,196

Weighted-average ordinary shares used in per share calculations - diluted
57,438

 
61,857

 
57,647

 
61,493







10



JAZZ PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)

 
September 30,
2019
 
December 31,
2018
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
795,175

 
$
309,622

Investments
275,000

 
515,000

Accounts receivable, net of allowances
267,031

 
263,838

Inventories
71,108

 
52,956

Prepaid expenses
30,841

 
25,017

Other current assets
81,401

 
67,572

Total current assets
1,520,556

 
1,234,005

Property, plant and equipment, net
129,472

 
200,358

Operating lease assets
141,878

 

Intangible assets, net
2,593,030

 
2,731,334

Goodwill
906,725

 
927,630

Deferred tax assets, net
183,944

 
57,879

Deferred financing costs
7,971

 
9,589

Other non-current assets
44,274

 
42,696

Total assets
$
5,527,850

 
$
5,203,491

LIABILITIES AND SHAREHOLDERS’ EQUITY
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
70,104

 
$
40,602

Accrued liabilities
238,740

 
264,887

Current portion of long-term debt
33,387

 
33,387

Income taxes payable
43,488

 
1,197

Deferred revenue
4,720

 
5,414

Total current liabilities
390,439

 
345,487

Deferred revenue, non-current
6,041

 
9,581

Long-term debt, less current portion
1,570,781

 
1,563,025

Operating lease liabilities, less current portion
153,434

 

Deferred tax liabilities, net
250,167

 
309,097

Other non-current liabilities
102,583

 
218,879

Total shareholders’ equity
3,054,405

 
2,757,422

Total liabilities and shareholders’ equity
$
5,527,850

 
$
5,203,491


11



JAZZ PHARMACEUTICALS PLC
SUMMARY OF CASH FLOWS
(In thousands)
(Unaudited)

 
Nine Months Ended
September 30,
 
2019
 
2018
Net cash provided by operating activities
$
688,603

 
$
580,808

Net cash provided by (used in) investing activities
3,753

 
(434,479
)
Net cash used in financing activities
(205,965
)
 
(32,674
)
Effect of exchange rates on cash and cash equivalents
(838
)
 
(672
)
Net increase in cash and cash equivalents
$
485,553

 
$
112,983




JAZZ PHARMACEUTICALS PLC
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
(In thousands, except per share amounts)
(Unaudited)

 
Three Months Ended
September 30,
 
Nine Months Ended
September 30,
 
2019
 
2018
 
2019
 
2018
GAAP reported net income
$
102,276

 
$
149,316

 
$
449,375

 
$
287,628

Intangible asset amortization
62,863

 
46,989

 
181,324

 
154,955

Share-based compensation expense
28,785

 
25,103

 
84,626

 
75,718

Loss contingency

 

 

 
57,000

Impairment charges and disposal costs

 

 

 
43,969

Upfront and milestone payments (a)
48,275

 

 
104,275

 
11,000

Non-cash interest expense
11,831

 
11,165

 
34,415

 
32,669

Income tax effect of above adjustments
(18,752
)
 
(13,786
)
 
(60,753
)
 
(47,145
)
Income tax benefit related to intra-entity intellectual property asset transfer

 

 
(112,274
)
 

U.S. Tax Act impact

 
2,868

 

 
2,868

Non-GAAP adjusted net income
$
235,278

 
$
221,655

 
$
680,988

 
$
618,662

 
 
 
 
 
 
 
 
GAAP reported net income per diluted share
$
1.78

 
$
2.41

 
$
7.80

 
$
4.68

Non-GAAP adjusted net income per diluted share
$
4.10

 
$
3.58

 
$
11.81

 
$
10.06

Weighted-average ordinary shares used in diluted per share calculations
57,438

 
61,857

 
57,647

 
61,493

________________________________________________
Explanation of Adjustments and Certain Line Items (in thousands):
(a)
Amount includes $48,275 attributed to acquired in-process research and development expense related to the acquisition of Cavion in the three and nine months ended September 30, 2019. The nine month period ended September 30, 2019 also includes a $56,000 upfront payment to Codiak under a collaboration agreement.


