JAZZ Jazz Pharmaceuticals plc

153.55
-17.95  -10%
Previous Close 171.5
Open 167.08
52 Week Low 108.46
52 Week High 189
Market Cap $9,319,571,224
Shares 60,694,049
Float 53,091,115
Enterprise Value $10,155,674,527
Volume 2,486,667
Av. Daily Volume 582,460
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Upcoming Catalysts

Drug Stage Catalyst Date
JZP-258
Idiopathic Hypersomnia
PDUFA priority review
PDUFA priority review
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
SATIVEX (nabiximols)
Spasticity due multiple sclerosis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
JZP-150
Post-traumatic stress disorder (PTSD)
Phase 2
Phase 2
Phase 2 trial to be initiated late-2021.
JZP-385
Essential Tremor
Phase 2b
Phase 2b
Phase 2b trial to be initiated late-2021.
SATIVEX (nabiximols)
Multiple sclerosis (MS)-related spasticity
Phase 3
Phase 3
Phase 3 trial to be initiated 3Q 2021.
EPIDIOLEX (cannabidiol)
Epilepsy with Myoclonic-Atonic Seizures (EMAS) / Doose syndrome
Phase 3
Phase 3
Phase 3 trial to be initiated 1H 2022.
EPIDIOLEX (cannabidiol)
Rett syndrome
Phase 3
Phase 3
Phase 3 trial stopped due to COVID-19 - November 12, 2020.
XYWAV
Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
Approved
Approved
FDA Approval announced July 22, 2020.
RYLAZE (JZP458)
Acute lymphoblastic leukemia (ALL)
Approved
Approved
FDA approval announced June 30, 2021.
EPIDIOLEX (cannabidiol)
Dravet Syndrome and Lennox-Gastaut syndrome
Approved
Approved
Approval announced June 25, 2018.
EPIDIOLEX (cannabidiol)
Tuberous Sclerosis Complex
Approved
Approved
FDA approval announced August 3, 2020.
VYXEOS (daunorubicin and cytarabine)
Acute myeloid leukemia
Approved
Approved
Approval announced August 3, 2017.
SUNOSI (solriamfetol)
Excessive sleepiness associated with narcolepsy
Approved
Approved
FDA Approval announced March 20, 2019.
XYREM (sodium oxybate)
Pediatric narcolepsy patients with cataplexy
Approved
Approved
FDA Approval announced October 26, 2018.
JZP-6 (sodium oxybate)
Fibromyalgia
CRL
CRL
CRL received October 11, 2010.
ZEPZELCA (lurbinectedin)
Small cell lung cancer (SCLC)
Approved
Approved
FDA Approval announced June 15, 2020.
Defibrotide
CAR-T associated neurotoxicity in diffuse large B-cell lymphoma (DLBCL) patients
Phase 2
Phase 2
Phase 2 commencement of enrolment announced October 10, 2019.
GWP42003
Schizophrenia
Phase 2b
Phase 2b
Phase 2b trial enrolling.
GWP42006 (CBDV)
Autism
Phase 2
Phase 2
Phase 2 trial has resumed - noted November 3, 2020.
Lurbinectedin
Small cell lung cancer (SCLC)
Phase 3
Phase 3
Phase 3 trial did not meet overall survival endpoint - December 3, 2020.
Defibrotide
acute Graft-versus-Host-Disease (aGvHD)
Phase 2
Phase 2
Phase 2 data showed modest trend toward benefit.
Defibrotide
VOD in high-risk patients following hematopoietic stem cell transplantation
Phase 3
Phase 3
Phase 3 trial stopped early due to lack of efficacy.
JZP-110
Excessive sleepiness associated with obstructive sleep apnea
Phase 3
Phase 3
Phase 3 data released March 20, 2017 - primary endpoints met.

Latest News

  1. DUBLIN, Aug. 3, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced financial results for the second quarter of 2021 and affirmed non-GAAP adjusted financial guidance for 2021.

    "As we enter what we expect to be a period of sustained growth, I have never been more excited about the future for Jazz. The recent approval and launches of Xywav and Rylaze exemplify Jazz today. We are rapidly establishing ourselves as an innovative biopharmaceutical company with expanding R&D capabilities and substantial commercial prowess, underscored by our consistent execution across the business. The addition of the GW cannabinoid platform and related pipeline complement and enhance our own growing R&D capabilities, accelerating our ability…

    DUBLIN, Aug. 3, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced financial results for the second quarter of 2021 and affirmed non-GAAP adjusted financial guidance for 2021.

    "As we enter what we expect to be a period of sustained growth, I have never been more excited about the future for Jazz. The recent approval and launches of Xywav and Rylaze exemplify Jazz today. We are rapidly establishing ourselves as an innovative biopharmaceutical company with expanding R&D capabilities and substantial commercial prowess, underscored by our consistent execution across the business. The addition of the GW cannabinoid platform and related pipeline complement and enhance our own growing R&D capabilities, accelerating our ability to improve the lives of patients," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "We have now executed four of five planned product launches since the beginning of 2020 and look forward to our anticipated launch of Xywav in idiopathic hypersomnia later this year, a critical step forward for these underserved patients. With 41% of our second quarter net product sales from recently launched or acquired products, we are well on track to meet our revenue diversification targets while driving significant shareholder value."

    Robert Iannone, M.D., M.S.C.E., executive vice president, research and development and chief medical officer, added, "We are excited that Rylaze was recently approved in the United States and is now broadly available to acute lymphoblastic leukemia and lymphoblastic lymphoma patients in critical need. We aim to further leverage our proven R&D capabilities to deliver on the significant value of our pipeline and the GW cannabinoid platform. The shared values and patient-centricity among the Jazz and GW teams, coupled with the successful ongoing integration, will further enhance our ability to innovate and execute, including the planned initiations of a Phase 3 pivotal trial for Epidiolex in epilepsy with myoclonic-atonic seizures and the third Phase 3 nabiximols clinical trial in multiple sclerosis-related spasticity."

    Business Updates

    Corporate Development

    On May 5, 2021, the Company completed the acquisition of GW Pharmaceuticals plc (GW) for a total value of approximately $7.2 billion, or $6.8 billion net of GW cash. The Company secured $5.35 billion of financing to fund the GW transaction. The financing structure supports the Company's plans for rapid deleveraging to its stated targets while also continuing to make investments to grow the business. The combined company is a leader in neuroscience with a global commercial and operational footprint, well positioned to maximize the value of its diversified portfolio.

    Neuroscience

    Oxybate (Xyrem® and Xywav):

    • Net product sales for the combined oxybate business increased 3% to $458.3 million in the second quarter of 2021 compared to the same period in 2020.
    • Average active oxybate patients on therapy were approximately 15,900 in the second quarter of 2021, an increase of approximately 5% compared to the same period in 2020.

    Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:

    • Xywav net product sales were $124.2 million in the second quarter of 2021.
    • There were approximately 5,100 active patients on Xywav exiting the second quarter of 2021.
    • In June 2021, FDA recognized seven years of Orphan Drug Exclusivity for Xywav. 
    • FDA published its summary of clinical superiority findings for Xywav 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, and 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.
    • The Company has achieved its goal of obtaining broad payer coverage, having entered into agreements with all three of the largest pharmacy benefit managers.

    Xyrem (sodium oxybate) oral solution:

    • Xyrem net product sales decreased 25% to $334.2 million in the second quarter of 2021 compared to the same period in 2020.

