Q4 2020 Jazz Pharmaceuticals PLC Earnings Call

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Operator: Hello and welcome to the Jazz Pharmaceuticals 4-Year and 4th Quarter 2020 Financial Results and Earnings Conference Call. Following an introduction from the company, we will open the call for questions. I will now turn the call over to Andrea Flynn, Head of Investor Relations at Jazz Pharmaceuticals. You may begin.

Hello, and welcome to the jazz Pharmaceuticals, full year and fourth quarter 2020 financial results earnings Conference call.

Following my introduction from the company, we will open the call for questions I will now turn the call over to Andrea Flynn head of Investor Relations at Jazz Pharmaceuticals, you may begin.

Thank you.

Andrea Flynn: Thank you and thanks to everyone joining the call. Today we reported our fourth quarter and full year 2020 financial results and provided our financial guidance for 2021. The press release and the slide presentation accompanying this call are available in the investors section of our website. On the call today are Bruce Cozadd, CEO; Rene Gala, CFO; Dan Swisher, President; and Rob Iannone, Executive Vice President, R&D, and Chief Medical Officer. Joining the Q&A are Kim Sablich, Executive Vice President, General Manager of North America; Phil Jochelson, Neuroscience Therapeutic Head, Ann Borgman, Hematology and Oncology Therapeutic Head, Sam Pierce, Senior Vice President, Europe and International, and Sean Mendes, Senior Vice President, Strategy and Finance.

Thanks to everyone joining the call.

Day, we reported our fourth quarter and full year 2020 financial results and provide our financial guidance for 2021.

The press release on the slide presentation accompanying this call are available on the investors section of our website.

On the call today are Bruce cause I'd, CEO, Renee Gala CFO, Dan Swisher, President and Rob you know on executive Vice President of R&D, and Chief Medical Officer.

Joining the Q&A or Kim Executive Vice President General manager of North America, So Jonathan Neuroscience therapeutic head Anne Borgman, Hematology and oncology therapeutic head, Sam Pearce Senior Vice President Europe, and International and Shawn Mendez, Senior Vice President strategy and finance.

Andrea Flynn: 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 forward-looking 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. 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 this call are included in today's press release and slide.

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 statements contained in today's press release, and our latest SEC disclosure documents, which identifies certain factors that may cause the company's actual results to differ materially.

From those projected 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 this call are included in today's press release and slide presentation available on our website.

Andrea Flynn: and slide presentation available on our website. This communication is not intended to constitute an offer to buy or sell, or the solicitation of an offer to buy, any securities, or the solicitation of any vote or approval.

This communication is not intended to constitute an offer to buy or sell or the supposed to patient of an offer to buy any securities or solicitation of any vote or approval.

Andrea Flynn: GW intends to file a proxy statement with the SEC regarding the proposed transaction that will be mailed to GW shareholders. You should review the materials filed with the FCC carefully, as they will include important information regarding the proposed transaction, including information about Jazz and GW, their respective directors, executive officers, and certain other members of management and employees who may be deemed to be participants in the solicitation of proxies from GW Pharmaceuticals security holders in connection with the proposed transaction. Please also review slides 2-5 of today's presentation for other important information.

GW intends to file a proxy statement with the SEC regarding the proposed transaction that will be mailed to GW shareholders.

Review materials filed with the SEC carefully as they will include important information regarding the proposed transaction, including information about Jonathan GW their respective directors executive officers and certain other members of management and employees, who may be deemed to be participants in the solicitation of proxies from GW Pharmaceuticals security holders in connection with the proposed transaction.

Please also review slides two through five of today's presentation for other important information, including where you can find more information on the proposed transaction and on the directors and executive officers of Jonathan GW with that I'll now turn the call over to Bruce.

Andrea Flynn: and other important information, including where you can find more information on the proposed transaction.

Bruce C. Cozadd: and on the Directors and Executive Officers of Jazz and GW. With that, I'll now turn the call over to Bruce.

Thanks, Andrea good afternoon, everyone and thank you for joining us today.

Bruce C. Cozadd: Thanks, Andrea. Good afternoon, everyone, and thank you for joining us today. 2020 was an exceptionally productive year for Jazz, driven by the expertise, commitment, and capabilities of our organization, and defined by operational excellence across commercial and R&D. We enter 2021 in a position of strength. We plan to execute on significant milestones that we expect will further enhance the growth and durability of our business and accelerate our transformation as an innovative biopharmaceutical company. I'm very proud that, from this position of strength and readiness, we announced earlier this month that we had signed a definitive agreement for the acquisition of GW Pharmaceuticals. We're excited about the potential to have epilepsy

'twenty 'twenty was an exceptionally productive year for jazz driven by the expertise commitment and capabilities of our organization and defined by operational excellence across commercial and R&D.

We enter 2021 in a position of strength, we plan to execute on significant milestones that we expect will further enhance the growth and durability of our business and to accelerate our transformation as an innovative Biopharma company.

I'm very proud that from this position of strength and readiness, we announced earlier this month that we signed a definitive agreement from the acquisition of GW Pharmaceuticals, We're excited about the potential Tad epilepsies, a third high growth commercial franchise to our business without the dialects of potential near term blockbuster.

Bruce C. Cozadd: A third high-growth commercial franchise to our business, with Epidiolex, a potential near-term blockbuster, as well as GW's robust neuroscience pipeline. The Combined Company would be a leader in neuroscience, with a global commercial and operational footprint, and we expect this transaction to deliver substantial shareholder value. We are excited to be joining two companies with a shared culture built around the same mission, innovating to transform the lives of patients. In 2020, we demonstrated the resilience of our business and our agility, innovation, and execution capabilities across the company despite the pandemic.

As well as Gw's robust neuroscience pipeline.

The combined company would be a leader in neuroscience with a global commercial and operational footprint and we expect this transaction to deliver substantial shareholder value.

We're excited to be joining two companies with a shared culture built around the same mission innovating to transform the lives of patients.

In 2020, we demonstrated the resilience of our business and our agility innovation and execution capabilities across the company. Despite the pandemic, we launched important new treatment options for patients, including Zilkha and XI waves in the U S and Sanofi in Europe deliver.

Bruce C. Cozadd: We launched important new treatment options for patients, including Zepzelka and Zywave in the U.S. and Sanosi in Europe. We delivered robust revenue growth and generated significant value for shareholders, successfully advanced early and late stage clinical trials, and added multiple new innovative products and targets to our expanding pipeline. Our R&D organization initiated regulatory submissions to FDA for JCP-458 in acute lymphoblastic leukemia under the Real-Time Oncology Review in December and completed the rolling SNDA submission for JCP-258 in idiopathic hypersomnia this month, which positions us for two more potential product launches in 2021.

Robust revenue growth and generated significant value for shareholders successfully advanced early and late stage clinical trials and added multiple new innovative products and targets to our expanding pipeline.

Our R&D organization initiated regulatory submissions to FDA for JCB $4 58 in acute lymphoblastic leukemia under the real time oncology review in December and completed the Rolling S. NDA submission for J C. P $2 58 in idiopathic hypersomnia, this month, which positions us.

For two more potential product launches in 2021.

Last year. We also continued the expansion of our innovative oncology and neuroscience pipeline through internal and external collaborations with a focus on highly differentiated products that are durable and can be effectively commercialized positioning us to transform patient lives and continue to deliver long term growth.

Bruce C. Cozadd: Last year, we also continued the expansion of our innovative oncology and neuroscience pipeline through internal and external collaborations with a focus on highly differentiated products that are durable and can be effectively commercialized, positioning us to transform patient lives and continue to deliver long-term care. Highlights of our successful execution on key 2020 objectives include the successful launch of Zepzolca in the US in July 2020, just six months after we acquired US licensing rights. The launch of Zywave in November 2020 for the treatment of cataplexy and excessive daytime sleepiness in narcolepsy.

Highlights of our successful execution on key 2020 objectives include.

The successful launch of <unk> in the U S. In July 2020, just six months after we acquired U S licensing rights for.

The launch of XI wave in November 2020.

Treatment of cataplexy, and excessive daytime sleepiness and narcolepsy I couldnt be more pleased with our early progress on this launch.

The initiation of the European Rolling launch for Sanofi in May 'twenty 'twenty, the initiation of a new drug submission for <unk> Zilkha in Canada in December the announcement of compelling top line results in the JCB $2 58 Phase III study in idiopathic Hypersomnia in October 2020, followed by the completion.

Bruce C. Cozadd: I couldn't be more pleased with our early progress on this launch. The initiation of the European rolling launch for Cynosi in May 2020, the initiation of a new drug submission for Zepzelka in Canada in December, the announcement of compelling top-line results in the JCP 258 phase three study in idiopathic hypersomnia in October 2020, followed by the completion of the rolling supplemental NDA submission to FDA in February 2021, positioning us for a potential launch in the fourth quarter of this year.

<unk> of the rolling supplemental NDA submission to FDA in February 2021 positioning us for a potential launch in the fourth quarter of this year.

The initiation of the BLA submission to FDA for JCB $4 58 in a L. L. In December 2020, with a potential launch in mid 2021 and deployment of capital through multiple corporate development deals to grow and diversify revenues with innovative new early to late stage product candidates such as J S.

Bruce C. Cozadd: The initiation of the BLA submission to FDA for JCP 458 in ALL in December 2020 with a potential launch in mid 2021 and deployment of capital through multiple corporate development deals to grow and diversify revenues with innovative new early to late stage product candidates, such as JCP 150 for post-traumatic stress syndrome and Zepselka for the treatment of small cell lung cancer. As we think about our key objectives for 2021, we are excited about the potential GW transaction and maintaining the significant momentum of GW's Epidiolex and our Zywave and Zepfelco launches.

$1 50, and post traumatic stress syndrome ends up sell OCA for the treatment of small cell lung cancer.

As we think about our key objectives for 2021, we are excited about the potential GW transaction and maintaining the significant momentum of gw's up of dialects and hours I wave ends up sell for launches.

We also remain on track to execute and deliver on to more important product approvals and launches in 2021 with JCB for 58, and a L. L and JCB $2 58 in idiopathic hypersomnia wall strategically diversifying our pipeline and revenues as a reminder, both JCB for 58 and JCB $2 50.

Our products, we've taken from concept to commercial readiness underscoring the strength of our portfolio and development capabilities.

Bruce C. Cozadd: We also remain on track to execute and deliver on two more important product approvals and launches in 2021 with JCP-458 in ALL and JCP-258 in idiopathic hypersomnia, while strategically diversifying our pipeline and revenue. As a reminder, both JCP-458 and JCP-258 are products we've taken from concept to commercial readiness. Underscoring the Strength of Our Portfolio and Development Capabilities. Finally, the foundation we have built across our operations has resulted in a highly productive period of consistent execution and robust financial results and has prepared us for this transformative transaction.

Finally, the foundation, we have built across our operations has resulted in a highly productive period of consistent execution and robust financial results and has prepared us for this transformative transaction.

I'll now turn the call over to Dan to give an overview of our commercial performance after which Rob will provide an update on progress across our R&D programs before Renee closes out with a financial overview over to you Dan Yeah. Thanks Bruce.

I'm also very excited about the progress of the launches of <unk> and sideways in the U S and Sanofi in Europe, the strong execution across our commercial R&D and operating teams.

During the pandemic continued to demonstrate our resilience and our agility to advance key corporate priorities, while fully supporting our customers and our patients.

Bruce C. Cozadd: I'll now turn the call over to Dan to give an overview of our commercial performance, after which Rob will provide an update on progress across our R&D programs before Rene closes out with a financial overview.

We're also excited about the prospect of two U S product launches in 2021 of J C. P for a five eight and a L. L. E N G. P 258 in idiopathic hypersomnia.

Daniel N. Swisher: Yeah. Thanks, Bruce. I'm also very excited about the progress of the launches of Zebzelka and ZyWave in the U.S. and Synosian in Europe. The strong execution across our commercial, R&D, and operating teams during the pandemic continues to demonstrate our resilience and our agility to advance key corporate priorities while fully supporting our customers and our patients. We're also excited about the prospect of two U.S. product launches in 2021 for JZP458 in ALL and JZP258 in idiopathic hypersomnia.

Now starting with Xyrem and XI with the successful initial launches highways in November last year, which is the first asset we have taken from concept to approval and onto the market demonstrates our execution excellence across our R&D and commercial teams.

Beginning now with the fourth quarter 2020 results, we will be providing you with metrics around the combined oxidate franchise, including Xyrem enzyme weighs in.

In addition, we will provide you with the number of patients adopting <unk> therapy. This information is intended to help you understand the growth and the durability of our entire oxy based franchise.

Daniel N. Swisher: Now starting with Xyrem and Xywave, the successful initial launch of Xywave in November last year, which is the first asset we have taken from concept to approval and on to the market, demonstrates our execution excellence across our R&D and commercial teams. Beginning now with the fourth quarter 2020 results, we will be providing you with metrics around the combined Oxubate franchise, including Xyrem and Xywave. In addition, we will provide you with a number of patients who are adopting Xywave therapy.

In the fourth quarter Oxidate net products sales were $455 million, 4% higher than the same period in 2019.

For full year 2020, Oxidate net products sales were $1 $76 billion, an increase of 7% over 2019.

Total oxidate revenue bottle volume growth was 2% for the quarter and 4% for the year compared to the same periods in the prior year through the fourth quarter. Despite the ongoing negative impact of COVID-19 on new patient diagnoses in enrollment.