12



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
 
September 30, 2019
 
September 30, 2018
 
GAAP Reported
 
Adjustments
 
Non-GAAP Adjusted
 
GAAP Reported
 
Adjustments
 
Non-GAAP Adjusted
Total revenues
$
537,702

 
$

 
$
537,702

 
$
469,373

 
$

 
$
469,373

Cost of product sales (excluding amortization of intangible assets)
31,400

 
(1,985
)
(a) 
29,415

 
26,574

 
(1,525
)
(a) 
25,049

Selling, general and administrative
178,706

 
(20,302
)
(b) 
158,404

 
155,873

 
(18,978
)
(b) 
136,895

Research and development
79,855

 
(6,498
)
(c) 
73,357

 
51,160

 
(4,600
)
(c) 
46,560

Intangible asset amortization
62,863

 
(62,863
)
 

 
46,989

 
(46,989
)
 

Acquired in-process research and development
51,775

 
(48,275
)
(d) 
3,500

 

 

 

Interest expense, net
17,861

 
(11,831
)
(e) 
6,030

 
18,920

 
(11,165
)
(e) 
7,755

Foreign exchange loss
1,033

 

 
1,033

 
756

 

 
756

Income before income tax provision and equity in loss of investees
114,209

 
151,754

(f) 
265,963

 
169,101

 
83,257

(f) 
252,358

Income tax provision
10,903

 
18,752

(g) 
29,655

 
19,348

 
10,918

(g) 
30,266

Effective tax rate (h)
9.5
%
 
 
 
11.2
%
 
11.4
%
 
 
 
12.0
%
Equity in loss of investees
1,030

 

 
1,030

 
437

 

 
437

Net income
$
102,276

 
$
133,002

(i) 
$
235,278

 
$
149,316

 
$
72,339

(i) 
$
221,655

Net income per diluted share
$
1.78

 
 
 
$
4.10

 
$
2.41

 
 
 
$
3.58



13



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)

 
Nine Months Ended
 
September 30, 2019
 
September 30, 2018
 
GAAP Reported
 
Adjustments
 
Non-GAAP Adjusted
 
GAAP Reported
 
Adjustments
 
Non-GAAP Adjusted
Total revenues
$
1,580,021

 
$

 
$
1,580,021

 
$
1,414,465

 
$

 
$
1,414,465

Cost of product sales (excluding amortization of intangible assets)
92,582

 
(5,352
)
(j) 
87,230

 
95,207

 
(5,022
)
(j) 
90,185

Selling, general and administrative
522,667

 
(61,357
)
(k) 
461,310

 
521,665

 
(115,085
)
(k) 
406,580

Research and development
202,344

 
(17,917
)
(l) 
184,427

 
169,959

 
(24,684
)
(l) 
145,275

Intangible asset amortization
181,324

 
(181,324
)
 

 
154,955

 
(154,955
)
 

Acquired in-process research and development
109,975

 
(104,275
)
(m) 
5,700

 

 

 

Impairment charges

 

 

 
42,896

 
(42,896
)
 

Interest expense, net
54,017

 
(34,415
)
(e) 
19,602

 
59,171

 
(32,669
)
(e) 
26,502

Foreign exchange loss
3,577

 

 
3,577

 
5,181

 

 
5,181

Loss on extinguishment and modification of debt

 

 

 
1,425

 

 
1,425

Income before income tax provision (benefit) and equity in loss of investees
413,535

 
404,640

(n) 
818,175

 
364,006

 
375,311

(n) 
739,317

Income tax provision (benefit)
(38,631
)
 
173,027

(o) 
134,396

 
75,018

 
44,277

(o) 
119,295

Effective tax rate (h)
(9.3
)%
 
 
 
16.4
%
 
20.6
%
 
 
 
16.1
%
Equity in loss of investees
2,791

 

 
2,791

 
1,360

 

 
1,360

Net income
$
449,375

 
$
231,613

(p) 
$
680,988

 
$
287,628

 
$
331,034

(p) 
$
618,662

Net income per diluted share
$
7.80

 
 