    Xywav in Idiopathic Hypersomnia

    • FDA has granted Priority Review Designation and accepted the supplemental New Drug Application (sNDA) for Xywav in adult patients with idiopathic hypersomnia (IH). The Prescription Drug Fee User Act (PDUFA) target date for an FDA decision has been set for August 12, 2021, which is in line with the Company's objective of launching in the fourth quarter of 2021 following risk evaluation and mitigation strategy (REMS) implementation.

    Epidiolex/Epidyolex®  (cannabidiol):

    • Epidiolex/Epidyolex net product sales were $109.5 million in the second quarter of 2021. This includes sales from May 5, 2021, the closing date of the GW Acquisition.
    • On an unaudited pro forma basis, net product sales in the second quarter of 2021 increased by 32% to $155.9 million compared to the same period in 2020.
    • The Company expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures (EMAS), also known as Doose syndrome, in the first half of 2022. EMAS represents the fourth target indication for Epidiolex.

    Sunosi® (solriamfetol):

    • Sunosi net product sales increased by 41% to $12.1 million in the second quarter of 2021 compared to the same period of 2020.
    • In the second quarter of 2021, U.S. prescriptions increased by 25% compared to the first quarter of 2021.

    Nabiximols:

    • The Company expects to initiate the third Phase 3 nabiximols clinical trial in multiple sclerosis (MS)-related spasticity this year.
    • The two ongoing Phase 3 clinical trials in MS-related spasticity continue to progress.

    JZP385:

    • JZP385, a highly selective modulator of T-type calcium channels, is in clinical development for the potential treatment of essential tremor.
    • The Company expects to initiate a Phase 2b trial in late 2021.

    JZP150:

    • JZP150, a fatty acid amide hydrolase (FAAH) inhibitor, is in clinical development for the potential treatment of post-traumatic stress disorder.
    • The Company expects to initiate a Phase 2 trial in late 2021.

    Oncology

    Zepzelca™ (lurbinectedin):

    • Zepzelca net product sales were $55.9 million in the second quarter of 2021.
    • Sequential demand growth over the first two quarters of 2021 was 8% and 9% respectively, offset mainly by reduced inventory holding by distributors.
    • Robust Zepzelca development program planned:
      • The Company's partner, PharmaMar, plans to initiate a confirmatory trial in second-line small cell lung cancer (SCLC) later this year. If positive, this trial would confirm the benefit of Zepzelca in the treatment of SCLC when patients progress following first-line treatment with a platinum-based regimen.
      • The Company is collaborating with Roche to initiate a Phase 3 pivotal clinical trial in first-line extensive stage SCLC in combination with immunotherapy this year.
      • The Company expects to initiate a Phase 2 basket trial in early 2022 to explore lurbinectedin monotherapy in patients with select advanced or metastatic solid tumors. Cohorts will include advanced urothelial cancer, large cell neuroendocrine tumor of the lung, and homologous recombinant deficient positive (HRD+) cancers.
      • The Company has initiated a Phase 4 observational study to collect real world safety and outcome data in adult Zepzelca monotherapy patients with extensive stage small cell lung cancer who progress on or after prior platinum-containing chemotherapy.

    Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):

    • On June 30, 2021, FDA approved Rylaze under the Real-Time Oncology Review program for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric patients one month and older and adult patients who have developed hypersensitivity to E. coli-derived asparaginase.
    • Rylaze was launched and commercially available in the U.S. on July 15, 2021.
    • Rylaze is the only recombinant Erwinia asparaginase manufactured product that maintains a clinically meaningful level of asparaginase activity throughout the entire duration of treatment. It was developed by Jazz to address the needs of patients and healthcare providers for an innovative, high-quality Erwinia asparaginase with reliable supply.
    • Rylaze was granted orphan drug designation for the treatment of ALL/LBL by FDA in June 2021.
    • The Company will continue to work with FDA and plans to submit additional data in support of a Monday/Wednesday/Friday dosing schedule. Part B of the study is evaluating intravenous administration and is ongoing. The company also plans to submit this data for presentation at a future medical meeting.
    • The Company anticipates that data from the current development program will support regulatory filings in Europe in 2022 and is currently working with an in-country partner to advance the program for filing, approval and launch in Japan.

    Vyxeos® (daunorubicin and cytarabine) liposome for injection: 

    • Vyxeos net product sales increased 18% to $31.5 million in the second quarter of 2021 compared to the same period in 2020. 

    Defitelio® (defibrotide sodium) / defibrotide:

    • Defitelio/defibrotide net product sales increased 13% to $48.1 million in the second quarter of 2021 compared to the same period in 2020.

    Erwinaze® / Erwinase® (asparaginase Erwinia chrysanthemi):

    • Erwinaze/Erwinase net product sales decreased 13% to $28.3 million in the second quarter of 2021 compared to the same period in 2020. 
    • The Company's agreement with Porton Biopharma Limited terminated on December 31, 2020. The Company had the right to sell certain Erwinaze inventory post-termination. Sale of this inventory was completed in June 2021.

    Financial Highlights



    Three Months Ended

    June 30,



    Six Months Ended

    June 30,

    (In thousands, except per share amounts)

    2021



    2020



    2021



    2020

    Total revenues

    $

    751,811





    $

    562,436





    $

    1,359,392





    $

    1,097,162



    GAAP net income (loss)

    $

    (363,316)





    $

    114,801





    $

    (241,484)





    $

    (43,032)



    Adjusted net income1

    $

    240,575





    $

    207,316





    $

    469,394





    $

    233,149



    GAAP EPS

    $

    (6.11)





    $

    2.06





    $

    (4.17)





    $

    (0.77)



    Adjusted EPS1

    $

    3.90





    $

    3.71





    $

    7.82





    $

    4.14



    ________________________

    1.

    Commencing in 2020, following consultation with the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission, the Company no longer excludes upfront and milestone payments from the Company's non-GAAP adjusted net income, its line item components and non-GAAP adjusted EPS. See "Non-GAAP Financial Measures" below.

    GAAP net income (loss) for the second quarter of 2021 was ($363.3 million), or ($6.11) per diluted share, compared to $114.8 million, or $2.06 per diluted share, for the second quarter of 2020. 

    Non-GAAP adjusted net income for the second quarter of 2021 was $240.6 million, or $3.90 per diluted share, compared to $207.3 million, or $3.71 per diluted share, for the second quarter of 2020.

    Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

    Total Revenues



    Three Months Ended

    June 30,



    Six Months Ended

    June 30,

    (In thousands)

    2021



    2020



    2021



    2020

    Xyrem

    $

    334,182





    $

    446,808





    $

    669,732





    $

    854,683



    Xywav

    124,164









    199,580







    Total Oxybate

    458,346





    446,808





    869,312





    854,683



    Epidiolex/Epidyolex1

    109,481









    109,481







    Sunosi

    12,124





    8,578





    23,730





    10,502



    Sativex® (delta-9-tetrahydrocannabiol and cannabidiol)1

    1,961









    1,961







    Total Neuroscience

    581,912





    455,386





    1,004,484





    865,185



    Zepzelca

    55,924









    110,258







    Vyxeos

    31,453





    26,568





    64,608





    59,288



    Defitelio/defibrotide

    48,096





    42,714





    97,715





    90,146



    Erwinaze/Erwinase

    28,314





    32,683





    69,382





    70,415



    Total Oncology

    163,787





    101,965





    341,963





    219,849



    Other

    2,641





    852





    5,424





    3,374



    Product sales, net

    748,340





    558,203





    1,351,871





    1,088,408



    Royalties and contract revenues

    3,471





    4,233





    7,521





    8,754



    Total revenues

    $

    751,811





    $

    562,436





    $

    1,359,392





    $

    1,097,162



    __________________________

    1.

    Net product sales for Epidiolex and Sativex are included from the closing of the GW Acquisition on May 5, 2021.