Daniel N. Swisher: This information is intended to help you understand the growth and the durability of our entire Oxubate franchise. In the fourth quarter, Oxibate net product sales were $455 million, 4% higher than the same period in 2019. For full year 2020, OxyBait net product sales were $1.76 billion, an increase of 7% over 2019. Total Oxybate revenue bottle volume growth was 2% for the quarter and 4% for the year compared to the same periods in the prior year.

Average active oxidate patients increased to 15300, a 2% increase over the same period last year.

We are pleased that our initials highway of launch efforts have resonated well with both hcp's in patients.

On the first two months of launch Zywiec generated net products sales of $15 million and we ended 2020 with approximately 1900 active <unk> patients.

We are confident that XI wave will become the preferred oxalate therapy over time through strong adoption by existing xyrem patients, reaching patients who have been unable to take xyrem due to sodium sensitivity and expanding opportunities with our planned fourth quarter launch this year in idiopathic hypersomnia.

Daniel N. Swisher: Through the fourth quarter, despite the ongoing negative impact of COVID-19 on new patient diagnoses and enrollment, average active oxidate patients increased to 15,300, a 2% increase over the same period last year. We are pleased that our initial XyWave launch efforts have resonated well with both HCPs and patients. In the first two months of launch, Zywave generated net product sales of $15 million. And we ended 2020 with approximately 1,900 active Zywave patients.

Which would be the first FDA approved treatment for this serious hypersomnia Lynch disorder.

We remain on track for broad commercial payer coverage is <unk> within the first six to nine months of launch we've entered into agreements that provide coverage for two of the three largest pbms in the U S. With total commercial coverage now exceeding 60% of lives. We continue discussions with other major payer.

Errors and Pbms.

So while we continue to secure additional commercial payer coverage, we do have robust patient access programs in place to help reduce barriers to access or initiation of <unk> treatment.

Daniel N. Swisher: We are confident that XyWave will become the preferred OxyBait therapy over time through strong adoption by existing XyRim patients, reaching patients who have been unable to take Xyrem due to sodium sensitivity and expanding opportunities with our planned fourth quarter launch this year in idiopathic hypersomnia, which would be the first FDA-approved treatment for this serious hypersomnolence disorder.

Our market research indicates that a significant majority of hcp's.

Recognize the EPS associated with transitioning patients over to <unk>.

In November and December our field sales team engaged with the large majority of the top HCP prescribers and in December. We also started our direct to patient education.

Daniel N. Swisher: We remain on track for broad commercial payer coverage of ZyWave within the first six to nine months of launch. We've already entered into agreements that provide coverage for two of the three largest PVMs in the U.S., with total commercial coverage now exceeding 60% of lives. We continue discussions with other major payers and PBMs. So while we continue to secure additional commercial payer coverage, we do have robust patient access programs in place to help reduce barriers to access or initiation of ZyWave treatment.

Most notably with XI wave leaflets attitude of Xyrem shipments. We also began our XI wave webinar series and have had significant interest in both our K O L lead HCP and patient education programs.

So we look forward to continuing the strong launches I wave a very important step forward in oxalate treatment for narcolepsy patients to support their total health and wellbeing.

Additionally, we are excited to be preparing for the planned <unk> launch NIH and the fourth quarter. This year and the opportunity for continued growth of our oxy based franchise.

Daniel N. Swisher: Our market research indicates that a significant majority of HCPs recognize the ease associated with transitioning patients over to Zywave. In November and December, our field sales team engaged with a large majority of the top HCP prescribers, and in December, we also started our direct-to-patient education, most notably with Zywave leaflets added to all Zyram shipments.

We are confident in and we are on track for our goal of having the majority of all oxalate patients benefit from <unk> treatment. In 2023, we set this goal taking into accounts that patients may have multiple oxidate treatment options to choose from in that timeframe, we believe that as we educate.

Kate patients and physicians on the lifelong impact of high sodium intake XI wave will be the oxalate therapy of choice.

Daniel N. Swisher: We have also begun our Zywave webinar series and have had significant interest in both our KOL-led HCP and patient education programs. So we look forward to continuing the strong launch of Zywave, a very important step forward in oxybate treatment for narcolepsy patients to support their total health and well-being. Additionally, we are excited to be preparing for the planned JZP258 launch in IEH in the fourth quarter of this year and the opportunity for continued growth of our OxyBaid franchise.

So before I turn to Sanofi I would also like to mention that we are currently expanding and realigning our neuroscience sales force into two teams to focus exclusively on either XI wave or Sanofi, allowing us to provide dedicated products support and invest in the unique growth opportunities.

For each product.

For <unk>, we will continue our outreach to the top narcolepsy prescribers with a dedicated sales force and reimbursement team to support the adoption of <unk> as the preferred oxalate treatment and for Sanofi, We will continue to increase our reach and frequency of calls among the top OSA treating.

Daniel N. Swisher: We are confident in, and we are on track for, our goal of having the majority of all OxyBate patients benefit from ZyWave treatment in 2023. We set this goal taking into account that patients may have multiple OxyBate treatment options to choose from in that timeframe. We believe that as we educate patients and physicians on the lifelong impact of high sodium intake, ZyWave will be the OxyBate therapy of choice.

And physicians with a goal of driving significant awareness and uptake among these prescribers.

So now turning to Sanofi during the fourth quarter Sanofi net products sales were $9 million approximately approximately in line with third quarter with full year net revenue for 2020 at 28 million prescriptions.

Daniel N. Swisher: So before I turn to Synosy, I'd also like to mention that we are currently expanding and realigning our neuroscience sales force into two teams to focus exclusively on either ZyWave or Synosy, allowing us to provide dedicated product support and invest in the unique growth opportunities ahead for each product. For Zywave, we will continue our outreach to the top narcolepsy prescribers with a dedicated sales force and reimbursement team to support the adoption of Zywave as a preferred Oxybate treatment.

Prescriptions in the fourth quarter increased 9% in the U S compared to the third quarter of 2020.

COVID-19 disproportionately affected our Sanofi launch impairing, our ability to build new relationships, especially with Pulmonologist. The main OSA treating group who were also at the forefront and the initial battle against the pandemic.

As we move into 2021, we're excited about the investments, we're making in Sanofi with our expanded and dedicated sales force and our recent initiation of our television DTC campaign.

We remain focused on driving the next phase of Sanofi growth, which will build on our broad commercial payer coverage at over 90% the positive feedback and perception of Sanofi among existing prescribers and the large opportunity of under treatment of excessive daytime sleepiness in the Ole.

Daniel N. Swisher: And for Cynosi, we will continue to increase our reach and frequency of calls among the top OSA treating physicians with a goal of driving significant awareness and uptake among these prescribers. So now, turning to Synosy, during the fourth quarter, Synosy net product sales were nine million, approximately in line with the third quarter, with full year net revenue for 2020 at 28 million. Prescriptions in the fourth quarter increased 9% in the U.S. compared to the third quarter of 2020.

A patient population.

And lastly, we are pleased with the progression of our rolling launches in Europe, including the encouraging use of Sanofi in Germany for Narcolepsy, which is ahead of our OSA launch expected later this year.

Daniel N. Swisher: COVID-19 disproportionately affected our CENOSI launch, impairing our ability to build new relationships, especially with pulmonologists, the main OSA treating group, who were also at the forefront in the initial battle against the pandemic. As we move into 2021, we're excited about the investments we're making in CENOSI with our expanded and dedicated sales force and our recent initiation of our TV DTC campaign. We remain focused on driving the next phase of Sanosi growth, which will build on our broad commercial payer coverage at over 90%, the positive feedback and perception of Sanosi among existing prescribers, and the large opportunity for undertreatment of excessive daytime sleepiness in the OSA patient population. And lastly, we're pleased with the progression of our rolling launches in Europe, including the encouraging use of Cyanocin in Germany for narcolepsy Turning now to ZepZelka.

Turning now to ZIP Cellcom, we were pleased with our fourth quarter's upsell could net products sales of $53 million.

This is just the second quarter of product launch and increase of $16 million over Q3.

We continue to see significant patient growth in uptake across the community and the academic settings with use in the second line setting in both platinum sensitive and platinum resistant patients.

Our education and promotional campaigns remain focused towards the top small cell lung cancer treating physicians.

We are seeing considerable interest positive feedback and increased awareness across the academic and community cancer centers, reflecting the significant unmet need the favorable zip sales.

<unk> profile as well.

So thanks to our team's outstanding execution. This launch continues to exceed expectations.

We were pleased in the U S hemo flow poetic stem cell transplants rebounded through third quarter and into fourth quarter and we also observed robust growth in Europe, where our field teams have share that physicians in select regions are treating the serious complications of bone marrow transplants, including Vod.

Daniel N. Swisher: We were pleased with our fourth-quarter ZepZelka net product sales of $53 million, and this is just the second quarter of product launch, an increase of $16 million over Q3. We continue to see significant patient growth and uptake across the community and the academic settings with use in the second line setting in both platinum sensitive and platinum resistant patients. Our education and promotional campaigns remain focused on the top small cell lung cancer treating physicians.

Earlier in order to minimize the risk of patients having to go to ICU.

This resulted in fourth quarter <unk> net product sales of 55 million, 16% higher than the same period in 2019 2020 debt facility and net product sales were $196 million, an increase of 13% over 2019.

While intensive therapies had been affected by Covid and the entrance of new therapies. We continue to believe in the growth opportunity for <unk>. Both in terms of our ongoing development activities and continued expansion into new markets internationally as well as our ability to return to in person promotional.

Daniel N. Swisher: We are seeing considerable interest, positive feedback, and increased awareness across academic and community cancer centers, reflecting the significant unmet need and the favorable Zepzelka product profile as well. Thanks to our team's outstanding execution, this launch continues to exceed expectations. We were pleased that U.S. hemopoietic stem cell transplants rebounded through the third quarter and into the fourth quarter. And we also observed robust growth in Europe, where our field teams have shared that physicians in select regions are treating the serious complications of bone marrow transplants, including VOD, earlier in order to minimize the risk of patients having to go to ICU.

Activity in continuation of our education on the importance of this clinically meaningful improvements.

As highlighted in the recently presented five year survival data from the pivotal study.

In the fourth quarter <unk> net products sales were $31 million, 2% below the same period in 2019 2020, <unk> net product sales were $121 million approximately in line with 2019.

So turning now to asparaginase in the fourth quarter <unk> net product sales were 57 million, 3% above the same period in 2019, 2020, <unk> net product sales were $147 million or 17% below 2019.

Daniel N. Swisher: This resulted in fourth quarter defitilio net product sales of $55 million, 16% higher than the same period in 2019. In 2020, defitilio net product sales were $196 million, an increase of 13% over 2019. While intensive therapies have been affected by COVID and the entrance of new therapies, we continue to believe in the growth opportunity for VIXIOS, both in terms of our ongoing development activities and continued expansion into new markets internationally, as well as our ability to return to in-person promotional activities and continuation of our education on the importance of this clinically meaningful improvement seen as highlighted in the recently presented five-year survival data from the pivotal study.

Our agreement with PD L terminated at the end of 2020, we have the right to sell certain Irwin inventory post termination and we expect to distribute this inventory during the first half of this year.

Given the urgent need for reliable and high quality recombinant <unk> asparaginase, we remain focused on bringing <unk> four or five eight to market as quickly as possible.

Our commercial team is currently preparing for U S launch, which is targeted for mid year and.

In summary, I'm extremely pleased with our overall fourth quarter and 2020 performance.

Last year was highly productive for jazz, we clearly demonstrated our expanded capabilities and the ability to execute across our operating teams highlights include the successful launches of both <unk> and <unk>.

Daniel N. Swisher: In the fourth quarter, Vixios net product sales were $31 million, 2% below the same period in 2019. However, 2020 Vixios Net Product Sales were $121 million, approximately in line with 2019. So turning now to asparaginase, in the fourth quarter, Irwin Ace Net Product Sales were 57 million, 3% above the same period in 2019. In 2020, Irwin Ace Net Product Sales were 147 million, or 17% below 2019. Our agreement with PBL terminates at the end of 2020. We have the right to sell certain Irwin Ace inventory post-termination, and we expect to distribute this inventory during the first half of this year.

I'm proud of the agility and resilience of our teams.

Have shown to support the programs the products and patience throughout this very challenging past year, we look forward to continuing to execute and meaningfully advance our pipeline and commercial programs through 2021 with a particular focus on our ongoing launches and following FDA approval of our two planned launches for <unk>.

Five eight and <unk> 45 day.

I'm now going to turn the call over to Rob for an update on our development programs Rob.

Thank you Dan.

In the fourth quarter, we continued to make significant progress across R&D, including initiating the BLA submission of <unk> for $5 eight under real time oncology revenue for patients with acute lymphoblastic leukemia and lifted elastic lymphoma.

Daniel N. Swisher: Given the urgent need for a reliable and high-quality recombinant asparaginase, we remain focused on bringing JZP458 to market as quickly as possible. Our commercial team is currently preparing for the U.S. launch, which is targeted for mid-year. In summary, I'm extremely pleased with our overall fourth quarter and 2020 performance. Last year was highly productive for Jazz. We clearly demonstrated our expanded capabilities and the ability to execute across our operating team. Highlights include the successful launches of both Zepselka and Zywave.

Initiating the rolling submission.

NDA submission of <unk> in patients with COPD like Hypersomnia in December with.

