Q1 2020 Earnings Call

[noise] welcome to the gas pharmaceutical P.L.C. first quarter 2020, or any topic huh.

Operator: Welcome to the Jazz Pharmaceuticals PLC First Quarter 2020 Earnings Conference Call. Following an introduction from the company, we will open the call for questions. I will now turn the call over to Kathy Luttrell, Head of Investor Relations at Jazz Pharmaceuticals.

Bonnie introduction from the company, we will open the coffee question, how many are trying to call over to Capitalise right. Okay. Then that's the relation <unk>.

Kathy Luttrell: Thank you, Valerie. And thanks to those of you who joined our investor call. Today, we reported our first quarter 2020 financial results and updated our financial guidance for 2020. The press release and the slide presentation accompanying this call are available in the investor section of our website. On the call today are Bruce Cozadd, CEO; Dan Swisher, President; Rene Gala, CFO; and Rob Iannone, Executive Vice President, R&D. And then joining for questions, our Q&A session will include Mike Miller, Executive Vice President, U.S. Commercial, Phil Jochelson, Sleep and Neuroscience Therapeutic Head, Ann Borgman, Hematology and Oncology Therapeutic Head, Jed Black, our Sleep Neuroscience Fellow, and Shawn Mendez, Senior Vice President, Strategy and Finance.

Thank you Valerie and thanks to those of you joining our investor call today, We reported our first quarter 2020 financial results and updated our financial guidance for 2020, the press release and the slide presentation accompanying that's called are available in the Investor section of our website.

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Are sleep neuroscience fellow and Shawn Mendez, Senior Vice President strategy and finance.

Kathy Luttrell: I'd like to remind you that today's call includes forward-looking statements, such as those related to our future financial and operating results, and which involve risks and uncertainties that could cause actual events, performance, and results to differ materially. We encourage you to review the statements contained in today's press release and our latest SEC disclosure documents, which identify certain factors that may cause the company's actual results to differ materially from those projected. In particular, there is significant uncertainty about the duration and severity of the COVID-19 pandemic and its impact on Jazz's business and operations. The updated guidance reflects management's current expectations about the impact of these factors on our business. We undertake no duty or obligation to update our forward-looking statements. On this call, we discuss non-GAAP financial measures. Reconciliations of GAAP to non-GAAP financial measures discussed on the call are included in today's press release and slide presentation, both of which are available on our website. I'll now turn the call over to Bruce.

Good luck to remind you that today's calling please forward looking statements such as those related to our future financial and operating results and which involve risk and uncertainties that could cause the actual events performance and results to defer material late.

We encourage you to review the statements contained in today's press release, and our latest F.C.C. disclosure docks, which identifies certain factors that may cause the company's actual results to differ materially from those projected in particular, there is significant uncertainty about the duration.

Familiarity of the code at 19 pandemic and its impact on job good business and operations. The updated guidance reflects management's current expectations of the impact of these factors on our business, we undertake take no duty or obligation to update our forward looking statements.

On this call we discussed non gap financial measures reconciliation of gap Q. non gap financial measures discussed on the call are included in today's Pressrelease and slide presentation available on our website I'll now turn to call over to perks.

Thank you Cathy and I I'm not sure whether you measure mentioned audio visual risk factors in your a precursor, but we apologize an advanced chip you hear dogs barking or children playing in the background.

Bruce C. Cozadd: Thank you, Kathy, and I'm not sure whether you mentioned audiovisual risk factors in your precursor, but we apologize in advance if you hear dogs barking or children playing in the background. Good afternoon, everyone, and thank you for joining us. I'll begin by sharing how proud I am of Jazz employees and their commitment to support continued delivery of our essential medicines to patients around the world during this unprecedented time and would like to thank them for their dedication and ingenuity. In the first quarter, we generated total net revenues of $535 million and made significant progress toward our key 2020 objectives. We are actively preparing for the U.S. launches of Lerbanectadin and JCP258 and are excited by the opportunity to bring these two important treatment options to patients later this year.

A good afternoon, everyone and thank you for joining us all begin by sharing how proud.

Of jazz employees and their commitment to support continue delivery of are essential medicines to patients around the world. During this unprecedented time.

I'd like to thank them for their dedication and ingenuity.

In the first quarter, we generate a total net revenues of $535 million and made significant progress toward our key 2020 objectives.

Are actively preparing for the U.S. launches alert connected in and JCP 258.

Are excited by the opportunity to bring these two important treatment options to patients later this year.

Bruce C. Cozadd: Although we experienced limited financial impact of COVID-19 in the first quarter, given the global economic slowdown, the increasing unemployment rate, and the overall disruption to global health care systems, we have updated our financial guidance, including proactively reducing operating expenses, to reflect the potential impact on our business for the remainder of 2020. We are excited about the opportunities ahead for Jazz and remain focused on diversifying our portfolio of essential medicines to provide innovative and life-changing options for patients through both our internal efforts and corporate development transactions. Building off the four transactions we entered into last year, we will continue to pursue opportunities that align with our strategy. Our strong balance sheet, with cash investments and undrawn revolver totaling $2.6 billion, positions us well to manage through the impact of the pandemic. And that's my phone in the background, everyone. Sorry about that.

Although we experienced limited financial impact of coded 19 in the first quarter, given the global economic slowdown be increasing unemployment rate and the overall disruption to global health care systems, we have updated our financial guidance, including proactively reducing operating expenses to reflect the Patel.

Impact on our business for the remainder of 2020.

We're excited about the opportunities ahead for jazz and remain focused on diversifying our portfolio of a central medicines to provide innovative and life changing options for patients through both our internal efforts and corporate development transactions building off the for transactions. We entered into last year, we will continue to.

Pursue opportunities that aligned with our strategy are strong balance sheet with cash investments and undrawn revolver totaling $2.6 billion position us well to manage through the impact of the pandemic.

And that's my phone at the back on everyone sure about that.

Bruce C. Cozadd: With the ongoing global impact of COVID-19, we are focused on ensuring the continuity of patient care and our business operations. Our key priorities are maintaining a sufficient supply of our medicines and ensuring patient access, including through comprehensive support of patient assistance programs for those impacted by changed economic circumstances. Protecting the safety and welfare of patients in our clinical studies, minimizing delays in enrollment, and maintaining the integrity of our clinical studies, engaging with health care providers through digital platforms and other remote access activities to continue to support and educate them as they care for patients. Ensuring the safety of Jazz employees by creating Optimal Remote Work Environments, and Seeking Growth Opportunities Through Our Internal Efforts and Corporate Development Activities

With the ongoing global impact of covert 19, we are focused on ensuring the continuity as patient care and our business operations are key priorities are maintaining sufficient supply of our medicines and ensuring patient access including through comprehensive support with patients assistance programs for those.

Packed it by changed economic circumstances.

Protecting the safety in welfare of patients in our clinical studies, minimizing delays and enrollment and maintaining the integrity of our clinical studies.

Engaging with health care providers through digital platforms and other remote access activities to continue to support and educate them as they care for patients.

Ensuring the safety of jazz employees by creating optimal remote work environments and seeking growth opportunities through our internal efforts and corporate development activities.

Bruce C. Cozadd: I want to take a moment to thank and share our admiration and gratitude for the many healthcare workers, first responders, and others on the front lines caring for COVID-19 patients and our communities. Now I'll review our Sleep Neuroscience Portfolio. Xyrem delivered strong growth in the first quarter, with bottle volume growth of 5% compared to the same period in 2019.

I want to take a moment to tank ensure our admiration and gratitude for the many health care workers first responders and others on the front lines caring for coded 19 patients and our communities.

Now all reviewer asleep neuroscience portfolio.

Iram delivered strong growth in the first quarter with bottle volume growth of 5% compared to the same period and 2019.

Bruce C. Cozadd: The Central Pharmacy successfully navigated through the typical first-quarter, industry-wide payer churn. We observed an increase in the number of patients on therapy, with the average number of active Xyrem patients at 15,025, up 3% compared to the same period last year. While the company observed a decline in daily new patient enrollments beginning in mid-March due to COVID-19, recent patient enrollment trends are strengthening, and we expect new patient diagnoses to start to increase as sleep centers reopen. Given the importance of managing narcolepsy, a serious and chronic disease, we believe that the demand for Xyramine 2020 will remain strong. Turning to JCP 258, we submitted our NDA early in the first quarter and received priority review. At this time, we have not been notified by FDA of any delay in the July 21 PDUFA action date.

Central pharmacy successfully navigated through the typical first quarter industrywide payer churn we observed an increase in the number of patients on therapy with the average number of active desire impatience at 15025 up 3% compared to the same period last year.

While the company observe to decline in daily New patient enrollments beginning in mid March to decode that 19 recent patient enrollment trends are strengthening and we expect new patient diagnoses just start to increase as sleep centres reopened.

Given the importance of managing narcolepsy, a serious and chronic disease. We believed that the demand presided in 2020 will remain strong.

Turning to J.C.P. 258, we submitted or end da early in the first quarter and receive priority review at this time, we have not been notified by F.D.A. If any delay the July 21 could do for action date.

Bruce C. Cozadd: Bringing JCP 258 to patients as early as the fourth quarter following approval and REMS implementation is a top priority. JCP 258 is a novel oxibate formulation with 92% less sodium than xyrum, which equates to between 1,000 and 1,500 milligrams less sodium a day, depending on dose. We are aware that narcolepsy is associated with an increased risk of cardiovascular disease and metabolic disorders and believe that JCP 258 will be an important treatment advance for people with narcolepsy. Our pre-launch activities include disease education programs to improve the understanding of the relationship between reducing sodium and improving cardiovascular health. Following FDA approval, we will begin discussions with payers regarding the important value that JCB 258 can provide to narcolepsy patients. Moving to Sanosi.

Bringing J.C.P. 258 to patients as early as the fourth quarter following approval and reminisce implementation is a top priority.

JCP 258 is a novel Oxybate formulation with 92% less sodium the desire.

Equates to between 1015 hundred milligrams less sodium a day depending on dos.

We are aware that narcolepsy is associated with an increased risk of cardiovascular disease and metabolic disorders and believe the J.C.P. 258 will be an important treatment advance for people with narcolepsy.

Our pre launch activities include disease education programs to improve the understanding of the relationship between reducing sodium and improving cardiovascular health.

Following F.D. approval, we will begin discussion with payers regarding the important value. The J.C.B. 258 can provide to narcolepsy patients.

Moving to know seat.

Bruce C. Cozadd: In the first quarter, we were encouraged by the positive feedback received from patients and health care providers, as well as a 41% growth in prescriptions versus fourth quarter 2019. Sanosi refill rates during the quarter were strong, indicating patient satisfaction and minimal out-of-pocket cost concerns. From launch through March 31, there have been more than 3,400 unique prescribers and more than 27,000 cumulative prescriptions representing our continued progress in expanding relationships with OSA physicians. We are pleased that more than 80% of commercially insured patients have access to coverage for Sinusitis during the quarter. During the quarter, we experienced high coupon utilization, which is common with typical first quarter payer churn due to insurance plan changes and the resetting of patient deductibles. This resulted in a high gross-to-net deduction.

In the first quarter, we were encouraged by the positive feedback receive from patients and health care providers as well as a 41% growth in prescriptions versus fourth quarter 2019.

