What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-11-07 compared with 2024-08-01 · 156 added, 148 removed, 424 unchanged (42% of the section changed)

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In particular, we encourage you to review the risks and uncertainties described in “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023, as supplemented by the risks and uncertainties described in "Risk Factors" Item 1A.

Risk Factors in Part II of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024.

Risk Factors in Part II of this Quarterly Report on Form 10-Q.

These risks and uncertainties could cause actual results to differ materially from those projected in forward-looking statements contained in this report or implied by past results and trends.

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In addition, we leverage our efficient, scalable operating model and integrated capabilities across our global infrastructure to effectively reach patients around the world.

In January 2022, we announced Vision 2025, which outlined our key priorities to deliver sustainable growth and enhanced value across three pillars:

commercial execution, pipeline productivity and operational excellence.

In recent quarters, Vision 2025 has created significant focus on one single year in our future and achievement of near-term financial metrics, rather than how management is running the business for long-term value creation.

Consequently, in July 2024, we announced that we will no longer be providing Vision 2025 metrics, and that 2025 financial guidance will be provided on our fourth quarter 2024 earnings call as we continue to focus on creating long-term value.

Our strategy to deliver sustainable growth and enhanced value continues to be focused on:

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May 2023 Canada

Xyrem® (sodium oxybate) Treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy.

July 2002 U.S.

Treatment of cataplexy in patients with narcolepsy.

August 2005 Canada

Treatment of narcolepsy with cataplexy in adult patients, adolescents and children from age of 7 years.

October 2005 European Union, or EU, Great Britain, other markets (through licensing agreement)

Epidiolex® (cannabidiol) Treatment of seizures associated with Lennox-Gastaut syndrome, or LGS, Dravet syndrome, or DS, or tuberous sclerosis complex, or TSC, in patients 1 year of age and older.

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September 2021 Canada (licensed from PharmaMar) 4

Product Indications Initial Approval Date Markets

Defitelio® (defibrotide) Treatment of severe hepatic veno-occlusive disease, or VOD, also known as sinusoidal obstruction syndrome, or SOS, following hematopoietic stem cell transplantation, or HSCT, therapy.

October 2013 EU, Great Britain, EEA 2 , Switzerland, Israel, Australia, South Korea, Saudi Arabia

Defitelio® (defibrotide sodium) Treatment of adult and pediatric patients with hepatic VOD, also known as SOS, with renal or pulmonary dysfunction following HSCT.

March 2016 U.S.

Defitelio® (defibrotide sodium) Treatment of severe hepatic VOD, also known as SOS, following HSCT therapy.

July 2017 Canada, Brazil

Defitelio® (defibrotide) Treatment of hepatic SOS (hepatic VOD).

June 2019 Japan

Vyxeos® (daunorubicin and cytarabine) liposome for injection Treatment of newly-diagnosed, therapy-related acute myeloid leukemia, or t-AML, or AML with myelodysplasia-related changes, or AML-MRC, in adults and pediatric patients one year and older.

August 2017 U.S.

Vyxeos® liposomal

44 mg/100 mg powder for concentrate for solution for infusion Treatment of adults with newly-diagnosed t-AML or AML-MRC.

August 2018 EU, Great Britain, Switzerland, Israel, Australia, South Korea, Saudi Arabia

Vyxeos® Daunorubicin and cytarabine liposome for injection Powder, 44 mg daunorubicin and 100 mg cytarabine per vial, intravenous, or IV, infusion Treatment of adults with newly diagnosed, therapy-related t-AML or AML with AML-MRC.

April 2021 Canada

Vyxeos® Combination for I.V.

Injection High-risk AML March 2024 Japan (through licensing agreement) 5

1 The clobazam restriction limited to EU and Great Britain

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4 Conditional approval received from Health Canada

5 Development and commercialization rights held by Nippon Shinyaku Co.

We are the global leader in the development and commercialization of oxybate therapy for patients with sleep disorders.

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In June 2021, FDA recognized seven years of Orphan Drug Exclusivity, or ODE, for Xywav in narcolepsy.

ODE extends through July 2027.

ODE extends through January 2028.

Nevertheless, Lumryz, a fixed-dose, high-sodium oxybate, was approved by FDA on May 1, 2023, for the treatment of cataplexy or EDS in adults with narcolepsy.

FDA continues to recognize seven years of ODE for Xywav in narcolepsy.

In connection with granting ODE, FDA stated that "Xywav is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem.” FDA's summary also stated that "the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated." FDA has also recognized that the difference in sodium content between Xywav and Lumryz is likely to be clinically meaningful in all patients

with narcolepsy and that Xywav is safer than Lumryz in all such patients.

Lumryz has the same sodium content as Xyrem.

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We have seen strong adoption of Xywav in narcolepsy since its launch in November 2020, and increasing adoption in IH since its launch in November 2021.

Exiting the second quarter of 2024, there were approximately 13,225 patients taking Xywav, including approximately 9,925 patients with narcolepsy and approximately 3,300 patients with IH.

Exiting the third quarter of 2024, there were approximately 13,625 patients taking Xywav, including approximately 10,075 patients with narcolepsy and approximately 3,550 patients with IH.

We acquired Epidiolex (Epidyolex outside the U.S.) in May 2021 as part of the acquisition of GW Pharmaceuticals plc, or GW, which we refer to as the GW Acquisition, which expanded our growing neuroscience business with a global, high-growth childhood-onset epilepsy franchise.

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The rolling European launch of Epidyolex is also underway following European Commission, or EC, approval in September 2019 for use as adjunctive therapy of seizures associated with LGS or DS, in conjunction with clobazam, for patients two years of age and older.

The clobazam restriction is limited to the EU and Great Britain.

Epidyolex is now launched in all five key European markets:

United Kingdom, Germany, Italy, Spain and France.

The clobazam restriction is limited to the EU and Great Britain.

Epidyolex was also approved for adjunctive therapy of seizures associated with TSC for patients 2 years of age and older in the EU in April 2021 and Great Britain in August 2021, and is approved or under review for this indication in other markets.

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that maintains a clinically meaningful level of asparaginase activity throughout the entire course of treatment.

We developed Rylaze to address the needs of patients and health care providers for an innovative, high-quality erwinia asparaginase with reliable supply.

We developed Rylaze to address the needs

of patients and health care providers for an innovative, high-quality erwinia asparaginase with reliable supply.

The initial approved recommended dosage of Rylaze was for an intramuscular, or IM, administration of 25 mg/m2 every 48 hours.

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In collaboration with F.

Hoffmann-La Roche Ltd, or Roche, we have an ongoing Phase 3 pivotal clinical trial in first-line extensive stage SCLC of Zepzelca in combination with Tecentriq® (atezolizumab).

Hoffmann-La Roche Ltd, or Roche, we have an ongoing Phase 3 pivotal clinical trial in maintenance treatment for extensive-stage SCLC of Zepzelca in combination with Tecentriq® (atezolizumab) following induction therapy with carboplatin, etoposide and Tecentriq.

In October 2024, we announced positive top-line results from the trial showing a statistically significant and clinically meaningful benefit for Zepzelca and atezolizumab in combination in the first-line maintenance setting.