With completion of this submission this month.

We have also continued our efforts in geographic expansion for key products, including <unk>, <unk> <unk> and <unk>.

I'll start with an update on the progress in our neuroscience portfolio.

Starting with <unk> 258.

We're looking forward to the presentation of our phase III study results.

<unk> patients idiopathic hypersomnia at an upcoming medical conference in second quarter 2021.

Daniel N. Swisher: I'm proud of the agility and resilience of our team, which has shown to support the programs, the products, and patients throughout this very challenging past year. We look forward to continuing to execute and meaningfully advance our pipeline and commercial programs through 2021, with a particular focus on our ongoing launches and, following FDA approval, our two planned launches for JCP 258 and JCP 458. I'm now going to turn the call over to Rob for an update on our development programs.

We're excited by the compelling study results, we observed and look forward to sharing these data.

On the fast track designation, we prioritize the rapid initiation and completion of the rolling NDA submission for <unk>.

Within approximately four months of announcing our topline data.

As we work to bring JCB two five day to patients with IH as soon as possible a debilitating disorder for which there are no approved treatment options.

Turning to <unk> three five for the treatment of patients with essential tremor program.

<unk> is irreversible and chronic debilitating disorder.

Family impact quality of life.

Robert Iannone: Thank you, Dan. In the fourth quarter, we continued to make significant progress across R&D, including initiating the BLA submission of JCP458 under real-time oncology review for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma. initiating the rolling submission.

In 2020, we completed our healthy volunteer study and we anticipate initiating initiating our phase <unk> trial in mid 2021.

Moving now to GBP, one five flow.

And irreversible <unk> inhibitor, which were initially investigating in post traumatic stress disorder.

We plan to initiate a phase II study in late 2021.

Robert Iannone: SNDA submission of JZP 258 in patients with idiopathic hypersomnia in December, with completion of this submission this month. We have also continued our efforts in geographic expansion for key products, including Daffodilio, Pixios, Sanofi, and Zepselca. I'll start with an update on the progress in our neuroscience portfolio. Starting with JCP 258, we are looking forward to the presentation of our phase three study results in adult patients with idiopathic hypersomnia at an upcoming medical conference in the second quarter of 2021. We're excited by the compelling study results we observed and look forward to sharing these data.

I'm excited to get both <unk> one five on GBP three its important clinical trials this year.

I'll move a step closer to helping these patients suffer significant impacts to their quality of life and for whom there are limited treatment options.

Now turning to our oncology development programs, starting with <unk>.

We're continuing to work on the development program from some sales call income.

<unk> on collab.

Collaboration with farmer, Marc will support robust data generation in combination with other therapies and small cell lung cancer as.

As well as in other tumor types.

We are working toward the 2021 initiation on the phase III study evaluating immunotherapy on celebrity accident as maintenance therapy.

Average of immunotherapy alone in patients with extensive stage small cell lung cancer after the induction chemotherapy.

Robert Iannone: Under Fast Track designation, we prioritize the rapid initiation and completion of the rolling SNDA submission to FDA within approximately four months of announcing our top-line data, as we work to bring JCP 258 to patients with IH as soon as possible, a debilitating disorder for which there is no approved treatment. Turning to JCP385 for the treatment of patients with essential tremor, a progressive, irreversible, and chronic debil In 2020, we completed our Healthy Volunteer Study, and we anticipate initiating our Phase 2B trial in mid-2021.

Following the results of the Atlantic study, we are not.

Farmer Mac with the FDA share the top line results.

We understand them are agreed that Atlanta would not serve as the confirmatory study.

And are actively engaging with FDA to determine the required confirmatory study package.

We're also working with pharma to continue evidence generation loans itself.

We anticipate initiating a phase four study.

In mid 2021.

With an objective to provide additional data and information on treatment practices patient characteristics in real world efficacy sales team.

Finally, we submitted the new drug application to health, Canada in December 2020.

Now moving to <unk> 458, a recombinant erwinia asparaginase in the treatment of patients with alcohol and LVL.

Robert Iannone: Moving now to JCP 150, and the Irreversible Thaw Inhibitor, which we were initially investigating in post-traumatic stress disorder. We plan to initiate our Phase 2 study in late 2021. I'm excited to get both JZP 150 and JZP 385.

Who have hypersensitivity to E coli derived asparaginase.

In December we initiated the BLA submission to FDA under real time oncology review.

On track and working closely with FDA to complete the BLA submission and remain focused on bringing <unk> 458 to patients as quickly as possible.

Robert Iannone: It will conduct important clinical trials this year and move a step closer to helping these patients who suffer significant impacts on their quality of life and for whom there are limited current treatment options. Now turning to our oncology development programs and starting with Zimzalka. We are continuing to work on the development program for Zimzalka in collaboration with PharmaMar to Support Robust Data Generation in Combination with Other Therapies in Small Cell Lung Cancer as well as in Other Tumor Types.

We are targeting a mid 2021 launch in the U S.

We're also working on our regulatory strategy in Europe, and Canada, and working with our partner on the approach in Japan.

We anticipate the data from our current development program for <unk> for a five day will support our efforts to seek approval in Europe and Canada.

And we will be confirming these plans with regulators later in the year.

Turning now to VIX sales.

Robert Iannone: We are working toward the initiation of a phase three study evaluating immunotherapy plus lerbanectadin as maintenance therapy compared to immunotherapy alone in patients with extensive stage small cell lung cancer after induction chemotherapy. Following the results of the Atlanta study, we and our partner, PharmaMar, met with the FDA and shared the top-line results. We in Panama agreed that Atlantis would not serve as the confirmatory study and are actively engaging with FDA to determine the required confirmatory study.

We have submitted data to help authorities in the U S and in Europe for <unk> in relapsed refractory pediatric AML.

We anticipate a potential approval in Europe in a label update in the U S. In 2021.

While pediatric patients represent a relatively small percentage of total AML patients.

That's the average age of an AML patient 67.

There is a critical need for more effective therapies in this setting.

I will now turn the call over to Rene.

Thanks, Rob I'm very pleased to share our financial results for fourth quarter, and full year, 2020, which reflect considerable topline revenue growth, including a meaningful contribution from our recent launch on <unk>.

Robert Iannone: We're also working with PharmaMar to continue evidence generation on Zypzalka. We anticipate initiating a Phase 4 study with Zypzalka in mid-2021, with the objective to provide additional data and information on treatment practices, patient characteristics, and real-world efficacy and safety. Finally, we submitted the new drug application to Health Canada in December 2020. Now, moving to JCP458, a recombinant erwinia asparaginase for the treatment of patients with ALL and LBM who have hypersensitivity to E. coli-derived asparagin.

With our strong financial and operational performance in 2020, and our planned acquisition of GW pharma in second quarter 2021, we are poised for substantial future growth.

In addition, the transaction will accelerate and enhance our revenue diversification goal.

Turning us to deliver more than 65% of our total 2022 revenue from products launched or acquired since 2019.

2020 was a great year for jazz.

Total revenues for the fourth quarter increased 14% to $666 million and for the full year increased 9% to $2 $6 billion to $3 $6 billion over the same periods last year.

Robert Iannone: In December, we initiated the BLA submission to FDA under real-time oncology review. We are on track and working closely with FDA to complete the BLA submission, and remain focused on bringing JCP 458 to patients as quickly as possible. We are targeting a mid-2021 launch in the U.S. We are also working on our regulatory strategy in Europe and Canada and working with our partner on the approach in Japan. We anticipate the data from our current development program for JCP 458 will support our efforts to seek approval in Europe and Canada, and we will be confirming these plans with regulators later in the year.

Our full year 2020 revenue growth was driven by robust double digit growth on our oncology portfolio and high single digit growth in our neuroscience portfolio.

Neuroscience net sales for the fourth quarter increased 6% to $463 billion and full year revenues increased 8% to $179 billion compared to the same periods in 2019.

Robert Iannone: Turning now to Vixios. We have submitted data to health authorities in the U.S. and in Europe for Vixios and relapsed refractory pediatric AML. We anticipate potential approval in Europe and a label update in the U.S. in 2021. While pediatric patients represent a relatively small percentage of total AML patients, the average age of an AML patient is 67. There is a critical need for more effective treatments in this setting. I will now turn the call over to Renee.

Full year 2020 growth in neuroscience was driven by continued notable performance of Xyrem. Despite the pandemic growth of Sanofi prescriptions and the initial launch of <unk> in November.

Oncology net sales for the fourth quarter of 2020 increased 46% to $196 million and for the full year increased 18% to $554 million compared to the same periods in 2019.

'twenty 'twenty oncology sales growth was driven by the robust launch of <unk> in July 2020, which generated net sales of $90 million in its first two quarters on the market and the continued growth of <unk>, partially offset by the decrease of <unk> sales due to.

Rene D. Gal: Thanks, Rob. I'm very pleased to share our financial results for the fourth quarter and full year 2020, which reflect considerable top line revenue growth, including a meaningful contribution from our recent launch of ZepSilca. With our strong financial and operational performance in 2020 and our planned acquisition of GW Pharma in the second quarter of 2021, we are poised for substantial future growth. In addition, the transaction will accelerate and enhance our revenue diversification goal, positioning us to deliver more than 65% of our total 2022 revenues from products launched or acquired since 2019. 2020 was a great year for jazz.

Two ongoing supply disruptions.

Turning to operating expenses as we move through 2020 and assess the impact of the pandemic, we balanced our investments in the business and focused on key value drivers our 'twenty 'twenty adjusted SG&A expense was 33% of total revenues an increase.

Compared to 2019 of two percentage points or $112 million driven by targeted investments to support our multiple new and planned 2021 commercial launches.

Rene D. Gal: Total revenues for the fourth quarter increased 14% to $666 million, and for the full year increased 9% to $2.36 billion over the same periods last year. Our full year 2020 revenue growth was driven by robust double-digit growth in our oncology portfolio and high single-digit growth in our neuroscience portfolio. Neuroscience net sales for the fourth quarter increased 6% to $463 billion, and full year revenues increased 8% to $1.79 billion compared to the same periods in 2019. Full year 2020 growth in neuroscience was driven by continued notable performance of Xyrem despite the pandemic, growth of Sanosi prescriptions, and the initial launch of Xywave in November.

We increased our 2020 adjusted R&D expense by $32 million compared to 2019, as we expanded our robust and productive R&D pipeline with new innovative product candidates and targets.

As a ratio of total revenues spend was in line with 2019 at approximately 13%.

We are pleased with the business progress made in 2020 as a result of our disciplined approach to capital allocation and strong operational and financial performance.

And we remain excited about the opportunity to deliver continued growth through our innovative and expanding neuroscience and oncology portfolios in the future.

Rene D. Gal: Oncology net sales for the fourth quarter of 2020 increased 46% to $196 million, and for the full year, increased 18% to $554 million compared to the same period in 2019. 2020 oncology sales growth was driven by the robust launch of Zepzelka in July 2020, which generated net sales of $90 million in its first two quarters on the market, and the continued growth of Daffodilio, partially offset by the decrease in Irwinase sales due to ongoing supply disruption.

Turning to guidance.

For our 'twenty 'twenty, one guidance I'll provide jazz Standalone guidance and we will update this to include the previously announced GW transaction after it closes.

Starting with topline financial guidance, our total revenue guidance is in a range of 2.55 to $2 $7 billion.

Which represents a double digit 11% increase at the midpoint over our 2020 total revenue.

And there is science, we are providing net sales guidance in a range of $1 $75 billion to $1.885 billion, which which reflects an increase of 3% at the midpoint of the range.

Rene D. Gal: Turning to operating expenses, as we moved through 2020 and assessed the impact of the pandemic, we balanced our investments in the business and focused on key value drivers. Our 2020 adjusted SG&A expense was 33% of total revenues, an increase compared to 2019 of 2 percentage points, or $112 million, driven by targeted investments to support our multiple new and planned 2021 commercial launches. We increased our 2020 adjusted R&D expense by $32 million compared to 2019 as we expanded our robust and productive R&D pipeline with new innovative product candidates and targets as a ratio of total revenue.

<unk> 2020.

And reflects our expectations of the robust adoption of sideways and for 'twenty 'twenty, one Sanofi performance.

Courted by our investments to accelerate growth and adoption of both products.

With regards to <unk> as mentioned previously we are pleased with the strong initial adoption.

As we work towards broad payer coverage over the first six to nine months post launch our investment in patient access and bridging programs is helping to enable seamless access to <unk> by patients.

Rene D. Gal: Spend was in line with 2019 at approximately 13%. We are pleased with the business progress made in 2020 as a result of our disciplined approach to capital allocation and strong operational and financial performance, and we remain excited about the opportunity to deliver continued growth through our innovative and expanding neuroscience and oncology portfolios in the future. Turning to Guidance.

The temporary impacts of these programs, which are important to the long term durability and growth of the Oxidate franchise are reflected in our 2021 neuroscience guidance.

For our oncology portfolio, we are providing 2021 net sales guidance in a range of $715 million to $835 million, which represents an increase of 40% or $221 million at the midpoint compared to <unk>.

Rene D. Gal: For our 2021 guidance, I'll provide Jazz standalone guidance, and we will update this to include the previously announced GW transaction after it closes. Starting with top-line financial guidance, our total revenue guidance is in the range of $2.55 to $2.7 billion, which represents a double-digit 11% increase at the midpoint over our 2020 total revenue. In neuroscience, we are providing net sales guidance in a range of 1.785 to 1.885 billion dollars, which reflects an increase of 3% at the midpoint of the range compared to 2020 and reflects our expectations of the robust adoption of ZyWave and for 2021 Synosy performance, supported by our investments to accelerate growth and adoption of both products. With regard to ZyWave, as mentioned previously, we are pleased with its strong initial adoption.