So no see refill rates during the quarter were strong, indicating patient satisfaction and minimal out of pocket cost concerns.

From launched through marks 31, there have been more than 3400 unique prescribers and more than 27000 cumulative prescriptions.

Representing our continued progress in expanding relationships and so I say physicians.

We are pleased that more than 80% of commercially insured patients have access to coverage for <unk>.

During the quarter.

Excuse me during the quarter, we experienced high coupon utilization, which is common with typical first quarter patient churn pay return did insurance plan changes and the resetting a patient deductibles. This resulted in high gross to net deduction. At this time, we believe snow see gross to nets, we'll trend lower for the.

Bruce C. Cozadd: At this time, we believe Cenosi gross-to-nets will trend lower for the remainder of the year. While we have implemented plans to mitigate the challenges of COVID-19, we anticipate our efforts to continue to reach new OSA treating physicians will be impacted by the extent and duration of the disruption. With the pandemic, many physician offices have closed, and pulmonologists, one of our target physician audiences, have been focusing their attention on patients who present with respiratory complications of COVID-19. Our mitigation plans include remote sales force engagement with health care providers to the extent possible, with a shift to virtual speaker programs, satellite disease awareness programs, and implementation of online sample and voucher programs.

Remainder of the year.

While we have implemented plans to mitigate the challenges of coded 19, we anticipate our efforts to continue to reach new O.S.A. treating positions will be impacted by the extent and duration of the disruption.

With the pandemic many physician offices have closed and Pulmonologists one of our target physician audiences have been focusing their attention on patients who present with respiratory complications of coded 19 are mitigation plans include remotes sales force engagement with health care providers to the extent possible.

Shift to virtual speaker programs satellite disease awareness programs.

And implementation of online sample and voucher programs.

In Europe.

Bruce C. Cozadd: In Europe, we are actively preparing for the rolling launch of Sanosi, beginning in Germany this month with an initial focus on EDS and narcolepsy, and then expanding to EDS in OSA early next year. The recruitment of our German neuroscience sales force is largely complete, and they are concluding product training in preparation for launch. To ensure we are supporting customers appropriately, we have plans to conduct a targeted virtual launch until we are able to progress to in-person interactions with healthcare providers. As we navigate through the COVID-19 pandemic, we anticipate there will be delays by some European regulatory authorities in their pricing and reimbursement reviews. We will monitor the impact and plan Salesforce recruitment appropriately. I'll now turn the call over to Dan to update you on key hematology and oncology activities. Then Rob will provide an update on our development programs, and Rene will follow with an update on our financial performance.

Actively preparing for the rolling launch of Susi, beginning in Germany. This month within initial focus on E.D.S. narcolepsy, and then expanding T.E.D.S. in Oh essay early next year.

<unk> of our German neuroscience sales forces largely complete an air concluding product trading in preparation for launch.

To ensure we are supporting customers appropriately we have plans to conduct a targeted virtual launch until we were able to progress to in person interactions with health care providers.

As we navigate through the coded 19 pandemic, we anticipate there will be delays by some European regulatory authorities in their pricing and reimbursement reviews, we will monitor the impact and play in sales force recruitment appropriately.

All now turn the call over to dance update you on key hematology oncology activities than Rob will provide an update on or development programs and Rene will follow with an update on our financial performance.

Daniel N. Swisher: Thanks Bruce, I hope all of you can hear me. All right, so we saw strong growth in global Definilio and Vixio sales in the first quarter versus the same period last year. However, Irwin A sales in the first quarter were negatively impacted due to an extended and ongoing supply disruption. So starting with Vixios, in the first quarter, sales performance was driven by strong performance in Europe. In the U.S., our focus has been on reinforcing our efficacy profile in front-line secondary AML while reaching new physicians and broadening adoption among community accounts. Well, we made some progress this quarter, in the first quarter.

Thanks Spurs hope all of you can hear me.

Alright, so we saw strong growth in global Defitelio and Vyxeos sales.

In the first quarter versus the same period in 2019.

However, however, or when a sales in the first quarter word negatively impacted due to an extended.

Ongoing supply disruption.

Starting with Vyxeos in the first quarter sales performance was driven by strong performance in Europe.

In the U.S.R. focus has been on reinforcing our advocacy profile in front line secondary and now while reaching into new physicians and broadening adoption among community accounts.

We made some progress in this quarter in the first quarter. This has been challenging due to the impact to cope at 19.

Daniel N. Swisher: This has been challenging due to the impact of COVID-19. Recent recommendations for managing cancer patients are focused on avoiding hospitalization to limit exposure risk, including the use of oral oncolytics and less intensive treatment. This has had a negative impact on Vixio's demand, primarily in the U.S., and until this disruption resolves, we expect challenges to remain, but we do look to support future growth opportunities for VIXEO. This quarter, we did make progress in launching an expanded distribution footprint by putting in place contracts with group purchasing organizations, or GPOs, which will help improve access to community accounts. Additionally, we look forward to the presentation of five-year overall survival data from our Pivotal 301 study later this month at the virtual ASCO meeting, which will add to the strength of evidence for Vixios for the treatment of newly diagnosed secondary AML patients. Now on to Defitilio.

Recent recommendations for managing cancer patients are focused on avoiding hospitalization to limit exposure risk, including the use of oral oncolytics and less intensive treatment.

This has had a negative impact on vyxeos demand, primarily in the U.S. and until this disruption resolves we expect challenges to remain.

But as we do look to support future growth opportunities for Vyxeos.

This quarter, we did make progress in launching an expanded distribution footprint by putting in place contracts with group purchasing organizations or Gpms, which will help them prove access and community accounts.

Additionally, we look forward to the presentation of five your overall survival data from our pivotal 301 study later this month at the virtual ASKO meeting, which will add to the strength of evidence for vyxeos for the treatment of newly diagnosed secondary A.M.L. patience.

Now on to Defitelio, we are pleased with the strong global performance in the first quarter.

Daniel N. Swisher: We are pleased with the strong global performance in the first quarter compared to the same period in 2019. However, the COVID-19 pandemic is having an impact on recent defitilio use. At present, hospitals have reduced deferred deferral or applied temporary stricter eligibility criteria for hematopoietic stem cell transplantations to prioritize intensive care beds for patients with coronavirus who may require ventilator support. For Irwinace, quality and manufacturing issues at PBL continue to result in supply disruptions during the first quarter, and they're continuing into the second quarter, unrelated to COVID-19. The broad range of our 2020 hematology oncology guidance reflects ongoing and potential future supply disruptions. Last month, PBL announced it entered into a new agreement with a different partner to commercialize and distribute Irwin Ace after December 31, 2020. Our current agreement will expire at the end of this year, and we have the right to sell certain Irwin Ace inventory in 2021.

Compared to the same period and 2019.

However, the covert 19 pandemic is having an impact on recent defitelio use.

At present hospitals have reduced deferred or applied temporary stricter eligibility criteria for him out of poetic stem cell transplantations.

You prioritize intensive care beds for patience with current a virus who may require ventilator support.

For one nice quality of manufacturing issues that Pvl continue to result in supply disruptions during the first quarter and they're continuing into the second quarter.

Related to code at 19.

Broad range of our 2020, hematology oncology guidance reflects ongoing and potential future supply disruptions.

Last month, PBL announced it entered into a new agreement with the different partner to commercialize and distribute Irwin Ace After December 31 2020.

Our current agreement will expire at the end of this year and we have the right to sell certain or when ace inventory and 2021.

Daniel N. Swisher: We currently hold the U.S. BLA and marketing authorizations in other countries for IRWIN-ACE, as well as rights to certain clinical data. We plan to work with PBL toward a transition of commercialization rights post-termination to ensure continuity of patient care. So turning to Lerb and Ectoden, launch planning is well underway. Our launch efforts will initially focus on driving awareness and understanding of the data among top small cell lung cancer prescribers and developing strong relationships with lung cancer KOLs. We continue to recruit for key positions across the U.S., including sales representatives, medical science liaisons, and reimbursement managers. We expect to hire 28 additional representatives to augment the current Vixio sales force, for a total of 72 adult oncology sales representatives promoting both lurbinectadine and vixiosin.

We currently hold the U.S.B.L.A. and marketing authorizations and other countries for when Ace.

As well as rights to certain clinical data.

We plan to work with PBL toward a transition of commercialization rights post termination to ensure continuity of patient care.

So attorney until urban actor, then launched planning is well underway.

Are launch efforts will initially focus on driving awareness and understanding of the data among top small cell lung cancer prescribers and developing strong relationships with lung cancer care wells.

We continue to recruit for key positions across the U.S.

<unk> sales Representatives medical science, liaisons and reimbursement managers.

We expect to hire 28 additional representatives to augment the current Vyxeos sales force.

For a total of 72 adult oncology sales representatives promoting both urban acted and and Vyxeos.

In late March the phase two basket trial in small so lung cancer was published on line and land sit on <unk>.

Daniel N. Swisher: In late March, the Phase II basket trial in small cell lung cancer was published online in Lancet Oncology. We submitted this data to the NCCN Small Cell Lung Cancer Panel, and after product approval, we will submit the final label to NCCN for review and potential inclusion in the guidelines. We will also be working early in the launch to leverage our relationships recently established on behalf of Vixios to contract with key distributors and GPOs to ensure broad access to lerbanectadin in community centers where it can be used in the outpatient setting. Recent market research indicates that oncologists continue to prescribe and administer the best treatments available for their small cell lung cancer patients, given the aggressive nature of the disease and the risk of delaying or defer We look forward to launching Lerb & Exodin to bring this important new treatment option to patients with relapsed small cell lung cancer, a disease where there is a significant unmet medical need. I'll now turn the call over to Rob for an update on our development programs. Rob?

Submitted this data to the NCCN small cell lung cancer panel and after product approval.

In my old label to NCCN for review and potential inclusion and the guidelines.

We will also be working early in the launched leverage our relationships recently established on behalf of Vyxeos to contract with key distributors and G.P.S. to ensure broad access to <unk>.

Community centers, where it can be used in the outpatient setting.

Recent market research indicates that on colleges continued to prescribe and administer the best treatments available for their small cell lung cancer patients.

Given the aggressive nature of the disease and the risk of delay pain or differing treatment even in the face of this pandemic.

We look forward to launch in urban action to bring this important new treatment option to patients with relapse small cell lung cancer.

These where there is a significant unmet medical need.

Now turn the call over to Rob for an update on our development programs Rob.

Thank you Dan.

During the first quarter her already priorities were directed toward advancing R.T. development programs, making progress and key regulatory submissions.

Robert Iannone: Thank you, Dan. During the first quarter, our R&D priorities were directed toward advancing our key development program and Making Progress on Key Regulatory Submissions. We implemented our continuity plans to mitigate the impact of COVID-19 on our R&D program. However, we are starting to see some impact to patient enrollment and delays in the initiation of new clinical trials. Our priorities remain focused on ensuring the safety of patients enrolled in our clinical trials while maintaining the integrity of our studies so that we can advance important treatment options for patients. We are working closely with our investigators and study sites to mitigate delays in initiating and progressing clinical trials. I'll begin with our development activities in sleep and nursing.

We implemented a continuity plan to mitigate active coded 19.

Indy programs.

However, we are starting to see some impact could patient enrollment.

<unk>, an initiation of new clinical trials.

Our priorities remain focused ensuring the safety of patients enrolled in clinical trials.