We plan to submit a supplemental New Drug Application, or sNDA, in the first half of 2025 to support this combination in the first-line maintenance setting.

Defitelio is the first and only approved treatment for patients with VOD, severe VOD, or sVOD, or VOD with renal or pulmonary dysfunction following HSCT by regulatory authorities in the U.S., Europe, Japan and other markets.

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Moving forward, while HSCT procedures are gradually returning to pre-pandemic numbers, we expect changes in chemotherapy regimens and the increasing use of cell therapies to potentially lower the incidence of sVOD;

additionally, there has been a reduction of prophylactic use of Defitelio in Europe.

additionally, there has been a reduction of

prophylactic use of Defitelio in Europe.

Vyxeos is a treatment for adults with newly-diagnosed t-AML, or AML-MRC.

In March 2021, FDA approved a revised label to include a new indication to treat newly-diagnosed t-AML, or AML-MRC, in pediatric patients aged one year and older.

We continue to expand into new markets internationally as the product receives approvals and reimbursement in relevant

We continue to expand into new markets internationally as the product receives approvals and reimbursement in relevant markets.

In the U.S., with ongoing trends towards lower-intensity treatments and away from intensive chemotherapy regimens for AML, we have seen increasing competition from other therapeutic options.

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In addition, we have an ongoing Phase 3 randomized clinical trial evaluating zanidatamab in combination with chemotherapy plus or minus tislelizumab as a first-line treatment for HER2-expressing gastroesophageal adenocarcinoma, or GEA, and an ongoing Phase 2 trial examining zanidatamab in combination with chemotherapy in first-line patients with HER2-expressing metastatic GEA.

In July 2024, we announced the initiation of the Phase 3 EmpowHER-BC-303 to evaluate zanidatamab plus chemotherapy or trastuzumab plus chemotherapy in patients with HER2-positive breast cancer whose disease has progressed on previous trastuzumab deruxtecan (T-DXd) treatment.

In July 2024, we announced the initiation of the Phase 3 EmpowHER-BC-303 to evaluate

zanidatamab plus chemotherapy or trastuzumab plus chemotherapy in patients with HER2-positive breast cancer whose disease has progressed on previous trastuzumab deruxtecan, or T-DXd, treatment.

There are also multiple ongoing clinical trials exploring zanidatamab in breast cancer and other HER2-expressing tumor types.

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We are collaborating with Roche on a pivotal Phase 3 clinical trial evaluating Zepzelca in combination with Tecentriq in first-line extensive-stage SCLC.

We plan to submit an sNDA in the first half of 2025 to support this combination in the first-line maintenance setting.

In December 2021, our licensor PharmaMar initiated a confirmatory trial in second-line SCLC.

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In addition, we have an ongoing Phase 4 observational study to collect real world safety and outcome data in adult Zepzelca monotherapy patients with SCLC who progress on or after prior platinum-containing chemotherapy.

Preliminary findings from this study presented at the 2024 World Conference on Lung Cancer demonstrated Zepzelca provided clinical benefit when administered as second-line SCLC therapy.

The safety and tolerability profile observed in this study was consistent with prior findings, with no new safety signals reported.

In June 2022, we announced the FDA had cleared our Investigational New Drug application for JZP815 and, in October 2022, we enrolled the first patient in a Phase 1 trial.

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If approved, Werewolf is eligible to receive a tiered, mid-single-digit percentage royalty on net sales of JZP898.

This transaction underscores our commitment to enhancing our pipeline to deliver novel oncology therapies to

patients, and also provides us with an opportunity to expand into immuno-oncology.

This transaction underscores our commitment to enhancing our pipeline to deliver novel oncology therapies to patients, and also provides us with an opportunity to expand into immuno-oncology.

JZP898 is a differentiated, conditionally-activated interferon alpha, or IFNα, INDUKINE™ molecule.

We initiated a Phase 1 clinical trial of JZP898 in late 2023.

Our neuroscience R&D efforts include an ongoing Phase 3 trial of Epidyolex for LGS, DS and TSC in Japan initiated in October 2022.

Our neuroscience R&D efforts include an ongoing Phase 3 trial of Epidyolex for LGS, DS and TSC in Japan.

In August 2024, we announced top-line results from the trial.

The trial did not meet the primary efficacy endpoint of a pre-specified percentage change in indication-associated seizure frequency during the treatment period (up to 16 weeks) compared to baseline in Japanese pediatric patients;

however, numeric improvements were observed in the primary and several secondary endpoints.

No new safety signals were observed in the trial.

We are continuing to collect data in Japanese patients and plan to engage with regulatory authorities in Japan regarding a potential new drug application.

In December 2021, we initiated a Phase 2 clinical trial for suvecaltamide (JZP385), for essential tremor, or ET.

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We are continuing to evaluate data from this trial and await results from the ongoing Parkinson's disease tremor trial to determine next steps, if any, for the suvecaltamide program.

In December 2023, we announced that our Phase 2 clinical trial for JZP150 for treatment of post-traumatic stress disorder, or PTSD, did not meet the primary endpoint.

We plan to fully evaluate these data;

however, based on top-line results we do not anticipate moving forward with additional JZP150 development in PTSD.

We are also pursuing early-stage activities related to the development of JZP324, an extended-release low sodium, oxybate formulation that we believe could provide a clinically meaningful option for narcolepsy patients.

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no liver toxicity signals were observed.

Following additional review of the trial findings, in July 2024, we announced that pending additional input from FDA, we plan to initiate a small Phase 1b trial of JZP441 in narcolepsy Type 1 patients.

Following additional review of the trial findings and input from FDA, we plan to initiate a small Phase 1b trial of JZP441 in narcolepsy Type 1 patients in 2025.

We expect data from this trial will further our understanding of JZP441 and orexin-2 receptor agonism, providing learnings that could inform future development efforts.

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Zanidatamab HER2-expressing GEA, BTC or colorectal cancer in combination with standard first-line chemotherapy (ongoing trial)

Zanidatamab Basket trial including HER2-positive solid tumors (DiscovHER-Pan-206) (ongoing trial)

Vyxeos High-risk MDS (European Myelodysplastic Syndromes) (cooperative group study) (ongoing trial)

Newly diagnosed untreated patients with intermediate- and high-risk AML (cooperative group study) (ongoing trial)

Product Candidates Description

Vyxeos + other approved therapies Relapsed/refractory, or R/R AML or hypomethylating agent failure MDS (MD Anderson collaboration study) (ongoing trial)

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JZP815 Raf and Ras mutant tumors (acquired from Redx Pharma plc, or Redx) (ongoing trial)

Zanidatamab Previously treated metastatic HER2-expressing cancers in combination with select antineoplastic therapies (ongoing trial)

Zanidatamab Previously treated metastatic HER2-expressing cancers in combination with select antineoplastic therapies (cooperative group study) (ongoing trial)

JZP341 (long-acting Erwinia asparaginase)

Solid tumors (licensed from Ligand Pharmaceuticals Incorporated, or Ligand) (ongoing trial)

Solid tumors (licensed from Ligand Pharmaceuticals Incorporated) (ongoing trial)

JZP898 Conditionally-activated IFNα INDUKINE™ molecule in solid tumors (ongoing trial)

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Hematology/oncology exploratory activities

Product Candidates Description

Epidyolex LGS, TSC and DS (ongoing trial in Japan)

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*Also known as DSP-0187

Other Challenges, Risks and Trends Related to Our Business

Challenges, Risks and Trends Related to Our Business

Our operating plan assumes that Xywav, with 92% lower sodium compared to high-sodium oxybates (depending on the dose) absence of a sodium warning and dosing titration option, will remain the treatment of choice for patients who can benefit from oxybate treatment.