 
$
11.81

 
$
4.68

 
 
 
$
10.06

________________________________________________
Explanation of Adjustments and Certain Line Items (in thousands):
(a)
Share-based compensation expense of $1,985 and $1,525 for the three months ended September 30, 2019 and 2018, respectively.
(b)
Share-based compensation expense of $20,302 and $18,978 for the three months ended September 30, 2019 and 2018, respectively.
(c)
Share-based compensation expense of $6,498 and $4,600 for the three months ended September 30, 2019 and 2018, respectively.
(d)
Acquired in-process research and development expense of $48,275 arising from the acquisition of Cavion for the three months ended September 30, 2019.
(e)
Non-cash interest expense associated with debt discount and debt issuance costs for the respective three-and nine-month periods.
(f)
Sum of adjustments (a) through (e) plus the adjustment for intangible asset amortization, as applicable, for the respective three-month period.
(g)
Income tax adjustments include the income tax effect of adjustments between GAAP reported and non-GAAP adjusted net income of $18,752 and $13,786 offset by the impact of the U.S. Tax Act of $0 and $2,868 for the three months ended September 30, 2019 and 2018, respectively.
(h)
Income tax provision (benefit) divided by income before income tax provision (benefit) and equity in loss of investees for the respective three-and nine-month periods.
(i)
Net of adjustments (f) and (g) for the respective three-month period.
(j)
Share-based compensation expense of $5,352 and $5,022 for the nine months ended September 30, 2019 and 2018, respectively.
(k)
Share-based compensation expense of $61,357 and $57,012, loss contingency of $0 and $57,000 and disposal costs of $0 and $1,073 for the nine months ended September 30, 2019 and 2018, respectively.
(l)
Share-based compensation expense of $17,917 and $13,684 and upfront and milestone payments of $0 and $11,000 for the nine months ended September 30, 2019 and 2018, respectively.
(m)
Acquired in-process research and development expense of $48,275 arising from the acquisition of Cavion and $56,000 upfront payment to Codiak under a collaboration agreement for the nine months ended September 30, 2019.
(n)
Sum of adjustments (j), (k), (l), (m) and (e) plus the adjustments for intangible asset amortization and impairment charges, as applicable, for the respective nine-month period.

14



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)

(o)
Income tax adjustments include the income tax benefit related to an intra-entity intellectual property asset transfer of $112,274 and $0 and the income tax effect of adjustments between GAAP reported and non-GAAP adjusted net income of $60,753 and $47,145, partially offset by the impact of the U.S. Tax Act of $0 and $2,868 for the nine months ended September 30, 2019 and 2018, respectively.
(p)
Net of adjustments (n) and (o) for the respective nine-month period.


15



JAZZ PHARMACEUTICALS PLC
RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2019 NET INCOME GUIDANCE
(In millions, except per share amounts)
(Unaudited)


GAAP net income1,2
$460 - $520
Intangible asset amortization1,2
350 - 370
Share-based compensation expense
110 - 125
Upfront and milestone payments1
104
Non-cash interest expense
40 - 50
Income tax effect of adjustments1
(80) - (100)
Income tax benefit related to intra-entity intellectual property asset transfer
(112)
Non-GAAP adjusted net income1
$900 - $930
 
 
GAAP net income per diluted share1,2
$8.00 - $9.00
Non-GAAP adjusted net income per diluted share1
$15.50 - $16.15
 
 
Weighted-average ordinary shares used in per share calculations
58
____________________________
1.
Updated November 5, 2019.
2.
Includes expected intangible asset amortization of $111 million in the fourth quarter of 2019 as a result of the Company’s notification to the FDA of its intention to redeem its priority review voucher for the planned NDA submission for JZP-258.
 


Contacts:

Investors:
Kathee Littrell
Vice President, Investor Relations
Jazz Pharmaceuticals plc
Ireland, +353 1 634 7887
U.S., +1 650 496 2717

Media:
Jacqueline Kirby
Vice President, Corporate Affairs & Government Relations
Jazz Pharmaceuticals plc
Ireland, +353 1 697 2141
U.S., +1 215 867 4910


16