While maintaining the integrity of our studies so that we can advance important treatment options for patients.

We are working closely with our investigators and study sites mitigate delays in initiating progressing clinical trials.

I'll begin with our development activities sleep in neuroscience.

Her study as JCP to find a idiopathic hypersonic completed enrollment ahead of schedule in the first quarter.

We implemented the use of remote monitoring.

Robert Iannone: Our study of JZP258 and idiopathic hypersomnia completed enrollment ahead of schedule in the first quarter. We implemented the use of remote monitoring and are working with our contract research organization to enable enrolled patients to remain in the study. Our goals are to ensure that the study investigators continue to monitor patient safety, provide access to the study drug, and maintain patient continuity. We have implemented mitigation plans to enable us to maintain the integrity of this important Phase 3, Moving to Sanosi.

Working with their contract research organization to enable enrolled patients to remain in the study.

Our goals are to ensure that steady investigators continue to monitor patient safety.

Provide access to study drug and maintain patient continuity.

We had implemented mitigation planned enable us to maintain the integrity.

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Moving to say no see.

We continue to believe that EDSS in major depressive disorder, or M.D.D. is an important unmet medical need.

Robert Iannone: We continue to believe that EDS and major depressive disorder (MDD) is an important unmet medical need and an important market opportunity given the data generated in patients who had a history of depression in the phase 3 narcolepsy and OSA studies. We have an objective to initiate a phase 3 study evaluating CENOSI for EDS related to NDD later this year. However, given the challenge to initiating and enrolling studies in the current COVID-19 environment and our prioritization activities, we are no longer planning to initiate an indication-enabling study. We will continue to investigate ways to explore CENOSI for EDFs through MDD.

Market opportunity.

Given the data generated in patients they had a history of depression and the face to me narcolepsy.

Studies.

We had an object is to initiate a phase three steady evaluating to know see for E.D.S. related to NDD later this year.

However, given the chance to initiating enrolling studies in the current coded 19 environment.

And our privatization activities.

We are no longer planning.

She ate an indication enabling study.

We will continue to investigate ways to explore so no secret media MDD.

Robert Iannone: Turning to JCP385 for essential tremor. The Phase 1 Healthy Volunteer Study, evaluating the modified release formulation, has been suspended due to challenges in conducting such a study of healthy volunteers in the midst of the COVID-19 pandemic. We anticipate reinitiating the Phase 1 study as soon as it is considered safe and feasible to proceed. The timing of the Phase 2B study initiation is dependent upon the completion of the Phase 1 study. At this time, we believe the Phase 2B study may initiate in the first half of 2021. Turning to Hematology Oncology, starting with Nixios.

Turning to JCP three five for essential tremor.

Phase one healthy volunteers study evaluating the modify release formulation has been suspended duty challenges and conducting such a study and healthy volunteers in the midst and decoded 19 pandemic.

We anticipate re initiating the phase one study as soon as it is considered safe and feasible receipt.

The timing of the takes to be steady initiation is dependent upon the completion and the phase one study.

At this time, we believe that space to be study.

In the first half of 2021.

Turning to hematology oncology starting vyxeos.

Robert Iannone: Our development program is advancing as we continue to evaluate Vixiotes as a treatment for upfront intermediate risk AML in both fit and unfit populations through multiple cooperative group, investigator-sponsored, and jazz-sponsored studies, as well as academic collaboration. We are looking forward to the five-year overall survival data from the 301 study and believe this will be an important data set for physicians. We continue to believe we may see some early vixios and targeted agent combination data from our ongoing VFAST and MD Anderson collaboration studies later this year. Moving on to the favorite time.

Or development program is advancing as we continue take valuing vyxeos as the treatment.

Intermediate risk.

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Armpit population.

Multiple co-operative group investigators farm Teared.

Jazz sponsored studies.

As well as academic collaboration.

You're looking forward to the five year overall survival data from the real one study and believe this will be an important data set her positions.

But continued to believe we may see.

Early vyxeos targeted agent combination data from our ongoing the fast and the Anderson collaboration studies later this year.

Moving to their favorite time.

Robert Iannone: Last week, we announced that we are stopping enrollment in the Phase 3 study for Prevention of Veno-Occlusive Disease, or VOD. After a predefined interim analysis by an independent data monitoring committee. As a reminder, we designed this Phase 3 study to fulfill a post-marketing commitment to assess safety and explore the possibility of an expanded label in the prevention of VOD setting. We do anticipate submitting the safety data to regulatory authorities to satisfy this obligation and expect to analyze the full data set for presentation at a future medical meeting. Given its unique mechanism of action, we are receiving considerable inbound interest in evaluating defibritide in patients with coronavirus and acute respiratory distress syndrome, or ARDS; we are providing ConfibriTi to multiple investigator-sponsored studies for this use.

Last week, we announced that we are stopping enrollment in the face three study intervention vino inclusive disease.

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After a pre defined in <unk> independent data monitoring committee.

As a reminder, we design this study.

And then this phase three study post marketing commitment.

Safety.

Exploring the possibility of an expanded label and the prevention of V.O.D. setting.

We do anticipate submitting the safety data to regulatory authorities satisfy this obligation and expect to analyze old data set for presentation and the future medical meeting.

Given its unique mechanism of action, we are receiving considerable inbound interest and evaluating favorite tied in patients with Corona virus.

Respiratory distress syndrome or A.R.D.S.

We are providing.

Tied to multiple investigators sponsors studies for this use.

Robert Iannone: The fibrotide, which has anti-thrombotic, protective effects on the vascular endothelium and immune-modulating properties, has been evaluated in idiopathic pneumonia syndrome after hematopoietic stem cell transplant, and we are looking to understand the potential risk benefit in coronavirus patients with ARDS. Now, turning to our recombinant Erwinia spiroginase program. Enrollment in our single-arm pivotal phase 2-3 study of JZP458, conducted in collaboration with the Children's Oncology Group, is ongoing, and we are continuing to work toward our goal of a BLA submission as early as the fourth quarter. We're highly focused on mitigating potential delays and are continuing to activate sites remotely, enroll patients, and utilize remote monitoring where feasible. As enrollment in this study continues, with the ongoing support of investigators, we are advancing toward the important goal of providing a reliable, consistent supply of non-E. coli-derived spiroginase to patients with ALL and LBD. I will now turn the call over to Rene for the financial update.

If every time, we test anti thrombotic protecting fact, something ASCII learned alien an immune modulating properties has been evaluated.

Pneumonia syndrome after madam poetic stem cell transplant, and we are looking to understand the potential risk benefit corona virus patients with Rds.

Turning tar recombinant <unk> program.

Enrollment in our single arm.

Two three study in K.P.P. four or five eight.

In in collaboration with the children can called you grew up.

And we are continuing to work turn our goal or the delay submission as early as fourth quarter.

We're highly focused mitigating potential delays.

Tearing to activate sites remotely enrolled patients and utilize remote monitoring where feasible.

Has enrollment in this study continues with the ongoing support investigators.

Advancing toward the important goal at providing a reliable consistent supply nine <unk> patience with.

I'll be out.

I will now turn the call over Cabernet for the financial update.

Thanks, Rob first I'd like to take a moment to share how excited I am to join jobs during such a catalyst threats time for the company.

Renee Gala: Thanks, Rob. First, I'd like to take a moment to share how excited I am to join Jazz during such a catalyst-rich time for the company and be able to contribute to our important mission of providing essential medicines to patients around the world. Turning to the financial updates, in the first quarter, our net revenues were $535 million, an increase of 5% from the first quarter last year. This was primarily driven by double-digit growth in Zyrum, Defotilio, and Vixios, which grew 11, 14, and 13 percent, respectively. Total net product sales increased 11%, excluding Irwin Ace, which was significantly impacted by reduced product availability. Now we'll turn to operating expenses. During the first quarter, our adjusted SG&A expenses increased 27% to $188 million, and adjusted R&D expenses increased 46% to $80 million over the same period last year.

And be able to contribute to our important mission of providing essential medicine to patients around the world.

Turning to the financial update and the first quarter, our net revenues for $535 million, an increase of 5% from the first quarter last year.

This was primarily driven by the double digit growth siren, Defitelio, and Vyxeos, which grew 11 14 and 13% respectively.

Total net product sales increased 11%, excluding Irwin ace, which was significantly impacted by reduced product availability.

Now I'll turn it to operating expenses.

During the first quarter are adjusted S.G.N.A. expenses increase 27% to $188 million and adjusted R. and D. expenses increased 46% to $80 million over the same period last year.

This was in line with our expectations and reflects our intentional and disciplined investment in key value drivers, including preparing for multiple product launches diversifying our commercial portfolio and growing our r. and D. pipeline.

Renee Gala: This was in line with our expectations and reflects our intentional and disciplined investment in key value drivers, including preparing for multiple product launches, diversifying our commercial portfolio, and growing our R&D pipeline. Our first quarter adjusted net income and EPS included acquired IPR&D expense for the $200 million upfront payment we made to PharmaMar for the exclusive U.S. rights to Lerbanectadin. Our adjusted net income for the quarter was $26 million, or $0.45 per share, compared to $164 million, or $2.83 per share, for the same period last year.

Our first quarter adjusted net income and E.P.S. included acquired I.P.R. and D. expense for the 200 million dollar upfront payment, we need to farm and Mar for the exclusive U.S. rights to learn <unk>.

Are adjusted net income for the quarter was $26 million or 45 cents per share.

Paired to $164 million or $2, an 83 cents per share for the same period last year.

Turning to guidance, we recognize the uncertainty associated with the impact of covert 19.

And we assume that the majority of the negative financial impact on our business related to the pandemic will be in the second quarter with a return to normalized operations later in the year.

Renee Gala: Turning to guidance, we recognize the uncertainty associated with the impact of COVID-19, and we assume that the majority of the negative financial impact on our business related to the pandemic will be in the second quarter, with a return to normalized operations later in the year. Our guidance takes into account the impact of multiple factors, including declines in medical visits with fewer patients accessing treatment and reduced sales representative interactions with health care providers. Government-imposed stay-at-home orders, closure of physician offices, prioritization of COVID-19 patients, increased Unemployment, and Loss of Healthcare Coverage.

Our guidance takes into account the impact of multiple factors, including.

Declines in medical visits with fewer patients accessing treatment.

<unk> sales representative interactions with health care providers.

Government imposed stay at home orders.

I'm sure a physician offices prioritization of coded 19 patients.

Increased the unemployment and lots of healthcare coverage.

We are providing revenue guidance for our two therapeutic areas sleeping neuroscience and hematology oncology.

With the current level of uncertainty we believe that this provides a more meaningful guidance range rather than at the individual product sales level.

Renee Gala: We are providing revenue guidance for our two therapeutic areas, Sleep and Neuroscience, and Hematology-Oncology. With the current level of uncertainty, we believe that this provides a more meaningful guidance range, rather than at the individual product sales level. In the Sleep and Neuroscience Therapeutic Area, which includes Xyrem, Sanosi, and JZP258, our guidance includes the impact of declines in diagnostic testing leading to decreased narcolepsy and OSA diagnoses.

In the sleeping neuroscience therapeutic area, which includes <unk> and J.D.P. 258.

Or guidance includes the impact of declines and diagnostic testing leading to decreased narcolepsy and L.S.A. diagnoses.