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While we expect that our business will continue to meaningfully depend on oxybate revenues, there is no guarantee that oxybate revenues will remain at current levels.

Our ability to successfully commercialize Xywav will depend on, among other things, our ability to maintain adequate payor coverage and reimbursement for Xywav and acceptance of Xywav by physicians and patients, including of Xywav for the treatment of IH in adults.

Our ability to successfully commercialize Xywav depends on, among other things, our ability to maintain adequate payor coverage and reimbursement for Xywav and acceptance of Xywav by physicians and patients, including of Xywav for the treatment of IH in adults.

In an effort to support strong adoption of Xywav and patient success, we are focused on facilitating payor coverage for Xywav and providing robust patient copay and savings programs.

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market in June 2023.

On June 22, 2023, we filed a complaint in the United States

District Court for the District of Columbia seeking a declaration that FDA’s approval of the New Drug Application, or NDA, for Avadel's Lumryz was unlawful.

In the complaint, we allege that FDA acted outside its authority under the Orphan Drug Act, when, despite ODE protecting Xywav, FDA approved the Lumryz NDA and granted Lumryz ODE based on FDA’s finding that Lumryz makes a major contribution to patient care and is therefore clinically superior to Xywav and Xyrem.

On June 22, 2023, we filed a complaint in the United States District Court for the District of Columbia seeking a declaration that FDA’s approval of the New Drug Application, or NDA, for Avadel's Lumryz was unlawful.

In the complaint, we alleged that FDA acted outside its authority under the Orphan Drug Act, when, despite ODE protecting Xywav, FDA approved the Lumryz NDA and granted Lumryz ODE based on FDA’s finding that Lumryz makes a major contribution to patient care and is therefore clinically superior to Xywav and Xyrem.

On September 15, 2023, we filed a motion for summary judgment.

On October 20, 2023, Avadel and FDA filed cross motions for summary judgment.

Oral argument on these motions was held on May 10, 2024, and on October 30, 2024, the District Court issued an order denying Jazz’s motion for summary judgment and granting Avadel’s and the FDA’s cross-motions for summary judgment.

Jazz respectfully disagrees with the Court’s decision and is evaluating potential options for appeal.

We cannot at this time predict the timing or ultimate outcome of this litigation or the impact of this litigation on our business.

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In addition, Hikma would need to set up its own REMS (or join an existing REMS operated by another company), which must be open to any other company seeking to commercialize a sodium oxybate product.

In our settlements with Amneal, Lupin Inc., or Lupin, and Par Pharmaceutical, Inc., or Par, we granted each party the right to sell a limited volume of an AG product in the U.S.

In our settlements with Amneal, Lupin Inc., or Lupin, and Par Pharmaceutical, Inc., or Par, we granted each party the right to

sell a limited volume of an AG product in the U.S.

beginning on July 1, 2023 and ending on December 31, 2025, with royalties to be paid to us.

Amneal launched its AG version of sodium oxybate in July 2023.

Amneal launched its AG version of high-sodium oxybate in July 2023.

At this time, Amneal has rights to sell a low-single-digit percentage of historical Xyrem sales over each 6-month sales period.

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For example, in November and December 2022, we received notices from ten ANDA filers that they have each filed with FDA an ANDA for a generic version of Epidiolex.

In addition, there are non-FDA approved cannabidiol preparations being made available from companies through

the state-enabled medical marijuana industry, which might attempt to compete with Epidiolex.

In addition, there are non-FDA approved cannabidiol preparations being made available from companies through the state-enabled medical marijuana industry, which might attempt to compete with Epidiolex.

Thus, significant uncertainty remains regarding the commercial potential of Epidiolex/Epidyolex.

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Nonetheless, Epidiolex and the other products and technologies acquired may not be successful or continue to grow at the same rate as if our companies operated independently or they may require significantly greater resources and investments than originally anticipated.

For example, in the third quarter of 2022, we recorded a $133.6 million asset impairment charge as a result of the decision to discontinue the nabiximols program.

For example, in the third quarter of 2022, we

recorded a $133.6 million asset impairment charge as a result of the decision to discontinue the nabiximols program.

As a result, the anticipated benefits of the GW Acquisition may not be realized at the expected level, within the expected timeframe or at all or may take longer to realize or cost more than expected, which could materially and adversely affect our business, financial condition, results of operations and growth prospects.

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Government investigations with respect to our business practices, including as they relate to the Xywav and Xyrem REMS, the launch of Xywav, our Xyrem patent litigation settlement agreements or otherwise, could cause us to incur significant monetary charges to resolve these matters and could distract us from the operation of our business and execution of our strategy.

We may also become

subject to similar investigations by other state or federal governmental agencies.

In addition, from June 2020 to May 2022, a number of lawsuits were filed on behalf of purported direct and indirect Xyrem purchasers, alleging that the patent litigation settlement agreements we entered with certain generic companies violate state and federal antitrust and consumer protection laws.

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Any of the foregoing risks and uncertainties could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

These risks and uncertainties are discussed in greater detail, along with other risks and uncertainties, in “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023, as supplemented by the risks and

uncertainties described in "Risk Factors" in Part II, Item 1A of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024.

Results of Operations

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Three Months Ended

June 30, Increase/ Six Months Ended

June 30, Increase/

September 30, Increase/ Nine Months Ended

September 30, Increase/

2024 2023 (Decrease) 2024 2023 (Decrease)

Product sales, net $ 989,707 $ 938,398 5 % $ 2,795,953 $ 2,769,604 1 %

Royalties and contract revenues 59,681 10,330 N/A(1) 119,562 18,923 N/A(1)

Royalties and contract revenues 65,262 33,742 93 % 184,824 52,665 N/A(1)

Cost of product sales (excluding amortization of acquired developed technologies) 111,611 102,153 9 % 317,000 328,334 (3) %

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Interest expense, net 58,702 71,497 (18) % 186,841 219,114 (15) %

Foreign exchange (gain) loss (507) 2,382 (121) % 1,186 (811) (246) %

Foreign exchange loss 701 1,377 (49) % 1,887 566 233 %

Income tax benefit (14,533) (47,176) (69) % (33,517) (86,823) (61) %

Equity in loss of investees 12 1,669 (99) % 1,359 2,674 (49) %

Equity in loss (gain) of investees 285 (126) N/A(1) 1,644 2,548 (35) %

____________________________

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Three Months Ended

June 30, Increase/ Six Months Ended

June 30, Increase/

September 30, Increase/ Nine Months Ended

September 30, Increase/

2024 2023 (Decrease) 2024 2023 (Decrease)

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Product sales, net 989,707 938,398 5 % 2,795,953 2,769,604 1 %

High-sodium oxybate AG royalty revenue 54,164 5,514 N/A(1) 104,111 7,610 N/A(1)

High-sodium oxybate AG royalty revenue 58,157 28,921 101 % 162,268 36,531 N/A(1)

Other royalty and contract revenues 7,105 4,821 47 % 22,556 16,134 40 %

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Product Sales, Net

Xywav product sales increased in the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily due to increased sales volumes of 14% and 15% in the respective periods and, to a lesser extent, a higher selling price, offset by higher gross to net deductions.