2020, and reinforces the confidence we have in this growing product portfolio.

Our oncology sales guidance reflects the impact of the first full year of sales for <unk> and our expectations for continued momentum in that launch.

Anticipated or when a supply for the first half of 2021 and the planned launch on <unk> 458 in mid 2021.

Now turning to our expense guidance, we were pleased with our operational excellence in 2020, and our ability to navigate the impacts of COVID-19, while still making investments for future growth as.

As we move into 2021, we will continue to prioritize our investments to drive our key objectives of growth and diversification.

Rene D. Gal: As we work towards broad payer coverage over the first six to nine months post-launch, our investment in patient access and bridging programs is helping to enable seamless access to ZyWave by patient. The temporary impacts of these programs, which are important to the long-term durability and growth of the Oxibate franchise, are reflected in our 2021 neuroscience guidance. For our oncology portfolio, we are providing 2021 net sales guidance in a range of $715 to $835 million, which represents an increase of 40% or $221 million at the midpoint compared to 2020 and reinforces the confidence we have in this growing product portfolio.

Our 2021, adjusted SG&A guidance range is $905 million to $945 million, which represents 35% of total revenues at the midpoint.

This increase investment reflects our continued prioritization of the launches of <unk> silica Sanofi and sideways and the planned launches of Jay Z P 458 in mid 2021.

J C P 258, and IH and the fourth quarter of 2021.

On the adjusted R&D front, our 'twenty 'twenty, one guidance is in the range of $330 million to $370 million or 13% of projected revenues at the midpoint, which is consistent with 2020.

With our exciting and differentiated R&D pipeline. We believe these investments will continue to fuel sustainable long term growth for our expanding and innovative portfolio.

Rene D. Gal: Our Oncology Sales Guidance reflects the impact of the first full year of sales for Zipsoca and our expectations for continued momentum in that launch, as well as anticipated Irwin-Ace supply for the first half of 2021 and the planned launch of JZP458 in mid 2021.

Our guidance for non-GAAP adjusted net income and EPS are in the ranges of $915 million to $985 million and $15 65 to 16 85, respectively.

Rene D. Gal: Now turning to our expense guidance. We were pleased with our operational excellence in 2020 and our ability to navigate the impacts of COVID-19 while still making investments for future growth. As we move into 2021, we will continue to prioritize our investments to drive our key objectives of growth and diversification. Our 2021 Adjusted SG&A Guidance Range is $905 to $945 million, which represents 35% of total revenues at the midpoint. This increased investment reflects our continued prioritization of the launches of Zepselka, Synose, and Zywave and the planned launches of JZP458 in mid-2021 and JZP258 and IH in the fourth quarter of 2021.

Our adjusted net income as a percentage of total revenues will increase to 36% at the midpoint up six percentage points compared to 2020.

Turning to our balance sheet in 2020, we generated $900 million in cash from operations and ended the year with cash and investments of $2.1 billion.

We are excited about the potential GW pharma transaction and see this as a transformative deal that is consistent with both our overall business and capital allocation strategy and effectively leverages, our strong financial and operational position.

As Lisa mentioned the transaction is expected to accelerate our double digit topline revenue growth and be EPS accretive in the first full year of combined operations and substantially accretive thereafter.

Rene D. Gal: On the adjusted R&D front, our 2021 guidance is in the range of $330 to $370 million, or 13% of projected revenues at the midpoint, which is consistent with 2020. With our exciting and differentiated R&D pipeline, we believe these investments will continue to fuel sustainable, long-term growth for our expanding and innovative portfolio. Our guidance for non-GAAP-adjusted net income and EPS is in the ranges of $915 to $985 million and $1565 to $1685, respectively.

At close we expect the pro forma company net debt to EBITDA leverage ratio to be approximately 5.4 times and given our significant cash flows we expect to reduce this to below three five times by the end of 2022.

We view this investment as a disciplined and productive use of our capital to significantly expand our growing neuroscience portfolio and drive substantial value for our shareholders.

Finally, we set out an ambitious range of transformative objectives for 'twenty 'twenty and 'twenty 'twenty. One we are well on our way to executing on five important product launches and diversifying our portfolio and revenue base with products to address significant.

Rene D. Gal: Our adjusted net income as a percentage of total revenues will increase to 36% at the midpoint, up 6 percentage points compared to 2020. Turning to our balance sheet, in 2020, we generated $900 million in cash from operations and ended the year with cash and investments of $2.1 billion.

Unmet medical needs and transform patient lives.

We are looking forward to the planned close at the GW pharma transaction in the second quarter and leveraging the combined talents and expertise of the jazz and GW global teams to develop and launch differentiated therapies to support often overlooked patient populations upon.

Rene D. Gal: We are excited about the potential GW Pharma transaction and see this as a transformative deal that is consistent with both our overall business and capital allocation strategy and effectively leverages our strong financial and operational position. As we've mentioned, the transaction is expected to accelerate our double-digit top-line revenue growth and be EPS accretive in the first full year of combined operations and substantially accretive thereafter. At close, we expect the pro forma company net debt to EBITDA leverage ratio to be approximately 5.4 times.

Clothes, we look forward to creating an innovative high growth global Biopharma leader with an enhanced product portfolio, providing the scale and expertise to reach and transform the lives of more patients around the globe with unmet needs.

Thank you for joining us today, and I'll now turn the call over to Andrea.

Thanks, Rick.

Rene D. Gal: And given our significant cash flows, we expect to reduce this to below three and a half times by the end of 2022. We view this investment as a disciplined and productive use of our capital to significantly expand our growing neuroscience portfolio and drive substantial value for our shareholders. Finally, we set out an ambitious range of transformative objectives for 2020 and 2021. We are well on our way to executing on five important product launches and diversifying our portfolio and revenue base with products to address significant unmet medical needs and transform patient lives.

We kindly request that you limit yourself to one question. During this call. So that everyone has an opportunity to ask a question. We will gladly address any additional questions. After the call or you can reenter the queue. So with that said. Please go ahead and open the line for Q&A.

Ladies and gentlemen to ask the question you will need to press Star then one on your telephone to.

To withdraw your question press the pound key.

Again, Thats star one to ask the question. Please.

Please standby, while we compile the Q&A roster.

Our first question comes from the line of Jessica Fye with Jpmorgan. Your line is open.

Hey, guys. Good afternoon. Thanks, so much for taking my question and for the color on the satellite launch I was wondering if you could say how many active patients are on Z wave currently.

Rene D. Gal: We are looking forward to the planned close of the GW Pharma transaction in the second quarter and leveraging the combined talents and expertise of the Jazz and GW global teams to develop and launch differentiated therapies to support often overlooked patient populations. Upon close, we look forward to creating an innovative, high-growth, global biopharma leader with an enhanced product portfolio, providing the scale and expertise to reach and transform the lives of more patients around the world with unmet needs. Thank you for joining us today, and I'll now turn the call over to Andrea.

Jeff This is Bruce.

We're not going to give intra quarter data like that it will obviously up.

Update again on our next call but.

Our body language here is we're really pleased with the way launches going on not just during the first couple of months, but.

As we continue through today.

Great. Thank you.

Thank you.

Our next question comes from Amy.

SBB Leerink your line is open.

Hi, Good morning, sorry, good evening, thanks for taking the question.

Can you talk about.

All of the patients that are on.

Can you talk about what.

Have been acquiring as you.

Andrea Flynn: Thanks, Rene. We kindly request that you limit yourself to one question during this call so that everyone has an opportunity to ask a question. We will gladly address any additional questions after the call, or you can re-enter the queue.

The climbing percentage are most of these patients on.

On behalf of Comorbidities or are you seeing a fair mix.

The patients that may or may not have comorbidity.

Yeah, maybe I'll ask him to weigh in on this one.

Operator: And with that said, please go ahead and open the line for Q&A.

Sure Hi.

So we're very pleased obviously with the progress that we're making here on the launch are focused here on the launch is on <unk>.

Jessica Fye: Ladies and gentlemen, to ask a question, you will need to press star then 1 on your telephone. To withdraw your question, press the pound key again at star 1 to ask the question again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Jessica Fye with J.P. Morgan. Your line is open.

Transitioning xyrem patients to XI Wade.

We really are seeing that the vast majority of those patients are experienced on xyrem in terms of the patients that are on that way, but both in terms of having just taken xyrem or have taken xyrem in the past, but we also see other <unk>.

Bruce C. Cozadd: Hey guys, good afternoon. Thanks so much for taking my question and for the update on the Zywave launch. I was wondering if you could say how many active patients are on Zywave currently.

<unk> of patients who are new to activate overall.

Bruce C. Cozadd: Jeff, this is Bruce. We're not going to give you intra-quarter data like that. We'll obviously update again on our next call, but, you know, our body language here is we're really pleased with the way the launch is going, not just during the first couple months but as we continue through today.

Lucas Island, so very pleased that it's been a consistent with our strategy.

Did you have a question about payer coverage and just trying to clarify that.

Yeah, so the Duke on the payer coverage I'm trying to understand.

How he was placed on the plan and then what might be sudden quite easy on the theaters on.

Bruce C. Cozadd: Great, thank you.

Ami Fadia: Thank you. Our next question comes from Alarm's Ami Fadia with SBB LaRinc. Your line is open.

Hiring position to address.

Before allowing patients to switch from guidance <unk> or de novo patients being allowed to go on diabetes.

Ami Fadia: Good morning.

Ami Fadia: Good evening. Thanks for taking the question. Can you talk about, you know, out of the patients that are on dialysis? Can you talk about what peers have been requiring as a requirement for switch? Are most of these patients patients that have comorbidities, or are you seeing a fair mix of patients that may or may not have comorbidities?

Thank you.

So I think as you know we've stated we've had basically a parity strategy between Xyrem and <unk>. Both in terms of our pricing strategy and our goal of pricing not only at the growth level, but also at the net level.

Kim Sablich: Yeah, maybe I'll ask Kim to weigh in on this one.

Two products at parity.

Kim Sablich: Sure. Hi.

Kim Sablich: So, you know, we're very pleased, obviously, with the progress that we're making here on the launch. Our focus here on the launch is on transitioning XyRM patients to XyWave. We really are seeing that the vast majority of those patients are experienced on XyRM in terms of the patients that are on XyWave, but, you know, both in terms of having just taken XyRM or having taken XyRM in the past. But we also see, you know, a portion of patients who are new to OxyBate overall and new to XyWave. So, very pleased that it's, you know, consistent with our strategy. And I think, did you have a question about payer coverage? I'm just trying to clarify that.

But also in terms of how the two products are treated ultimately on on formulary. We're looking for XI wave to be placed on formulary in a comparable position so that the xyrem enjoys today.

And within that means also not just where it sits in terms of the tier, but how it's treated in terms of utilization management and so far to date, we're very pleased to say that.

With the contracts that we signed we you know we are achieving that goal austerity treatment.

Okay, and if you don't mind, just a final point on that how does the patients that have been switched to <unk>.

Up until the end of the yeah.

Can you talk about whether or not.

You know on the mix of patients from that subset.

Ami Fadia: Yeah, so with regard to fair coverage, I'm trying to understand how you're placed on the plan and what might be certain criteria that there are requiring physicians to address before allowing patients to switch from xyrem to xyway or a de novo patient being allowed to go on xyway.

That may have other.

Other cardiovascular comorbidities or not.

Dan maybe I'll ask you to weigh in on that one.

Thanks Tommy.

Just where we're positioned and we're actually pleased with the uptake and the.

Officers that are adopting that really all patients who are on oxygen therapy lifelong treatment modifiable risk factor.

Kim Sablich: Yeah, so, as you know, we've stated we have basically a parity strategy between XyRim and XyWave both in terms of our pricing strategy and our goal of pricing, not only at the gross level but also at the net level, the two products at parity, but also in terms of how the two products are treated, ultimately, on formulary. We're looking for XyWave to be placed on formulary in a comparable position to that that XyRim enjoys today.

Or not they have for comorbidities, they're at risk of it and so we're seeing kind of a broad cross section of patients.

We're also seeing you know some new patients obviously coming on where you.

The other suite of access services enables in the rising payer coverage with more than 60% of commercial lives covered.

Coming on to XI wave initially for oxygen therapy versus Xyrem.

Kim Sablich: And within that, it means not just where it sits in terms of the tier but how it's treated in terms of utilization management. And so far, we're very pleased to say that, with the contract we signed, we are achieving that goal of parity treatment.

And we also think over time, we're going to find patients who had previously not been candidates.

For Xyrem coming into therapy as well in addition to growing into the IH indications so.

Very pleased with the uptake.

Kim Sablich: Okay, and if you don't mind, just a final point on that, out of the patients that have been switched to Zyway, until the end of the year, can you talk about whether or not the mix of patients from that subset that may have, you know, other cardiovascular comorbidities?

And physicians were further along in the journey at the time of launch and understanding the risk factors in the amount of sodium in xyrem.

Some some physicians were not and also the patients to become an active part of this dialogue as well.

Thank you.

Our next question comes from the line of Jason <unk> with Bank of America. Your line is open.

Kim Sablich: Yeah, Dan, maybe I'll ask you to...