Are 2020 net sales guidance for this area is in the range of $1.65 billion to $1.74 billion versus the previous range of $1.74 billion to $1.81 billion.

Renee Gala: Our 2020 net sales guidance for this area is in the range of $1.65 to $1.74 billion versus the previous range of $1.74 to $1.81 billion. I'll remind you that this guidance includes limited contribution from JCP 258, given the expected launch late in the year, and the Hematology-Oncology Therapeutic Area, which includes Irwinase, Defetilio, Vixios, and Lurbanect Our guidance includes the impact of delays in procedures, such as HSCTs, recommendations for shifting the care of cancer patients to the outpatient setting, reducing the number of treated patients, and for Irwin A's expected continued supply disruptions.

I'll remind you that this guidance includes limited contribution from J.C.P. 258, given the expected launch late and the here.

And the hematology oncology therapeutic area, which includes <unk> Vyxeos Adler been acted in our guidance includes the impact of delays and procedures such as H.S.A.T.'s recommendations shifting the care of cancer patients to the outpatient setting reducing the number.

If treated patients.

And for urban Ace expected continued supply disruptions.

Or 2020, not sales guidance is in the range of $420 million to $510 million compared to the previous range of 500 for $580 million.

As a result of these changes we have lowered our total revenue guidance for 2022, a range of $2.12 billion to $2.26 billion from the previous range of $2.32 billion to $2.4 billion, which at the midpoint represents a 7% decrease and our total revenue.

Renee Gala: Our 2020 Net Sales Guidance is in the range of $420 to $510 million compared to the previous range of $500 to $580 million. As a result of these changes, we have lowered our total revenue guidance for 2020 to a range of $2.12 to $2.26 billion from the previous range of $2.32 to $2.4 billion, which at the midpoint represents a 7% decrease in our total revenue guidance. Turning to operating expenses, we plan to closely manage operating expenses in 2020 as we prioritize investments in our key current and future revenue drivers, including preparing for our Lerban Actadon and JZP 258 launches and advancing our key development programs, such as JZP 458. These prioritization efforts will reduce our adjusted SG&A and R&D combined expenses by approximately $100 million at the midpoint of our guidance from the previous range.

Buttons.

Turning to operating expenses, we plan to closely manage operating expenses and 2020 as we prioritize investments in our key current and future rather new drivers.

Including preparing for our <unk> and J.C.P. 258 launches.

Advancing are key development programs, such as J.C.P. four or five eight.

These prioritization efforts will reduce our adjusted S.G.N.A.N.R. and D. combined expenses by approximately $100 million at the mid point of our guidance from the previous range.

Are adjusted S.G.N.A. guidance range is 700 $750 million or 31% to 35% of total revenues.

And adjusted R., and D. guidance range is $250 million to $280 million or 11% to 13% of total revenues.

Are adjusted effective tax rate guidance for 2020 has increased to 20% to 23% of our previous guidance.

Renee Gala: Our adjusted SG&A guidance range is $700 to $750 million, or 31 to 35% of total revenue. And our adjusted R&D guidance range is $250 to $280 million, or 11% to 13% of total revenue. Our adjusted effective tax rate guidance for 2020 has increased to 20 to 23% of our previous guidance for 2020 due to the recent release of the final US anti-hybrid regulations and some change in product mix due to the anticipated impact of COVID-19.

From our previous guidance, 18% to 20% due to the recent release of the final U.S. anti Highbred regulation and some change and product next due to the anticipated in packs of covert 19.

Taking our revenue and operating expense guide changes into account.

Reducing our 2020 guidance for non gap adjusted that income to arrange at $630 million to $700 million and adjusted E.P.S. Two a range of 11 25 to 12 50.

Oh also remind you that beginning this year following consultation with the S.C.C.R. Nongaap measures include expenses associated with upfront payments and as a result.

Renee Gala: Taking our revenue and operating expense guidance changes into account, we are reducing our 2020 guidance for non-GAAP adjusted net income to a range of $630 to $700 million and adjusted EPS to a range of $1,125 to $1,250. I'll also remind you that beginning this year, following consultation with the SEC, our non-GAAP measures include expenses associated with upfront payments. And as a result, the $200 million upfront payment made to PharmaMart impacted our non-GAAP financial measures. During the first quarter, we generated cash from operations of $273 million, used $139 million to repurchase 1.1 million shares, and ended the quarter with a strong cash and investment balance of $1 billion. Additionally, in light of the current uncertainties and disruption to the global financial markets resulting from COVID-19, and in an abundance of caution, last month we proactively drew down $500 million under the revolving credit facility.

200 million dollar upfront payment made so far <unk> impacted our nongaap financial measures.

During the first quarter, we generated cash from operations of $273 million used $139 million to repurchase 1.1 million shares and into the quarter with a strong cash and investment balance of a $1 billion.

Additionally, in light up the current uncertainties and disruption to the global financial markets, resulting from code that 19.

And and an abundance of caution.

Last month, we proactively drew down $500 million under the revolving credit facility.

This increases our cash position and preserved financial flexibility for corporate development and other investment opportunities.

We continue to have confidence in our business and we expect to generate meaningful operating cash flow for the remainder of 2020.

And the central component of our strategy and key priority for the company. It's further diversification of our portfolio of essential medicines to provide innovative and life changing options for patients.

Renee Gala: This increases our cash position and preserves financial flexibility for corporate development and other investment opportunities. We continue to have confidence in our business, and we expect to generate meaningful operating cash flow for the remainder of 2020. An essential component of our strategy and a key priority for the company is further diversification of our portfolio of essential medicines to provide innovative and life-changing options for patients. We strive to achieve this through both our internal efforts and corporate development transactions. Jazz strives to be a partner of choice in our industry, and we will continue to aggressively evaluate opportunities to acquire external innovation through productive partnerships and transactions that align with our important mission and strategy. COVID-19 has presented extraordinary challenges for the global economy, the health care system, and the lives of individuals around the world, and the full scope and timing of the effects of the pandemic remain uncertain.

We strive to achieve this through both our internal efforts and corporate development transactions.

Strives to be a partner a choice and our industry and we will continue to aggressively evaluate opportunities to acquire external innovation three productive partnership and transactions that aligned with our important mission and strategy.

How's It 19 has presented extraordinary challenges for the global economy, the healthcare system and the lives of individuals around the world.

And the full scope and timing of the effects of the pen down that remain uncertain.

However, with a dedicated team strong financials any solid underlying business, we are well positioned to execute on our key objectives, while supporting our employees patients and healthcare providers. During this difficult time.

I'm excited about that but the significant opportunities ahead for jazz pharmaceuticals, as we prepare for new product launches advance and expand our portfolio and bring multiple new and differentiated treatment options to patients.

Thank you for joining us on the call today I'll now turn the call over to Kathy.

Renee Gala: However, with a dedicated team, strong financials, and a solid underlying business, we are well positioned to execute on our key objectives while supporting our employees, patients, and health care providers during this difficult time. I am excited about the significant opportunities ahead for Jazz Pharmaceuticals as we prepare for new product launches, advance and expand our portfolio, and bring multiple new and differentiated treatment options to patients. Thank you for joining us on the call today. I'll now turn the call over to Kathy.

Thanks Renee.

<unk> everyone in the very long queue today, a week kindly required say your limit yourself to one question. During this call. So that everyone has an opportunity to answer their question. We will gladly address any additional questions. After the call or you can re enter the queue with that and operator. Please.

Helping the line for question.

Thank you ladies and had anything like that the question, please but I've been one on your Kutztown telephone.

If your question has the answer or maybe it's definitely a cue. Please press the pound key.

<unk> request.

Our first question count some branding folks are cantor Fitzgerald and a lot as open.

Hi, Thanks to pay my Christian then thank you very much for the <unk> the detailed guidance and they said it much on <unk>.

Kathy Luttrell: Thanks, Rene. To everyone in the very long queue today, we kindly request that you limit yourself to one question during this call so that everyone has an opportunity to ask their question. We will gladly address any additional questions after the call, or you can re-enter the queue. With that said, operator, please open the line for questions.

With regards to J.D.P. 258, and then we <unk>.

Can you just elaborate and how we should think about the switch planning out.

You think are too high they initially targeting new patient stock and maybe some of the high risk because our impatient or should we expect to see a strong push to switch well controls are impatient out of the gate. Thank you.

Operator: Ladies and gentlemen, if you'd like to ask a question, please press star then 1 on your touch-tone telephone. If your question hasn't been answered or you wish to remove yourself from the queue, please press the pound. One moment for questions. Our first question comes from Brandon Folkes of Cancer Fitzgerald. Your line is open. Hi, thanks for taking my questions.

Yeah. Thanks for the question, we've given some indication of where we're going with the 258 launched but we'll obviously, providing a more detailed as we come up to approval implementation on our Rams.

And the final launched but Dan wandering I handed over to you to give some color on how we're thinking about the appropriate patients Oh for 258, and how we might go about that.

Brandon Richard Folkes: And thank you very much for the detailed guidance amid so much uncertainty. And with regard to JVP 258, I know we've asked it a few times, but as we get closer, can you just elaborate on how we should think about the switch planning out? Should we think of 258 initially targeting new patient starts and maybe some of the high-risk czarin patients? Or should we expect to see a strong push to switch well-controlled czarin patients out of the gate? Thank you.

Yeah. Thanks Spurs.

Well you guys know we've been at this for quite some time in terms of looking for new formulation, because we had heard from our.

Seeing patients and physicians that this was a a real concern of having this level of sodium.

I'll be at the risk benefit was positive for Xyrem, given the severe nature of Narcoleptic disease.

So we actually see this as the preferred product for all patients clearly, there's gonna be new patients who may have had a concern about the sodium load and we're not getting access, but all sort of new patients coming in.

Bruce C. Cozadd: Yeah, thanks for the question. We've given some indication of where we're going with the 258 launch, but we'll obviously provide more detail as we come up to approval, implementation on our REMS, and the final launch. But Dan, why don't I hand it over to you to give some color on how we're thinking about the appropriate patients for 258 and how we might go about that?

Good access should should be put on to to five eight given the advocacy profile is yeah was shown to be very comparable and the switch friend. The conversion study we did in our phase three but we also think existing patience both.

Daniel N. Swisher: Yeah, thanks Bruce. Well, as you guys know, we've been at this for quite some time in terms of looking for a new formulation because we had heard from our, you know, existing patients and physicians that this was a real concern with this level of sodium, albeit the risk-benefit was positive for xyrem given the severe nature of narcoleptic disease. So we actually see this as the preferred product for all patients. Clearly, there are going to be new patients who may have had concerns about the sodium load and were not getting access, but all sorts of new patients coming in with good access should be put on 258, given the efficacy profile is, you know, was shown to be very comparable in the switch or in the conversion study we did in our phase three. But we also think existing patients, both patients themselves, as they become aware of another treatment option that retains efficacy but really gives a long-term safety benefit, as well as physicians, and as we've started to do the research there for lifelong therapy with patients that have, you know, significant comorbidities, we see this as the preferred long-term treatment

Patience themselves as they become aware of a a another treatment option that retains advocacy, but really gives a a long term safety benefit as well as physicians and as we've started to do the research there.

For lifelong therapy with patients that have you know significant and co morbidities.

We see that says the preferred long term treatment option.