Xywav product sales increased in the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to increased sales volumes of 17% and 15% in the respective periods and, to a lesser extent, a higher selling price, offset by higher gross to net deductions.

We continue to see Xywav adoption in patients with narcolepsy driven by educational initiatives around efficacy and the benefit of lowering sodium intake.

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Exiting the quarter, there were 10,075 patients taking Xywav for narcolepsy and 3,550 taking Xywav for IH, an increase of approximately 6% and 39%, respectively, compared to the same period in 2023 .

Xyrem product sales decreased in the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily due to decreased sales volumes of 57% and 61% in the respective periods, due to high-sodium oxybate competition, the adoption of Xywav by existing Xyrem patients and higher gross to net deductions, offset by a higher selling price.

Epidiolex/Epidyolex product sales increased in the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily due to increased sales volumes of 17% and 11% in the respective periods, due to increased demand and geographic expansion and a higher average selling price.

Rylaze/Enrylaze product sales increased in the three months ended June 30, 2024, compared to the same period in 2023, primarily due to a higher average selling price.

Rylaze/Enrylaze product sales increased in the six months ended June 30, 2024, compared to the same period in 2023, primarily due to increased sales volumes of 11% and a higher average selling price.

Rylaze demand is driven by widespread adoption in pediatric asparaginase-based oncology protocols in the U.S.

and adoption of the Monday/Wednesday/Friday dosing regimen.

Zepzelca product sales increased in the three and six months ended June 30, 2024, compared to the same periods in 2023, due to increased sales volumes and a higher average selling price, offset by higher gross to net deductions.

Defitelio/defibrotide product sales decreased in the three months ended June 30, 2024, compared to the same period in 2023, primarily due to decreased sales volumes offset by a higher average selling price.

Defitelio/defibrotide product sales increased in the six months ended June 30, 2024, compared to the same period in 2023, primarily due to a higher average selling price, offset by decreased sales volumes.

Vyxeos product sales increased in the three months ended June 30, 2024, compared to the same period in 2023, primarily due to an increase in sales volumes and lower gross to net deductions, offset by a lower average selling price due to regional mix.

Vyxeos product sales increased in the six months ended June 30, 2024, compared to the same period in 2023, primarily due to an increase in sales volumes, partially offset by a lower average selling price due to regional mix and higher gross to net deductions.

Xyrem product sales decreased

in the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to decreased sales volumes of 53% and 59% in the respective periods, due to high-sodium oxybate competition, the adoption of Xywav by existing Xyrem patients and higher gross to net deductions, partially offset by a higher selling price.

Epidiolex/Epidyolex product sales increased in the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to increased sales volumes of 13% and 12% in the respective periods, due to increased demand and geographic expansion and a higher average selling price.

Rylaze/Enrylaze product sales decreased in the three months ended September 30, 2024, compared to the same period in 2023, primarily due to decreased sales volumes of 2%, partially offset by a higher average selling price.

Rylaze/Enrylaze product sales increased in the nine months ended September 30, 2024, compared to the same period in 2023, due to a higher average selling price and increased sales volumes of 6%, partially offset by higher gross to net deductions.

Rylaze sales volumes in the three and nine months ended September 30, 2024, have been affected by a recent update to the Children’s Oncology Group, or COG, pediatric treatment protocols for ALL which impact the timing of asparaginase administration.

While this will have a temporary negative impact on Rylaze revenue in the third and fourth quarters of 2024, we do not expect it will affect ongoing demand and we anticipate our revenue will normalize by early 2025.

We expect that Rylaze demand will continue to be driven by widespread utilization in pediatric asparaginase-based oncology protocols in the U.S.

and the opportunity for future growth in the adolescent and young adult market.

Zepzelca product sales increased in the three and nine months ended September 30, 2024, compared to the same periods in 2023, due to increased sales volumes and a higher average selling price, offset by higher gross to net deductions.

Defitelio/defibrotide product sales increased in the three months ended September 30, 2024, compared to the same period in 2023, primarily due to increased sales volumes.

Defitelio/defibrotide product sales increased in the nine months ended September 30, 2024, compared to the same period in 2023, primarily due to increased sales volumes and, to a lesser extent, a higher average selling price.

Vyxeos product sales increased in the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to an increase in sales volumes, partially offset by a lower average selling price due to regional mix.

We expect total product sales will increase in 2024 over 2023, primarily due to our key growth drivers;

Xywav, through continued growth in the IH market, Epidiolex through growth in current markets and expansion into new markets and Rylaze through demand, offset by a decrease in sales of Xyrem due to the impact of high-sodium oxybate competition and continued Xywav adoption.

Xywav, through continued growth in the IH market, Epidiolex through growth in current markets and expansion into new markets and Rylaze through demand, offset by the impact of the update to the COG treatment protocol on the timing of Rylaze administration, which we expect to be primarily limited to the third and fourth quarters of 2024 and to normalize by early 2025, and a decrease in sales of Xyrem due to the impact of high-sodium oxybate competition and continued Xywav adoption.

Royalties and Contract Revenues

Royalties and contract revenues increased in the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily due to royalty revenue received from Hikma Pharmaceuticals plc on net sales of their high sodium

Royalties and contract revenues increased in the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to royalty revenue received from Hikma Pharmaceuticals plc on net sales of their high sodium oxybate AG.

We expect royalties and contract revenues to increase in 2024 compared to 2023, primarily due to increased royalty revenues arising from net sales of high-sodium oxybate AG, primarily due to higher royalty rates in 2024.

Cost of Product Sales

Cost of product sales increased in the three months ended June 30, 2024, compared to the same period in 2023, primarily due to an increase in the acquisition accounting inventory fair value step-up expense, or fair value step-up expense, and changes in product mix.

Cost of product sales decreased in the six months ended June 30, 2024, compared to the same period in 2023, primarily due to a reduction in the fair value step-up expense.

Gross margin as a percentage of net product sales was 88.6% for the three and six months ended June 30, 2024 compared to 89.7% and 87.6% for the same periods in 2023.

We expect our cost of product sales to increase in 2024 compared to 2023, primarily driven by a change in product mix.

Cost of product sales increased in the three months ended September 30, 2024, compared to the same period in 2023, primarily due to higher product sales, net and an increase in the acquisition accounting inventory fair value step-up expense, or fair value step-up expense.

Cost of product sales decreased in the nine months ended September 30, 2024, compared to the same period in 2023, primarily due to a reduction in the fair value step-up expense, partially offset by changes in product mix.

Gross margin as a percentage of net product sales was 88.7% for both the three and nine months ended September 30, 2024, compared to 89.1% and 88.1% for the same periods in 2023.

Cost of product sales for 2024 is expected to be in line with 2023.