    Total revenues increased 34% in the second quarter of 2021 compared to the same period in 2020.

    • Products launched or acquired since 2019 accounted for 41% of total net product sales in the second quarter of 2021.
    • Neuroscience net product sales in the second quarter of 2021 increased 28% to $581.9 million compared to the same period in 2020. Oxybate net product sales increased to $458.3 million led by strong Xywav net product sales of $124.2 million partially offset by a decrease in Xyrem net product sales as a result of the strong adoption of Xywav by existing Xyrem patients. Epidiolex/Epidyolex net product sales from the date of acquisition were $109.5 million
    • Oncology net product sales in the second quarter of 2021 increased 61% to $163.8 million compared to the same period in 2020 primarily driven by robust Zepzelca net product sales of $55.9 million. Zepzelca launched in the U.S. in July 2020.

    Operating Expenses and Effective Tax Rate



    Three Months Ended

    June 30,



    Six Months Ended

    June 30,

    (In thousands, except percentages)

    2021



    2020



    2021



    2020

    GAAP:















    Cost of product sales

    $

    119,194





    $

    28,008





    $

    159,383





    $

    56,665



    Gross margin

    84.1%





    95.0%





    88.2%





    94.8%



    Selling, general and administrative

    $

    429,031





    $

    191,406





    $

    689,539





    $

    399,806



    % of total revenues

    57.1%





    34.0%





    50.7%





    36.4%



    Research and development

    $

    132,696





    $

    78,922





    $

    209,269





    $

    165,029



    % of total revenues

    17.7%





    14.0%





    15.4%





    15.0%



    Acquired in-process research and development

    $





    $

    3,000





    $





    $

    205,250



    Impairment charge

    $





    $





    $





    $

    136,139



    Income tax provision

    $

    228,621





    $

    54,754





    $

    246,640





    $

    3,467



    Effective tax rate

    N/A(1)





    31.9%





    N/A(1)





    (9.2)%



    ________________________

    (1)

    Our effective tax rates for the three and six months ended June 30, 2021 on a GAAP basis are not meaningful metrics.











    Three Months Ended

    June 30,



    Six Months Ended

    June 30,

    (In thousands, except percentages)

    2021



    2020



    2021



    2020

    Non-GAAP adjusted:















    Cost of product sales

    $

    50,226





    $

    26,087





    $

    88,419





    $

    53,071



    Gross margin

    93.3%





    95.3%





    93.5%





    95.1%



    Selling, general and administrative

    $

    269,440





    $

    170,386





    $

    497,840





    $

    358,190



    % of total revenues

    35.8%





    30.3%





    36.6%





    32.6%



    Research and development

    $

    118,525





    $

    71,259





    $

    186,455





    $

    150,981



    % of total revenues

    15.8%





    12.7%





    13.7%





    13.8%



    Acquired in-process research and development

    $





    $

    3,000





    $





    $

    205,250



    Income tax provision

    $

    30,262





    $

    73,085





    $

    67,921





    $

    77,772



    Effective tax rate

    11.2%





    25.9%





    12.8%





    24.9%



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

    • Cost of product sales increased in the second quarter of 2021 compared to the same period in 2020, on a GAAP and non-GAAP adjusted basis, primarily due to increased net product sales as a result of the GW Acquisition. In addition, an acquisition accounting inventory fair value step-up expense of $66.0 million impacted GAAP cost of product sales.
    • Selling, general and administrative (SG&A) expenses increased in the second quarter of 2021 compared to the same period in 2020, 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 GW Acquisition, increased investment in sales, marketing and launch activities primarily related to Sunosi, Xywav and Zepzelca in the U.S. and the addition of costs related to Epidiolex. SG&A expenses in the second quarter of 2021 on a GAAP basis also included transaction and integration related expenses of $129.5 million related to the GW Acquisition.
    • Research and development expenses increased in the second quarter of 2021 compared to the same period in 2020, 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 for JZP385 and an increase in compensation-related expenses due to higher headcount primarily driven by the GW Acquisition.
    • On a GAAP basis, our income tax provision for the three months ended June 30, 2021, included an expense of $251.4 million arising on the remeasurement of our U.K. net deferred tax liability, which arose primarily in relation to the GW Acquisition, due to a change in the statutory tax rate in the U.K. following enactment of the UK Finance Act 2021. Due to the impact of this expense, our effective tax rate for the three months ended June 30, 2021, on a GAAP basis is not a meaningful metric.
    • On a non-GAAP basis, the decrease in the effective tax rate in the second quarter of 2021 compared to the same period in 2020 was primarily due to the impact in 2020 of the disallowance of certain interest deductions, provision for the settlement reached with the French tax authorities, and the impact of the change in income mix.

    Cash Flow and Balance Sheet

    As of June 30, 2021, cash and cash equivalents were $891.4 million, and the outstanding principal balance of the Company's long-term debt was $7.1 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $500.0 million.

    For the six months ended June 30, 2021, the Company generated $326.7 million of cash from operations.

    2021 Financial Guidance1

    Jazz Pharmaceuticals is reaffirming its previously communicated full year 2021 non-GAAP financial guidance and updating its 2021 GAAP guidance. This guidance reflects the Company's current and future expected operational performance, including COVID-19 related impacts, the strength of its underlying operations and the prioritization of new and ongoing value creating development projects.



    Guidance provided as of

    (In millions)

    June 17, 2021



    August 3, 2021

    Revenues

    $3,020 - $3,180



    $3,020 - $3,180

    Total net product sales

    $3,010 - $3,165



    $3,010 - $3,165

    -Neuroscience

    $2,260 - $2,360



    $2,260 - $2,360

    -Oncology

    $715 - $835



    $715 - $835





    GAAP:









    Guidance provided as of

    (In millions, except per share amounts and percentages)

    June 17, 2021



    August 3, 2021

    Gross margin %

    86%



    85%

    SG&A expenses

    $1,468 - $1,560



    $1,468 - $1,560

    SG&A expenses as % of total revenues

    46% - 52%



    46% - 52%

    R&D Expenses

    $542 - $596



    $542 - $596

    R&D expenses as % of total revenues

    17% - 20%



    17% - 20%

    Effective tax rate

    18% - 21%



    (58%) - (102%)

    Net loss per diluted share

    ($4.70) – ($2.00)



    ($9.40) – ($6.70)2

    Weighted-average ordinary shares used in per share calculations

    62



    60









    Non-GAAP:





    Guidance provided as of

    (In millions, except per share amounts and percentages)

    June 17, 2021



    August 3, 2021

    Gross margin %

    93%



    93%3,7

    SG&A expenses

    $1,120 - $1,180



    $1,120 - $1,1804,7

    SG&A expenses as % of total revenues

    35% - 39%



    35% - 39%

    R&D Expenses

    $500 - $540



    $500 - $5405,7

    R&D expenses as % of total revenues

    16% - 18%



    16% - 18%

    Effective tax rate

    13% - 15%



    13% - 15%6,7

    Net income per diluted share

    $13.40 - $14.70



    $13.40 - $14.702,7

    Weighted-average ordinary shares used in per share calculations

    62



    62

    ____________________________

    1.

    The Company's 2021 financial guidance includes the anticipated results of the acquired GW business from the date of acquisition (May 5, 2021) and related acquisition accounting adjustments, which are subject to change if the company obtains additional information during the measurement period (up to one year from the acquisition date); any such change could be material.





    2.

    The Company expects the transaction to be dilutive to both GAAP and non-GAAP adjusted net income per diluted share in 2021.  On a GAAP basis, this is expected to be primarily due to an increase in the amortization of acquisition-related intangible assets and transaction and integration related expenses, the amortization of inventory fair value step-up, increased interest expense and an increase in number of outstanding shares relating to the GW Acquisition.  On a non-GAAP adjusted basis, this is expected to be due to increased cash interest expense and an increase in the number of outstanding shares.





    3.

    Excludes $220-$260 million of amortization of acquisition-related inventory fair value step-up, $8-$10 million of share-based compensation expense and $2-$4 million of transaction and integration related expenses relating to the GW Acquisition from estimated GAAP gross margin.





    4.

    Excludes $221-$245 million of transaction and integration related expenses relating to the GW Acquisition and $127-$135 million of share-based compensation expense from estimated GAAP SG&A expenses.





    5.

    Excludes $35-$45 million of share-based compensation expense and $7-$11 million of transaction and integration related expenses relating to the GW Acquisition from estimated GAAP R&D expenses.





    6.

    Excludes the income tax effect of adjustments between GAAP net income and non-GAAP adjusted net income and an expense of $251 million arising on the remeasurement of our U.K. net deferred tax liability, which arose primarily in relation to the GW Acquisition, due to a change in the statutory tax rate in the U.K. following enactment of the UK Finance Act 2021.





    7.

    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 2021 Net Income Guidance" at the end of this press release.

    Conference Call Details

    Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET (9:30 p.m. IST) to provide a business and financial update and discuss its 2021 second 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 7187077.

    A replay of the conference call will be available through August 10, 2021 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 7187077. 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

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

    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 GAAP reported net income (loss) (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 impact of the change in the statutory tax rate in the U.K.  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. For example, commencing in 2020, the Company no longer excludes upfront and milestone payments from the Company's non-GAAP adjusted net income, its line item components and non-GAAP adjusted net income per diluted share. Likewise, the Company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

    Caution Concerning Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to the Company's growth prospects and future financial and operating results, including the Company's 2021 financial guidance and the Company's expectations related thereto; the potential launch of Xywav in IH and the timing thereof; the completion of integration in connection with the acquisition of GW Pharmaceuticals and the anticipated benefits of the addition of the GW Pharmaceuticals pipeline and cannabinoid platform to the Company's own pipeline; the anticipated supply and other benefits of Rylaze to patients and healthcare providers; the value of the Company's development platform; expected initiations of Epidiolex, nabiximols, JZP385, JZP150 and Zepzelca clinical trials and the timing thereof; the potential approval of nabiximols in MS Spasticity; the Company's plans to submit additional data for Rylaze; the therapeutic potential of the Company's product candidates; the value of the Company's diversified product portfolio; the Company's financing structure supporting its plans for rapid deleveraging to its stated targets; 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 the Company's oxybate products 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 supplemental new drug application seeking approval for Xywav in IH 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 GW Pharmaceuticals, including the risk that the legacy GW Pharmaceuticals business will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; the ultimate duration and severity of the COVID-19 pandemic and resulting global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the Company's business operations and financial results; regulatory initiatives and changes in tax laws; market volatility; 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, legal proceedings and other actions; identifying and acquiring, in-licensing or developing additional products or product candidates, financing these transactions and successfully integrating acquired product candidates, products and businesses; the Company's ability to realize the anticipated benefits of its collaborations and license agreements with third parties; the sufficiency of the Company's cash flows and capital resources to fund its debt service obligations, de-lever and meet its stated leverage targets; the Company's ability to achieve expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; the possibility that, if the Company does not achieve the perceived benefits of the acquisition of GW Pharmaceuticals as rapidly or to the extent anticipated by financial analysts or investors, the market price of the Company's ordinary shares could decline; 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' and GW Pharmaceuticals' Securities and Exchange Commission filings and reports, including the Company's Annual Report on Form 10-K for the year ended December 31, 2020, GW Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2020, and future filings and reports by the Company, including the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. 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 (LOSS)

    (In thousands, except per share amounts)

    (Unaudited)





    Three Months Ended

    June 30,



    Six Months Ended

    June 30,



    2021



    2020



    2021



    2020

    Revenues:















    Product sales, net

    $

    748,340





    $

    558,203





    $

    1,351,871





    $

    1,088,408



    Royalties and contract revenues

    3,471





    4,233





    7,521





    8,754



    Total revenues

    751,811





    562,436





    1,359,392





    1,097,162



    Operating expenses:















    Cost of product sales (excluding amortization of acquired developed technologies)

    119,194





    28,008





    159,383





    56,665



    Selling, general and administrative

    429,031





    191,406





    689,539





    399,806



    Research and development

    132,696





    78,922





    209,269





    165,029



    Intangible asset amortization

    140,480





    62,974





    208,672





    125,821



    Acquired in-process research and development





    3,000









    205,250



    Impairment charge













    136,139



    Total operating expenses

    821,401





    364,310





    1,266,863





    1,088,710



    Income (loss) from operations

    (69,590)





    198,126





    92,529





    8,452



    Interest expense, net

    (69,420)





    (26,210)





    (96,796)





    (44,706)



    Foreign exchange gain (loss)

    2,950





    (464)





    3,893





    (1,596)



    Income (loss) before income tax provision and equity in (gain) loss of investees

    (136,060)





    171,452





    (374)





    (37,850)



    Income tax provision

    228,621





    54,754





    246,640





    3,467



    Equity in (gain) loss of investees

    (1,365)





    1,897





    (5,530)





    1,715



    Net income (loss)

    $

    (363,316)





    $

    114,801





    $

    (241,484)





    $

    (43,032)



















    Net income (loss) per ordinary share:















    Basic

    $

    (6.11)





    $

    2.07





    $

    (4.17)





    $

    (0.77)



    Diluted

    $

    (6.11)





    $

    2.06





    $

    (4.17)





    $

    (0.77)



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

    59,448





    55,413





    57,966





    55,684



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

    59,448





    55,864





    57,966





    55,684









    JAZZ PHARMACEUTICALS PLC

    PRO FORMA NET PRODUCT SALES

    (In thousands)

    (Unaudited)



    The following unaudited pro forma information represents the net product sales for the three and six months ended June 30, 2021, compared to the same periods in 2020, as if the GW Acquisition had been completed on January 1, 2020:





    Three Months Ended

    June 30,



    Six Months Ended

    June 30,



    2021



    2020



    2021



    2020

    Xyrem

    $

    334,182





    $

    446,808





    $

    669,732





    $

    854,683



    Xywav

    124,164









    199,580







    Total Oxybate

    458,346





    446,808





    869,312





    854,683



    Epidiolex/Epidyolex

    155,868





    117,741





    304,130





    233,883



    Sunosi

    12,124





    8,578





    23,730





    10,502



    Sativex® (delta-9-tetrahydrocannabiol and cannabidiol)

    3,548





    3,488





    7,728





    7,873



    Total Neuroscience

    629,886





    576,615





    1,204,900





    1,106,941



    Zepzelca

    55,924









    110,258







    Defitelio

    48,096





    42,714





    97,715





    90,146



    Vyxeos

    31,453





    26,568





    64,608





    59,288



    Erwinaze/Erwinase

    28,314





    32,683





    69,382





    70,415



    Total Oncology

    163,787





    101,965





    341,963





    219,849



    Other

    2,641





    852





    5,424





    3,374



    Product sales, net

    $

    796,314





    $

    679,432





    $

    1,552,287





    $

    1,330,164









    JAZZ PHARMACEUTICALS PLC

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands)

    (Unaudited)





    June 30,

    2021



    December 31,

    2020

    ASSETS







    Current assets:







    Cash and cash equivalents

    $

    891,400





    $

    1,057,769



    Investments





    1,075,000



    Accounts receivable, net of allowances

    506,660





    396,490



    Inventories

    1,251,259





    95,396



    Prepaid expenses

    104,455





    62,422



    Other current assets

    200,190





    152,491



    Total current assets

    2,953,964





    2,839,568



    Property, plant and equipment, net

    277,066





    127,935



    Operating lease assets

    149,254





    129,169



    Intangible assets, net

    7,588,029





    2,195,051



    Goodwill

    1,887,699





    958,303



    Deferred tax assets, net

    296,493





    254,916



    Deferred financing costs

    13,406





    5,238



    Other non-current assets

    47,082





    25,721



    Total assets

    $

    13,212,993





    $

    6,535,901



    LIABILITIES AND SHAREHOLDERS' EQUITY







    Current liabilities:







    Accounts payable

    $

    64,826





    $

    26,945



    Accrued liabilities

    561,091





    352,732



    Current portion of long-term debt

    248,585





    246,322



    Income taxes payable

    3,645





    25,200



    Deferred revenue

    2,441





    2,546



    Total current liabilities

    880,588





    653,745



    Deferred revenue, non-current

    1,510





    2,315



    Long-term debt, less current portion

    6,489,315





    1,848,516



    Operating lease liabilities, less current portion

    156,556





    140,035



    Deferred tax liabilities, net

    1,421,027





    130,397



    Other non-current liabilities

    132,507





    101,148



    Total shareholders' equity

    4,131,490





    3,659,745



    Total liabilities and shareholders' equity

    $

    13,212,993





    $

    6,535,901









    JAZZ PHARMACEUTICALS PLC

    SUMMARY OF CASH FLOWS

    (In thousands)

    (Unaudited)





    Six Months Ended

    June 30,



    2021



    2020

    Net cash provided by operating activities

    $

    326,692





    $

    455,488



    Net cash used in investing activities

    (5,175,238)





    (801,245)



    Net cash provided by financing activities

    4,682,312





    494,851



    Effect of exchange rates on cash and cash equivalents

    (135)





    (356)



    Net increase (decrease) in cash and cash equivalents

    $

    (166,369)





    $

    148,738









    JAZZ PHARMACEUTICALS PLC

    RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION

    (In thousands, except per share amounts)

    (Unaudited)





    Three Months Ended

    June 30,



    Six Months Ended

    June 30,



    2021



    2020



    2021



    2020

    GAAP reported net income (loss)

    $

    (363,316)





    $

    114,801





    $

    (241,484)





    $

    (43,032)



    Intangible asset amortization

    140,480





    62,974





    208,672





    125,821



    Share-based compensation expense

    43,411





    30,604





    77,896





    59,258



    Transaction and integration related expenses1

    133,328









    141,590







    Non-cash interest expense2

    22,322





    17,268





    38,010





    29,268



    Acquisition accounting inventory fair value step-up

    65,991









    65,991







    Impairment charge3













    136,139



    Income tax effect of above adjustments

    (53,021)





    (18,331)





    (72,661)





    (74,305)



    Impact of U.K. tax rate change4

    251,380









    251,380







    Non-GAAP adjusted net income

    $

    240,575





    $

    207,316





    $

    469,394





    $

    233,149



















    GAAP reported net income (loss) per diluted share

    $

    (6.11)





    $

    2.06





    $

    (4.17)





    $

    (0.77)



    Non-GAAP adjusted net income per diluted share

    $

    3.90





    $

    3.71





    $

    7.82





    $

    4.14



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

    59,448





    55,864





    57,966





    55,684



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

    61,686





    55,864





    60,047





    56,328



    ________________________________________________

    Explanation of Adjustments and Certain Line Items:

    1.

    Transaction and integration related expenses related to the GW Acquisition.





    2.

    Non-cash interest expense associated with debt discount and debt issuance costs.





    3.

    Impairment charge related to the Company's decision to stop enrollment in its Phase 3 clinical trial of defibrotide for the prevention of veno-occlusive disease.





    4.

    Expense arising on the remeasurement of our U.K. net deferred tax liability, which arose primarily in relation to the GW Acquisition, due to a change in the statutory tax rate in the U.K. following enactment of the UK Finance Act 2021.







    JAZZ PHARMACEUTICALS PLC

    RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION

    CERTAIN LINE ITEMS - FOR THE THREE MONTHS ENDED JUNE 30, 2021 and 2020

    (In thousands, except percentages)

    (Unaudited)





    Three months ended June 30, 2021



    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

    $

    119,194





    84.1%





    $

    429,031





    $

    132,696





    $

    140,480





    $

    69,420





    $

    228,621





    N/A(1)



    Non-GAAP Adjustments:































    Intangible asset amortization

















    (140,480)















    Share-based compensation expense

    (2,572)





    0.4





    (30,046)





    (10,793)



















    Transaction and integration related expenses

    (405)









    (129,545)





    (3,378)



















    Non-cash interest expense





















    (22,322)











    Acquisition accounting inventory fair value step-up

    (65,991)





    8.8



























    Income tax effect of above adjustments

























    53,021





    N/A(1)



    Impact of U.K. tax rate change

























    (251,380)





    N/A(1)



    Total of Non-GAAP adjustments

    (68,968)





    9.2





    (159,591)





    (14,171)





    (140,480)





    (22,322)





    (198,359)





    N/A(1)



    Non-GAAP Adjusted

    $

    50,226





    93.3%





    $

    269,440





    $

    118,525





    $





    $

    47,098





    $

    30,262





    11.2%



    __________________________

    (1)

    Due to the impact of the U.K tax change, the GAAP effective tax rate is not a meaningful metric.







    Three months ended June 30, 2020



    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

    $

    28,008





    95.0%





    $

    191,406





    $

    78,922





    $

    62,974





    $

    26,210





    $

    54,754





    31.9%



    Non-GAAP Adjustments:































    Intangible asset amortization

















    (62,974)















    Share-based compensation expense

    (1,921)





    0.3





    (21,020)





    (7,663)



















    Non-cash interest expense





















    (17,268)











    Income tax effect of above adjustments

























    18,331





    (6.0)



    Total of Non-GAAP adjustments

    (1,921)





    0.3





    (21,020)





    (7,663)





    (62,974)





    (17,268)





    18,331





    (6.0)



    Non-GAAP Adjusted

    $

    26,087





    95.3%





    $

    170,386





    $

    71,259





    $





    $

    8,942





    $

    73,085





    25.9%









    JAZZ PHARMACEUTICALS PLC

    RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION

    CERTAIN LINE ITEMS - FOR THE SIX MONTHS ENDED JUNE 30, 2021 and 2020

    (In thousands, except percentages)

    (Unaudited)





    Six months ended June 30, 2021



    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

    $

    159,383





    88.2%





    $

    689,539





    $

    209,269





    $

    208,672





    $

    96,796





    $

    246,640





    N/A(1)



    Non-GAAP Adjustments:































    Intangible asset amortization

















    (208,672)















    Share-based compensation expense

    (4,568)





    0.4





    (53,892)





    (19,436)



















    Transaction and integration related expenses

    (405)









    (137,807)





    (3,378)



















    Non-cash interest expense





















    (38,010)











    Acquisition accounting inventory fair value step-up

    (65,991)





    4.9



























    Income tax effect of above adjustments

























    72,661





    N/A(1)



    Impact of U.K. tax rate change

























    (251,380)





    N/A(1)



    Total of Non-GAAP adjustments

    (70,964)





    5.3





    (191,699)





    (22,814)





    (208,672)





    (38,010)





    (178,719)





    N/A(1)



    Non-GAAP Adjusted

    $

    88,419





    93.5%





    $

    497,840





    $

    186,455





    $





    $

    58,786





    $

    67,921





    12.8%



    __________________________

    (1)

    Due to the impact of the U.K tax change, the GAAP effective tax rate is not a meaningful metric.







    Six months ended June 30, 2020



    Cost of

    product

    sales



    Gross

    margin



    Selling, general

    and

    administrative



    Research

    and

    development



    Intangible

    asset

    amortization



    Impairment

    charge



    Interest

    expense,

    net



    Income tax

    provision



    Effective

    tax rate

    GAAP Reported

    $

    56,665





    94.8%





    $

    399,806





    $

    165,029





    $

    125,821





    $

    136,139





    $

    44,706





    $

    3,467





    (9.2)%



    Non-GAAP Adjustments:



































    Intangible asset amortization

















    (125,821)



















    Share-based compensation expense

    (3,594)





    0.3





    (41,616)





    (14,048)























    Impairment charge





















    (136,139)















    Non-cash interest expense

























    (29,268)











    Income tax effect of above adjustments





























    74,305





    34.1



    Total of Non-GAAP adjustments

    (3,594)





    0.3





    (41,616)





    (14,048)





    (125,821)





    (136,139)





    (29,268)





    74,305





    34.1



    Non-GAAP Adjusted

    $

    53,071





    95.1%





    $

    358,190





    $

    150,981





    $





    $





    $

    15,438





    $

    77,772





    24.9%









    JAZZ PHARMACEUTICALS PLC

    RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2021 NET INCOME GUIDANCE

    (In millions, except per share amounts)

    (Unaudited)



    GAAP net loss

    ($560) – ($400)

    Intangible asset amortization

    525 – 545

    Acquisition accounting inventory fair value step-up

    220 – 260

    Share-based compensation expense

    170 – 190

    Transaction and integration related expenses

    230 – 260

    Non-cash interest expense

    90 – 110

    Income tax effect of above adjustments

    (195) - (205)

    Impact of UK tax rate change

    251

    Non-GAAP adjusted net income

     $830 – $910





    GAAP net loss per diluted share

    ($9.40) – ($6.70)

    Non-GAAP adjusted net income per diluted share

    $13.40 – $14.70





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

    60

    Weighted-average ordinary shares used in per share calculations - Non-GAAP

    62

    Contacts:

    Investors:

    Andrea N. Flynn, Ph.D.

    Vice President, Head, Investor Relations

    Jazz Pharmaceuticals plc



    Ireland +353 1 634 3211

    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

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

     

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    SOURCE Jazz Pharmaceuticals plc

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  2. Onera Health, a leader in sleep diagnostic and monitoring solutions, closed €10.5M in Series B funding. The round was led by Innovation Industries in close collaboration with Invest-NL and with existing investors imec.xpand, Jazz Pharmaceuticals, BOM and 15th Rock.

    Onera Health, a leader in sleep diagnostic and monitoring solutions, closed the Series B funding round today, which brought the total funding raised to date above the €24M mark.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005036/en/

    The model is wearing the head and chest patch of Onera STS innovative PSG system. (Photo: Business Wire)

    The model is wearing the head and chest patch of Onera STS innovative PSG system. (Photo: Business Wire)

    Led by Innovation Industries in close collaboration with Invest-NL and with…

    Onera Health, a leader in sleep diagnostic and monitoring solutions, closed €10.5M in Series B funding. The round was led by Innovation Industries in close collaboration with Invest-NL and with existing investors imec.xpand, Jazz Pharmaceuticals, BOM and 15th Rock.

    Onera Health, a leader in sleep diagnostic and monitoring solutions, closed the Series B funding round today, which brought the total funding raised to date above the €24M mark.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005036/en/

    The model is wearing the head and chest patch of Onera STS innovative PSG system. (Photo: Business Wire)

    The model is wearing the head and chest patch of Onera STS innovative PSG system. (Photo: Business Wire)

    Led by Innovation Industries in close collaboration with Invest-NL and with existing investors Jazz Pharmaceuticals, imec.xpand, BOM and 15th Rock, the company intends to use the funds to execute clinical studies and further commercialize its sleep diagnostics and monitoring products in Europe and the United States. Onera has recently obtained the CE mark for its first product, an innovative polysomnography (PSG) system that brings the gold-standard quality of a hospital diagnostic system directly to a user's home.

    "We're going to leverage the funding to conduct progressively larger scale clinical studies, expand our partnerships in the EU and US and expedite product development to broaden our portfolio in sleep diagnostics and monitoring," said Ruben de Francisco, Founder, CTO & interim CEO of Onera "This will facilitate the commercialization of our products and help the medical field provide the much-needed answers for millions who are affected by sleep disorders. We are excited to have such strong support from investors who share our vision."

    Harm de Vries, Partner at Innovation Industries, said: "We are delighted to lead this investment in Onera as the company is perfectly positioned to support the evolution of hospital-quality care to the home by its innovative sleep diagnostic products. With its world-class team, partners, and disruptive technology, we believe Onera is able to democratize gold-standard sleep medicine."

    Leo Holwerda, Director Capital of Invest-NL added: "Our investment in Onera is another good example of how we support promising Dutch start-ups and innovative companies to bring high-impact technologies and solutions to the market."

    "From the very beginning, we were convinced that Onera has the potential to revolutionize the remote monitoring industry. We look forward to seeing Onera's continued success, enabled by this investment, in the commercialization of its products in Europe and the United States", said Tom Vanhoutte, Partner at imec.xpand.

    Onera focuses on breakthrough sleep testing solutions that are quick, convenient, and clinically accurate. The user-centric technology of their PSG system enables not only at-home diagnostics but also offers opportunities for hospitals that have limited or no access to a sleep clinic to implement sleep diagnostic testing within their institution.

    Last month, the MedTech and Digital Health company showcased its first-generation product at the SLEEP 2021 congress and presented its latest research to renowned world-experts, further underlining the ambition to position itself as a leader in the field of sleep medicine.

    Onera recently relocated its headquarters to the Brainport region in Eindhoven, the Netherlands, while maintaining commercial operations in the United States.

    About Onera

    Onera Health is a leader in transforming sleep medicine and remote monitoring. Their breakthrough diagnostic solutions and services are poised to help millions of people struggling with sleep-related ailments, while also impacting other medical fields by monitoring a variety of chronic conditions, ultimately improving the health and quality of life for patients around the world. The company's innovative solutions provide comprehensive sleep test data to physicians in a variety of clinical and non-clinical environments to optimize patient care and reduce healthcare costs. Onera has offices in the Netherlands and the US. For more information, go to www.onerahealth.com

    About Innovation Industries

    Innovation Industries is a Deeptech venture capital investor that invests up to €30M in Hightech, Agri&Foodtech and Medtech businesses.

    Today, Innovation Industries manages over €275M across two funds and has a team of 15 investment professionals. Its largest investors are the Dutch pension funds PME and PMT. Innovation Industries invests from seed to late stage and has partnerships with all Dutch technical universities and research institute TNO. For more information on Innovation Industries see: www.innovationindustries.com

    About invest-NL

    Invest-NL is an impact investor committed to businesses and projects that will make the Netherlands more sustainable and innovative. Its focus lies on carbon-neutral and circular economy and on innovative, fast-growing companies, or scale-ups. Invest-NL supports innovative entrepreneurs through financing and advice according to one simple principle: impact is our goal, return is our means. As the Dutch partner for European investment institutions, Invest-NL is dedicated to cooperation and always works together with other investors. Invest-NL is headquartered in Amsterdam and employs a staff of 60 people. For more information, go to www.invest-nl.nl

    About imec.xpand

    imec.xpand is an early-stage and growth venture capital fund with powerful strategies that evolve hardware-driven nanotechnology innovations into successful global companies. The fund is independently managed by a team of entrepreneurs, seasoned investors and business experts who target ambitious tech start-ups where imec technology, expertise and infrastructure can impact success. For more information, please visit www.imecxpand.com

    About Jazz Pharmaceuticals plc

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

    About BOM (Brabant Development Agency)

    Entrepreneurship is the driver of change. From sustainable food sources to a healthy future, climate-neutral energy, and developing promising key technologies – the Brabant Development Agency (BOM) ensures that startups playing a role in these fields get off to a flying start and grow into scaleups, that the right facilities are always available to Brabant-based companies, and that companies that aspire to go global can actually do so. Over the last four years BOM has worked with over 600 companies to achieve such an impact. BOM. Catalyzing Change. For more information, please visit www.bom.nl

    About 15th Rock Ventures

    15th Rock Ventures is a venture capital firm that invests in human augmentation and information technology with the aim of creating a prosperous society in the age of 100 years. The definition of human augmentation is to create a world where people can improve their physical abilities, acquire various skills that were previously impossible, and have more options in life by combining multiple elemental technologies such as AI, robotics, electronics, AR/VR, and brain-machine interface. For more information, please visit www.en.15th-rock.com

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  3. DUBLIN, July 22, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the National Comprehensive Cancer Network® (NCCN) added Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) to the Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia (ALL), for both pediatric and adult patients.

    The NCCN Guidelines for ALL and the NCCN Guidelines for Pediatric ALL now include asparaginase erwinia chrysanthemi (recombinant)-rywn as a treatment option for patients with hypersensitivity to E. coli asparaginase products as a component of the multi-agent chemotherapeutic regimen to complete the full treatment course.

    "Asparaginase is a core component of chemotherapeutic regimens…

    DUBLIN, July 22, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the National Comprehensive Cancer Network® (NCCN) added Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) to the Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia (ALL), for both pediatric and adult patients.

    The NCCN Guidelines for ALL and the NCCN Guidelines for Pediatric ALL now include asparaginase erwinia chrysanthemi (recombinant)-rywn as a treatment option for patients with hypersensitivity to E. coli asparaginase products as a component of the multi-agent chemotherapeutic regimen to complete the full treatment course.

    "Asparaginase is a core component of chemotherapeutic regimens in ALL and lymphoblastic lymphoma; however, treatments derived from E. coli are associated with the potential for hypersensitivity reactions, which can affect a substantial number of these patients," said Rob Iannone, M.D., M.S.C.E., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals. "Before the FDA approval of Rylaze, there was a significant need for an effective and reliable supply of asparaginase medicine that would allow patients the opportunity to start and complete their prescribed treatment program with confidence. We are pleased by the NCCN's decision to quickly incorporate Rylaze into the Clinical Practice Guidelines for ALL."

    Rylaze was approved by the U.S. Food and Drug Administration (FDA) on June 30, 2021 for use as a component of a multi-agent chemotherapeutic regimen given by intramuscular injection for the treatment of ALL and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.1 The approval followed review of a Biologics Licensing Application under the FDA's Real-Time Oncology Review program, and it was based on clinical data from a pivotal Phase 2/3 trial conducted in collaboration with the Children's Oncology Group.

    The NCCN Guidelines play a pivotal role in decision-making processes for individuals involved in cancer care all over the world, including physicians, nurses, pharmacists, payers, and patients and their families. The guidelines present expert recommendations for cancer screening, diagnosis and treatment, as well as cancer care options that may increase the chances of favorable outcomes for patients.

    The NCCN is a not-for-profit alliance of 30 leading U.S. cancer centers devoted to patient care, research and education that aims to facilitate quality, effective, efficient and accessible care so that patients can live better lives.

    About Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) 

    Rylaze, also known as JZP458, is approved in the U.S. for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze has orphan drug designation for the treatment of ALL/LBL in the United States. Rylaze is a recombinant erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. JZP458 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in October 2019 for the treatment of this patient population. Rylaze was approved as part of the Real-Time Oncology Review program, an initiative of the FDA's Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.

    The full U.S. Prescribing Information for Rylaze is available at: <http://pp.jazzpharma.com/pi/rylaze.en.USPI.pdf>

    Important Safety Information

    RYLAZE should not be given to people who have had:

    • Serious allergic reactions to RYLAZE
    • Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment

    RYLAZE may cause serious side effects, including:

    • Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing), some of which may be life-threatening
    • Swelling of the pancreas (stomach pain)
    • Blood clots (may have a headache or pain in leg, arm, or chest)
    • Bleeding
    • Liver problems

    Contact your doctor immediately if any of these side effects occur.

    Some of the most common side effects with RYLAZE include: liver problems, nausea, bone and muscle pain, tiredness, infection, headache, fever, allergic reactions, fever with low white blood cell count, decreased appetite, mouth swelling (sometimes with sores), bleeding, and too much sugar in the blood.

    RYLAZE can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving RYLAZE and for 1 week after the final dose.

    Tell your healthcare provider if there are any side effects that are bothersome or that do not go away.

    These are not all the possible side effects of RYLAZE. For more information, ask your healthcare provider.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

    About ALL 

    ALL is a cancer of the blood and bone marrow that can progress quickly if not treated.2 Leukemia is the most common cancer in children, and about three out of four of these cases are ALL.3  Although it is one of the most common cancers in children, ALL is among the most curable of the pediatric malignancies due to recent advancements in treatment.4,5 Adults can also develop ALL, and about four of every 10 cases of ALL diagnosed are in adults.6  The American Cancer Society estimates that almost 6,000 new cases of ALL will be diagnosed in the United States in 2021.6 Asparaginase is a core component of multi-agent chemotherapeutic regimens in ALL.7  However, asparaginase treatments derived from E. coli are associated with the potential for development of hypersensitivity reactions.8

    About Lymphoblastic Lymphoma

    LBL is a rare, fast-growing, aggressive subtype of Non-Hodgkin's lymphoma, most often seen in teenagers and young adults.7 LBL is a very aggressive lymphoma – also called high-grade lymphoma – which means the lymphoma grows quickly with early spread to different parts of the body.9,10

    About Jazz Pharmaceuticals plc 

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

    Caution Concerning Forward-Looking Statements  

    This press release contains forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals' belief in the potential of Rylaze to provide a reliable therapeutic option for adult and pediatric patients to maximize their chance for a cure, the availability of a reliable supply of Rylaze, and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' 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, effectively launching and commercializing new products; obtaining and maintaining adequate coverage and reimbursement for the company's products; delays or problems in the supply or manufacture of the company's products; 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' Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2020 and future filings and reports by Jazz Pharmaceuticals. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

    Jazz Media Contact: 

    Jacqueline Kirby 

    Vice President, Corporate Affairs  

    Jazz Pharmaceuticals plc 

     

    Ireland, +353 1 697 2141 

    U.S. +1 215 867 4910

    Jazz Investor Contact: 

    Andrea N. Flynn, Ph.D. 

    Vice President, Head, Investor Relations 

    Jazz Pharmaceuticals plc 

      

    Ireland, +353 1 634 3211       

    References

    1. Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) injection, for intramuscular use Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
    2. National Cancer Institute. Adult Acute Lymphoblastic Leukemia Treatment (PDQ®)–Patient Version. Available at www.cancer.gov/types/leukemia/patient/adult-all-treatment-pdq. Accessed July 21, 2021
    3. American Cancer Society. Key Statistics for Childhood Leukemia. Available at https://www.cancer.org/cancer/leukemia-in-children/about/key-statistics.html. Accessed July 21, 2021.
    4. American Cancer Society. Cancer Facts & Figures 2019. www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2019.html. Accessed July 21, 2021.
    5. Pui C, Evans W. A 50-Year Journey to Cure Childhood Acute Lymphoblastic Leukemia. Seminars in Hematology. 2013;50(3), 185-196.
    6. Pui C, Evans W. A 50-Year Journey to Cure Childhood Acute Lymphoblastic Leukemia. Seminars in Hematology. 2013;50(3), 185-196.
    7. Salzer W, Bostrom B, Messinger Y et al. 2018. Asparaginase activity levels and monitoring in patients with acute lymphoblastic leukemia. Leukemia & Lymphoma. 59:8, 1797-1806, DOI: 10.1080/10428194.2017.1386305.
    8. Hijiya N, van der Sluis IM. Asparaginase-associated toxicity in children with acute lymphoblastic leukemia. Leuk Lymphoma. 2016;57(4):748–757. DOI: 10.3109/10428194.2015.1101098.
    9. Leukemia Foundation. Lymphoblastic Lymphoma. Available at https://www.leukaemia.org.au/disease-information/lymphomas/non-hodgkin-lymphoma/other-non-hodgkin-lymphomas/lymphoblastic-lymphoma/. Accessed July 21, 2021.
    10. Mayo Clinic. Acute Lymphocytic Leukemia Diagnosis. Available at https://www.mayoclinic.org/diseases-conditions/acute-lymphocytic-leukemia/diagnosis-treatment/drc-20369083. Accessed July 21, 2021.

     

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    SOURCE Jazz Pharmaceuticals plc

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  4. Ligand expects to receive $7 million in milestone payments

    Rylaze for the treatment of ALL or LBL utilizes Ligand's Pelican Expression Technology™ Platform

    Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced Jazz Pharmaceuticals plc (NASDAQ:JAZZ) has launched Rylaze™(asparaginase erwinia chrysanthemi (recombinant)-rywn), also known as JZP458. Rylaze, which was approved by the FDA on June 30, 2021, is a recombinant erwinia asparaginase used as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

    Under the terms of the license…

    Ligand expects to receive $7 million in milestone payments

    Rylaze for the treatment of ALL or LBL utilizes Ligand's Pelican Expression Technology™ Platform

    Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced Jazz Pharmaceuticals plc (NASDAQ:JAZZ) has launched Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn), also known as JZP458. Rylaze, which was approved by the FDA on June 30, 2021, is a recombinant erwinia asparaginase used as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

    Under the terms of the license agreement with Jazz Pharmaceuticals, Ligand received a $2 million payment upon FDA's acceptance for review of the product BLA and is entitled to receive a $5 million payment upon the first commercial sale following launch. Ligand is eligible to receive up to an additional $155.5 million in milestone payments and tiered low to mid-single digit royalties based on worldwide net sales of any products resulting from this collaboration, including Rylaze.

    "This partnership with Jazz Pharmaceuticals is one of the core scientific programs that catalyzed our acquisition of Pfenex last year. The Rylaze commercial launch really showcases our highly productive partnership with Jazz and the exceptional ability of our Pelican Expression Technology to enable life-saving therapeutics," said John Higgins, CEO of Ligand. "The robust manufacturing afforded by Ligand's Pelican Expression Technology combined with Jazz's demonstrated success in development and commercialization has enabled the delivery of a high-quality recombinant asparaginase option for patients with hypersensitivity to E. coli-derived asparaginase with reliable supply."

    About the Pelican Expression Technology™

    Pelican is a robust, validated, cost-effective and scalable platform for recombinant protein production, and is especially well-suited for complex, large-scale protein production where traditional systems are not suitable. Multiple global manufacturers have demonstrated consistent success with the platform and the technology is currently out-licensed for numerous commercial and development-stage programs. The versatility of the platform has been demonstrated in the production of enzymes, peptides, antibody derivatives and engineered non-natural proteins. Partners seek the platform as it can contribute significant value to biopharmaceutical development programs by reducing development timelines and costs for manufacturing therapeutics and vaccines. Given pharmaceutical industry trends toward large molecules with increasing structural complexities, Pelican is well positioned to meet these growing needs as the most comprehensive broadly available protein production platform in the industry. For more information, please visit www.pelicanexpression.com.

    About Ligand Pharmaceuticals

    Ligand is a revenue-generating biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Ligand's business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Ligand's goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Ligand's business model is based on doing what Ligand does best: drug discovery, early-stage drug development, product reformulation and partnering. Ligand partners with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue. Ligand's OmniAb® technology platform is a patent-protected technology stack used in the discovery of fully human mono- and bispecific therapeutic antibodies. The Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand's Pelican Expression Technology™ is a robust, validated, cost-effective and scalable approach to recombinant protein production, and is especially well-suited for complex, large-scale protein production that cannot be made by more traditional systems. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Amgen, Merck, Pfizer, Roche, Jazz Pharmaceuticals, Sanofi, Janssen, Takeda, Gilead Sciences, GSK and Baxter International. For more information, please visit www.ligand.com.

    Follow Ligand on Twitter @Ligand_LGND.

    Forward-Looking Statements

    This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as "plans," "believes," "expects," "anticipates," and "will," and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include the timing and amount of milestone payments Ligand expects; and the intellectual property protections with respect to Ligand's technologies, including its OmniAb® and Captisol® platforms and the Pelican Expression Technology™. Actual events or results may differ from Ligand's expectations due to risks and uncertainties inherent in Ligand's business, including, without limitation: Ligand is dependent on Jazz on the commercialization of Rylaze, including the timing of the first commercial sale, and Jazz may not generate net sales to generate royalties payable to Ligand; and other risks described in Ligand's prior press releases and filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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  5. DUBLIN, July 20, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that it will report its 2021 second quarter financial results on Tuesday, August 3, 2021 after the close of the financial markets. Company management will host a live audio webcast at 4:30 p.m. ET/9:30 p.m. IST to discuss second quarter 2021 financial results and provide a business and financial update.  

    Audio webcast/conference call:
    U.S. Dial-In Number: +1 855 353 7924
    International Dial-In Number: +1 503 343 6056
    Passcode: 7187077

    A replay of the conference call will be available through August 10, 2021.

    Replay U.S. Dial-In Number: +1 855 859 2056
    Replay International Dial-In Number: +1 404 537 3406
    Passcode: 7187077

    Interested parties may access the…

    DUBLIN, July 20, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that it will report its 2021 second quarter financial results on Tuesday, August 3, 2021 after the close of the financial markets. Company management will host a live audio webcast at 4:30 p.m. ET/9:30 p.m. IST to discuss second quarter 2021 financial results and provide a business and financial update.  

    Audio webcast/conference call:

    U.S. Dial-In Number: +1 855 353 7924

    International Dial-In Number: +1 503 343 6056

    Passcode: 7187077

    A replay of the conference call will be available through August 10, 2021.

    Replay U.S. Dial-In Number: +1 855 859 2056

    Replay International Dial-In Number: +1 404 537 3406

    Passcode: 7187077

    Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com

    About Jazz Pharmaceuticals

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.

    Jazz Pharmaceuticals Contacts:







    Investors:

    Media:

    Andrea N. Flynn, Ph.D.

    Jacqueline Kirby

    Vice President, Head, Investor Relations

    Vice President, Corporate Affairs & Government Relations

    Jazz Pharmaceuticals plc

    Jazz Pharmaceuticals plc

    Ireland, +353 1 634 3211

    Ireland, +353 1 697 2141

    U.S., +1 650 496 2717

    U.S., +1 215 867 4910

     

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

     

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    SOURCE Jazz Pharmaceuticals plc

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