Great. Thank you very much.

Our next crashing cars and Gary not spend a B.M. old capital markets around us okay.

Hi, Good afternoon, just regarding the impact from Cove at 19 patients are already well maintained nuns are is it easy enough for them to get product from yeah.

And continue with their treatment. So no major hiccups there does it really more new patients the treatment that are being impacted I just want to confirm that that's the dynamic that's been playing out so far in the second quarter and how you see that for the rest of the year.

Yeah, Mike maybe I can send that went over to you.

Yeah. Thanks, Bruce Yeah. The the overall pharmacy operations are very good Q1, remember that Q1 tends to be the tough recorder from a payer perspective, Perl specialty drugs not just.

Daniel N. Swisher: Great, thank you very much. Our next question comes from Gary Nachman of BMO Capital Markets. Your line is open. Hi, good afternoon.

And I think we navigated extremely well.

I think earlier.

He had stated that we saw peas.

In the second half a march slowing down we we do in more recent data have seen.

Gary Nachman: Just regarding the impact of COVID-19, if patients are already well-maintained on Xyrem, is it easy enough for them to get products from SDF and continue with their treatment? So there are no major hiccups there. It's really more new patients to treatment that are being impacted. I just wanna confirm that that's the dynamic that's been playing out so far in the second quarter and how you see it for the rest of the year. Yeah, Mike, maybe I can send that one over to you.

An improvement in that trend and that we feel good about.

Or full year guidance reserve.

Yeah, and P. eases patient enrollments.

And you know we just saw a break as people were sheltering in place where people were not going into visit.

Actors and so we anticipate some slow down to new diagnosis and people initiating therapy for the first time.

Okay. Thank you.

Thank you are next question comes from David and some apartments family along with Okay.

Mike Miller: Yeah, thanks, Bruce. Yeah, the overall pharmacy operations are very good in Q1. Remember that Q1 tends to be the tougher quarter from a payer perspective for all specialty drugs, not just syrup, and I think we did extremely well. I think earlier we had stated that we saw PEs in the second half of March slowing down. However, we do, in more recent data, have seen an improvement in that trend, and we feel good about our full year guidance for Xyro.

Thanks, So on some no see I'm just putting aside covert 19 for a moment are are you at all troubled and and how the product is gaining traction given that you have.

Good pair access looks like the footprint of the product is a fairly limited given that their access. So I'm wondering if you could help us.

Bruce C. Cozadd: Yeah, and PEs are patient enrollments. And, you know, we just saw a break as people were sheltering in places where they were not going in to visit their doctors. And so we anticipate some slowdown in new diagnosis and people initiating therapy for the first time. Okay, thank you.

Understand how you're thinking about the launch the trajectory.

What you are doing right and what you need to do differently. Thanks.

Yeah, we'll all start and then maybe asked Mike to join in.

You know I would say, we're very happy with our patient access. Although also remind you that's only a couple of months ago now that we got there.

David A. Amsellem: Thank you. Our next question comes from David Amsellem of Parkland Family. Your line is open.

Our key strategic emphasis for 2020 to spend a broad and the set of prescribers, particularly into the O.S. say audience and our sales force I think was out accomplishing exactly that objective when coven 19 hit and.

Bruce C. Cozadd: Thanks. So on Cenosi, just putting aside COVID-19 for a moment, are you at all troubled at how the product is gaining traction given that you have fairly good payer access? It looks like the footprint of the product is fairly limited given payer access, so I was wondering if you could help us understand how you're thinking about the launch, the trajectory, what you are doing right, and what you need to do differently. Thanks.

Access became limited.

Physician audiences, we sent our field a whole forced home for their own safety and to protect the communities in which they live.

Bruce C. Cozadd: Yeah, well, I'll start and then maybe ask Mike to join in. You know, I would say we're very happy with our patient access, although I'll also remind you that it was only a couple months ago now that we got there. Our key strategic emphasis for 2020 has been to broaden the set of prescribers, particularly among the OSA audience, and our sales force, I think, was out accomplishing exactly that objective when COVID-19 hit and access became limited to physician audiences. We sent our field force home for their own safety and to protect the communities in which they live, and that's obviously made it harder for us to achieve that objective. As I mentioned, we saw some really good things during the first quarter, and maybe I'll ask Mike to elaborate on that a bit.

And that's obviously made it harder for us to achieve that objective as I mentioned, we saw some really good things during the first quarter and maybe I'll ask Mike to elaborate on that a bit.

Yeah, Thanks produce and as Bruce touched on three out of the four major payers that we have secured for <unk> only began in this quarter. So we began with a a very much a whole fruit focus.

This quarter for our sales force Oh, I say has now cats for about 60% of our scratch and it was moving into very good trend and covert 19 is not only heard our access but has really preoccupied pulmonology.

Mike Miller: Yeah, thanks, Bruce. And as Bruce touched on, three out of the four major payers that we have secured for Sanosi only began in this quarter. So we began with a very much pull-through focus this quarter for our sales force. OSA now accounts for about 60% of our scripts and was moving in a very good trend, and COVID-19 has not only hurt our access but has really preoccupied pulmonology. Community.

Community.

And they are that major drivers.

Shall we continue be encouraged with the refill rates, we hear good things from physicians and and clearly from them from patients.

And we feel very good and excited to get back.

To it after Kobe 19 subsides.

Thank you are next question comes from Greg Gilbert expand trash amount is okay.

As high as wondering if you'd weighing on the comments.

That I have it they'll made a about its regulatory legal strategy as well as their data itself the top line and.

Mike Miller: and they are the major drivers of OSS. So we continue to be encouraged by the refill rates, we hear good things from physicians and, clearly through them, from patients, and we feel very good and excited to get back to it after COVID-19 subsides.

Also <unk> do you think it could come early in light of the blistering pace. So that we've seen for some other recent oncology approvals are the F.T.A. Thanks.

Greg Gilbert: Thank you. Our next question comes from Greg Gilbert of SunTrust. Your line is open. Hi, I was wondering if you'd weigh in on the comments that have been made.

Thanks, Greg for that sophisticated one question.

On on you know avid else comments I'm not sure we're going to respond specifically to to everything they've said.

Greg Gilbert: that Avidel made about its regulatory legal strategy, as well as its data itself, the top line. Also, Rob on Lurby, do you think it could come early in light of the blistering pace that we've seen for some other recent encounters?

What what we've said is that we've got a meaningful intellectual property protection.

Around sigh room with our Orange book listed patents.

Greg Gilbert: Approvals.

That go to drug drug interaction with fell <unk> and the method of safe distribution embodied in or around.

Bruce C. Cozadd: by the FTA. Thanks.

Bruce C. Cozadd: Thanks, Greg, for that sophisticated one question. On, on, you know, Avidel's comments, I'm not sure we're going to respond specifically to everything they've said. You know, what we've said is that we've got meaningful intellectual property protection around Xyrom with our orange book listed patents that go to drug-drug interaction with valproate and the method of safe distribution embodied in our REMS that we think is truly important to patients and the public in terms of the way to safely distribute and oxidize the product. Our belief is that Avidel should certify to both families of our patents. Those patents, as a reminder, go out to 2033 and 2023, and we have a long history of obtaining and defending intellectual property as necessary. But, you know, part of this does come down to what regulators do. And we think regulators share a commitment to the safe use of the product with respect to the drug-drug interaction and how it's distributed. Rob, maybe I can turn it over to you for the Lerb and Ektedin piece.

That we think is is truly important to patients and the public in terms of the way to safely distribute on oxybate product.

Our belief is that Avdel I should certify that both families of our patents those patents as a reminder, go out to 2033 and 2023.

And you know, we we have all along history of obtaining in defending intellectual property.

As necessary.

You know.

Part of this does come down to what regulators do and and I, we think regulators share.

A a commitment.

To a safe use of the product with respect to the inner drug drug interaction and how it's distributed.

Rob maybe I could turn it over to you for the <unk>.

Yeah, I mean, one that I wouldn't speculate on.

This is a priority review program, it's fairly discrete package.

There's a fairly straightforward review things are going as expected, but I, it's hard to speculate on mother comes in there anyway.

Or not.

Robert Iannone: Yeah, I mean, one that I wouldn't speculate on, you know, obviously this is the priority review program. It's a fairly discreet package, and it's a fairly straightforward review. You know, things are going as expected, but it's hard to speculate on whether it comes in early or not. Thanks.

Next to him.

Thank you and that's crossing paths and Jake and he's a wells Fargo.

Okay.

Hi, Thanks to take my question with respect to cope with 19 does that potentially slow down your appetite or ability to do deals in any color on the pipe playing now versus say pre <unk>.

Maybe I can ask grenade to weigh in a little bit about how we're thinking about corporate development.

Sure absolutely. So as I stated corporate development continues to be an important strategic objective for us.

Jacob Hughes: Our next question comes from Jacob Hughes of Wells Fargo Security. Your line is open. Hi, thanks for taking my question. With respect to COVID-19, does that potentially slow down your appetite or ability to do deals, and any color on the pipeline now versus, say, pre-COVID?

I'm clearly there complication to undertaking certain due diligence activities and what not during a a covert 19 environment, but I don't think that's going to have an impact on deals getting done this here and and as we think about what's most important to jazz will come.

Bruce C. Cozadd: Maybe I can ask Rene to weigh in a little bit about how we're thinking about corporate development.

Renee Gala: Sure, absolutely. As I stated, corporate development continues to be an important strategic objective for us. Clearly, there are complications to undertaking certain due diligence activities and whatnot during a COVID-19 environment, but I don't think that's going to have an impact on deals getting done this year. And as we think about what's most important to Jazz, we'll continue to look at both late-stage opportunities as well as early-stage opportunities to be able to fill the pipeline.

Continue to look at both late stage opportunities as well as early stage opportunities.

To be able to fill in the pipeline.

Yeah. Thank you.

Thank you and the question comes from a class to Laurie.

Research a lot of okay.

They think that much. So I just wanted to clear something up your labeling language for <unk> sodium recommended initial die room dose reduction of at least 20 per cent per patient, who who take both can prominently which sounds to me like your first though some diamonds reduce the second docent kind of this thing so given the Abigail product is basically kind of like a single.

Renee Gala: Thank you. Thank you. Our next question comes from Akash Tewari of Wolf Research and Annabel.

Akash Tewari: Hey, thanks so much. I just wanted to clear something up. Your labeling language for xyrem and valproate sodium recommends an initial xyrem dose reduction of at least 20% for patients who take both drugs incomminently, which sounds to me like your first dose of xyrem is reduced. The second dose is kind of the same. So given the Abadil product is physically kind of like a single satchel product, how would a patient who is on the Abadil product be able to incorporate the concomitant dosing language that you put on the current SIRM label? Thanks.

Actual product how would the patient who was on Diablo product being able to incorporate the contaminated dozing language that you put on the current bound label thing.

Yeah, I would say are are a language in our label was designed to ensure that patients and physicians understand that concomitant use of Oxybate and valproic.

Cults in higher levels of Oxybate.

Than would be predicted otherwise and that you know dose modification of a significant magnitude as warranted and we've got specific instructions for that.

Bruce C. Cozadd: Yeah, I would say our language in our label is designed to ensure that patients and physicians understand that concomitant use of oxibate and valproate results in higher levels of oxibate than would be predicted otherwise, and that, you know, dose modification of a significant magnitude is warranted, and we've got specific instructions for that in our label. On dosing and administration, and that's whether you're stable on oxibate and then you add valproate or whether you're stable on valproate and then you add oxibate. In either case, you need to be careful. Again, we don't know what Avidel is proposing to put on their label, and that will be between them and the regulators, but it is important that, again, doctors and patients understand that interaction to make sure you don't get an inadvertent overdose of Oximab.

You know or label on dosing into administration, and that's whether you're a stable on Oxybate, and then you're adding valproic or whether you're stable and valproic. It and then adding oxybate in either case you need to be careful again, we don't know what avdel is proposing to put in their label and that will be between them and the regular.

<unk>, but it is important.

That again, treaters and patience understand that interaction to make sure you don't get an inadvertent overdose of Oxybate.

Thanks, a lot appreciate.

Thank you My next question constantly <unk> thank God.

I've been called American get a lot of okay.

Hey, good evening and thanks for taking my question, maybe just on the or when a update you know from the outside looking in it looks like the assumption is jasmine been better off going it alone with four or five eight as a wholly owned assets versus conceding perhaps lesser economics.

Bruce C. Cozadd: Thanks a lot. I appreciate it. Thank you. Our next question comes from Jason Garberry of Bank of America in London. Hey, good evening, and thanks for taking my question. Maybe just on the Irwinase update, you know, from the outside looking in, it looks like the assumption is Jazz must have been better off going it alone with 458 as a wholly owned asset versus conceding, perhaps lesser economics, and trying to negotiate or extend with PBL. So can you address this? And, you know, whether you feel you could be in an equal or better position in terms of gross profit derived? From JCP 458 in a couple years post launch from say where you are with Irwinase in the past one or two years. Thanks.

And trying to negotiate or extend with P.D.L. So can you must address this and you know whether you feel you can be an equal or better place in terms of gross profit derived from G.P. four or five eight and a couple of years post launch from say, where you are with or when it is in the past one or two years. Thanks.

Yeah, I'll sort of flip that around and it's an answer you'd the narrow party of your question first which is around gross margin.

You know obviously from a gross margin perspective, or when Ace was not one of our higher gross margin products, we think with a more modern manufacturing process with a recombinant product will actually have an improvement.

Jason Garberry: Yeah, I'll sort of flip that around and answer the narrow part of your question first, which is around gross margin. Uh, you know, obviously, from a gross margin perspective, Irwin-Ace was not one of our higher gross margin products.

In terms of lower cost of goods, they're also some advantages from a.

Tax rate perspective to having developed this product with fat in mind.

Bruce C. Cozadd: Uh, we think with a more modern manufacturing, uh, process, uh, with a recombinant product, uh, we'll actually have an improvement. In terms of lower cost of goods, there are also some advantages from a tax rate perspective to having developed this product with that in mind. But I think much more important than the gross margin aspect is coming back to why we developed this product in the first place, which is to ensure that, ALL patients have access to a reliable, high-quality product where we're not limited by supply in meeting current demands, and thinking about growing demand, uh... to meet the needs of all patients including patients uh... in the adolescent young adult uh... group who would benefit from a pediatric inspired regimen that contains an asparaginase where we see better survival and to allow for broadening use of our product into more geographic markets as well.

But I think much more important than the gross margin aspect is coming back to why we develop this product in the first place which is to ensure that.

A.L. patients have access to a reliable high quality product, where we're not limited by supply.

Meeting current demand.

And thinking about growing demand.

To meet the needs of all patients, including patients in the adolescent young adult a group who would benefit from a pediatric inspired regimen that contains an experiment ace where we see better survival.

And to allow for broadening my use of our product into more geographic markets as well.

As a reminder of the existing product is approved in Japan, and still not launched there.

Bruce C. Cozadd: As a reminder, the existing product is approved in Japan and has not yet been launched there. So, you know, the most important driver for our development was really bringing that high-quality, reliable agent to market with the ability to meet current demand and grow demand beyond that. So, it's also true we think it would be a higher gross margin product for us, but that was not the driving force.

So you know the most important driver for development was really bringing.

That high quality reliable agent to market.

With the ability to meet current demand in grow demand beyond that so it's also true we think it'd be a higher gross margin product for us, but that was not the driving force.

Thank you.

Thank you next question comes from a nice idea F.B. has living in lines. Okay.

Bruce C. Cozadd: Got it. Thank you. Thank you. The next question comes from Ami Fadia of FBS Living. Your line is open.

Good afternoon, Thanks to take my question.

Ami Fadia: Good afternoon. Thanks for taking my question. Maybe, you know, in light of the AVIDEL data and the successful trial, could you talk to us about your program for the once nightly low sodium product and when do we think that it could reach phase three or a pivotal trial stage? And what are your development plans there?

Maybe you know in light of the.

Data and there's a pencil trial.

Could you talk to US about you are program and also the ones like need no sodium product and.

When do we think that it could be a basically you have to try on stage.

And what are you development yeah. Thank you.

Yeah, I mean, we haven't really said much about our plans for that we've been pretty quiet.

Bruce C. Cozadd: Yeah, Ami, we haven't really said much about our plans for that. We've been pretty quiet, uh... you know the most important thing for people to remember about our once nightly program is it's once nightly low sodium development. You know, we clearly feel that reducing that sodium load is critically important to the long-term health of patients, existing and new patients, and so we've incorporated that into our development plan, but we haven't given any more specifics yet on that.

You know the most important thing for people to remember about our one slightly program is it's once nightly low sodium.

Development, you know, we clearly feel that reducing that sodium.

Load is critically important to the long term health patients existing and new patients.

And so we've incorporated that into our development plan, but we haven't given.

Any more specifics yet on on that I will remind you. We've got a good track record is moving quickly through development.

Bruce C. Cozadd: I will remind you we've got a good track record of moving quickly through development with our agents. I think, you know, certainly we did a nice job of getting 258 through pivotal trials and into the regulators. Certainly happy with how we're doing that with 458 as we speak. So, you know, more to come.

With our agents I think you know certainly we did a nice job of getting to 58 through a pivotal trial and into the regulators and.

Certainly happy with how we're doing that with 458 as we speak so.

You know more to come but that's all we've said today.

Bruce C. Cozadd: Thank you. Thank you.

Thank you take your next question costs and justify data.

Jessica Fye: Our next question comes from Jessica Fye of JPL. JPMorgan, Good afternoon, thanks for taking my question. Within the updated CMONC guidance, can you elaborate a little bit on which products are harder hit within that, just with the overall range coming down by 14% at the midpoint? Was that largely Vixios? In particular, I'm also curious if a worse than expected interruption for Erwinase factors into that at all, which would, you know, obviously not be COVID related.

J.P. Morgan amount of okay.

A good afternoon things to take my question within the updated humanoid guidance can you elaborate a little bit on which products are harder hit within that I'm supposed to overall range coming down by 14% at the mid point was that largely vyxeos in particular in lots of curious if a worse than expected and.

Corruption for or one of these factors into that at all which would you know obviously not because they'd related.

Daniel N. Swisher: Yeah, maybe I'll ask Dan to address that question.

Yeah, maybe L.S. Dan to address that question.

Yeah, I think near term they've all been somewhat affected but I would say you know vyxeos a little more so in the U.S. where.

Daniel N. Swisher: Yeah, I think near term, they've all been somewhat affected. But I would say, you know, Vixio is a little more so in the US where there's kind of a push for outpatient treatment and finding, you know, oral oncolytics or other approaches. I think as capacity comes back with the inpatient setting, and people can manage, obviously, non-COVID cases as well as COVID. The five-year survival data that's coming through at ASCO reinforces the efficacy profile for Vixio. So we continue to show nice growth in Europe, and I think that's going to be relatively uninterrupted. But in the U.S., getting the data and getting back into physicians and enabling more intensive therapy options for patients will be something we anticipate in the second half. IRWIN ACE is non-COVID related, and unfortunately, some of the shortfall in guidance is related to worse than forecast disruption in supply.

There's kind of a push for outpatient and finding you know the orelon clinics or other approaches I think as.

The capacity comes back with the inpatient and people can manage obviously noncovered cases, as well as code that the five years survival data that's coming through it ask of reinforces yeah. The efficacy profile for for Vyxeos. So we continue to show nice growth in Europe.

I think that's gonna be relatively uninterrupted, but in the U.S. getting the data and getting back into physicians and you know, enabling more intensive therapy options for patients will be yeah, we'll be something we anticipate in the second half <unk> noncovered related and Unfortunately, you know some of the shortfall in guidance is.

Related to.

Worse than forecast disruption in supply.

Thank you.

Bruce C. Cozadd: Thank you.

Kim Caputoy: And Jess, I'll just add that in addition to being significantly supply constrained in the first quarter of 2020, we happen to be comparing back to the first quarter of 2019, where we had unusually positive supply. And that's, I think, why Rene highlighted that if you back out that swing in Irwin A's first quarter to the first quarter, I think you get a better sense for how the rest of our business is doing.

And and just solved all just add that in addition to being a significantly supply constrained in the first quarter of 2020 of coursework happened to be comparing back to a first quarter and 2019, where we had unusually positive supply and that's I think why Rene highlighted that if you.

Back out that swinging in or when A.'s first quarter to first quarter, I think you'd get a better sense for how the rest of our business is doing.

Bruce C. Cozadd: Thank you. Our next question comes from Kim Caputoy of CalWinning Company. Your line is open.

Got it.

Thank you I <unk>.

Ken Caputoy: Follow up on the Avidel questions and a question of my own on Avidel. Bruce, are there any FTC impediments to you buying Avidel? If you could comment on that, would you?

Huh.

Blow up on the Abigail questions in a question of my own on Abdel Bruce is there any F.T.C. impediments to you buying Avdel you could comment on that and then in the after hours. If we look at your share trading at less than five times 2021, you but.

Bruce C. Cozadd: And then in the after hours, if we look at your shares, they're trading at less than five times 2021 EBITDA. It's practically begging for you all to maybe take this company private. Can you give any thoughts as to where there would be a compelling reason for you all to maybe think about taking a more aggressive strategy, either a share buyback or actually going all the way and trying to take the company private? Thank you.

<unk> begging for you all to maybe take this company private can you give any thoughts as to where would be a compelling reason for you all to maybe think about taking him more aggressive strategy their share buyback are actually going all the way in trying to take the company private thank you.

Bruce C. Cozadd: So Ken, no comment on your first question for obvious reasons. On your second question, you know, I don't think you need to look at after-hours trading today. You can just look at where we're trading to say that, you know, the company has excellent cash flow relative to its current value. We continue to pursue a strategy that we think adds significant diversification to our revenue growth drivers. We think this is, as Rene said, a catalyst-rich year in terms of making that much more visible, whether that's progress on a Synosy launch, the launch of Lerb & Ectedin, the launch of 258, moving Synosy into Europe, continued growth of Vixios in Europe, moving 458 closer to the market, and the potential for additional corporate development transactions.

So can no comment on your first question for for obvious reasons on your on your second question.

I don't think you need to look it after hours trading today you can just look at in general. We're we're trading to say that you know the company has excellent cash flow.

Relative to its current value.

We continue to pursue his strategy that we think add significant diversification to a revenue growth drivers. We think this is as as Rene set a catalyst rich year in terms of making that much more visible whether that's progress on us to know see launch launch a blurb connected in launch of 258 moving.