Selling, General and Administrative Expenses

Selling, general and administrative expenses for the three months ended June 30, 2024, decreased compared to the same period in 2023, primarily due to costs related to program terminations of $23.5 million incurred in the three months ended June 30, 2023, partially offset by increased investment in our priority programs including higher marketing expense of $10.8 million.

Selling, general and administrative expenses for the six months ended June 30, 2024, increased compared to the same period in 2023, primarily due to an increase in compensation-related expenses of $21.4 million primarily driven by higher headcount in support of our key growth drivers, increased marketing investment in our priority programs of $20.5 million offset by costs related to program terminations of $23.5 million incurred in the six months ended June 30, 2023.

Selling, general and administrative expenses for the three months ended September 30, 2024, increased compared to the same period in 2023, primarily due to increased compensation-related expenses of $15.3 million, primarily driven by higher headcount in support of our key growth drivers.

Selling, general and administrative expenses for the nine months ended September 30, 2024, increased compared to the same period in 2023, primarily due to increased compensation-related expenses of $36.7 million, primarily driven by higher headcount in support of our key growth drivers, increased marketing investment in our priority programs of $18.5 million, increased litigation costs of $16.9 million, offset by costs related to program terminations of $23.5 million incurred in the nine months ended September 30, 2023.

For 2024, we expect selling, general and administrative expenses in 2024 to increase compared to 2023, primarily due to continued investment in our key growth drivers, such as Xywav in IH, Epidiolex and Rylaze along with increased employee expenses.

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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Total $ 199,919 $ 234,402 $ 643,500 $ 633,050

Research and development expenses increased by $11.5 million and $44.9 million in the three and six months ended June 30, 2024, compared to the same periods in 2023.

Clinical studies and outside services costs increased in the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily due to higher costs related to zanidatamab programs.

Personnel expenses increased in the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily driven by increased compensation costs and higher headcount in support of our development programs.

Research and development expenses decreased by $34.5 million in the three months ended September 30, 2024, compared to the same period in 2023.

Clinical studies and outside services costs decreased in the three months ended September 30, 2024, compared to the same period in 2023, primarily due to the inclusion of costs related to JZP150 (post-traumatic stress disorder, or PTSD) in the three months ended September 30, 2023 and lower costs related to zanidatamab.

Research and development expenses increased by $10.5 million in the nine months ended September 30, 2024, compared to the same period in 2023.

Clinical studies and outside services costs increased in the nine months ended September 30, 2024, compared to the same period in 2023, primarily due to higher costs related to zanidatamab programs, offset by the inclusion of costs related to JZP150 (PTSD) incurred in the nine months ended September 30, 2023.

Personnel expenses increased in the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily driven by increased compensation costs in support of our development programs.

For 2024, we expect that our research and development expenses will continue to increase compared to 2023, as we prepare for anticipated data read-outs from clinical trials, initiate and undertake additional clinical trials and related development work primarily relating to zanidatamab.

Intangible Asset Amortization

Intangible asset amortization increased in the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily due to the impact of foreign currency translation adjustments.

Intangible asset amortization increased in the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to the impact of foreign currency translation adjustments.

Intangible asset amortization for 2024 is expected to be in line with 2023.

Acquired In-Process Research and Development

Acquired in-process research and development, or IPR&D, expense in the six months ended June 30, 2024, related to the upfront payment of $10.0 million made in connection with our asset purchase and collaboration agreement with Redx to acquire global rights to the Kirsten rat sarcoma virus, or KRAS, Inhibitor Program.

Acquired in-process research and development, or IPR&D, expense in the nine months ended September 30, 2024, related to the upfront payment of $10.0 million made in connection with our asset purchase and collaboration agreement with Redx to acquire global rights to the Kirsten rat sarcoma virus, or KRAS, Inhibitor Program.

Interest Expense, Net

Interest expense, net decreased by $11.4 million and $19.5 million in the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily driven by higher interest income on investments.

We expect interest expense, net to decrease in 2024 compared to 2023, primarily due to higher interest income as a result of higher interest rates on our deposits and lower interest expense following the repricing of the seven-year $3.1 billion term loan B facility, or the Dollar Term Loan.

Interest expense, net decreased by $12.8 million and $32.3 million in the three and nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to higher interest income on investments driven by our increased deposits and higher interest rates and lower interest expense on the seven-year $2.7 billion term loan B facility, or the Tranche B-2 Dollar Term Loans.

We expect interest expense, net to decrease in 2024 compared to 2023, primarily due to higher interest income on investments driven by our increased deposits and higher interest rates and lower interest expense following the repricing of the Tranche B-2 Dollar Term Loans.

For further information on this, please refer to Liquidity and Capital Resources.

Foreign Exchange (Gain) Loss

The foreign exchange (gain) loss is primarily related to the translation of sterling and euro-denominated net monetary liabilities, primarily intercompany balances, held by subsidiaries with a U.S.

Foreign Exchange Loss

The foreign exchange loss is primarily related to the translation of sterling and euro-denominated net monetary liabilities, primarily intercompany balances, held by subsidiaries with a U.S.

dollar functional currency and related foreign exchange forward contracts not designated as hedging instruments.

Income Tax Benefit

Our income tax benefit was $30.7 million and $19.0 million for the three and six months ended June 30, 2024, respectively, compared to $24.3 million and $39.6 million for the same periods in 2023, relating to tax arising on income or losses in Ireland, the U.K., the U.S.

Our income tax benefit was $14.5 million and $33.5 million for the three and nine months ended September 30, 2024, respectively, compared to $47.2 million and $86.8 million for the same periods in 2023, relating to tax arising on income or losses in Ireland, the U.K., the U.S.

and certain other foreign jurisdictions and tax deficiencies from share based compensation, offset by deductions on subsidiary equity, foreign derived intangible income benefits and tax credits.

The decrease in the income tax benefit for the three and nine months ended September 30, 2024 compared to the same periods in 2023 resulted primarily from changes in the mix of pre-tax income and losses across tax jurisdictions.

Liquidity and Capital Resources

As of June 30, 2024, we had cash, cash equivalents and investments of $2.0 billion, borrowing availability under our five-year $500.0 million revolving credit facility, or the Revolving Credit Facility, of $500.0 million and long-term debt principal balance of $5.8 billion.

Our long-term debt included $2.7 billion aggregate principal amount of the Dollar Term Loan, $1.5 billion in aggregate principal amount of 4.375% senior secured notes, due 2029, or the Secured Notes, $1.0 billion principal amount on our 2.00% exchangeable senior notes due 2026, or 2026 Notes, and $575.0 million principal amount on our 1.50% exchangeable senior notes due 2024.

We generated cash flows from operations of $598.6 million during the six months ended June 30, 2024, and we expect to continue to generate positive cash flows from operations which will enable us to operate our business and de-lever our balance sheet over time.

Since the closing of the acquisition of GW in May 2021, we have fully repaid our Euro Term Loan of €625.0 million, or $753.0 million, and made voluntary and mandatory repayments of $300.0 million and $93.0 million, respectively, relating to the Dollar Term Loan.