Daniel N. Swisher: and on that one, yeah, thanks Ami, yeah, just we're positioned and we're actually pleased with the uptake and the offices that are adopting that really all patients who are on Oxybate therapy, lifelong treatment, modifiable risk factor. You know, whether or not they have current comorbidities, they're at risk of it. And so we're seeing kind of a broad cross-section of patients. We're also seeing, you know, some new patients obviously coming on where, you know, the suite of access services enables and the rising payer coverage with more than 60% of commercial lives covered.

Hey, Thanks, and thanks for taking the question. So Bruce I appreciate the commentary about favorable body language on the <unk> switch what I was wondering is.

It is the switch trending ahead of your expectation I know you put out some metrics for where you expect it to be in 2023%, but just curious if youre operating ahead of expectation or if we should consider there to be a pent up bolus.

I would assume maybe only 20% of patients I've seen probably their doctor since the switch occurred so I'm a little surprised how high the number was so just curious if you can.

Daniel N. Swisher: You know, coming on to ZyWave initially for oxidate therapy versus Xyrem. And we also think over time we're going to find patients who had previously not been candidates for Xyrem coming into therapy as well, in addition to growing into the IH indication. So, you know, very pleased with the uptake.

Provide any commentary there because I think that would help us think about the progression over the course of the year. Thanks.

Yeah, I mean were Jason we're still early in the launch but to directly answer. Your question. We are ahead of the expectations, we have set internally.

For the first couple of months.

Daniel N. Swisher: You know, certain physicians were further along in the journey at the time of launch and understood the risk factors and the amount of sodium in Xyrem. Some physicians were not, and also, patients became an active part of this dialogue as well.

And I think as you heard Kim and Dan comment our messaging is resonating with people about the benefits.

Of this therapy and excitement about it and so.

Jason Matthew Gerberry: Thank you. Our next question comes from the line of Jason Gerberry with Bank of America. Your line is open.

You know I don't think of this as just a bolus that adopted early we see continued interest.

Jason Matthew Gerberry: Hey, thanks. Thanks for taking the question.

And look forward to continue our educational efforts over the balance of this year and next and continuing to work toward our goal of this being the.

Bruce C. Cozadd: So, Bruce, appreciate the commentary about favorable body language on the Xiwave switch. What I was wondering is, is the switch trending ahead of your expectations? I know you put out some metrics for where you expect it to be in 2023, but just curious if you're operating ahead of expectation or if we should consider there to be a pent-up bullishness

The primary brand in the auction bait space even out in 2023.

Got it thank you.

Thank you.

Our next question comes from the line of.

Ken <unk> with Cowen Your line is open.

Thanks, so much Bruce it as we stare at the Xyrem and <unk> franchises, it's kind of a really fascinating modeling exercise as we kind of look at 2023, obviously you have.

Bruce C. Cozadd: I would assume maybe only 20% of patients have seen their doctor probably since the switch occurred.

Jason Matthew Gerberry: I'm a little surprised by how high the number was. So, just curious if you can provide any commentary there because I think that would help us think about the progression over the course of the year. Thanks.

I wave, which could be taking a vast majority of the franchise and then you have information about the settlements and who can come in the kind of the volume they can supply and you also know the royalties they owe back to you.

Bruce C. Cozadd: Yeah, I mean, we're Jason, we're still early in the launch. But to directly answer your question, we are ahead of the expectations we had set internally for the first couple months. You know, and I think, as you heard Kim and Dan comment, our messaging is resonating with people about the benefit of this therapy and excitement about it. And so you know.

So as we look at 2023, and we try to take all these individual pieces of kind of a significant conversion to the franchise and then your knowledge of.

What could be the generic supply for for Xyrem and again, what they owe you can you help qualitatively maybe talk through a little bit of either any enthusiasm you have or how we can start thinking about.

Bruce C. Cozadd: I don't think of this as just a bolus that was adopted early; we see continued interest and look forward to, you know, continuing our educational efforts over the balance of this year and next and continuing to work toward our goal of this being, you know, the primary brand in the Oxibate space, even in 2023. Okay. Thank you.

Maybe a preservation that some of us had modeled a little bit too negatively and then I just wanted to follow up on commentary you made on Irwin ease and poor five day I would assume that you all understand the supply that you're not able to put into the marketplace. I would think that information is almost perfect. So can you.

Maybe give us a sense of what we are unable to supply and therefore, what we may be able to supply with 458. Thank you.

Bruce C. Cozadd: Thank you.

Ken Castletor: Our next question comes from the line of... Ken Castletor, with Cohen, your line is open.

Yeah, Thanks, Ken and maybe I'll take the first part of the question around ox abate and on a stand to weigh in on Asparaginase.

Ken Castletor: Thanks so much. Bruce, as we look at the XyROM and XyWave franchises, it's kind of a really fascinating modeling exercise as we kind of look at 2023. Obviously, you have XyWave, which could be taking the vast majority of the franchise. And then you have information about the settlements and who can come and the kind of volume they can supply. And you also know the royalties that they owe back to you. So as we look at 2023, and we try to take all these individual pieces of a kind of significant conversion to the franchise,

In terms of ox abate you know the way we're thinking about this is we've got a great growth opportunity in front of US we're seeing continuing growth in diagnosis.

And initiation of therapy on ox abate that's it.

A trend we've had for a number of years now.

We see an opportunity was sideways to address.

Some patients whose physicians were unwilling to start them on therapy, historically due to the high sodium load.

Ken Castletor: and then your knowledge of what could be the generic supply for xyloxone.

We see an opportunity obviously with idiopathic hypersomnia.

Bruce C. Cozadd: Resirem, and again, What They Owe You. Can you help qualitatively maybe talk through a little bit of either any enthusiasm you have or how we can start thinking about maybe a preservation that some of us have modeled a little bit too negatively? And then I just wanted to follow up on the commentary you made on Irwinase and 458. I would assume that you all understand the supply that you're not able to put into the marketplace. I would think that information is almost perfect. So can you maybe give us a sense of what we are unable to supply and, therefore, what we may be able to supply with 458? Thank you.

Upon the approval on launch of that product later, this year and that's a substantial opportunity relative to the size of the narcolepsy population. So we see growth opportunity in front of us.

Now in as you go out a few years, we do expect there will be you know on.

<unk> generic competition beginning in 2023.

Or potentially earlier in some circumstances and as we've disclosed we have economics.

In some cases substantial economics in those authorized generics, which we distributed through our revenue.

Bruce C. Cozadd: Yeah, thanks, Ken. And maybe I'll take the first part of the question about oxybate and ask Dan to weigh in on asparaginase. In terms of Oxibate, you know, the way we're thinking about this is we've got a great growth opportunity in front of us. We're seeing continuing growth in diagnosis, and initiation of therapy on Oxibate, you know; that's a continuing trend we've had for a number of years now. We see an opportunity with XiWave to address some patients whose physicians were unwilling to start them on therapy historically due to a high sodium load.

But to be clear, we think that most patients in this lifelong therapy.

In this group known to have high cardiovascular risk will benefit.

From the advantages of Lightwave therapy.

So we see.

Now the opportunity to expand the product and then really to be a continued preferred treatment of.

Far out into the future and do you want to take asparaginase.

On your question about Asparaginase, I mean, we don't have perfect information in the sense that.

We've been supply constrained for four years and probably last year was our.

Bruce C. Cozadd: We see an opportunity, obviously, with idiopathic hypersomnia upon the approval and launch of that product later this year, and that's a substantial opportunity relative to the size of the narcolepsy population. So, you know, we have a growth opportunity in front of us. You know, as we go out a few years, we do expect there will be, you know, authorized generic competition beginning in 2023 or potentially earlier in some circumstances. And as we've disclosed, we have economics, in some cases substantial economics, in those authorized generics, which we distribute through our rep.

Worst year in terms of our supply capacity to the U S market and so as that happens we've cut.

Cut back completely on promotion and Isps in clinical work.

So put in sort of patient by patient verification for our products supply. So no inventory sits on on the shelves at the hospitals and.

And we haven't sort of penetrated into certain new geographies like Japan, or really helped with the promotion of.

Asparaginase containing regimens for adolescent and young adults.

So before we were supply constrained we're moving.

The above $200 million in products sales that was several years ago. We believe there is substantial room for expansion with <unk>.

Bruce C. Cozadd: But to be clear, we think that most patients in this lifelong therapy, in this group known to have high cardiovascular risk, will benefit from the advantages of Zywave Therapy. So we see the opportunity to expand the product and then really be a continued preferred treatment far out into the future. Ann, do you want to take a spare today?

High quality fully recombinant.

That physicians can count on that when they start the course of therapy that can get to the end of the therapy and ensure the really successful treatment outcomes that they currently have with asparaginase.

Thank you.

Thank you.

Our next question comes from the line, but largely <unk> Prasad with Barclays. Your line is open.

Bruce C. Cozadd: Yeah, Ken, on your question about asparaginase, I mean, we don't have perfect information in the sense that we've been supply constrained for, you know, four years, and probably last year was our worst year in terms of supply capacity to the U.S. market, and so as that happened, we've, you know, cut back completely on promotion and ISTs and clinical work. We've also put in a sort of patient-by-patient verification for product supply, so, you know, no inventory sits on the shelves at the hospitals.

Hi, good evening, everyone on the same question.

Maybe just on <unk>.

This item with the pace of conversion on that we're seeing.

Is that on missile and become becoming more blind, but wanted to get an update on Avondale. It's been two months since our filed what is the strategy now on.

If FDA accepts the filing is there any way for you just sell mandate that there'd be a battle for considerate about a floor.

Do we think about the <unk>.

<unk> of this especially on Nextgen.

Yes. Thanks for the questions. You know we were not going to do any disclosure on behalf of Alcatel they'll keep people posted on on where they are with FDA will remind you that we do believe they should need to paragraph four certify against Orange book listed patents on Xyrem that has to do with the safe distribute.

Bruce C. Cozadd: And we haven't sort of penetrated into certain new geographies like Japan or really helped with the promotion of, you know, asparaginase-containing regimens for adolescents and young adults. So, you know, before we were supply constrained, we were moving, you know, above $200 million in product sales. That was several years ago. We believe there is substantial room for, you know, expansion with, you know, a high-quality, fully recombinant product that physicians can count on that when they start the course of therapy, they can get to the end of therapy and ensure the really successful treatment outcomes that they currently have with asparaginase.

And of the drug both as regards.

Our our distribution system, which ensures safe use of the product and limits of abuse misuse and diversion as well as.

Helping patients understand an important drug drug interaction that paragraph four certification can happen on submission, but it can be required at any point.

During the review process as well and then of course, we have on <unk>.

Daniel N. Swisher: Thank you.

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

What we believe is relevant intellectual property and we will defend that are in the best way possible for jazz.

Balaji V. Prasad: Good evening everyone, and thanks for the question. Maybe just on Xyrem, with the pace of conversion that we are seeing, Xyrem may soon become

Thanks Bruce.

Thank you.

Our next question comes from Atlanta, Randall <unk> with RBC capital markets. Your line is open.

Balaji V. Prasad: remote point, but

Balaji V. Prasad: I wanted to get an update on Avidel. It's been two months since they filed. What is your strategy now, and if FDA accepts their filing?

Great. Thanks, Bruce how are you guys thinking about total on volume growth for 2021 and specifically we're.

Bruce C. Cozadd: Is there any way for you to still mandate that Para 4 be considered?

We're hearing from physicians that there is an expectation of a big pick up going forward in Oxford patient volumes and I'm trying to understand if that's consistent with what you're expecting and then how much of that would be.

Bruce C. Cozadd: How do we think about the impact of this, especially next year?

Bruce C. Cozadd: Yeah, thanks for the questions. You know, we're not going to do any disclosure on behalf of AVID, although people have posted on where they are with FDA. We'll remind you that we do believe they should need to paragraph 4 certify against Orange Book listed patents on Xyrem that have to do with the safe distribution of the drug, both as regards our distribution system, which ensures the safe use of the product and limits abuse, misuse, and diversion, as well as Helping Patients Understand an Important Drug-Drug Interaction.

Related to the lifting of COVID-19 headwinds versus you'll be on.

On boarding of new high risk patients coming until the patient pool.

Or even just you being out there more aggressively educating physicians around XI wave and and detailing the product. Thanks.

Yeah, maybe I'll start and then I'll ask Dan if he wants to add.

In General Randall I'd say you know this is a really exciting period for narcolepsy patients with.

The additions to Xyrem is the standard of care.

The addition of Sanofi as a new weight promoting agent patrol the sand coming to market now with <unk> coming to market there.

Bruce C. Cozadd: That Paragraph 4 certification can happen on submission, but it can be required at any point during the review process as well. And then, of course, we have... on what we believe is relevant intellectual property, and we'll defend that in the best way possible for jazz.

There are treatment options that weren't available before there are more people out talking to doctors about appropriate diagnosis and treatment options and that's good for patients and.

If that leads to either more diagnosis or more treatment that would be really helpful. Since narcolepsy is still an under diagnosed and under treated disease.

Bruce C. Cozadd: Thanks, Bruce.

Bruce C. Cozadd: Thank you. Our next question comes from Alana Brando-Fenicki with RBC Capital Markets. Your line is open.

In terms of our growth expectations, we know that COVID-19 had an impact we think that impact is lessening as we moved through 2020 and we like the rest of the world are hopeful that 2021 will turn out to be on.

Bruce C. Cozadd: Great, thanks. Bruce, how are you guys thinking about total occipate volume growth for 2021, and specifically, we're hearing from physicians that there's an expectation of a big pickup going forward in occipate patient volumes, and I'm trying to understand if that's consistent with what you're expecting, and then how much of that would be.

A better year in terms of patients being able to.

Access from medical care and get get appropriate treatments, we're excited to be promoting.

Bruce C. Cozadd: of the lifting of COVID headwinds versus, you know, the onboarding of new high-risk patients coming into

New product and as we head towards the end of the year look forward to a launch in a indication with no currently approved therapy, Dan any color you want to add.

Bruce C. Cozadd: Coming to the patient pool, or even just you being out there more aggressively.

Bruce C. Cozadd: Progressively educating physicians around XyWave and detailing...

I would just add on to what you said say persistence and compliance is something we did see pick up during COVID-19, but a headwind was of course.

Bruce C. Cozadd: and details about the product. Thanks.

Daniel N. Swisher: Yeah, maybe I'll start and then I'll ask Dan if he wants to add. You know, in general, Randall, I'd say, you know, this is a really exciting period for narcolepsy patients with, uh... you know the additions to Xyrem as a standard of care uh... you know the addition of Sinosi as a new weight promoting agent, Patola Sand coming to market now is iWave coming to market you know there are treatment options that weren't available before there are more people out talking to doctors about appropriate diagnosis and treatment options and that's good for patients and you know if that leads to either more diagnosis or more treatment that would be really helpful since narcolepsy is still an under-diagnosed and under-treated disease uh... in terms of our growth expectations we know that COVID-19 had an impact uh... we think that impact is lessening as we move through 2020 and we like the rest of the world are are hopeful that that 2021 will turn out to be uh... a better year in terms of patients being able to uh... access medical care and get get appropriate treatments we're excited to be promoting uh... a new product and as we head toward the end of the year look forward to a launch in a indication with no currently approved therapy Dan, any color you want to add?

The diagnosis of patients and that's been definitely impacted again in the fourth quarter with the with Covid. So.

And in narcolepsy still remains pretty under diagnosed the other thing in terms of growth will be.

Patients are becoming aware of the treatment option, whether they had tried xyrem and come off or haven't tried it before knowing.

There's sort of a longer term healthier treatment option I think the patient will play a part of the journey and reaching the patients.

Going to be important to us and then lastly, I would say those patients who clearly were salt sensitive and not candidates who know sideways.

<unk> as a therapy for them and also significant expansion into the idiopathic hypersomnia market, where there is no FDA approved drugs and the managed care has made sure that.

Ox debate has not been widely available for those patients.

Bruce are you able to share our volume growth number.

On dose so we provided a neuroscience net sales guidance for the year, which has the puts and takes of Xyrem XI wave and continued Sanofi growth both in the U S.

And ex U S, but we're not giving a specific volume.

Growth expectation, obviously as we move out into.

At the very end of the year on next year with a successful <unk> launch we expect that there is opportunity for the kind of volume growth, we haven't seen in recent years.

Daniel N. Swisher: Yeah, I just add to what you said, saying, you know, persistence and compliance is something we did see pick up during COVID. But the headwind was, of course.

Daniel N. Swisher: The diagnosis of patients, and that's definitely been impacted again in the fourth quarter with COVID, so narcolepsy still remains pretty underdiagnosed. The other thing in terms of growth will be patients as they're becoming aware of the treatment option, whether they have tried Xyramine come off or haven't tried it before, knowing there's sort of a longer-term, healthier treatment option. I think the patient will play part of the journey, and reaching the patient is going to be important to us.

Got it thanks guys.

Thank you.

Our next question comes from the line of Gary Nachman with BMO capital markets. Your line is open.

Hi, guys just on that.

Last question.

Okay.

Okay.

Thanks.

Okay.

Cleaning preparing.

Getting into the market. So how do you plan.

Okay.

Okay.

Okay.

Yeah.

Thanks.

So Gary Unfortunately that was garbled like I was trying to pick out enough words, but I could answer a question that was related to what you asked but I am not sure what you asked so.

I don't know if the debt, let me get a better connection.

Could you could you hear me now.

Better so any day.

Okay.

Daniel N. Swisher: And then lastly, I would say there are patients who clearly were salt-sensitive and not candidates who now Xywave provides the therapy for them, and also significant expansion into the idiopathic hypersomnia market where there are no FDA-approved drugs and managed care has made sure that

Okay.

I was just.

Okay.

Potentially the theory on the guidance and just how you're preparing to launch indications into the market.

Now that you've had a lot more time to think about the overall opportunity just gives us a better sense of.

How are you going to be going after that once it's on.

I know you were asking about that launch was that was that idiopathic hypersomnia or JCB $4 58.

Daniel N. Swisher: Bruce, are you able to share a volume growth number?

Idiopathic hypersomnia I don't know why I'm, sorry for the connection that connection yeah. Just yeah now that you've had more time to think about it the overall opportunity and and if it's in the guidance for this year, if there's anything baked into the latter part of this year once it's approved.

Bruce C. Cozadd: I know so we provided neuroscience net sales guidance for the year, which you know has the puts and takes of sirens I wave and continued Sinosi growth both in the US and X us, but we're not giving it a specific volume growth expectation. You know, obviously, as we move out into the very end of the year next year with a successful IH launch, we expect that there's opportunity for the kind of volume growth we haven't Thanks, guys.

Yeah, maybe maybe I'll start with the last piece, which is there would be very little in our guidance for.

2021, because the launch would be happening towards the very back end of the year.

Take a little while to build awareness.

Bruce C. Cozadd: Thanks guys.

Gary Nachman: Thank you. Our next question comes from the line of Gary Nachman with VMO Capital Markets.

As you know as Youre seeing with the launches of <unk> XI wave you don't necessarily have perfect coverage day, one so I wouldn't think of it as a major revenue contributors this year, although we'd love to get some patients on therapy.

Gary Nachman: Hi guys, um, just...

Gary Nachman: And that last question.

Bruce C. Cozadd: How are you preparing to launch that decision in the market? Thank you.

Gary Nachman: So Gary, unfortunately, that was garbled, like I was trying to pick out enough words that I could answer a question that was related to what you asked, but I'm not sure what you asked. So I don't know if there's a way to get a better connection. Could you hear me now?

Maybe we could just ask Rob to jump in for a minute and just talk about Rob or Phil just talk about idiopathic hypersomnia as an opportunity from a medical standpoint.

Bruce C. Cozadd: That's better. Okay. Potentially, here in the guidance and just how you're preparing to launch the indication into the market. So now that you've had a lot more time to think about the overall opportunity, just give us a better sense of how you're going to be going after that.

And then Kim maybe a few reflections on launch.

One on.

Have you go first and then I'll join on as needed.

Okay, great. Thank you Rob, yes, so I think as we've said.

Gary Nachman: I know you were asking about the launch. Was that idiopathic hypersomnia or JCP-458?

So this population more and more.

We clearly understand that this is a chronic disabling disease and these patients have a lot of certain other any excessive daytime sleepiness debt without a lot of dysfunction.

Gary Nachman: It was idiopathic hypersomnia. I don't know why. I'm sorry for the connection, that connection.

Bruce C. Cozadd: Yeah, just now that you've had more time to think about it, the overall opportunity, and if it's in the guidance for this year, if there's anything baked into the latter part of this year once it's approved.

As a result of that excessive daytime sleepiness have a lot of sleep inertia and I think we've talked to you about debt people.

Robert Iannone: Yeah, maybe I'll start with the last piece, which is that there would be very little in our guidance for 2021 because the launch would be happening toward the very back end of the year. You know, take a little while to build awareness. As you know, as you're seeing with the launches of Cenosi and Zywave, you don't necessarily have perfect coverage day one, so I wouldn't think of it as a major revenue contributor this year, although we'd love to get some patients on therapy.

A lot of difficulty waking up.

And had very long see periods in many cases.

As we have understood this more and more.

We see the benefits.

From our <unk> study, we recognized that we can treat many of the symptoms.

Associated with feed this chronic disabling disease.

From Ow.

Haynes databases. We are aware of is that I think we've shared before debt we have about 37000 patients.

Robert Iannone: Maybe we could just ask Rob to jump in for a minute and just talk about Rob or Phil, just talk about idiopathic hypersomnia as an opportunity from a medical standpoint, and then Kim, maybe a few reflections on launch.

From pains debt basis, but we've also heard reports from a number of key opinion leaders, who also prescribed as hub. The narcolepsy population that they see a large number of these patients that have ranged.

Robert Iannone: Yeah, why don't I have you go first, and I'll join in as needed.

Robert Iannone: Great, thank you, Rob. Yes, so as we've understood this population more and more, we clearly understand that this is a chronic disabling disease, and these patients have a lot of not only excessive daytime sleepiness but also a lot of dysfunction as a result of that excessive daytime sleepiness, and have a lot of sleep inertia. I think we've talked to you about that before. They have a lot of difficulty waking up and having very long sleep periods in many cases.

From any way from a.

Two similar number from anyway, I think from 10% up to $80 to 90%.

Some of the population in size to the narcolepsy. So we haven't completed all the data around this I think we will continue to do that when you're just now within the health claims databases, we think it's going to be a sizable opportunity and I think when we have a chance to share all of the day that the upcoming meeting.

Rob alluded to in the in.

Robert Iannone: As we've understood this more and more, and we see the benefits from our 080 study, we recognize that we can treat many of the symptoms associated with this chronic disabling disease. From our TAMES databases, we're aware, as I think we've shared before, that we have about 37,000 patients in our TAMES databases. But we've also heard reports from a number of key opinion leaders who are also prescribers in the narcolepsy population that they see a large number of these patients that have ranged, you know, from anywhere from a 10% up to 80% to 90% of a similar population in size to narcolepsy.

In the second quarter of this year.

It's really compelling and I think we'll be resonate very well with the prescribing population for this accounts its population.

Yeah, and just to pivot quickly over to our launch planning we've got a team ready to go obviously significant overlap with the physician audience.

<unk> already got relationships with and are educating about <unk> therapy.

We think there's a significant number of under diagnosis, but the current diagnosed patients from a chart poll was 37000 so.

It's a big opportunity to start with and then very importantly, we do have our clinical data from the phase III that has been accepted at our upcoming medical conference in Q2 really.

We're really pleased to not only having statistical significance, but really clinically meaningful data in terms of the endpoints and that will be shared six months ahead, and that's great as part of the medical education in advance of the fourth quarter launch.

Robert Iannone: So we haven't completed all the epi data around this, but I think we'll continue to do that. We just know within the health claims databases that we think it's going to be a sizable opportunity. And I think when we have a chance to share all of the data at the upcoming meeting that Rob alluded to in the second quarter of this year, the data is really compelling and I think will resonate very well with the prescribing population for this target population.

Okay, great. Thank you. Thank you.

Our next question comes from the line of David Ansell.

With Piper Sandler your line is open.

Thank you so.

Just another question on.

On.

H. So the contracting that you have in place right now is that going to.

Kim Sablich: And just to pivot quickly over to launch planning, we've got a team ready to go. Obviously, you know, significant overlap with the physician audience. They already have relationships with and are educating about XiWave therapy.

Apply.

Two IH patients and just maybe give us some clarification on how broadly applicable those contracts are as he said.

Kim Sablich: You know, we think there's a significant number of underdiagnosis, but the current diagnosed patients from a chart poll were 37,000. So, you know, that's a big opportunity to start with. And then, very importantly, we do have our clinical data from phase three that has been accepted at an upcoming medical conference in Q2. You know, I'm really pleased that not only does it have statistical significance, but really clinically meaningful data in terms of the endpoints. And, you know, that will be shared six months ahead. And that's great as part of medical education in advance of the fourth quarter launch.

Think about the edge launch and then a longer term question is with me.

<unk> agonist in development, how do you think about.

The potential impact on the footprint of oxy in general to the extent that one or more actions get commercialized. Thank you.

Yes, David on the first part of the question on contracting you know, we've certainly done our contracting with a view toward the evolving narcolepsy treatment landscape.

But to your question narrowly.

We do need an approved label and to have conversations with payers about.

Kim Sablich: Okay, great. Thank you. Thank you.

David A. Amsellem: Thank you. Our next question comes from the line of David Amsellem, with Piper Sandler. Your line is open.

About that before we're done so no it's not a fait accompli.

And then on.

David A. Amsellem: Thank you. So, just another question on...

On Orexin, maybe I'll ask a jet or Phil to just weigh in a little bit about.

David A. Amsellem: on IH. So the contracting that you have in place right now, is that going to apply to IH patients? I mean, just maybe give us some clarification on how broadly applicable those contracts are as you think about the IH launch. And then a longer-term question is, you know,

The potential of Orexin vs of the oxalate.

This is Jed I'll jump in.

Okay.

Right.

I think it's fair to say that everyone is excited about the potential for our Orexin agonist.

To be.

David A. Amsellem: How do you think about the potential impact on the footprint of OxyBate in general to the extent that one or more orexins get commercialized? Thank you.

Helpful in the treatment of narcolepsy.

The mechanism of Orexin agonist is substantially different from the mechanism.

Oxo base.

Bruce C. Cozadd: Yeah, David, on the first part of the question on contracting, you know, we've certainly done our contracting with a view toward the evolving narcolepsy treatment landscape. But to your question, narrowly, you know, we do need an approved label and to have conversations with payers about that before we're done. So no, it's not a fait accompli. And then on.

Yes.

We anticipate the Orexin agonist will likely.

Have an impact a pharmacodynamic impact.

Similar to what we see with wake promoting agents on stimulus.

And.

So we expect that long term those agents would be complementary to.

Those potential recognize with the complementary to.

<unk>.

In treating narcolepsy.

Bruce C. Cozadd: On Erexin, maybe I'll ask Jed or Phil to weigh in a little bit about the potential of Erexin vis-a-vis Oxybate.

Okay.

Thank you.

Thank you.

Our next question comes from the line of Gregg Gilbert with Deutsche Securities. Your line is open.

Bruce C. Cozadd: This is Chet. I'll jump in. I think it's fair to say that everyone is excited about the potential for Erexin agonists to be helpful in the treatment of narcolepsy. However, the mechanism of rexanaganus is substantially different from the mechanism of oxidase and

Thanks, So I hadn't thought to ask you had a question, but since he is got the Mike maybe you could offer any thoughts you have on cannabinoids in sleep I'm guessing you have some thoughts there, but my other question was for ne.

When you closed the GW deal do you provide updated guidance.

Bruce C. Cozadd: We anticipate the Erection Agonist will likely... have an impact, a pharmacodynamic impact that's similar to what we see with weight-promoting agents and stimulants, and so we expect that, long-term, those agents would be complementary to those potential recognizers would be complementary to oxidate in treating narcolepsy. Thank you.

Right on the back of that or the next.

Scheduled quarterly conference call, maybe you could just set the stage for us on what and how you will got it. Thanks.

Yeah.

<unk>.

In the interest of time I'm going to suggest we would not take the cannabinoid and sleep question right now we will have.

More to say about the combined neuroscience pipeline.

Greg Gilbert: Our next question comes from the line of Greg Gilbert with Troy Securities. Your line is open.

At closing, but I'll, let Renee take your guidance question.

Yeah. Thank you and as you can appreciate.

Greg Gilbert: Thanks. I hadn't thought to ask Jed a question, but since he's got the mic, maybe you could offer any thoughts you have on cannabinoids and sleep. I'm guessing you have some thoughts there. But my other question was for Rene. When you closed the GW deal, did you provide updated guidance right on the back of that or the next scheduled quarterly?

Still working through.

Getting to close on the transaction and so once we actually close the transaction.

And are actually running the business then we will have on much better feel for the timing of the guidance that will provide for the combined company. We will certainly provide updated guidance to reflect jazz combined with GW post close but the exact timing of that is a little early to say.

Bruce C. Cozadd: I hope you could just set the stage for us on what and how you will guide us. Thanks. Yeah, I think in the interest...

Yes.

Yes.

Yes.

Thank you.

Rene D. Gal: In the interest of time, I'm going to suggest we not take the cannabinoid in sleep question right now. We'll have, you know, more to say about the combined neuroscience pipeline at closing, but I'll let Renee take your guidance question.

Our next question comes from the line of David Risinger with Morgan Stanley. Your line is open.

Thanks very much.

So.

Management had hosted a very compelling call on the risk of high salt intake last year and it seems logical debt.

Rene D. Gal: Yeah, thank you. And as you can appreciate, we're still working through getting to the close of the transaction. And so once we actually close the transaction and are actually running the business, then we'll have a much better feel for the timing of the guidance that we'll provide for the combined company. We will certainly provide updated guidance to reflect Jazz combined with GW Post, but the exact timing of that is a little early to say.

Most doctors and patients would.

Opt for XI wave instead of Xyrem and that should potentially drive a faster than expected switch.

But my question is how would you characterize the risk of potentially triggering an early.

IRA on generic entry in 2020 to.

David Reisinger: Thank you. Our next question comes from the line of David Reisinger with Morgan Stanley. Your line is open.

Before you have.

Full year to drive XI waves adoption in idiopathic hypersomnia, obviously, the current assumption is the IH launch occurs at the end of 'twenty 'twenty, one I believe and then the generic entry against Xyrem is in January of 2023.

David Reisinger: Thanks very much. Management hosted a very compelling call on the risk of high salt intake last year, and it seems logical that most doctors and patients would opt for Zywave instead of Xyrem, and that should potentially drive a faster-than-expected switch. But my question is, how would you characterize the risk of potentially triggering an early Xyrem Generic Entry in 2022?

So if you could just provide some perspective on that that would be helpful. Thank you.

David Reisinger: for you have, you know, a full year to drop.

Bruce C. Cozadd: Thank you.

Brandon Richard Folkes: Yeah, good question Dave, and you know, let's just say we want to help as many narcolepsy patients as possible with Zyways. We are not holding back in any way. If we're so successful that we've triggered earlier AG entry, that is a success scenario from our standpoint in terms of our progress with Zywave. You know, specific to the IH launch, we did our studies with JCP-258, or what's on the market as iWave, and the IH indication would be specific to that product.

Yes, good question, Dave and and you know.

Let's just say, we want to help us from many narcolepsy patients as possible with Lightwave.

We are not holding back in any way.

If were so successful that we've triggered on.

Earlier AG entry that is a success scenario from our standpoint in terms of our progress with.

With sideways specific to the IH launch.

We did our studies with JCB $2 58, or what's on the market as I wave and the IH indication would be specific to that product.

Kim Sablich: Thank you.

Thank you.

Kim Sablich: Our next question comes from the line of Brandon Folkes with Tanner Fixed Gerald. Your line is open.

Thank you.

Our next question comes from the line of Brandon Folkes from Cantor Fitzgerald. Your line is open.

Brandon Richard Folkes: Hi, thanks for taking my question and congratulations on another good quarter. Maybe just changing gears a little bit here and focusing on DepthVulca. Another good quarter there.

Hi, Thanks for taking my question on congratulations on another good quarter.

Maybe just changing gears, a little bit here and focusing on debt okay.

Good quarters there.

Kim Sablich: Can you provide some color in terms of, you know, how much pent up demand are we still seeing in third and fourth line versus pure second line? And I know you mentioned that both platinum sensitive and platinum resistant are growing in usage. Any way to explain that a bit more just in terms of the uptake between sensitive and resistant? Thank you.

Could you provide some color in terms of.

How much pent up demand or we still skiing in third and fourth line versus pure second line and I know you mentioned that price platinum sensitive and platinum resistant all growing and you're seeing usage anyway to parse that out a bit more just in terms of uptake halved between sensitive and resistant. Thank you.

Kim Sablich: Yeah, for Zep Zilka color, maybe I could ask Kim to just talk a little bit about what you're seeing in terms of how the launch is progressing.

Yes for <unk> silk of color, maybe I could ask.

Kim to just talk a little bit about what youre seeing in terms of how the launch is progressing.

Kim Sablich: Yeah, sure. So we remain very pleased with the response to the launch among the small cell lung cancer treating community's feedback on the profile. And what they've seen in their patients has been quite positive. And as you can see there, we're seeing nice, you know, growth in the product overall. What I can tell you is that we're seeing growth, you know, through through December in the data that we have across all patient types, including second line, as you said, and both types of second line patients in terms of platinum sensitive and platinum resistant.

Yes sure. So we remain very pleased with the response to the launch I'm on the small cell lung cancer treating community feedback to the profile the profile and what they've seen in their patients has been quite positive and as you see there we're seeing nice growth in the products overall, what I can tell you is debt.

We're seeing growth.

Through that through December the data that we have across all patient types, including.

Including second line as you said in both types of second line patients in terms of platinum sensitive and platinum resistant. So I think we're still on a stage where.

Kim Sablich: So I think we're still in a stage where, you know, physicians are getting experience with it and are, you know, seeing a tremendous unmet need, a strong profile, and still using it across, you know, a broad spectrum of patient types.

Physicians are getting experience with it and are seeing a tremendous unmet need a strong profile and still using it across a broad spectrum of patient types.

Kim Sablich: Okay, thanks. And are we still seeing usage from third and fourth line patients, as we saw last quarter?

Okay and are we still seeing usage from third and fourth line patients as we saw last quarter.

Kim Sablich: Yes, based on the data that we have, we're still seeing strong usage there. Great, thank you very much.

Yes through the data that we have we're still seeing strong usage there.

Great. Thank you very much.

Bruce C. Cozadd: You know, I would say our goal is, over time, to have this become the standard for second-line small cell lung cancer treatment and to have patients get it at that point. Obviously, that hasn't been true in the first few months after launch, right, because we're establishing awareness. But over time, we'd expect that second line to go up and, therefore, to see less usage later. Of course, in the second line, we'd expect a longer duration of therapy as well.

I will say our goal is over time.

To have this become the standard for second line small cell lung cancer treatment and to have patients get it at that point, obviously that hasnt been true in the first few months after launch right because we're establishing awareness, but over time, we'd expect that second line.

Share to go up and therefore to see less usage later.

Of course in second line, we would expect longer duration of therapy as well.

Bruce C. Cozadd: Thank you. Our next question comes from the line of Esther Wajabalu with UBS. Your line is open.

Thank you.

Our next question comes from the line of Esther <unk> with UBS. Your line is open.

Esther Wajabalu: Hey there, thank you for the question. So two for me, one on JCP-458. Dan, you mentioned that you've been somewhat out of the market with this product. So I'm wondering, as you're preparing to launch 458 if you can help us understand how we should be thinking about the launch trajectory compared with where UrbanAce sort of left off, or leaves off in the middle of the year. Dan, do you want to take

Thank you for the question from.

From me one on GBP 458, Dan you mentioned that.

You've been somewhat Addison market.

With this products I'm wondering as you're preparing to launch $4 58, if you can help us understand how we should be thinking about the launch trajectory compared with with where <unk> left off.

So it leaves off and on the left a year.

Yeah.

Dan do you want to take that yeah, I think I'm going to punt on.

Daniel N. Swisher: Yeah, I think I'm going to punt on that question. I mean, we're going to give more detail as we've got precise launch timing and launch label and, frankly, also know what the asparaginase market looks like in the U.S. But we do see, you know, opportunity for growth from where we've been clearly, you know, across all the categories I referenced. But I'd say...

That question I mean, we're going to give more.

Details, we've got precise launch timing and launch label and frankly also know whats the asparaginase market look like in the U S. But we do see opportunity for growth from where we've been clearly.

Across other categories I referenced but I.

I'd say stay stay tuned a little bit longer on anything more precise.

Esther Wajabalu: Okay, and then for 385 you've talked about essential tremor as an attractive opportunity before, Bruce, and I think you just mentioned on the call that you've had some Phase 1 Healthy Volunteer data, so can you give us some context about the data that you've produced for 385 versus what's been in the public realm in the past?

Got it Okay and then on slide 385, you talked about Tim or essential tremor, as an attractive opportunity Bruce the floor.

And I think you just mentioned on the call that <unk> had from phase one healthy volunteer data. So can you give us some context of the cash.

But you've produced twitchy 85 split.

Whats been in the public realm in the past.

Robert Iannone: Yeah, so Phil or Rob, do you want to jump in on that?

Yeah, So Phil or Rob do you want to jump in on that.

Robert Iannone: Sure, I'm happy to Bruce, this is Robert Iannone. The proof of concept phase two study was conducted, you know, before the acquisition, and it was done with a formulation that was fit for purpose. So our initial steps were to develop one. Daily Formulation that can be commercialized, and that's what we refer to as the Healthy Volunteer Study, and that will be taken forward into the Pivotal Phase 2B study that we referenced earlier.

Sure I'm happy to Bruce This is Ravi.

The proof of concept phase II study was conducted.

Before the acquisition it was done with a formulation that was fit for purpose and so on our initial steps was to develop a once.

Daily formulation that can be commercialized and that's what we refer to as the healthy volunteer study and that will be taken forward into the pivotal phase <unk> study that we referenced earlier.

Robert Iannone: Thank you. Our next question comes from the line of David Steinberg with Jeffries. Your line is open.

Thank you.

Our next question comes from the line of David Steinberg with Jefferies. Your line is open.

David Steinberg: Thanks. I know you've taken several questions about the XyWave switch, but just want to see if we can get a little more granular. So if you take the number of patients that were on OxyBate therapy that you gave out at the end of the year, as well as those you mentioned were active XyWave patients, you get about a 12% switch rate. And I know it's not that because you mentioned there were some newer patients who've come in. I was just curious about the non-most recent OxyBate switches.

Thanks, I know you've taken a several questions about the XI weighted switch, but just wanted to see if we could get a little more granularity. So if you take the number of patients.

Debt, we're on OXXO based therapy that you gave out at the end of the year as well as those you mentioned, we're on we're active XI weighted patients you get about 12% switch rate and I know, it's not that because you mentioned there were some newer patients who've come in I was just curious on the on the non most recent OXXO based switches.

David Steinberg: What percent of those new patients were just the natural evolution of newly diagnosed narcolepsy patients and which were patients who previously were deemed not able to be on XyWave simply because they had cardiovascular issues or comorbidities? And then related to the patients with severe cardio issues who previously could not be put on XyRM, some of the CAOs we've spoken to think there's a very small percent and others up I'm just curious, from your own research, what would be the theoretical number of patients who have severe enough CV issues that could not be put on XyRM? Thanks.

How many or what.

What what percentage of those new patients were just natural evolution of <unk>.

Newly diagnosed narcolepsy patients.

Which where where patients who previously.

Redeem not not being able to be on and on.

Xyrem simply because they had cardiovascular issues or Comorbidities, and then related to the patients with severe cardio issues.

Previously could not be put on on Xyrem.

Some of the chaos, we've spoken to think Theres, a very small percent and others up to 20% I'm just curious.

Your own research what would be the theoretical number of patients who have severe enough CV issues that previously could not be put on on xyrem. Thanks.

Bruce C. Cozadd: Yeah, Dave, you make a couple good points there. You know, you keep using the word switch. I would just remind you that, as you said in your question, we've got patients coming to Zywave, in some cases directly from Xyrem, in some cases from prior Xyrem, in some cases, new diagnosis, in some cases, their physicians may not have felt they were good oxibate candidates with the high sodium product in the past, even though they were diagnosed.

Yeah.

Yeah, Dave a couple of good points there.

You keep using the word switch I would just remind you that.

You said on your question, we've got patients coming to <unk> in some cases directly from Xyrem in some cases from prior xyrem in some cases, new diagnosis in some cases there are physicians may have not felt they were.

Good oxalate candidates with the high sodium products in the past.

Even though they were diagnosed and so it's a variety at the beginning as we would have expected prior.

Bruce C. Cozadd: And so, it's a variety at the beginning, as we would have expected prior to launch. We are seeing a majority of ZyWave starts come from patients with Zyrem experience. That's not a surprise to us. On the exact size of the opportunity for patients who didn't receive Zyrem historically because of those concerns, I'm not sure we have any better hard data to give you other than that it's a significant population. But we see, like you do, varied estimates in that. There's no precise way to track that.

To launch we are seeing a majority of the XI wave starts come from patients with VI Ziram experience, that's not a surprise to us on the exact size of the opportunity of patient who didn't receive xyrem historically because of those concerns I'm not sure we have any better hard data to give you other than.

It's a significant population.

But we see like you do a varied estimates on that and there's no precise way to track that.

Annabel Eva Samimy: Thank you. Our next question comes from the line of Annabel Samimy with Stiefel. Your line is open.

Thank you.

Our next question comes from the line of Annabel <unk> with Stifel. Your line is open.

Annabel Eva Samimy: Hi, thanks for taking my question.

Hi, Thanks for taking my question so.

Annabel Eva Samimy: I just want to ask about Dyselka for a minute. I know that you have to do a confirmatory trial and that you're still in discussions with FDA. Is there any color they can provide?

I just want to add.

Ask about the telco for a minute I know that you have to do a confirmatory trial that you're still on discussions with FDA is there any.

Color. They can provide on a type of trial that you might consider.

For us itself.

Annabel Eva Samimy: The Sodium Oxidate franchise, obviously, the pricing parity has helped, I guess, accelerate.

Whether it would be combination or.

Or anything else and then on the.

The Saudi market bit franchise, obviously the pricing.

He has helped I guess accelerated contracting a bit and you're already a pretty 60%. So pretty good do you expect this to continue to proceed rapidly or faster than average and what can we assume for timing of.

Annabel Eva Samimy: The next question is, when you are at 60% of the average, do you expect this to continue to proceed rapidly or faster than average? What can we assume for timing of net price normalization where you are not providing as much patient assistance as these payers get the drug on board and start reimbursing regularly?

I guess net price normalization, where we're not providing as much on.

Patient assistance as these payers get the drug on board.

And start reimbursing regularly thanks.

Bruce C. Cozadd: So I'll take the second question first and then maybe ask Rob to talk about where we're going with Zep Celka's additional study. On the contracting, when we say we've got contracts in place for 60%, that doesn't necessarily mean all the rest are not revenue bottles, and I know I used a double negative there, but that doesn't mean we aren't getting paid for some of the others; it's just in place Um, and you know, our goal at the time of launch was we said within six to nine months of launch. Launch was in November, and we still feel comfortable with that.

So I'll take the second question first and then maybe ask Rob to talk about where we're going was up silica additional study.

On on the contracting when we say we've got contracts in place for 60% that doesn't necessarily mean, all the rest are not revenue bottles I know I used to double negative there, but that doesn't mean, we aren't getting paid for somebody others. It's just we don't have contracts.

In place.

And you know our goal at the time of launch was we said within six to nine months of launch launch was in November we still feel comfortable with that.

Bruce C. Cozadd: You know, sooner is better, but we want to put in place sensible contracts. So it's quality over speed to make sure we've got good access for patients going forward. Rob, do you want to talk about SubSALCA?

Sooner is better, but we want to put in place sensible contract. So it's.

It's quality over speed to make sure we've got good access for patients going forward Rob.

Rob do you want to talk about sub soccer.

Robert Iannone: Yeah, we just mentioned that we have so far only had a very preliminary discussion with FDA where we presented the Atlantis data, and we expect to have a more meaningful discussion on what will constitute a confirmatory data package sometime in Q2. So no further details really to offer on that.

Yeah, I would just mentioned that we so far have only had a very preliminary discussion with FDA. When we presented the Atlantis data and we expect to have a more meaningful discussion on whats what would constitute a confirmatory data package.

Some time in Q.

So with no further details really to offer on that I would say that.

Robert Iannone: I would say that, you know, we have disclosed that we're very interested in evaluating Nefselka in first-line extensive stage small cell lung cancer, and that would be a switch maintenance design where we'd be adding on to existing therapy. So in the maintenance setting, it would be immunotherapy plus or minus Nefselka versus immunotherapy plus placebo. Also, I would mention that we do have an observational phase 4 study that is intentionally designed to gather additional useful information in the second line indicated.

We have disclosed that we're very interested in evaluating net.

<unk> in first line extensive stage small cell lung cancer and that would be.

Which maintenance design, where we'd be adding on to.

Existing therapies on the maintenance setting it would be.

Immunotherapy, plus or minus thats outcome versus immunotherapy.

Placebo.

Simple.

Also we mentioned that we are.

We do have.

<unk> phase four study that is intentionally designed.

To gather additional useful information.

In the second line indication.

Robert Iannone: Great, thanks.

Great. Thanks.

Craig Savannies: Thank you. Our next question comes from the line of Craig Savannies with Goldman Sachs. Your line is open.

Thank you.

Our next question comes from the line of Craig <unk> with Goldman Sachs. Your line is open.

Craig Savannies: Hi, thanks for taking my question; congrats on a really nice quarter. Maybe I'll ask a different question that has to do with...

Hi, Thanks for taking my question congrats on a on a really nice quarter.

Maybe I'll.

I'll ask a different question that has to do with.

Your BD strategy is going forward clearly the last 12 plus months or so you've executed on a number of nice deals that kind of change that trajectory.

Craig Savannies: Your Beatty strategy going forward Clearly, in the last 12 plus months or so, you've executed on a number of nice deals, and it's kind of changed the trajectory of the top line. And with that in mind, given the size of the GW acquisition, what should we be thinking about in terms of BD and whether it's a priority over the next 12 to 24 months? You have, you know, a quite robust pipeline, and you're integrating a fairly significant acquisition. So we'd love to get any color there. Thanks.

Of the top line.

And with that in mind, given the size of the GW acquisition.

What should we be thinking about in terms of.

BD and whether it is a priority.

Over the next 12 months to 24 months you have.

Quite robust pipeline and you're integrating a fairly significant acquisition, so would love to get any color. There. Thanks so much.

Rene D. Gal: Sure. Greg, this is Renee. I'll take that one.

Sure Greg This is Renee I'll take that one so.

Rene D. Gal: You know, granted, the GW transaction is a meaningful transaction for us that we're very excited about. We've talked for a while about the potential opportunity to do a transformative transaction, to be able to accelerate our strategy. And we've lined up financing that we think still gives us adequate flexibility to both invest in our important product launches, invest in our pipeline, and then invest in additional business development transactions for the right asset.

Granted the <unk> transaction is a meaningful transaction for us that we're very excited about we've talked for a while about the potential opportunity to do the transformative transaction to be able to accelerate our strategy.

We've.

Lined up financing that we think still gives us.

Adequate flexibility to both invest in our important product launches invest in our pipeline and then invest in additional business development transaction for the right assets.

Rene D. Gal: We still see plenty of opportunities to continue to add to and expand the pipeline both in neuroscience as well as in oncology because, you know, we have quite a few things we've brought into the pipeline, and we want to continue to focus on bringing in both differentiated assets and then building a durable business.

We still see plenty of opportunities to continue to add to expand the pipeline both in neuroscience as well as in oncology because you see we have quite a few things we've brought into the pipeline and we want to continue to focus on bringing in both differentiated assets.

And then building a durable business.

Rene D. Gal: Thank you. Our next question comes from the line of Akash Tewari with Wolf Research. Your line is open.

Thank you.

Our next question comes from the line of of cash toward Wolfe Research. Your line is open.

Akash Tewari: Hey guys, thanks so much. On Zywave, have you heard anything back from the FDA on your application for orphan drug exclusivity for narcolepsy? And additionally, if you do get the ODE, what would that mean theoretically for the Avidult product?

Hey, guys. Thanks, so much.

On <unk> have you heard anything back from the FDA on your application for orphan drug exclusivity for narcolepsy.

And Additionally, if you do get Vod, what would that mean theoretically for the avid all products.

Akash Tewari: Additionally, do you have any updates on your Once Nightly program? I know it looks like your Phase 1 trial should have read out by now. Thanks.

Additionally, do you have any updates on your once nightly program I know it looks like your phase one trial should've brought out by now.

Bruce C. Cozadd: Yeah, so no particular updates on either. As you know, FDA does not have a particular clock they're on when it comes to ODE, so we're waiting to hear on that. That should become public once it's decided, and I won't speculate on its impact on Avidel. You can ask them that question, and I forget the second part of the question.

Yeah, So no particular updates on either.

As you know FDA does not have a particular clock there on when it comes to <unk>. So we're waiting to hear on that that should become public.

Once it's decided.

And I won't speculate on impact on avid Ela you can ask on that question.

And I forget the second part of your question.

Bruce C. Cozadd: Oh, once nightly. On your one nightly, yeah.

Oh, Oh on slightly on your watch so yeah. Yeah. So we're we have not said more about our once nightly development program. Although it continues.

Bruce C. Cozadd: Yeah, so we're have not said more about our once nightly development program, although it continues.

Bruce C. Cozadd: Got it.

Okay.

Rene D. Gal: Thank you. Our next question comes from the line of Ronnie Gal with Bernstein. Your line is open.

Thank you.

Our next question comes from the line of Ronny Gal with Bernstein. Your line is open.

Rene D. Gal: Good evening, and thank you for fitting me in. Bruce, I wonder if the payer agreements that you have on Zywave and Zyrem give you a preferred position versus other oxybate drugs. And to the extent you choose not to take that one, I was wondering if I could ask you about the share of prescribers that have not used Zubzilica yet.

Hey, good evening and thank you for fitting me in Bruce.

Bruce I Wonder if you can share with us whether the Bayer agreement that you have on XI ways Xyrem give you a preferred position versus other oxo bay drugs and to extent you choose not to take that one I was wondering if I can ask you about the share of prescribers, who have not used <unk>.

Bruce C. Cozadd: Yeah, so on the first one, we're trying to ensure patients have good access to what we believe is a really important treatment option in Zywave. You know, in general, that means we want them to have reasonable ways to get treatment with appropriate diagnosis. And in some cases, you know, having tried other therapies, but essentially, it's not different from what we've had with Xyrem for a long time. And then on Zepselka, you know; happy to have any of my colleagues jump in on, for those doctors who have not yet used Zepselka and SecondLine, what your expectations are there.

Yes, so on the first one we're trying to ensure patients have good access to what we believe is a really important treatment option in <unk>.

In general that means we want them to have reasonable.

<unk> to get treatment with appropriate diagnosis and in some cases.

Having tried other therapies, but essentially it's not different from what we've had with xyrem for a long time.

And then on <unk>.

Happy to have any of my colleagues jump in on.

For those docs, who have not yet used <unk> in second line on what your expectations are there.

Bruce C. Cozadd: Thank you. I'm showing no further questions in the queue. I will now turn the call back over to Andrea.

Thank you.

I'm showing no further questions in the queue I will now turn the call back over to Andrew from closing remark.

Andrea Flynn: Thank you, and thanks to you all for joining us. Maybe just before I flip it back to Andrea, just to say, you know, thanks to the team at Jazz for an incredibly productive 2020. And I hope all of you on this call take away that 2021 looks like another exciting year with lots of product launches, lots of clinical progress, excitement about the GW transaction, and what that can mean for Jazz, for patients, for employees, and for our shareholders. We've got a lot ahead of us, and we hope to continue executing exceptionally well. Andrea?

Okay, and maybe just yes.

Maybe just before I flip it back to Andrea just to say.

Thanks to the team at jazz for really an incredibly productive.

2020, and I hope all of you on this call takeaway that 'twenty 'twenty, one looks like another exciting year with lots of product launches lots of clinical progress.

Heitman about the GW transaction on what that can mean for jazz for patients for employees and for our shareholders. We've got a lot ahead of us and hope to continue executing exceptionally well Andrea.

Andrea Flynn: Thanks, Bruce. And thanks, everyone, for joining us today. We'll be participating in the upcoming Learinc and Calend virtual conferences, and we hope to speak with many of you then. This concludes our call.

Thanks, Bruce and thanks, everyone for joining us today, we will be participating in the upcoming Leerink and Cowen virtual conferences, and we hope to speak with many of you. Then this concludes our call.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

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