So no see into Europe continued growth Vyxeos in Europe, moving four or five eight closer to the market and the potential for additional corporate development.

A transaction. So you know we've got work to do but we're excited about making progress on that and and making it clear to investors you know what that longer term more diversified revenue stream looks like.

Bruce C. Cozadd: So, you know, we've got work to do, but we're excited about making progress on that and making it clear to investors, you know, what that longer term, more diversified revenue stream looks like. You know, you raise a good question, which is the use of cash to buy back shares. And in fact, we've been an aggressive purchaser of our own shares over the last few years. We continued that in the first quarter, I will admit we hit pause a little bit as we came into COVID, 19, just to make sure we understood a little bit about how initial efforts to contain viral spread to flatten the curve, uh... to eventually get people back uh... you know toward normalcy in terms of resuming customer interactions uh... ability to advance clinical trials and the like so we we did hit pause a little bit but we remain uh... convinced that our shares are a good investment for us so long as we don't constrain our ability to be aggressive on the corporate development side which continues to be uh... significant priority for us

You know you raise a good question, which is the use of cash to buyback shares and in fact, we've been an aggressive.

Purchaser of her own shares over the last few years, we continued that in the first quarter I will admit we hit pause a little bit as we came into coded.

Ah 19, just to make sure we understood a little bit about how initial efforts.

To contain viral spread to flatten the curve.

To eventually get people back you know toward normalcy in terms of resuming customer interactions ability you advance clinical trials and the like so we we did hit pause a little bit but we remain.

Convinced that are shares are are good investment for us so long as we don't constrain our ability to be aggressive on the corporate development side, which continues to be a significant priority for us.

Thank you.

Thank you.

Randall Finicky: Thank you. Our next question comes from Randall Finicky of RBC Capital Markets, Rhino Group. Great, thanks.

On this question time for Randall Cunningham Arden capital markets a lot of okay.

Great. Thanks, Bruce New talk about 258, and specifically how should we think about the the promo and an AD spend there and you need to expand the rap data and trying to understand how how much incremental spend we could see from the launched 258, and then specifically did that fall into 2020 or 2021. Thanks.

Bruce C. Cozadd: Bruce, can you talk about 258? And specifically, how should we think about the promo and ad spend there? And do you need to expand the rep base? I'm trying to understand how much incremental spend we could see from the launch of 258. And then specifically, does that fall into 2020 or 2021? Thanks.

Yeah. So Randall you know some of that spend will absolutely fall into this year. Our our goal is to gain approval in July.

Bruce C. Cozadd: 2020 or 2021. Thanks.

Bruce C. Cozadd: Yes, so Randall.

You know implement our rams and be ready to launch in the fourth quarter.

Bruce C. Cozadd: You know, some of that spend will absolutely fall into this year. Our goal is to gain approval in July, implement our REMS, and be ready to launch in the fourth quarter. So some of that spend will happen this year in terms of promotion. We are going to do what we can to make this a very successful launch. We want patients to have access to what we believe is a better Lifelong Therapy. And, you know, you can expect that our focus will be on 258 and less on Xyrem once we make that switch. In terms of the field force, I think that's a broader question. We want to make sure we do right by Xyrem this year, certainly preparing for a successful launch of 258, but continuing our progress on Cynosi. And so, you know, as we think about having the right Field Force for that, we're really thinking holistically about sleep and neuroscience now and into the future. Dan, anything you want to add to that?

So some of that spend will happen this year in terms of promotion.

You know we are going to do what we can to make this a very successful launch we want patients have access to what we believe as a better.

A lifelong therapy and you know you can expect that our focus will be on 258.

And less on Xyrem once we make that switch in terms of field force I think that's or broader question, we want to make sure. We're doing right by Xyrem. This year certainly preparing for a successful launch of 258, but continuing our progress on snow C. and so you know as we think about having the rights.

A field force for that were really thinking holistically about sleeping neuroscience now it into the future.

Dan anything you want to add to that.

No I think you covered it well thanks for years.

I think sake you.

Oh cool I next question classroom and about.

Okay.

Hi, Thanks for taking my question.

A question on four or five eight and everything continues with involvement in the trial you are able to file by fourth quarter can you confirm whether you're going to be having to refer to the P.B.L.V.L.A. filing and whether you have to refer to anything that might block you from an I.P. perspective.

Daniel N. Swisher: No, I think you covered it well. Thanks, Bruce.

Operator: Thank you. Thank you. Our next question comes from Annabel Samimy of People. Your line is open. Hi. Thanks for taking my question. Just a question on 458. If everything continues with enrollment and the trial and you're able to file by the fourth quarter, can you confirm whether you're going to be having to refer to the PBLVLA filing and whether you have to refer to anything that might block you from an IP perspective from launching immediately on approval if it's available to you? Thanks.

To launch immediately on approval if it's available to good. Thanks.

So in about we're really excited about the progress, we're making with 458.

And want to make sure we continue to do everything Kate everything we can in combination with.

Annabel Eva Samimy: So Annabel, we're really excited about the progress we're making with 458 and want to make sure we continue to do everything we can in combination with Cog and FDA to make this therapy available, you know, particularly as we continue to have periods where we're out of stock with Irwin A. I think this is essential. We're confident we have everything we need to move through the regulatory process. The regulatory process, just as a reminder, we have a relatively straightforward endpoint in our trial, so we, you know, we think we're in good shape to move quickly to the market.

Cog and F.D.A. to make sure we make this therapy available you know, particularly as we continue to have periods, where we're out of stock.

With her when A.'s I I think this is essential we're confident we have everything we need to move through.

The regulatory process.

Just as a reminder, we have a relatively straightforward endpoint.

In our trial. So we you know we think we're in good shape to move quickly to the market.

Thank you.

Bruce C. Cozadd: Thank you. Our next question comes from Ronnie Gale of Bernstein. Your line is open.

I'm from Lani Gallup right Okay.

Hi, I'm just gonna you read I got one and a half just reading on a boat question is they're they're legal barriers you guys do come aren't going to hear about a cool, but he's direct t., but you have to contend with and then my question here I think about.

Renee Gala: Just to read Annabel's question, are there legal barriers for you guys to go to market? I hear about approval, but is there IT that you have to contend with? And then my question here is, if we think about the U.S. going from unemployment of somewhere under 5% to something like 11%, which is the CBO prediction for next year, have you begun to think about what that would mean in terms of headwinds for Xyrem? The expectation is that most of those unemployed will shift to Medicaid towards the end of the year as opposed to now. And I kind of wonder if you kind of think year over year, have you begun to think about the impact there?

Going from.

Someone under five something like 11%, which is a studio <unk> addiction for next year have you begin to think about what that would mean in terms of headwinds desire and.

<unk> boy will shift the Medicaid.

<unk> as opposed to now.

And I'm kind of wonder if you've got to think you have a year of you begin to think about the impact them.

Oh, so Ronnie I'll give you the one and a half questions because I wasn't trying to duck the end of the the prior a question. We think what we <unk>, we have what we need to move forward, we developed a new drug product.

Bruce C. Cozadd: So, Ronnie, I'll give you the one and a half questions because I wasn't trying to duck the end of the prior question. We think we have what we need to move forward. We developed a new drug product, and I don't see a barrier to bringing that to market. So maybe, Mike, I could turn it over to you to reflect a little bit on what any change in, you know, employment status, for example, would mean for payer mix and to how we think about Xyrom revenues in 2020 and beyond.

And don't see a barrier to bringing net.

To market, so maybe Mike I could turn it over you to reflect a little bit on what.

Any change in you know employment status for example would mean to pay or mix and to how we think about xyrem revenues and 2020 and beyond.

Yeah, Bruce as.

Mike Miller: Yeah, Bruce. As you know, Ronnie, the primary payer for Xyrom is commercial, overwhelmingly. And we have not seen a significant shift in the payer mix on Xyrom so far. We continue to provide patient support programs that enable patients to get the drug if they financially qualify. We will continue to do that. Again, we feel very good about where we are in our guidance and our gross net and where we are.

Ronnie the primary payer for his arms commercial.

<unk>.

And we have not seen a significant shift in the pay or mix.

So far we continue to provide patients support programs that enabled patients to get drug if they financially qualify.

We will continue to do that.

Up again, we feel very good about where we are guidance and our grossed Annette and where we're heading in.

Bruce C. Cozadd: But to be clear, our guidance for the rest of the year does contemplate that we would see.

But but to be clear our guidance for the rest of the your does contemplate that we would see a shift in pay or mix that would actually results in higher gross to net overall for his arm.

Mike Miller: A shift in payer mix that would actually result in higher gross pin net overall for Xyron. Thank you.

Thank you.

Our next question comes from a lousy Bazardo Barclays alignments open.

Balaji V. Prasad: Our next question comes from Balaji Prasad of Barclays. Your line is open.

Oh I ended up on things things <unk>. So my question is on the neck to then so we lost spoke about your thoughts and exploring this one friend like that to be.

Robert Iannone: Hi, good afternoon. Thanks for taking the question. So my one question is on lupinectadine. We last spoke about your thoughts on exploring this for front-line therapy. Has there been any progress on that front in identifying the form lupinectadine could play a role in first-line lung cancer? Thank you.

There'd been any progress and but friend in I didn't find the form illuminating good play a role in coastline again, so I guess.

So Rob maybe it can ask you oriental weigh in on that.

David Reissner: So Rob, maybe I can ask you or Ann to weigh in on that.

Bruce C. Cozadd: Sure, happy to. So based on the data that is publicly available, liver necrosis is highly active and even more so in patients who are sensitive to platinum, which is the greatest majority of small cell patients. And so we do see an opportunity to move into first-line small cell lung cancer. However, as you know, despite recent advances there with the addition of immuno-oncology PD-L1 inhibitors, the prognosis is still extremely poor. The median survival is about 12 to 13 months, depending on whether you look at the atezo or infancy data. And so given the tolerability profile of lurbinectadine, we do think that there's an opportunity, ultimately, to move it into the front line.

It's very happy to.

So we know based on the data that are publically available that lebron accidents highly active and even more more active than patients who are sensitive to platner, which is the greatest majority small song cancer.

So we do see an opportunity.

Moving into first line small so lung cancer as you know despite recent advances there with the addition of.

Algae P.D.O. one inhibitors, the prognosis is still extremely poor.

The median survival is about 12 13 months, depending on whether you look at the teeth into data.

So given the Tolerability profile.

Connected then we do things and there's an opportunity ultimately to move into the front garden setting.

Robert Iannone: Our next question comes from David Reissner of Morgan Family Alarm. The line is open.

Thank you.

Question comes from David Arisen Oh, Morgan Stanley allowed to vote then.

Yes, thanks very much.

David Reissner: Yes, thanks very much.

I just wanted to ask a quick question. Most of my questions have been answered with respect to earn when A.'s and 2021 could you just talk about how we should think about that occur over the course of 2021. Thank you.

Bruce C. Cozadd: I just wanted to ask a quick question. Most of my questions have been answered. With respect to IRWIN-As in 2021, could you just talk about how we should think about that?

David Reissner: Over the course of 2021, thank you.

Bruce C. Cozadd: Yeah, so David, as we publicly said, you know, our contract will conclude at the end of 2020, but with a contractual right to sell through inventory in production. As we hit the end of the year, we think that will take us part way through 2021, depending on the level of that inventory, and of course, we're doing everything we can to make sure that patients will have access to therapy even beyond the current supply by bringing 458 to market as rapidly as we can. You know, we've got a goal of getting that BLE in as early as the end of this year. We think FDA is motivated to move quickly through the regulatory process as well, and you know our focus for this year is keeping that timeline as short as possible. We're starting to explore a path for ex-U.S. approval in the EU and other markets as well.

Yeah. So David as we publicly said you know our contract will conclude at the end of 2020.

But with a contractual rights to sell through inventory in production.

As we hit the end of the year, we think that will take us partway through 2021, depending on the level of that inventory.

I and of course, we're doing everything we can to make sure that patients will have access to therapy.

Even be on current supply by bringing 458 to market as rapidly as we can you know we've got a goal of getting that B.L.E.N. as early as the end of this year.

We we think F.D.A. is motivated to.

If the data is what we hope the data will be move quickly.

Through the regulatory process as well and you know our our focus for this year is keeping that timeline as short as possible war starting to explore path for X.U.S. approval in E.D.U.I. in other markets as well.

Esther Rodriguez: Thank you. Thank you. Our next question comes from Esther Rodriguez of Oppenheimer. Your line is open.

Thank you.

Okay and that's the question Council asked arrival.

Okay.

Hey, Thanks sleeping in I'm, just curious to see if you are seeing any impact is tele medicine, especially on the sleep franchise I do you anticipate that maybe contributing to to uptake, especially for the new launches over the course of the year.

Bruce C. Cozadd: Hey, thanks for squeezing me in. I'm just curious to see if you are seeing any impact of telemedicine, especially on the sleep franchise, or do you anticipate that maybe contributing to uptake, especially for the new launches over the course of the year?

Yeah. So good good question and maybe all broaden my answer a little bit to say you know we're not far into this right we are.

Daniel N. Swisher: Yes, a good, good question. And maybe I'll broaden my answer a little bit to say, you know, we're not far into this, right? We are coming up on two months into a pretty radical change in how patients and physicians interact, and I think we're still at the early end of figuring out the art of the possible in terms of diagnosing, treating, and monitoring patients with a variety of disorders remotely or requiring fewer in-person visits. I think that a willingness to find new ways to get things done has long-lasting implications on how companies like ours and healthcare professionals may interact in a way that could be more efficient. It is more impactful than, you know, the focus we've had historically, which has been largely on in-person, not entirely, but largely on in-person promotions.

Coming up on two months into a pretty radical change in.

How patients and physicians interact and I think we're still at the early end of figuring out the art of the possible.

In terms of diagnosing treating monitoring.

Patience with a variety of disorders remotely or.

Or requiring less in person visits.

I think that a willingness to find new ways to get things done has long lasting implications on.

How companies like ours and healthcare.

Professionals may interact in a way that could be more efficient.

I am more impactful then.

You know the focus we've had a historically which has been largely on in person not entirely boat largely on in person promotion. So.

Daniel N. Swisher: So, you know, I will say we're seeing things now, but I just also want to stress, I think we're still early on in figuring out the art of the possible. Uh, and, uh, you know, that may require changes in how people go about doing diagnostics, what diagnostics can be done in a less intensive setting as well as regular visits. Dan or Mike, anything you guys want to add to that?

<unk> I will say, we're seeing things now, but I I. Just also want to stress I think we're still early on and figuring out the art of the possible.

And you know that may require changes in.

How people go about doing diagnostics, you know what diagnostics can be done.

In a less intensive setting a as well as a regular visits danner, Mike anything you guys want to add to that.

Daniel N. Swisher: You know, I'd just sort of add that I think Jazz is in a particularly strong position both because of the medicines we're currently providing for significant, whether life-threatening or life-changing therapy, say in narcolepsy or in cancer. And we are a pretty flexible, innovative company, so we are trying a number of things to continue that engagement both within the company but, obviously, with our customers and healthcare practitioners. You know, a good example is COVID Hit, and we have hired the entire neuroscience field force in Germany, remotely trained them, and they're ready for a virtual launch in mid-May. And there's a number of ways to really leverage those relationships more broadly with digital means, and so we're experimenting with a number of different brands and regions, and look forward to continuing to get that leverage post-COVID. And then, as I say, with new product launches, there's obviously a lot of customer interest regardless of the situation, so we're looking forward to the second half.

Just sort of that that I think jazz is in particularly strong position.

Both because of the medicines were currently providing for significant whether life, threatening or or life, changing therapy, saying narcolepsy or in cancer.

And we are pretty flexible innovative company. So we are trying on number of things to continue that engagement both within the company, but obviously with our customers and healthcare practitioners a good example is.

If it hit and we have hired the entire neuroscience field force in Germany remotely train them and they're ready for virtual lunch and mid May and there's a number of there's a high degree of customer interesting engagement and so the look forward to get getting face to face I don't think you can ever.

Gate, the importance of that but there's ways to really leverage those relationships more broadly with digital means and so we're experimenting and with a number of different brands and and regions and look forward to continue into.

Get that leverage post <unk>, and then as I say with new product launches. There's obviously a lot of customer interest regardless of the situation. So we're looking forward to the second half of 2020.

Kathy Luttrell: And I will just piggyback on what Dan said specifically with respect to the upcoming launch of Lerbinectadin. We've reached out to doctors of small cell lung cancer to see how their treatment of their patients has changed. And you know, there's certainly an awareness of mitigating risks of COVID-19, but clearly, for these patients, the most important treatment objective is to, in fact, continue their treatment, first line, and then with progression, the second line. And we're not hearing that, from their perspective, there'll be a significant impact.

I.

I will just piggy back on what Dan said, specifically with respect to the upcoming launch a blurb connected in we've reached out to treaters of small so lung cancer to see how they're you know treatment. Other patients has changed and you know there's certainly.

You know one awareness of mitigating risks of code that 19, but but clearly for these patients. The most the most important treatment objective is to in fact continues there.

You know their treatment first line and then with progression the second line.

Yeah, we're not hearing that from their perspective, there'll be a significant impact.

And the operator, so the the up coming question will be our last question.

Umar: And Operator, this will be the upcoming question will be our last question.

Bruce C. Cozadd: I found a question... [inaudible] Hi, thanks so much for taking my question. Bruce, I wanted to touch on Avidel and specifically two parts. Number one, I'm curious how you think about their cataplexy attack reduction relative to the trial experience we've seen with Xyrem. And also, as it relates to the carve-out point, I recall one of the end-of-filers, Par, was trying to carve out Valparaiso, and FDA obviously didn't allow that. But what if Avidel attempts a contraindication? How do you think about that in the context of what your patent claims?

Thank you I found a question come from <unk> Everquest, yes.

I think so much for taking my question Bruce I wanted to touch up on Avdel and.

Ugly two part number one I'm curious how you thought about their cataplexy attack reduction relative to the trial experience with females on them and also as it relates to the carve out point I recall I'm one of the end up filers part trying to carve out the output and F.D., obviously didn't allow that.

But what if Abdel attempt a contraindication how do you think about that in the context about your patent claims.

Yeah, so or on on that latter points.

Umar: Yeah, so Umar, on that latter point, again, I think we said what we were going to say about their carve-out strategy in terms of what we think is important for patients and physicians to understand about the safe and effective use of Oxybate. You know, they may have a different point of view, but I think we're clear as to what our point of view is.

Again, I think we said what we're going to say about.

They're carveouts strategy.

In terms of what we think is important for a patient some physicians to understand about safe and effective use of oxybate.

You know they they they may have a different point of view, but I think we're clear as to what our point of view is.

Bruce C. Cozadd: On the cataplexy data, you know, I'll say, You know, with Xyrem and with 258, we've put our data out. Many of you may remember that our 258 data in the spring last year led to a much fuller discussion of that data at World Sleep in Vancouver in September. And we'll look forward to seeing more data from Avidel over time in an appropriate setting. But I think it's too early, with the amount of data they provided, which, by the way, is perfect.

On the Cataplexy data you know all say.

<unk> Xyrem and with 258, we've put our data out.

Many of you may remember to 58 data in the spring last year led to you know a much fuller discussion of that data at world sleep in Vancouver in September.

And we'll look forward to seeing more data from Avdel over time in an appropriate setting I think it's too early.

With the amount of data they provided which by the ways perfectly understandable as you're just releasing top line data wouldn't have expected a lot of detail at this point, but given the trial designs.

Bruce C. Cozadd: Transcripts provided by Transcription Outsourcing, LLC. But we're different.

Operator: I think it'll take a while to understand what the data do and don't mean for safety and efficacy. You know, we do know in the case of Xyrem, the product has been used for a long time as a mainstay of narcolepsy therapy. And then more recently, we've got good 258 data, which we think addresses the most important liability of Xyrem from a patient and physician standpoint, which is the high sodium content that leads to the type of sodium warnings we see on the Xyrem label. So, you know, more to come as we see more data from Avidel, but probably too early to make any significant conclusions on that front.

We are different I think it will take a while to to understand what the data do and don't mean on safety and efficacy.

You know, we do know in the case of Xyrem the product has a long use.

It as a mainstay of narcolepsy therapy.

And then more recently got good to 58 data, which we think addresses the most important liability of desire.

From a patient and physicians and point, which is of a high sodium content that leads to the type of sodium warnings, we see undesirable labels. So yeah more to come as we see more data.

From avid l., but probably too early to make any significant conclusions on that on that front.

Bruce C. Cozadd: And maybe since Kathy said that was the last question, I'll just end by, again, thanking you all for joining us and reiterating our enthusiasm about the business. I have to say our team on Xyrem is doing an excellent job under the circumstances in making sure patients continue to have access to their therapy during this time. We look forward to resuming our growth of Xyrem and then quickly bringing Lerbanectadin and JCP258 to market and continuing our clinical development plans with heavy emphasis on 458 this year, and then continuing our efforts to broaden our portfolio through internal development and corporate development. So, with that, thank you all for joining us.

And maybe since Kathy said that was the last question I'll, just and buy again thanking you all for joining us and reiterating our enthusiasm about the business I have to say our team <unk> an excellent job.

Under the circumstances and making sure patients continue to have access to their therapy through this time.

We look forward to resuming our growth of <unk>.

And then quickly, bringing lebron accident in J.C.P. 258, some marketing click continuing our clinical development plans with heavy emphasis on 458 this year.

And then continuing our efforts to broaden our portfolio through internal development and corporate development so with that.

You all for joining us.

Kathy Luttrell: Thank you. I'd like to turn the call back over to Kathy Luttrell for any closing remarks.

Thank you I like and trying to call back over to Capitalise for all 40 plus online.

Thank you again for join you have to get out echo libraries that but we will be participating in the upcoming virtual bank of America, RBC and Goldman Sachs healthcare conferences.

Kathy Luttrell: Thank you again for joining us today. I'll echo what Bruce said, but we will be participating in the upcoming virtual Bank of America, RBC, and Goldman Sachs Health Care Conferences and hope to speak with many of you during those events. This now ends our call.

And hope to speak with many <unk> during those in that it's now and dark.

Operator: Ladies and gentlemen, you may all disconnect. Have a great day.

Ladies.

Just for that I would write that.

Operator: BF-WATCH TV 2021

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