As of September 30, 2024, we had cash, cash equivalents and investments of $2.6 billion, borrowing availability under our five-year $500.0 million revolving credit facility, or the Revolving Credit Facility, of $500.0 million and long-term debt principal balance of $6.2 billion.

Our long-term debt included $2.7 billion aggregate principal amount of the Tranche B-2 Dollar Term Loan, $1.5 billion in aggregate principal amount of 4.375% senior secured notes, due 2029, or the Secured Notes, $1.0 billion principal amount on our 2.000% exchangeable senior notes due 2026, or 2026 Notes, and $1.0 billion principal amount on our 3.125% exchangeable senior notes due 2030, or 2030 Notes.

We generated cash flows from operations of $997.3 million during the nine months ended September 30, 2024, and we expect to continue to generate positive cash flows from operations which will enable us to operate our business and de-lever our balance sheet over time.

Since the closing of the acquisition of GW in May 2021, we have fully repaid our seven-year €625.0 million ($753.0 million) term loan B facility, or the Euro Term Loan, made voluntary and mandatory repayments of $300.0 million and $100.8 million, respectively, relating to our Tranche B-2 Dollar Term Loans (formally our seven-year $3.1 billion term loan B facility, or Dollar Term Loan).

In August 2024, we repaid the $575.0 million aggregate principal amount of our 1.50% exchangeable senior notes due 2024, or the 2024 Notes.

We have a significant amount of debt outstanding on a consolidated basis.

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This substantial level of debt could have important consequences to our business, including, but not limited to the factors set forth in “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2023, under the heading “We have incurred substantial debt, which could impair our flexibility and access to capital and adversely affect our financial position, and our business would be adversely affected if we are unable to service our debt obligations.”

We believe that our existing cash, cash equivalents and investments balances, cash we expect to generate from operations and funds available under our Revolving Credit Facility will be sufficient to fund our operations and to meet our existing

obligations for the foreseeable future.

The adequacy of our cash resources depends on many assumptions, including primarily our assumptions with respect to product sales and expenses, as well as the other factors set forth in "Risk Factors" under the heading "Risks Related to our Lead Products and Product Candidates” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023, as supplemented by the risks described in “Risk Factors" under the heading “Delays or problems in the supply of our products for sale or for use in clinical trials, loss of our single source suppliers or failure to comply with manufacturing regulations could materially and adversely affect our business, financial condition, results of operations and growth prospects” in Part II, Item 1A of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as well as those factors set forth in “Risk Factors" under the heading and “To continue to grow our business, we will need to commit substantial resources, which could result in future losses or otherwise limit our opportunities or affect our ability to operate and grow our business” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023.

problems in the supply of our products for sale or for use in clinical trials, loss of our single source suppliers or failure to comply with manufacturing regulations could materially and adversely affect our business, financial condition, results of operations and growth prospects” in Part II, Item 1A of this Quarterly Report on Form 10-Q, as well as those factors set forth in “Risk Factors" under the heading and “To continue to grow our business, we will need to commit substantial resources, which could result in future losses or otherwise limit our opportunities or affect our ability to operate and grow our business” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023.

Our assumptions may prove to be wrong or other factors may adversely affect our business, and as a result we could exhaust or significantly decrease our available cash resources, and we may not be able to generate sufficient cash to service our debt obligations which could, among other things, force us to raise additional funds and/or force us to reduce our expenses, either of which could have a material adverse effect on our business.

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This current pre-emption opt-out authority is due to expire in January 2026.

If we are unable to obtain further pre-emption authorities from our shareholders in the future, or otherwise continue to be limited by the terms of new pre-emption authorities approved by our shareholders in the future, our ability to use our unissued share capital to fund in-licensing, acquisition or other business opportunities, or to otherwise raise capital, including at the time we are required to make repurchases of the 2026 Notes, the 2030 Notes and/or the Secured Notes, are required to repay outstanding amounts under the Amended Credit Agreement (as defined below), or pay cash upon exchange of the 2026 Notes or the 2030 Notes, could likewise be adversely affected.

In any event, an inability to borrow or raise additional capital in a timely manner and on attractive terms could prevent us from expanding our business or taking advantage of acquisition opportunities and could otherwise have a material adverse effect on our business and growth prospects.

In addition, if we use a substantial amount of our funds to acquire or in-license products or product candidates, we may not have sufficient additional funds to conduct all of our operations in the manner we would otherwise choose.

Furthermore, any equity financing would be dilutive to our shareholders, and could require the consent of the lenders under our credit agreement, or the Credit Agreement, that provides for (i) the Dollar Term Loan, (ii) the Euro Term Loan and, together with the Dollar Term Loan, collectively known as the Term Loan and (iii) the Revolving Credit Facility, and the indenture for the Secured Notes for certain financings.

In November 2016, our board of directors authorized a share repurchase program and as of June 30, 2024, had authorized the repurchase of ordinary shares having an aggregate purchase price of up to $1.5 billion, exclusive of any brokerage commissions.

Under this program, which has no expiration date, we may repurchase ordinary shares from time to time on the open market.

The timing and amount of repurchases will depend on a variety of factors, including the price of our ordinary shares, alternative investment opportunities, restrictions under the May 2021 credit agreement, corporate and regulatory requirements and market conditions.

The share repurchase program may be modified, suspended or discontinued at any time without prior notice.

During the three and six months ended June 30, 2024, we spent a total of $161.4 million to purchase 1.5 million of our ordinary shares under the share repurchase program at an average total purchase price, including commissions, of $110.75 per share.

During the three and six months ended June 30, 2023 , we spent a total of $95.6 million to purchase 0.8 million of our ordinary shares under the share repurchase program at an average total purchase price, including commissions, of $126.37 per share.

Furthermore, any equity financing would be dilutive to our shareholders, and could require the consent of the lenders under the Amended Credit Agreement that provides for (i) the Tranche B-2 Dollar Term Loans, (ii) the Euro Term Loan (iii) the Revolving Credit Facility, and the indenture for the Secured Notes for certain financings.

In July 2024, our board of directors authorized a share repurchase program to repurchase ordinary shares having an aggregate purchase price of $500.0 million, exclusive of any brokerage commissions, or the New Repurchase Program.

Under the New Repurchase Program, which has no expiration date, we may repurchase ordinary shares from time to time by any methods and/or structures permitted by applicable law.

The timing and amount of repurchases will depend on a variety of factors, including the price of our ordinary shares, alternative investment opportunities, restrictions under the Amended Credit Agreement and the indenture for our Secured Notes, corporate and regulatory requirements and market conditions.

The New Repurchase Program may be modified, suspended or discontinued at any time without our prior notice.

The New Repurchase Program replaces and supersedes the share repurchase program authorized by our board of directors in November 2016, which, as of the date of it being superseded by the New Repurchase Program, had authorized the repurchase of ordinary shares having an aggregate purchase price of up to $1.5 billion, exclusive of any brokerage commissions, or the Old Repurchase Program, and, together with the New Repurchase Program, the “repurchase programs”.

During the three months ended September 30, 2024, we spent a total of $150.0 million to repurchase 1.4 million of our ordinary shares, all under the New Repurchase Program, at a purchase price, including commissions, of $109.32 per share.

The repurchases during the three months ended September 30, 2024 were effected in privately negotiated transactions with or through one of the initial purchasers of the 2030 Notes concurrently with the pricing of the offering of the 2030 Notes.

During the nine months ended September 30, 2024, we spent a total of $311.4 million to purchase 2.8 million of our ordinary shares under the share repurchase programs at an average total purchase price, including commissions, of $110.06 per share.

During the nine months ended September 30, 2023, we spent a total of $170.0 million to purchase 1.3 million of our ordinary shares under the Old Repurchase Program at an average total purchase price, including commissions, of $128.89 per share.

All ordinary shares repurchased were cancelled.

As of June 30, 2024, the remaining amount authorized under the share repurchase program was $47,475, exclusive of any brokerage commissions.

In July 2024, our board of directors authorized a new share repurchase authorization to repurchase ordinary shares having an aggregate purchase price of $500 million, exclusive of any brokerage commissions.

As of September 30, 2024, the remaining amount authorized for repurchases under the New Repurchase Program was $350.0 million, exclusive of any brokerage commissions.

The following table presents a summary of our cash flows for the periods indicated (in thousands):

Six Months Ended

Nine Months Ended

September 30,

Net cash provided by operating activities $ 997,328 $ 924,668

Net cash used in investing activities (314,908) (264,860)

Net cash used in financing activities (217,637) (126,455)

Net cash provided by (used in) financing activities 28,791 (204,948)

Effect of exchange rates on cash and cash equivalents 614 (652)

Net increase (decrease) in cash and cash equivalents $ (150,508) $ 400,822

Net increase in cash and cash equivalents $ 711,825 $ 454,208

Operating activities

Net cash provided by operating activities in the six months ended June 30, 2024, was broadly in line with the same period in 2023.

Net cash provided by operating activities increased by $72.7 million in the nine months ended September 30, 2024, compared to the same period in 2023, primarily due to cash received from increased sales of our products and the timing of payment of accrued expenses.

Investing activities

Net cash used in investing activities increased by $438.4 million in the six months ended June 30, 2024, compared to the same period in 2023, primarily due to the following:

Net cash used in investing activities increased by $50.0 million in the nine months ended September 30, 2024, compared to the same period in 2023, primarily due to the following:

• $30.1 million net increase in the acquisition of investments, driven by time deposits;

• $10.0 million upfront payment to Redx related to our asset purchase and collaboration agreement in the six months ended June 30, 2024.

• $10.9 million increase in purchases of property, plant and equipment;

• $10.0 million upfront payment to Redx related to our asset purchase and collaboration agreement in the nine months ended September 30, 2024.

Financing activities

Net cash used in financing activities increased by $91.2 million in the six months ended June 30, 2024, compared to the same period in 2023, primarily due to:

Net cash provided by (used in) financing activities increased by $233.7 million in the nine months ended September 30, 2024, compared to the same period in 2023, primarily due to:

• An increase of $405.8 million in debt financing due to net proceeds from issuance of the 2030 Notes of $980.8 million, offset by the repayment of the 2024 Notes of $575.0 million;

partially offset by

• An increase of $141.5 million in share repurchases;

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In January and July 2024, we entered into amendments to the Credit Agreement, as described below.

In July 2024, we made an irrevocable election to fix the settlement method for exchanges of the 2026 Notes and, as a result, an exchanging noteholder will receive (i) up to $1,000 in cash per $1,000 principal amount of the 2026 Notes and (ii) any combination of cash and/or ordinary shares of the Company, for any exchange consideration in excess of $1,000 per $1,000 principal amount of the 2026 Notes.

During the six months ended June 30, 2024, there were no other changes to our financing arrangements, as set forth in Note 12, Debt, of the Notes to Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2023.

In July 2024, we made an irrevocable election to fix the settlement method for exchanges of the 2026 Notes and, as a result, an exchanging noteholder will receive (i) up to $1,000 in cash per $1,000 principal amount of the 2026 Notes exchanged and (ii) any combination of cash and/or our ordinary shares, for any exchange consideration in excess of $1,000 per $1,000 principal amount of the 2026 Notes.

In August 2024, we repaid the $575.0 million aggregate principal amount of the 2024 Notes at maturity, plus accrued and unpaid interest thereon.

In September 2024, Jazz Investments I Limited, our wholly owned subsidiary, or Jazz Investments, completed a private offering of an aggregate $1.0 billion principal amount of the 2030 Notes.

During the nine months ended September 30, 2024, there were no other changes to our financing arrangements, as set forth in Note 12, Debt, of the Notes to Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2023.

Credit Agreement

On May 5, 2021, the Company, Jazz Financing Lux S.à.r.l., or Jazz Lux, and certain of our other subsidiaries, as borrowers, or, collectively with the Company and Jazz Lux, the “Borrowers”, entered into the Credit Agreement by and among the Borrowers, the lenders and issuing banks from time to time party thereto, Bank of America, N.A., as administrative agent and U.S.

Bank Trust Company, National Association, as collateral trustee, or the Credit Agreement, that provided for (i) the Dollar Term Loan which was drawn by Jazz Lux on the Closing Date in U.S.

dollars (ii) the Euro Term Loan which was drawn by Jazz Lux on the Closing Date in Euros and (iii) the Revolving Credit Facility.

In January 2024, Jazz Lux entered into an amendment, or Repricing Amendment No.1, to the Credit Agreement.

Upon entry into the Repricing Amendment No.1, certain existing lenders converted outstanding Dollar Term Loan into a new tranche of U.S.

dollar term loans, or the Tranche B-1 Dollar Term Loans, and Jazz Lux borrowed $201.9 million aggregate principal amount of additional Tranche B-1 Dollar Term Loans, the proceeds of which were used to repay the outstanding Dollar Term Loan that were not converted.

In July 2024, Jazz Lux entered into an amendment, or Repricing Amendment No.

Bank Trust Company, National Association, as collateral trustee, or the Credit Agreement.

The Credit Agreement initially provided for (i) the Dollar Term Loan which was drawn by Jazz Lux on the closing date thereof in U.S.

dollars (ii) the Euro Term Loan which was drawn by Jazz Lux on the closing date thereof in Euros and (iii) the Revolving Credit Facility.

In January 2024, Jazz Lux entered into an amendment, or the Repricing Amendment No.1, to the Credit Agreement.

Upon entry into the Repricing Amendment No.1, certain existing lenders converted a portion of the outstanding Dollar Term Loan into a new tranche of U.S.

dollar term loans, or the Tranche B-1 Dollar Term Loans, and Jazz Lux borrowed $201.9 million aggregate principal amount of additional Tranche B-1 Dollar Term Loans, the proceeds of which were used to repay the portion of the outstanding Dollar Term Loan that was not converted.

In July 2024, Jazz Lux entered into an amendment, or the Repricing Amendment No.

2, to the Credit Agreement, or the Amended Credit Agreement.

Upon entry into the Amended Credit Agreement, certain existing lenders converted the outstanding Tranche B-1 Dollar Term Loans into a new tranche of U.S.

dollar term loans, or the Tranche B-2 Dollar Term Loans, and Jazz Lux borrowed $289.6 million aggregate principal amount of additional Tranche B-2 Dollar Term Loans, the proceeds of which were used to repay the outstanding Tranche B-1 Dollar Term Loans that were not converted.

The Tranche B-2 Dollar Term Loans are a separate class of term loans under the Amended Credit Agreement with the same material terms (including with respect to maturity, prepayment, security, covenants and events of default) as the previously outstanding Tranche B-1 Dollar Term Loans and the initial Dollar Term Loans incurred on May 5, 2021, with the interest rate amended as described below and the removal of the credit spread adjustment.

Upon entry into the Amended Credit Agreement, certain existing lenders converted a portion of the outstanding Tranche B-1 Dollar Term Loans into a new tranche of U.S.

dollar term loans, or the Tranche B-2 Dollar Term Loans, and Jazz Lux borrowed $289.6 million aggregate principal amount of additional Tranche B-2 Dollar Term Loans, the proceeds of which were used to repay the portion of the outstanding Tranche B-1 Dollar Term Loans that were not converted.

The Tranche B-2 Dollar Term Loans are a separate class of term loans under the Amended Credit Agreement with the same material terms (including with respect to maturity, prepayment, security, covenants and events of default) as the previously outstanding Tranche B-1 Dollar Term Loans and the initial Dollar Term Loan incurred on May 5, 2021, with the interest rate amended as described below and the credit spread adjustment removed.

The principal amount of Tranche B-1 Dollar Term Loans outstanding immediately prior to the Repricing Amendment No.

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The applicable margin for the Tranche B-2 Dollar Term Loans is 2.25% (in the case of Term SOFR borrowings) and 1.25% (in the case of borrowings at the prime lending rate), a decrease of 75 basis points from the applicable margin on the Tranche B-1 Dollar Term Loans.

The Tranche B-2 Dollar Term Loan is subject to a Term SOFR floor of 0.50%.

As of June 30, 2024, the interest rate and effective interest rate on the Tranche B-1 Dollar Term Loans were 8.46% and 9.04%, respectively.

At the closing of Repricing Amendment No.

2, the interest rate and effective interest rate on the Tranche B-2 Dollar Term Loans were 7.59% and 8.27%, respectively.

The Tranche B-2 Dollar Term Loans are subject to a Term SOFR floor of 0.50%.

As of September 30, 2024, the interest rate and effective interest rate on the Tranche B-2 Dollar Term Loans were 7.10% and 8.27%, respectively.

The Tranche B-2 Dollar Term Loans will amortize in quarterly installments equal to 0.286294791% of the initial aggregate principal amount thereof, with the remaining balance payable on May 5, 2028.

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The Revolving Credit Facility has a commitment fee payable on the undrawn amount ranging from 0.50% to 0.40% per annum based upon our first lien secured net leverage ratio.

As of June 30, 2024, we had an undrawn Revolving Credit Facility totaling $500.0 million.

As of September 30, 2024, we had an undrawn Revolving Credit Facility totaling $500.0 million.

In September 2024, Jazz Investments completed a private placement of $1.0 billion principal amount of the 2030 Notes.

Interest on the 2030 Notes is payable semi-annually in cash in arrears on March 15 and September 15 of each year, beginning on March 15, 2025, at a rate of 3.125% per year.

In certain circumstances, we may be required to pay additional amounts as a result of any applicable tax withholding or deductions required in respect of payments on the 2030 Notes.

The 2030 Notes mature on September 15, 2030, unless earlier exchanged, redeemed or repurchased.

The holders of the 2030 Notes have the ability to require us to repurchase all or a portion of their 2030 Notes for cash at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date in the event we undergo a fundamental change (as defined in the indenture related to the 2030 Notes), such as specified change of control transactions, our liquidation or dissolution or the delisting of our ordinary shares from any of The New York Stock Exchange, The Nasdaq Global Market, The Nasdaq Global Select Market or The Nasdaq Capital Market (or any of their respective successors).

Additionally, the terms and covenants in the indenture related to the 2030 Notes include certain events of default after which the 2030 Notes may be due and payable immediately.

Prior to September 15, 2030, we may redeem the 2030 Notes, in whole but not in part, in connection with certain tax-related events.

We also may redeem the 2030 Notes on or after September 20, 2027 and prior to June 15, 2030, in whole or in part (subject to the partial redemption limitation described in the indenture related to the 2030 Notes), if the last reported sale price per ordinary share has been at least 130% of the exchange price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

The 2030 Notes are exchangeable at an initial exchange rate of 6.5339 ordinary shares per $1,000 principal amount of 2030 Notes, which is equivalent to an initial exchange price of approximately $153.05 per ordinary share.

Upon exchange of the 2030 Notes, we will pay cash up to the aggregate principal amount of the 2030 Notes to be exchanged and pay or deliver, as the case may be, cash, ordinary shares or a combination of cash and ordinary shares, at our election, in respect of the remainder, if any, of our exchange obligation in excess of the aggregate principal amount of the 2030 Notes being exchanged.

The exchange rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest.

In addition, following certain make-whole fundamental changes (as defined in the indenture related to the 2030 Notes) that occur prior to the maturity date or upon our issuance of a notice of redemption, we will, in certain circumstances, increase the exchange rate for a holder who elects to exchange its 2030 Notes in connection with that make-whole fundamental change or exchange its 2030 Notes called (or deemed called) for redemption during the related redemption period.

Prior to June 15, 2030, the 2030 Notes will be exchangeable only upon satisfaction of certain conditions and during certain periods, and thereafter, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date.

Contractual Obligations

During the six months ended June 30, 2024, there were no material changes to our contractual obligations as set forth in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023.

During the nine months ended September 30, 2024, there were no material changes to our contractual obligations as set forth in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023.

Critical Accounting Estimates

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• Adequate coverage and reimbursement from third party payors may not be available for our products and we may be unable to successfully contract for coverage from pharmacy benefit managers and other organizations;

conversely, to secure coverage from these organizations as they consolidate and gain negotiating leverage, we may be required to pay rebates or other discounts or other restrictions to reimbursement, either of which could diminish our sales or adversely affect our ability to sell our products profitably.

conversely, to secure coverage from these organizations, we may be required to pay rebates or other discounts or other restrictions to reimbursement, either of which could diminish our sales or adversely affect our ability to sell our products profitably.

• The pricing of pharmaceutical products has come under increasing scrutiny as part of a global trend toward healthcare cost containment and resulting changes in healthcare law and policy, including changes to Medicare, may impact our business in ways that we cannot currently predict, which could have a material adverse effect on our business and financial condition.

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• To continue to grow our business, we will need to commit substantial resources, which could result in future losses or otherwise limit our opportunities or affect our ability to operate and grow our business.

Additional discussion of the risks, uncertainties and other factors described above, as well as other risks material to our business, can be found under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023, as supplemented by the risks and uncertainties described in "Risk Factors" Part II, Item 1A.in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024.

in this Quarterly Report on Form 10-Q.

Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements.

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Except as required by law, we undertake no obligation to update or supplement any forward-looking statements publicly, or to update or supplement the reasons that actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

Quantitative and Qualitative Disclosures About Market Risk

During the six months ended June 30, 2024, there were no material changes to our market risk disclosures as set forth in Part II, Item 7A “Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report on Form 10-K for the year ended December 31, 2023.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis