Q3 2020 Jazz Pharmaceuticals PLC Earnings Call

Welcome to the jazz Pharmaceuticals plc third quarter 2020 earnings conference call.

Operator: Welcome to the Jazz Pharmaceuticals PLC 3rd Quarter 2020 Earnings Conference Call. Following an introduction from the company, we will open the call to questions. I will now turn the call over to Kathy Littrell, Head of Investment Relations at Jazz Pharmaceuticals. Thank you, Sheena.

Following an introduction from the company, we will open the call to questions.

I'll turn the call over to Kathy Littrell head of Investor Relations at Jazz Pharmaceuticals.

Thank you Sheena thanks to those of you joining our investor call today, we reported our third quarter 2020 financial results and updated our financial guidance for 2020.

Kathy Littrell: And thanks to those of you who joined our investor call. Today, we reported our third quarter 2020 financial results and updated our financial guidance for 2020. The press release and the slide presentation accompanying this call are available in the investor section of our website. On the call today are Bruce Cozadd, CEO; Renee Gala, CFO; Dan Swisher, President; and Rob Iannone, Executive Vice President, R&D. Joining for the Q&A session are Kim Sablich, Executive Vice President, General Manager of North America; Phil Jochelson, Neuroscience Therapeutic Head, Anne Borgman, Hematology and Oncology Therapeutic Head, Sam Pierce, Senior Vice President, Europe and International; Shawn Mendes, Senior Vice President, Strategy and Finance; and Larry Carter, Global Development Lead, Neuroscience. I'd like to remind you that today's call includes forward-looking statements We encourage you to review the forward-looking statements contained in today's press release and our latest SEC Disclosure Docs, 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.

This 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, Renee Gala CFO, Dan Swisher, President and Bob Young Executive Vice President R&D, Jordi pretty kinase section our Kim travelers.

<unk> Executive Vice President General manager of North America, Phil Johnson Neuroscience therapy, the cat and Boardman hematology and oncology therapeutic CAD Cam Pearson Senior Vice President Europe and International that's senior.

On your Vice President strategy, and finance and Larry Carter Global development, we narrowed to try and.

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 read these statements contained in today's press release, and our latest SBC disclose your dart, 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 forward.

Our forward looking statements on this call we discuss non-GAAP financial measures reconciliation 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.

Kathy Littrell: On this call, we discuss non-GAAP financial measures. Reconciliation of GAAP to non-GAAP financial measures discussed on this call is included in today's press release and slide presentation, available on our website. I'll now turn the call over to Bruce.

Now I'll turn the call over to Bruce.

Good afternoon, everyone and thank you for joining us in the third quarter, we delivered strong financial and operational results.

Bruce C. Cozadd: Good afternoon, everyone, and thank you for joining us. In the third quarter, we delivered strong financial and operational results that build on the significant progress we made during the first half of the year. We executed on our key objectives, positioning us to deliver significant value and long-term growth. Since mid-year, despite ongoing impacts from COVID-19, our team has worked diligently to advance our strategy and align with the goals and milestones we set for Jazz at the beginning of the year, including five key product launches in 2020 and 2021. Our focus on transforming our business through execution across regulatory, commercial, and R&D operations has continued, and today, we achieved another exciting milestone in our neuroscience franchise with our U.S. launch of ZyWave for EDS and cataplexy in narcolepsy. We strongly believe, based on more than 15 years of engagement with sleep specialists and patients, that reducing the lifelong burden of high sodium intake is an important advance for Oxy

Build on the significant progress we made during the first half of the year we.

We executed on our key objectives positioning us to deliver significant value and long term growth.

Since mid year. Despite ongoing impacts recorded 19, our team has worked diligently to advance our strategy and along with the goals and milestones we set for jobs at the beginning of the year, including five key product launches in 2020 and 2021.

Our focus on transforming our business through execution across regulatory commercial and R&D operations has continued and today, we achieved another exciting milestone in our neuroscience franchise with our U.S. launch of sideways for EPS and cataplexy and narcolepsy.

We strongly believe based on more than 15 years of engagement with sleep specialists and patients that reducing the lifelong burden of high sodium intake isn't important advance for oxybate patients.

Bruce C. Cozadd: We are working hard to optimize our patient and physician education initiatives to ensure that existing and new Oxybate patients fully understand this benefit. Additionally, last month we announced positive and compelling top-line data for JCP-258 in idiopathic hypersomnia, or IH, bringing us another step closer to improving the lives of IH patients for whom there is no approved therapy.

We're working hard to optimize our patient and physician education initiatives to ensure the existing and new oxybate patients fully understand this benefit.

Additionally, last month, we announced positive and compelling top line data for GCP to 58 in idiopathic hyper sommelier, where I H, bringing us another step closer to improving the lives of ice age patients for whom there is no approved therapy.

Bruce C. Cozadd: We look forward to submitting our SNDA in the first quarter of 2021 and our targeting launch in the fourth quarter next year. Our launch of xylitol and narcolepsy today, coupled with our progress toward launching an IH next year, continue to give us confidence in the durability of our Oxabate franchise. Another important milestone this quarter was the launch of Zepzelka in the U.S. This successful launch demonstrated both our agility and our strong commercialization capabilities. Progressing from a deal announcement to launch in a matter of months, Sepselka represents a major advance for patients with relapsed small cell lung cancer and is the first approved therapy in a second line setting in over 20 years, giving physicians an important new tool in the management of this disease.

We look forward to submitting our SMB area in the first quarter of 2021 and are targeting a launch in the fourth quarter next year.

Our launch of its like narcolepsy today, coupled with our progress toward launching an I.H. next year continue to give us confidence and the durability of our Oxybate franchise.

Another important milestone this quarter was the launch EPS absaloka in the U.S. This successful launch demonstrated both our agility and our strong commercialization capabilities.

Progressing from a deal announcement to launch in a matter of months.

Sept Selco represent a major advance for patients with relapsed small cell lung cancer and is the first approved therapy in second line setting in over 20 years.

Giving physicians an important new tool in the management of this disease.

Bruce C. Cozadd: Our team is executing exceptionally well, and I'm pleased that physicians have enthusiastically embraced Zep Celka's benefits and profile. Through flexibility, innovation, and commitment, we remain on track to execute on our important objectives across product launches and pipeline advancements through 2020 and 2021, with three launches already underway and two planned for next year. To that end, our overarching priority is to develop and bring new life-changing medicines to patients in areas of high unmet need.

Our team is executing exceptionally well and I'm pleased that physicians have been Tuesday, optically embraced zakas benefits and profile.

Through flexibility innovation and commitment we remain on track to execute on our important objectives across product launches and pipeline advancements through 2020, and 2021 with three launches already underway and to plan for next year.

Our overarching priority is to develop and bring new life changing medicines to patients in areas of high unmet need.

To that end this year ranks as one of the most productive in jobs is history.

Bruce C. Cozadd: I'm excited about this. With continued innovation, our strong commercial franchises, a robust and productive pipeline, and our commitment to investing in and leveraging our global platform, we are well positioned to change the lives of more patients and deliver tremendous shareholder value. I'll now turn the call over to Rene for a financial update. Dan will then give an overview of our commercial performance, and Rob will provide an update on progress across our R&D program. Thanks, Bruce.

I'm excited about the future with continued innovation, our strong commercial franchises, a robust and productive pipeline and our commitment to investing in and leveraging our global platform.

We are well positioned to change the lives of more patients and deliver tremendous shareholder value.

I'll now turn the call over to <unk> for a financial update Dan will then give an overview of our commercial performance and Rob will provide an update on progress across our R&D programs.

Thanks, Bruce I.

Renee Gala: I'm pleased to share our financial results this quarter, which reflect strong top and bottom line growth, including a meaningful contribution from our recent launches at Zilka. With our strong financial and operational performance this year, we are poised for growth and revenue diversification as we continue to make substantial progress towards our goal of delivering nearly half of our 2022 revenues from products launched since 2019. Total revenues for the third quarter were $601 million, representing an increase of 12% over the same period last year, led by double-digit growth in our oncology portfolio. Excluding Irwin Ace, where sales have been significantly impacted by supply constraints, total revenues increased 15% in the third quarter compared to last year.

I'm pleased to share our financial results this quarter, which reflects strong top and bottom line growth, including a meaningful contribution from our recent launch of that silica with our strong financial and operational performance. This year, we are poised for growth and revenue diversification as we continue to make substantial progress.

Towards our goal of delivering nearly half of our 2022 revenues from products launched since 2019.

Total revenues for the third quarter were 601 million, representing an increase of 12% over the same period last year led by double digit growth in our oncology portfolio.

Excluding or when Ace where sales have been significantly impacted by supply constraints total revenues increased 15% in the third quarter compared to last year.

Renee Gala: Oncology net sales increased 37%, driven by a robust launch of Zepzelka that generated net sales of $37 million in its first quarter on the market, and a $13 million increase in Depotilio net sales as physicians resumed stem cell transplants that had been delayed due to COVID-19. Neuroscience net sales grew 7% in the quarter, led by continued strong performance of Xyrem. Turning to operating expenses, our adjusted SG&A expense increased by $28 million compared to the third quarter of 2019, driven by targeted investments to support our multiple commercial launches. During the quarter, we also recorded a $10 million acquired IPR&D expense related to our expanded collaboration with Red X Pharma. Our disciplined approach to capital allocation, combined with our top-line revenue growth, is enabling us to make significant investments in our business while still delivering growth in our non-gap adjusted EPS of 5% over the same period last year, resulting in non-gap adjusted EPS of $4.31 a share.

Oncology unit sales increased 37% driven by robust launch of the silica the generated net sales of $37 million in its first quarter on the market and the 13 million dollar increase than Defitelio net sales as physicians reasons stem cell transplants that had been delayed.

Due to cope at 19.

[noise] neuroscience that sales grew 7% in the quarter led by continued strong performance of Xyrem.

Turning to operating expenses, our adjusted EPS DNA expense increased by $28 million compared to the third quarter of 2019, driven by targeted investments to support our multiple commercial launches.

During the quarter. We also recorded a $10 million acquired IP R&D expense related to our expanded collaboration with Red ex pharma.

Our disciplined approach to capital allocation combined with our topline revenue growth is enabling us to make significant investments in our business.

While still delivering growth in our non-GAAP adjusted EPS up 5% over the same period last year, resulting in non-GAAP adjusted EPS of $4.31 a share.

Renee Gala: Turning to guidance, as we approach the end of the year, we're taking the opportunity to update our full year 2020 financial guidance. On the top line, we are raising our total revenue guidance to a range of $2.32 to $2.38 billion, which represents an increase from our prior guidance of $75 million at the midpoint. For oncology, we're increasing our net sales guidance to a range of 525 to $565 million, reflecting the robust launch performance of Zepselca and improved trends for Daffodilio and Vixio. This updated guidance represents a $60 million increase at the midpoint from prior guidance.

Turning to guidance as we approach the ended the year, we're taking the opportunity to update our full year 2020 financial guidance.

On the top line, we are raising our total revenue guidance to a range of $2.32 billion to $2.38 billion, which represents an increase from our prior guidance of $75 million at the midpoint.

For oncology, we're increasing our net sales guidance to a range of $525 million to $565 million, reflecting the robust launch performance obsessed celica and improved trends for Defitelio and Vyxeos there.

This updated guidance represents a 60 million dollar increase at the mid point from prior guidance.

In neuro science, we are raising the lower end of our net sales guidance to a range of $1.76 billion to $1.8 billion to reflect continued strong performance of this business.

Renee Gala: In neuroscience, we are raising the lower end of our net sales guidance to a range of $1.76 to $1.8 billion to reflect continued strong performance of this business. As a reminder, we expect minimal sales of ZyWave in the fourth quarter. Also, throughout our ZyWave launch, we expect both revenue bottle growth and growth to nets to be impacted by our investment in patient access programs, which are designed to enable seamless access to the product while we obtain broad commercial payer coverage. The launch of Zywave and Narcolepsy today, coupled with the potential launch of JZP258 in IH next year, reinforce our confidence that Oxivate will continue to be a key revenue contributor for Now turning to our expense guidance, given our strong operational performance and ability to navigate the impacts of COVID-19, we have increased our adjusted SG&A guidance to a range of $735 to $765 million to reflect further investment behind our commercial launches.

As a reminder, we expect minimal sales of die wave in the fourth quarter.

Also throughout our Xively of launch we expect both rather new bottle growth and gross to nets to be impacted by our investment in patient access programs, which are designed to enable seamless access to the product, while we obtain broad commercial payer coverage.

The launch of BSI way, the narcolepsy today, coupled with the potential launch of Jay Z P. 258 in I.H. next year reinforce our confidence that Oxybate will continue to be a key revenue contributor for many years.

Now turning to our expense guidance, given our strong operational performance and ability to navigate the impacts of COVID-19, we have increased our adjusted SGN a guidance to a range of $735 million to $765 million to reflect further investment behind our.

Commercial launches.

Renee Gala: Our adjusted R&D guidance remains unchanged. However, we are raising the lower end of our guidance for non-GAAP-adjusted EPS to a range of $1220 to $13 per share while continuing to invest in the diversification of our pipeline, as reflected in the $46 million increase in acquired IPR&D expense, which includes the $10 million upfront payment to REDx, as well as a $35 million upfront payment to SpringWorks in As a reminder, we no longer subtract payments of this nature from our adjusted net income.

Our adjusted R&D guidance remains unchanged.

We are raising the lower end of our guidance for non-GAAP adjusted EPS to a range of 12 20 to $13 per share while continuing to invest in the diversification of our pipeline as reflected in the 46 million dollar increase in acquired IP R&D expense.

Which includes the $10 million upfront payment to route Act.

As well as a $35 million upfront payment to spring works in the fourth quarter.

As a reminder, we no longer subtract payments of this nature from our adjusted net income.

Renee Gala: Turning to our balance sheet, year to date, we have generated $713 million in cash from operations and ended the quarter with cash and investments of $1.9 billion. Driving sustainable and robust profitability and cash flow remains a priority, and our healthy balance sheet and liquidity give us the capacity to pursue a broad set of corporate development opportunities. With recent transactions, such as the collaboration with Red X and acquisition of the Pha Inhibitor Program from SpringWorks, we have expanded our neuroscience and oncology pipeline with innovative assets. The Red X Steel is a great example of how we externalize research with very capable partners to pursue specific pathways of interest.

Turning to our balance sheet year to date, we have generated 713 million in cash from operations and ended the quarter with cash and investments of $1.9 billion.

Driving sustainable and robust profitability and cash flow remains a priority and our healthy balance sheet and liquidity gives us the capacity to pursue a broad set of corporate development opportunities.

With recent transactions such as the collaboration with Red acts and acquisition of the fall inhibitor program from Spring works, we have expanded our neuroscience and oncology pipeline with innovative assets.

The rhetoric steel is a great example of how we externalize research with very capable partners to pursue specific pathways of interest.

And the spring works transaction brings global commercial rights to a promising phase two ready asset that is strategically aligned with our portfolio and has large market potential.

Finally, our transaction with farm alarm, which closed at the beginning of this year enabled us to rapidly convert cash on our balance sheet into a revenue generating assets that we expect to deliver meaningful growth and diversification for the company.

Renee Gala: And the SpringWorks transaction brings global commercial rights to a promising Phase 2 ready asset that is strategically aligned with our portfolio and has large market potential. Finally, our transaction with PharmaMar, which closed at the beginning of this year, enabled us to rapidly convert cash on our balance sheet into a revenue-generating asset that we expect to deliver meaningful growth and diversification for the company. With a substantial balance sheet combined with productive and growing capabilities across development, regulatory, and commercial, we look forward to leveraging our strengths in corporate development to continue to drive long-term value for the company. I'll now turn the call over to Dan.

With a substantial balance sheet combined with productive and growing capabilities across development regulatory and commercial we look forward to leveraging our strengths and corporate development to continue to drive long term value for the company.

Ill now turn the call over to Dan.

Thank you Renee.

2020 has been a catalyst rich year for us and I'm pleased weve achieved multiple key objectives across our commercial and regulatory organizations, including the FDA approvals of the subs OCA and <unk>.

Three product launches.

Your opinion rolling launch of snows in May.

The U.S. launches up soaking in July.

Daniel N. Swisher: Thank you, Rene. 2020 has been a catalyst-rich year for us, and I'm pleased we've achieved multiple key objectives across our commercial and regulatory organizations, including FDA approvals of Subzelka and Zywave. FREE PRODUCT LAUNCH, European rolling launch of Cenocian May, U.S. launch of Zepselka in July, and today's launch of Zywave in the U.S. for the treatment of narco... With many of our engagements this past quarter with physicians, payers, and regulators being virtual. Our strong operational performance reflects the agility and innovativeness of our products, as well as the therapeutic value of our products. Xyrem delivered strong results.

Today's launches I wave in the U.S. for the treatment of narcolepsy.

With many of our engagements this past quarter with physicians payers and regulators being virtual.

Our strong operational performance reflects the agility and commitment of our innovative teams.

As well as a therapeutic value of our products.

Xyrem delivered strong results despite the challenges of COVID-19 pandemic.

In the third quarter Xyrem volume increased 4% compared to the same period last year, reflecting strong patient persistence and compliance.

Average number of active Xyrem patients is 15075.

The increase of 2% from the same period last year.

New patient diagnoses and enrollments continued to be negatively impacted by code at 19.

Daniel N. Swisher: Despite the challenges of COVID-19, in the third quarter, Xyron volume increased 4%, reflecting strong, patient-persistent demand. The average number of active Zyrum patients..., an increase of 2% from the same period last year. New patient diagnoses and enrollments continued to be negatively impacted by COVID-19 during the quarter, and we expect the impact to continue during the pandemic. However, we were encouraged by an upward trend. Patient enrollment during the quarter. More sleep centers reopened, and patients with more severe symptoms were prioritized. Although we observed in this quarter a slight COVID-19-related increase in demand, there was no meaningful mix.

During the quarter and we expect the impact to continue during the pandemic. However, we were encouraged by an upward trend in new patient enrollments during the quarter as more sleep centers reopened and as patients with more severe symptoms.

Prioritize.

Although we observed in this quarter, a slight cove in 19 related increase in demand for.

Patient assistance and government programs.

There was no meaningful mix or no meaningful shift in the payer mix.

Turning to <unk>, which is now commercially available for narcolepsy patients following the rapid implementation of <unk>.

The first and only lower sodium oxybate approved for the treatment of cataplexy in.

In narcolepsy and represents a significant advance for patients.

Our launch efforts are focused on unlocking the potential in narcolepsy through awareness programs for physicians and patients to ensure their understanding of the lifelong burden of narcolepsy in high sodium intake.

Daniel N. Swisher: No meaningful shift in the payer. Turning to Zywave, which is now commercially available for narcolepsy patients following the rapid implementation of our REM. Xywave is the first and only lower-sodium Oxybate approved for the treatment of cataplexy, NARCLIP, and represents a significant advance for, Our launch efforts are focused on unlocking the potential in narcolepsy through awareness programs for physicians and patients to ensure their understanding of the lifelong burden. Additionally, our health care provider education is emphasized. The importance of patience, total

Additionally, our health care provider education is emphasizing the importance of patients total health.

I'm pleased that today on our first day of launch.

Weve has coverage on the express scripts national preferred formulary.

Our commercial lives.

Well, we continue to secure additional commercial payer coverage, we have robust patient assistance programs in place to help reduce barriers to initiating treatment.

Daniel N. Swisher: I'm pleased that today, on our first day of launch, Xywave has coverage on the Express Scripts National Preferred Formula while we continue to secure additional commercial payer coverage. We have robust patient assistance programs in place to help reduce barriers to initiating xy-wave. Particularly important for those patients, which you may not yet have commercial coverage for. Our goal is to have the majority of Oxybate patients on Zyway by 2023. Think about the launch curve.

Which is particularly important for those patients who may not yet have commercial coverage at launch.

Our goal is to have the majority of oxybate patients onsite ways.

2023.

We think about the launch curve.

Our expectation is that patients will adopt sideways overtime.

We know that patients don't see their doctor each month, and many may still have xyrem and their medicine cabinet.

<unk> finished their xyrem supply before seeking a new script.

We expect so I would have to become the oxybate treatment of choice of all patients, including currents Xyrem patients patients, who previously were not prescribed xyrem based on sodium concerns and newly diagnosed narcolepsy patients.

Daniel N. Swisher: Our expectation is that patients will adopt Zywave over time. We know that patients don't see their doctor each month and many may still have Xyrem in their medicine, and they will finish their Xyrem supply before seeking a new script. We expect Zywave to become the Oxivate treatment of choice of all patients, including current Xyrem patients. Patients who previously were not prescribed Xyrum based on sodium and newly diagnosed narcolepsy.

Additionally, with the recently announced positive phase three top line results in idiopathic hypersonic.

We look forward to bringing GCP to fight to the age patient population next year.

Turning now to Sanofi during the quarter. We were pleased with Sonos is continued progress and growth in new patient starts. Despite the continued challenges in engaging with Pulmonologists, who are on the front line managing COVID-19 patients.

Daniel N. Swisher: Additionally, with the recently announced positive phase 3 top line results, we look forward to bringing JCP 258 to the IH patient population. Turning now to CENOSI, during the quarter, we were pleased with CENOSI's continued progress. Growth and New Patients Start, Despite the continued challenges in engaging with pulmonologists who are on the frontline managing COVID-19, our sales force was able to... face-to-face interactions with physicians during the third quarter. Approximately 40% of CINOSI interactions were in.. observed a 7% increase in U.S. prescriptions compared to the second quarter of 2020. Including strong patient demand, net sales were $9 million in the third quarter of 2020. $20 million for the nine-month period and included inter-quarter variability in gross net.

Our sales force was able to increase fees.

Face to face interactions with physicians during the third quarter and approximately 40% of Sonos interactions were in person.

We observed a 7% increase in U.S. prescriptions compared to the second quarter.

2020, including strong patient refills.

Net sales were 9 million in the third quarter of 2020 and $20 million for the nine month period and included inter quarter variability in gross to nets.

Continue to expect full year 2020 gross to nets in the 40% to 60% range consistent with other analog.

Two expenses no see promotional efforts and reach the larger say prescriber audience.

We have partnered with a contract sales organization to deployed 50 additional sales representatives dedicated exclusively to Sanofi.

These sales representatives each with over 10 years of experience.

Daniel N. Swisher: Continue to expect full year 2020 gross to nets in the 40 to 60 percent range. To expand CENOSI promotional efforts and reach the larger OSA prescriber audience, we have partnered with a contract sales organization to deploy 50 additional sales representatives, dedicated exclusively to CINOSAC.

Third and trained last month and there in the field, reaching customers starting today.

These representatives will engage with 6000 additional let's say prescribers.

We are looking forward to expanding our reach and ensuring more each <unk> makes this important treatment option.

It's a little too there are lets say and narcolepsy patients.

Additionally, we're making progress in bringing Sonos C to more patients around the world, We launched in Denmark last month, and we look forward to continuing the rolling launched two other European countries over the next 18 months.

Daniel N. Swisher: Sales Representatives, each with over 10 years of experience, were hired and trained last month, and they're in the field, reaching customers, starting today. These representatives will engage with 6,000 additional OSA prescribers. We are looking forward to expanding our reach and ensuring more is available for their OSA and Narcoleps. Additionally, we're making progress in bringing Cynosi to more patients around the world. We launched in Denmark last... We look forward to continuing the rolling launch to other European countries over the next few years.

Turning now to the oncology portfolio I'm very pleased to give you an update on our launch of sub Selco, which became commercially available in early July for the treatment of metastatic small cell lung cancer.

Third quarter net sales were $37 million.

Our launch efforts have been focused on the top prescribers and we were seeing strong interest from physicians, reflecting the significant unmet need for new treatment options and small cell lung cancer and in particular is up so 'cause favorable product profile in this setting.

Daniel N. Swisher: Turning now to the Oncology Portfolio, I'm very pleased to give you an update on our launch of ZepSalc, which became commercially available in early July for the treatment of metastatic small cell lung cancer. THIRD QUARTER NET SALES WERE $37 MILLION. Our launch efforts have been focused on the top prescribers. We are seeing strong interest from physicians, reflecting the significant unmet need, for new treatment options in small cell lung cancer, and in particular, Zabzelka's favorable product profile in this setting. During the third quarter, more than 800 accounts placed orders. Approximately 80% of customers will reorder. There was a 70-30 split between community and academic research, in line with our expectations.

During the third quarter more than 800 accounts placed orders and approximately 80% reordered.

There was a 70 30 split between community and academic centers in line with our expectations.

Based on early claims data from the first month of launch we observed up soccer usage in both second line and third line and beyond settings.

We expect there would be some initial pent up demand in this three third line plus setting and we anticipate that usage decreases.

Going forward as more second line patients are treated was up soco.

Subs OCO was included in the NCCN guidelines in July and last month, we received the NCCN promotional materials and began rolling these out to our health care audiences.

Daniel N. Swisher: Based on early claims data from the first month of launch, we observed ZAPZOCA usage in both second-line and third-line and beyond settings. I suspect there would be some initial pent-up demand in this third line plus setting, and we anticipate that usage will decrease going forward as more second-line patients are treated with Zepcel. Zevzelko was included in the NCCN guidelines in July.

We are extremely pleased with so because.

Robust initial launch performance.

Lastly, we recently entered into a license agreement with farm Amar for Canadian rights, and we look forward to bringing subs OCA to patients in Canada as well.

Now turning to Irwin is due to continued quality and manufacturing issues.

Daniel N. Swisher: Last month, we received the NCCN promotional materials and began rolling these out to our healthcare audience. We are extremely pleased with Zeph Zelka's robust initial launch. Lastly, we recently entered into a license agreement with PharmaMar. Canadian Rights, and we look forward to bringing Zep Zelka to patients in Canada as well. Now turning to Irwin Ace due to continued quality and manufacturing issues at PVL. The owner and sole manufacturer of Erwin Ace, the product was only available in the U.S. market for one day.

The owner and so manufacturer of Berlin Ace product was only available in the U.S. market for one day in the third quarter we.

We expect significant global supply disruptions to continue for the remainder of the year unrelated to COVID-19.

Our agreement with P.L. expires at the end of this year, we have the right to sell certain Irwin ace.

Inventory post termination, we expect to distribute available or when they supply during the first half of 2021.

Given the urgent need for reliable and high quality recombinant spares and ASE, we are focused on bringing GBP four or five day to market as quickly as possible.

Robert Iannone: 3rd quarter, We expect significant global supply disruptions to continue for the remainder of the year, unrelated to COVID-19. Our agreement with PBL expires at the end of this month. We have the right to sell, sir, in Irwin Ace Inventory, post-termination, as we expected, Available Erwin H. Supply during the first half. Given the urgent need for a reliable and high-quality recombinant asparagin, we are focused on bringing JZP 458 to market as quickly as possible. In summary, I'm extremely pleased with our third quarter, year-to-date execution across our portfolio. Including the progress that we've made with new products, we look forward to continuing to deliver significant near and long-term revenue from an Expanding Diversified Portfolio, durable and high-value programs as we bring multiple new medicines and indications to market. I will now turn the call over to Rob for an update on our development. Thank you, Dan.

In summary, I'm extremely pleased with our third quarter and year to date execution across our portfolio.

Putting the progress that we've made with new product launches.

We look forward to continuing to deliver significant near and long term revenue from an expanding diversified portfolio portfolio.

Durable high value programs, as we bring multiple new medicines and indications to market.

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

Thank you Dan.

In the third quarter, we work tirelessly to mitigate the impact of COVID-19, and made significant progress across our R&D portfolio, including the recent delivery of topline.

Data from our JV P to Pfizer idiopathic hypersound.

Continued strong enrollment in the JCP 458 study as well as the re initiation and completion are healthy volunteer studies for JCP, three five and GBP three to four.

I'm pleased that since the start of the third quarter, we have made to targeted additions to our early to mid stage pipeline areas of significant interest and unmet need.

Robert Iannone: In the third quarter, we worked tirelessly to mitigate the impact of COVID-19 and made significant progress across our R&D portfolio, including the recent delivery of top-line data from our JZP 258 trial in idiopathic hypersomnia, continued strong enrollment in the JZP 458 study, as well as the reinitiation and completion of our healthy volunteer studies for JZP 385 and JZP 324. I'm pleased that since the start of the third quarter, we have made two targeted additions to our early to mid-stage pipeline in areas of significant interest and unmet need. In September, we entered into a collaboration agreement with Red X for the discovery and preclinical development of two cancer targets in the RAS-RAF MAP kinase pathway.

In September we entered into a collaboration agreement with Red X for the discovery and preclinical development of two cancer targets in the Ras route map kinase pathway.

This complements our Pan RAF inhibitor program and broadens our approach in this interesting and important pathway.

In October we announced the acquisition of Spring works Therapeutics saw inhibitor program, which includes yeah, Oh for four or 578, or five which all abbreviated yeah, a four or five.

And your there's some books on hibbett or that is phase two ready.

Consistent with our strategy to focus on life changing medicines for people affected by conditions.

Its current therapies are lacking we plan to initially focus this program and the potential treatment of post traumatic stress disorder PTSD in patients with inadequate response to approved therapies.

We expect to initiate a phase two study who late 2021, following protocol development and global regulatory interactions.

Robert Iannone: This complements our PAN-RAF inhibitor program and broadens our approach to this interesting and important path. In October, we announced the acquisition of SpringWorks Therapeutics' Pha Inhibitor Program, which includes PF-04457845, which I'll abbreviate as PF-845, and an Irreversible Thaw Inhibitor that is Phase 2 ready. Consistent with our strategy to focus on life-changing medicines for people affected by conditions for which current therapies are lacking, we plan to initially focus this program on the potential treatment of post-traumatic stress disorder, PTSD, in patients with inadequate response to improved therapy. We expect to initiate a phase two study in late 2021 following protocol development and global regulatory interaction. PTSD is a chronic disorder and a significant public health concern for which there have been no new approved pharmacotherapies for nearly two decades. Current treatments include frontline treatment with psychotherapy, two approved SSRIs, and multiple other agents that are used off-label to try to control symptoms.

Yes, he is a chronic disorder and a significant public health concern for which there had been no new approved pharmacotherapy is for nearly two decades.

Current treatments include front line treatment psychotherapy, two crews and assess our eyes and multiple other agents that are used off label to try to control symptoms. However, 45% of patients are not well controlled and have residual symptoms.

With the other under diagnosed rate of PTSD, no treatment rates and significant number of patients with inadequate treatment responses.

The U.S. target population and Pts the patience is approximately 2 million.

[noise] symptoms the Pts C.

Particularly impaired fear extinction anxiety and.

And sleep disturbances have significant negative effects on patients ability to function and their quality of life.

Yes, 845 represents an innovative approach to treating PTSD novel mechanism of action and has the potential to address multiple core symptoms of the disease, I enhancing fear extinction, reducing anxiety and improving disrupted sleep.

Based on clinical results from the healthy volunteer experimental model year extinction.

So with all the positive effects on sleep and mood observed in patients with kind of this houston sooner undergoing acute cannabis withdrawal.

Robert Iannone: However, over 45% of patients are not well controlled and have residual symptoms, with an underdiagnosed rate of PTSD, low treatment rates, and a significant number of patients with inadequate treatment response. The U.S. target population of PTSD patients is approximately 2 million. Symptoms of PTSD, particularly impaired fear extinction, anxiety, and sleep disturbances, have significant negative effects on patients' ability to function and their quality of life.

There was a strong rationale to support the evaluation of this molecule in patients with PST.

We are therefore really excited to be adding the foreign hibbett or to our expanding clinical stage there are sites pipeline.

Turning to JCP 258 last month, we were pleased to share the positive clinically meaningful highly statistically significant topline results from our JCP to find the phase three study in adult patients with idiopathic Hypersonics area.

Robert Iannone: PF845 represents an innovative approach to treating PTSD with a novel mechanism of action that has the potential to address multiple core symptoms of the disease by enhancing fear extinction, reducing anxiety, and improving disrupted sleep. Based on clinical results from a healthy volunteer experimental model of fear extinction.

We are excited by the compelling results and the magnitude of improvement improvement observed in the study.

We are now fully focused on submitting a supplemental NDA to the FDA in the first quarter 2021 being.

We intend to bring this important therapy to patients as soon as possible launch targeted in the fourth quarter of 2021.

To this end we were pleased that in September FDI granted fast track designation JCP to fighting for the treatment of idiopathic Hypersound there.

Robert Iannone: As well as the positive effects on sleep and mood observed in patients with cannabis use disorder undergoing acute cannabis withdrawal, there is a strong rationale to support the evaluation of this molecule in patients with PTSD. We're therefore really excited to be adding the PHA inhibitor to our expanding clinical stage neuroscience pipeline. Turning to JCP 258, last month, we were pleased to share the positive, clinically meaningful, and highly statistically significant top line results from our JCP 258 phase 3 study in adult patients with idiopathic hypersomnia. We are excited by the compelling results and the magnitude of improvement observed in the study. We are now fully focused on submitting a supplemental NDA to the FDA in the first quarter of 2021. We intend to bring this important therapy to patients as soon as possible, with launch targeted in the fourth quarter of 2021. To this end, we were pleased that, in September, FDA granted fast-track designation to JZP258 for the treatment of idiopathic hypersomnia. Turning to JCP385, our highly selected modulator of T-type calcium channels for the treatment of patients with essential tremor,

Turning to JCP create five are highly selective modulator teekay calcium channels for the treatment of patients with essential tremor.

After a pause due to koby 19.

We made important progress in September completing our PK study of an improved formulation.

I'm proud that our team was able to efficiently and quickly restart and complete this trial, while protecting the safety of the study volunteers.

Keeping us on track for initiation of the Phase Twob study in the first half of 2020 more.

Now turn call development programs and starting with subsea okay.

Actively working on the development program because itself in collaboration with our partner farmer more and supporting robust data generation in collaboration with external investigators.

Areas of interest include evaluating is himself small cell lung cancer in combination with other therapies.

The first point and post Latin settings, as well as exploration of sunk in other tumor types.

In the relapse small cell cancer setting.

So lung cancer setting.

Combination immunotherapy two investigator initiated phase one two studies are underway one in combination with Pembrolizumab and another with a teaser listen that.

We expect to receive results of the phase three Atlanta study this quarter.

Now moving to JCP, four or five Nate.

Our recombinant her when the asparagus days in the third quarter, we continue to enroll patients in our pivotal phase two three study.

Robert Iannone: After a pause due to COVID-19, we made important progress in September, completing our PK study of an improved formulation. I'm proud that our team was able to efficiently and quickly restart and complete this trial while protecting the safety of the study volunteers and keeping us on track for initiation of a Phase 2B study in the first half of 2021. Now to our Oncology Development Programs, starting with Zitzelka. We're actively working on the development program for Zipselka in collaboration with our partner, PharmaMar, and supporting robust data generation in collaboration with external investigators. Areas of interest include evaluating Zipf-Celca in small cell lung cancer in combination with other therapies in both the first line and post-platinum settings, as well as exploration of Zipf-Celca in other tumor therapies in the relapsed small cell cancer setting.

We're pleased that in September FCTA granted JCP, four or five a rare pediatric disease designation for the treatment of pediatric MLL, a further endorsement of the clear unmet need among patients with AOL.

Pediatric patients with ALS.

We are focused on bringing JCP four or five days to patients as quickly as possible and remain on track with our goal to launch in the U.S. and mid 2021 Tony.

Following ballet submission.

Early as year end.

The Defitelio phase two proof of concept study for prevention of acute graft versus host disease was completed and the outcome of the study demonstrated a modest trend toward a benefit with defitelio, which was more pronounced in a subgroup of patients receiving anti Simon thank god.

The safety profile was consistent with previously reported clinical studies and continues to support the favorable safety profile.

Overtime.

Only an evaluation of the full data a decision will be made about any further research for the prevention of acute gvhd.

Robert Iannone: Two investigator-initiated Phase I, II studies are underway, one in combination with pembrolizumab and another with atezolizumab. We expect to receive results from the Phase 3 Atlanta study this quarter. Now moving to JCP 458, our recombinant Erwinia asparaginase. In the third quarter, we continue to enroll patients in our Pivotal Phase II-III study. We were pleased that in September, FDA granted JCP 458 Rare Pediatric Disease Designation for the treatment of pediatric ALL, a further endorsement of the clear unmet need among patients with ALL, especially pediatric patients with ALL. We are focused on bringing JCP-458 to patients as quickly as possible and remain on track with our goal to launch in the U.S. in mid-2021, following BLA submission, as clearly as you're at. The Defitilio Phase 2 Proof of Concept study for prevention of acute graft-versus-host disease was completed, and the outcome of the study demonstrated a modest trend toward a benefit with Defitilio, which was more pronounced in a subgroup of patients receiving anti-thymocyte globulin.

For Vyxeos.

Clinical data has been submitted for presentation at the upcoming American Society of Hematology virtual meeting in December 2020, including preliminary luminary data.

From a phase two clinical study being conducted at the University of Texas, MD Anderson Cancer Center evaluating Vyxeos in combination with Minetta KLAX in relapse refractory or de Novo acute myeloid leukemia.

I'll now turn the call back over to Bruce for closing remarks.

Thank you Rob.

We set out an ambitious range of transformative objectives for 2020, and 2021 I'm proud that through the flexibility innovation and commitment of our teams. We are on track to deliver on our key objectives. Despite the impact of the pandemic I really want to thank our employees all around the globe for their incredible efforts this year.

We are well on our way to executing five launches through the end of 2021 with three products already launched and to next year. JCP 458 is on track for launch in mid 2021, and JCP to 58 for I.H. is targeted for launch in the fourth quarter.

We have made significant advances in our R&D pipeline and have also completed a number of corporate development transactions. This year.

Robert Iannone: The safety profile is consistent with previously reported clinical studies and continues to support the favorable safety profile of defibrillators. Following an evaluation of the full data, a decision will be made about any further research for the prevention of acute QVH with VIXIOS. Clinical data have been submitted for presentation at the upcoming American Society of Hematology virtual meeting in December 2020, including preliminary data from a phase two clinical study being conducted by the University of Texas MD Anderson Cancer Center evaluating Vixios in combination with venetoclax and relapsed refractory or de novo acute myeloid leukemia.

And our disciplined and thoughtful management of resources financial performance and liquidity will allow us to take advantage of additional strategic opportunities as they arise.

Together this gives us a strong and durable foundation and positions us well to continue to deliver significant improvements to the lives of the patients we serve as well as growth and value to shareholders. Thank you for joining us on the call today.

Kathy.

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 with that said operator.

Please open the line for questions.

Okay. So as a reminder, just a question you will need to press star one on your telephone services all your questions first about okay.

Bruce C. Cozadd: I'll now turn the call back over to Bruce for closing remarks. Thank you, Rob. We set out an ambitious range of transformative objectives for 2020 and 2021. I'm proud that, through the flexibility, innovation, and commitment of our team, we are on track to deliver on our key objectives despite the impact of the pandemic. I really want to thank our employees all around the globe for their incredible efforts this year.

Again that is star one on your telephone please stand by were weaker Bogusky a neighbor Austin.

We do have a question from Brandon Folkes from Cantor Fitzgerald.

All lines.

Hi, Thanks for taking my question and congratulations on the quarter and maybe just on J.P. full five eight.

Can you talk about if you remain confident that we will see interim data in the near term and just what is the clinical path from here in terms of remaining on track to submit a filing by year end. Thank you.

Operator: We are well on our way to executing five launches through the end of 2021, with three products already launched and two next year. JCP 458 is on track for launch in mid 2021, and JCP 258 for IH is targeted for launch in the fourth quarter. We have made significant advances in our R&D pipeline and have also completed a number of corporate development transactions this year, and our disciplined and thoughtful management of resources, financial performance, and liquidity will allow us to take advantage of additional strategic opportunities as they arise. Together, this gives us a strong and durable foundation and positions us well to continue to deliver significant improvements to the lives of the patients we serve as well as growth and value to shareholders. Thank you for joining us on the call today.

Yeah. Thanks, Brandon for that question I'll, just point out to people that we have not said we will necessarily publicly.

Release.

Interim analysis data what we have said is we'll be looking at data along the way and that will inform our path.

Forward with F.D.A., Rob maybe I could ask you to comment a little bit on what lies ahead.

So we continue to work with the FDA and the appropriate data package and timing for the OLED submission.

And as we said in the transcript, where we continue to target a mid year launch.

Potential deal a submission is as early as this year.

Great. Thank you very much.

Next one on acute with whom were filed from Evercore fewer and all lives.

Hi, Thanks, so much for taking my question first congrats on the hyper Samuel study. My question was if you could speak Bruce to the size of the market and perhaps also remind us how many have kearns arm patients are on I are for hypersound indication and and on that note also could you remind us.

Operator: 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. With that said, Operator, please open the line for questions. Okay, so as a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Again, that is star 1 on your telephone.

Bruce I'm, sorry could you could you tell us if you believe there's if there's any real risk to the settlement structure you have on Xyrem post 2022, Thank you very much.

So thanks tumor I'll take the second part of that question first you know we entered a number of settlement agreements and were confident those are good agreements.

Don't have anything more to say at this point, maybe I'll come to Dan Oh for the question on the idiopathic I personally opportunity and whether there's overlap with current treated xyrem patients yeah. Thanks Russ.

Brandon Richard Folkes: Please stand by while we compile the Q&A roster. We do have a question from Brandon Folkes from Canter Fitzgerald. You are now live. Hi, thanks for taking my question and congratulations on the quarter. Maybe just on JDP 458, can you talk about if you remain confident that we will see interim data in the near term and just what is the clinical path from here in terms of remaining on track to submit a filing by year end? Thank you. Yeah, thanks, Brandon, for that question.

And this is some of the information. We also gave last a week on the I'm as I leave.

Teleconference, but in the U.S. based on claims data, which we think is probably an under diagnosis Theres 30 cents 37000 diagnosed I age patients. We also know that the majority of that diagnosis.

Is generated by sleep doctors similar to two.

Bruce C. Cozadd: I'll just point out to people that we have not necessarily said we will necessarily publicly release the Interim Analysis Data. What we have said is we'll be looking at data along the way, and that'll inform our path forward with FDA. Rob, maybe I could ask you to comment a little bit on what lies ahead. And as we said in the transcript, we continue to target a mid-year launch with a potential BLA submission as early as February. Great, thank you very much. Next one on the queue is Umar Rafat from Evercore. You are now live.

Writers really was a strong 90% overlap with 800.

Physicians.

In terms of the question about how many patients are currently being treated with Xyrem. We think very few based on anecdotes and what we know on.

Clinic basis, and even in the study.

We had.

I don't know 40, or so patients only a single digit number had previous xyrem exposure. So we really do you think this will unlock a new opportunity for US which is obviously got very close overlap with where we are and it will also open up for an unmet need a payer access.

Thank you Richard.

Yes excellent on the Q is a reason that Schmidt from BMO capital markets. Your Dol lives.

Umar Rafat: Hi, thanks so much for taking my question. First, congrats on the hypersomnia study. My question was, Bruce, about the size of the market and perhaps also remind us how many current XyRM patients are on it for hypersomnia. And on that note, also, could you remind us, Bruce, sorry, could you tell us if you believe there's any real risk to the settlement structure you have on XyRM post-2022? Thank you very much. So, thanks, Umar.

Hi, guys does that felt good number was very impressive in the third quarter. So just provide some more detail on the early feedback from physicians on the product how they're initially using it in their patients how much is getting on the NCCN guidelines helped with uptake and what does receptivity from payers been on pricing.

And how is reimbursement been so far with that okay. Thank you.

Yeah, Thanks, Gary maybe I'll turn it over to Kim to take this question.

Bruce C. Cozadd: I'll take the second part of that question first. You know, we entered into a number of settlement agreements, and we're confident those are good agreements, and we don't have anything more to say at this point. Maybe I'll come to Dan for the question on the idiopathic hypersomnia opportunity and whether there's overlap with current treated xyrem patients, and this is some of the information we also gave last week at the Zaiwis Teleconference. U.S. based on claims data, which we think is probably under-diagnosed; we also know that the majority of that generated by sleep doctors is similar, really with a strong 90% overlap with 800 physicians. In terms of the question about how many I.H.

Sure. Thank you. Yes. We are also very pleased and excited with the performance and the customer response to the launch of of that Delta you know Dan highlights out of the most important numbers. There in terms of you know how to 800 accounts, having placed orders and 80% of having them.

Having reordered would you see a nice mix of business the craft community counts and academic you know early based on early claims data that we looked at from the first month of launch we're observing that delta usage in both the second line and the third line and beyond setting in a nice healthy portion of that in the second line setting which is.

Very positive indicator for us all prescribers see the value of using this product early.

Daniel N. Swisher: Patients are currently being treated with Xyrem, but we think very few, based on clinic basis and even in the study where we had 140 or so patients, a single-digit number had previous Xyrem exposures. We really do think this will unlock a new opportunity for us, close overlap with where we are, and it will also open up for an unmet need. Pay your, Operator? Operator?

On a patient.

Treatment regimen, we would've said did expect that there would be some initial pent up demand in the third line and beyond setting on until dissipate that that group.

The patient is going to decline moving moving forward.

In terms of reimbursement, we're very pleased where in this very strong situation on payers have.

Embraced that Delta and there's really no issues on that front from a coverage and reimbursement standpoint.

Operator: Mm-hmm, yep. Next one on the queue is Gary Nachman from BMO Capital Markets. You are now live.

Okay. Thank you.

Gary Nachman: Hi guys, the Zabzelka number was very impressive in the third quarter, so just provide some more detail on the early feedback from physicians on the product, how they were initially using it in their patients, how much getting on the NCCN guidelines helped with uptake, and what receptivity from payers has been on pricing, and how reimbursement has been so far with Zabzelka. Thank you. Yeah, thanks, Gary. Maybe I'll turn it over to Kim to ask this question.

Next one on the Q is Sammy for deals from SVB, Leerink fewer and all lines.

Thank you for the question congratulations on a nice quarter on that because that's that's got fail.

Hi, My question is on the side by the franchise you talked about it.

Expecting some impact.

Well the next couple of months as you gain coverage for diving.

I'm not going to be on the net realized price alone or should we anticipate some impact on blogging bell.

Kim Sablich: Sure. Thank you. Yes, we are also very pleased and excited with the performance and the customer response to the launch of Zelka. Dan highlights some of the most important numbers there in terms of having 800 accounts having placed orders and 80% of them having reordered. We do see a nice mix of business across community accounts and academic.

And also into context can you talk about weeks and that's having you know if you expect to have any impact on that or.

I think that that product will expand the market. Thank you.

Yeah, maybe I'll come to Kim first just to talk about what's going on at the at the patient level.

And then Ah Rene maybe you could comment on what people will see from a financial standpoint.

Just to clarify on the front part of that question at the patient level what is the specific question.

Kim Sablich: You know, based on early claims data that we looked at from the first month of launch, we're observing Zelka usage in both the second line and the third line and beyond setting, and a nice healthy portion of that in the second line setting, which is a very positive indicator for us that prescribers see the value of using this product early in a patient's treatment regimen. We did expect that there would be some initial pent-up demand in the third line and beyond setting and anticipate that that group of patients is going to decline moving forward. In terms of reimbursement, we're very pleased. We're in a very strong situation.

Oh. The question is that are we going to see an impact on the next realized price alone.

Or would you anticipate an impact on total patient number or what have you.

Has that.

So I'm, sorry, I'm not understanding the patient the patient part of the question.

I'll jump in I'll jump in Kim I mean.

No as we said in the call script, we're working very hard to make sure all patients who want to fly wave have access to fly waived can transition onto the product.

Rene maybe I can ask you to take the piece on financials.

Kim Sablich: Payers have, you know, embraced Zelka, and there are really no issues on that front from a coverage and reimbursement standpoint. Okay. Thank you. The next one on the queue is Ami Fadia from SVB Lyrinc. You are now live.

Sure Yeah. So we do expect through the payer access program sorry, the patient access programs that we've put in place that you will see as we have patience adopting sai wave an impact to both the revenue bottle growth.

Ami Fadia: Thank you for the question. Congratulations on a nice quarter for the Zercat sales. My question is about the Xyrum Xywave franchise. You talked about...

As well as an impact to gross to nets and not because of the different programs that are offered.

Kim Sablich: I'm expecting some impact. Over the next couple of months as you gain coverage for Zyvate, is that going to be on the net realized price alone, or should we anticipate some impact on volumes as well? And also, in this context, can you talk about Wakex and if that's having, you know, if you expect to have any impact from that, or if you think that that product will expand the market? Thank you.

So sub programs will come through as such has couponing stream gross to nets and other bridge program will come in the form of free bottles. So since we do report revenue bottle growth you may not be able to completely connect what you're seeing in terms of revenue bottles.

Renee Gala: Yeah, maybe I'll come to Kim first just to talk about what's going on at the patient level. And then Renee, maybe you could comment on what people will see from a financial standpoint. Just to clarify on the front part of that question, at the patient level, what is the specific question?

Xyrem versus revenue bottle growth in sideways since the patient access programs will provide that smooth transition does that make sense.

That's very helpful. Thank you.

And then maybe just to weigh in on your question about weak economy.

Kim Sablich: Oh, the question is that, are we going to see an impact on the naturalized price alone? Or would you anticipate an impact on total patient numbers or volume as well? So I'm sorry, I'm not understanding the patient part of the question. I'll jump in.

Yeah Wake Ics has been on the market for some time now and the reason.

Supplemental a change to their label, including Cataplexy is really just a re analysis of data that had been published and presented and was already out there. So we don't see a we haven't seen much of an impact if anything.

Having additional competitors in the market to grow the market given the still relatively low diagnosis rate can be a benefit in those patients who eventually come to oxybate.

Bruce C. Cozadd: I mean, you know, as we said in the call script, we're working very hard to make sure all patients who want Zywave have access to Zywave and can transition onto the product. Rene, maybe I can ask you to take the piece on financials. Sure, yeah, so we do expect through the payer access program, sorry, the patient access programs that we've put in place, that you will see, as we have patients adopting Zywave, an impact on both the revenue bottle growth, as well as an impact on growth to nets. And that's because of the different programs that are offered.

It's got a very unique profile does for addressing EPS and cataplexy and that was I believe we have the first and only low sodium oxybate that we believe will be the treatment of choice for Oxybate patience.

Thanks, Dan.

Next question comes from the line of David Amsellem from Piper Sandler you were no longer.

Thanks. So my question is surrounding Sonos C. I noted your comments about the contract sales organization and targeting.

Renee Gala: So subprograms will come through, such as couponing through growth to nets, and other large programs will come in the form of free bottles. So, since we do report revenue bottle growth, you may not be able to completely connect what you're seeing in terms of revenue bottles in Zyram versus revenue bottle growth in Zywave since the patient access programs will provide that smooth transition. Does that make sense?

More positions I guess the question here is are you comfortable with the overall strategic direction of that franchise.

And specifically.

Given the investment the.

The significant investments in sales and marketing focusing on Oh I say.

Is that.

Renee Gala: And then maybe just to weigh in on your question about Wacox, Ami. Yeah, Wacox has been on the market for some time now, and the recent... Supplemental change to their label, including cataplexy, is really just a reanalysis of data that had been published and presented, was already out there, so we don't see, we haven't seen much of an impact, if anything.

You know appropriate given the trajectory of the product and I guess, where I'm getting at is that would a you know a rare disease focus in other words exclusively at narcolepsy focused.

May have made more sense, maybe help me understand or help us understand how you're thinking about that product going forward. Thanks.

Ken maybe Kim I'll ask you to weigh in on this.

Sure I.

We remain very optimistic about the future Sanofi, we had very strong and favorable feedback from the prescribers and the patients that have utilized it. So we do believe that incremental investment and this product is going.

Daniel N. Swisher: So having additional competitors in the market to grow the market given the still relatively low diagnosis rate can be a benefit, and those patients who eventually come to OxyBait. It's got a very unique profile both for addressing EDS and cataplexy. And now, as I wave, we have the first and only low-sodium product.

Going to pay off and be warranted as Dan mentioned right now, we're adding 15 additional sales represented yeah. The sales representatives are very experienced each with over 10 years of experience. They were hired and trained last month.

Daniel N. Swisher: Oxibate that we believe will be the treatment of choice for, Thanks, Dan. Next question comes from the line of David Amsellem from Piper Sandler. You are now live. Thanks. So my question is about Sanosi.

In.

An additional 6000 always say prescribers, starting today that we have and with our current sales force been able to reach a and we do believe that this will be an important investments for us. So we're looking forward to expanding our reach and continuing to bring this important medications to both narcolepsy and let's say patient.

David A. Amsellem: I noted your comments about the contract sales organization and targeting more positions. I guess the question here is, are you comfortable with the overall strategic direction of that franchise? And specifically, given the investment, the significant investment in sales and marketing and focusing on OSA, is that appropriate given the trajectory of the product? And I guess where I'm getting at is that a rare disease focus, in other words, exclusively a narcolepsy focus, may have made more sense.

Excellent on the Q is roni call from Bernstein fewer and all lines.

Hi, Good afternoon. Thank you for taking my question and congratulations on the beat this quarter, especially since it was not driven by Xyrem, but some of your some of your other partner.

My question is on the pair dynamics for Skywave Asia somebody you kind of said he has spiked my ears.

[laughter], which is.

You got coverage from your partner he aside but you still need to get coverage can be all their large payers. Despite some discounts you've already given either.

Kim Sablich: Maybe help me understand or help us understand how you're thinking about that product going forward. Thanks. And maybe, Kim, I'll ask you to weigh in on this. Sure. We remain very optimistic about the future of Sanosi.

This year on Xyrem I was just wondering if you could just kind of give us a directional thinking here as we think about the transition of the franchise to Zaire wave away from Xylene should we expect the net price per bottle.

Kim Sablich: We've had very strong and favorable feedback from prescribers and patients that have utilized it. So we do believe that incremental investment in this product is going to pay off and be warranted. As Dan mentioned, right now, we're adding 50 additional sales representatives. These sales representatives are very experienced, each with over 10 years of experience. They were hired and trained last month, and they're going to enable us to reach an additional 6,000 OSA prescribers starting today that we haven't, with our current sales force, been able to reach.

To be low whereby you know not nontrivial amount. So this is not going to be a 234 cents decline, but something north of 10 or more I know those contracts and I've done and you kind of want to be careful here and what you say, but just you can just give us a a directional directional call. Just so we don't know if you want a reasonable expectation.

And second you said on the call on Monday that you have made some deals to do to get people access to design a Z wave through multiple pharmacies and I was wondering if you can elaborate on that and most importantly does that mean, the Threeforty me pharmacies will now be able to.

Be spans or at least at.

Ronnie Kaul: And we do believe that this will be an important investment for us. So we're looking forward to expanding our reach and continuing to bring this important medication to both narcolepsy and OSA patients. Next one on the queue is Ronnie Kaul from Bernstein. You are now live. Good afternoon. Thank you for taking my question and congratulations on the bid this quarter, especially since it was not driven by Xyron but some of your other products. My question is about the pair dynamics for Zywave.

Be that transition point for the orders on Xively.

Yeah, Ronny, maybe I'll take the second part of that first shows I wave likes I run this still shipped exclusively from.

A single pharmacy, and that's for Rems related reasons. So.

Maybe I'll, let him come back to the broader access question.

Yes, sure I think as we've mentioned on other calls at the gross level, we have priced at parity xylene xyrem at parity and really our objective as we move into contracting is for the two products to be at approximately the same level as well of course subject to the payer negotiate.

Bruce C. Cozadd: Something you kind of said here spiked my ears, which is... You got coverage from your partner, ESI, but you still need to get coverage from the other large payers, despite some discounts you've already given this year on Xyram. I was just wondering if you could just, you know, kind of give us a directional thinking thought here. As we think about the transition of the franchise to Xywave away from Xyram, should we expect the net price per bottle to be lower by, you know, non-trivial amounts? So this is not going to be a two, three percent decline but something north of 10 or more. I know those contracts are not done, and you kind of want to be careful here in what you say, but if you can just give us a directional call just so we don't kind of give you unreasonable expectations.

Patients that we have going on right now.

So just a quick.

But I guess the question is worse or do you view your net price in 2020, as we think about 22 and beyond should we kind of had stepped stepped down or you don't anticipate such such a step down in pricing for the franchise.

Rene you want to comment on that.

Well, we haven't given specific guidance for 2021 or 2022, Ronnie but what we have said is that we do expect our topline sales to grow in 2021, and we expect them to grow in 2022 and that by 2022, we would have nearly 50.

Percent of our revenues coming from our newer products for 2019 that sorry that have been launched from 2019 forward. So while we're not giving specific guidance for xylene right. Now we are looking to this diversified portfolio of products, we're launching to contribute really meaningful to our revenue going forward.

Bruce C. Cozadd: And second, you said on your call on Monday that you have made some deals to give people access to Xywave through multiple pharmacies. And I was wondering if you could elaborate on this. And, most importantly, does that mean that 340B pharmacies will now be able to dispense or at least be the transition point for orders on Xywave? Yeah, Ronnie. Maybe I'll take the second part of that first.

And we are expecting that growth at the topline for 2021, and 2022 and as you know the Oxybate franchise is they makes up still a large percentage of our revenues.

Bruce C. Cozadd: So Zywave, like Zyrem, is still shipped exclusively from a single pharmacy, and that's for REMS-related reasons. So maybe I'll let Kim come back to the broader access question. That's sure.

I appreciate it thank you.

Excellent on acute is Jason Gerberry from Bank of America fewer doll line.

Hi, Good evening. Thank you for taking my questions question just for Bruce can you comment maybe whats going on with the supply situation with or when is 20 million out of the lowest I've I've ever seen from from this product and looks like a bit of a dislocation.

Kim Sablich: I think, as we've mentioned in other calls, we have priced at parity, Zywave and Zyram at parity. And really, our objective as we move into contracting is for the two products to be at approximately the same net level as well, of course, subject to the payer negotiations that we have going on right now. So, let's get to questions. So I guess the question is, versus your net price in 2020, as we think about 22 and beyond, should we kind of step down, or do you not anticipate such a step down in pricing for the franchise? Rene, do you want to comment on that?

And I realize you're kind of in a sensitive position with the unwind of the contract ended the year with.

PBL, but I think it's important for investors to think about the competitive dynamics that GDP for fivea could be launching into next year. So can you provide any incremental color on perhaps what's going on with the supply situation.

Yeah, Jason Good good question and the important thing here is to just separate in your mind supply and demand.

You know there is still absolute demand for or Wynia asparaginase base and we're doing everything we can to make sure we provide as much supply to the market as possible. It's just been erratic in terms of when we have a watch that can be distributed.

Renee Gala: Well, we haven't given specific guidance for 2021 or 2022, Ronnie, but what we have said is that we do expect our top line sales to grow in 2021. And we expect them to grow in 2022. And that by 2022, we would have nearly 50% of our revenues coming from our newer products for 2019 that, sorry, that have been launched from 2019 forward. So while we're not giving specific guidance for Zywave right now, we are looking to this diversified portfolio of products we're launching to contribute really meaningfully to our revenue going forward. And we are expecting that growth at the top line for 2021 and 2022. And as you know, the Oxybate franchise still makes up a large percentage of our revenues. I appreciate it.

I am when they you.

Our available they are are dispersed quickly to help.

Patients who need the need the product.

So we think a you know it's it's even more important than we would have said a year or two ago that we have a reliable high quality.

In addition capacity.

More moderately manufactured product.

It will reliably meet the needs of patients both in the U.S. and then over time in all markets. So we're doing everything we can.

You're just seeing you know unpredictable.

Availability of product and very limited availability of product Dan anything you want to add on that.

Just you know each gosh takes quite some time to work through the quality system with the particular in the U.S.

And we do keep our customers as informed as we possibly can and we have.

Jason Matthew Gerberry: Thank you. Next one on the queue is Jason Gerberry from Bank of America. You are now live. Hey, good evening.

Did the supply website recently that we are anticipating a new Dutch available on November 4th to six but its going to continue to be sporadic, but we do see some product coming soon.

Jason Matthew Gerberry: Thank you for taking my questions. Question just for Bruce: can you comment maybe on what's going on with the supply situation with Erwin Ace? $20 million is probably the lowest I've ever seen from this product, and it looks like a bit of a dislocation.

Great. Thank you.

Next one is from Annabel Samimy from Stifel.

No lives.

Hi, Thanks for taking my question and congratulations on launches that socket that was that was great can you maybe give us a sense. If there was any initial stocking into the challenge or if it was all driven oh demand, specifically pent up demand and does that mean that there's going to be a decline.

Bruce C. Cozadd: And I realize that you're kind of in a sensitive position with the unwind of the contract end of year with PBL, but I think it's important for investors to think about the competitive dynamics that JCP 458 could be launching into next year. So can you provide any additional color on perhaps what's going on with the supply situation? Yeah, Jason, good, good question.

Quarter and.

If you could just give us a little bit of granularity or what underlying command represents in terms of patient cycles per patient average price per cycle I'm, just how that looks like.

Bruce C. Cozadd: And the important thing here is to just separate in your mind supply and demand. Uh, you know, there is still absolute demand for Erwinia asparaginase, and we're doing everything we can to make sure we provide as much supply to the market as possible. It's just been erratic in terms of when we have lots that can be distributed.

So Dan do you want to jump in on this yeah.

Yeah.

If you listen carefully the script, what we're saying is there was a a bolus as we expected third one fourth line.

And the good news was you know there was some benefit for those patients, but it's really good.

That ends up so could it be standard of care for relapsed second line patients and that's.

Daniel N. Swisher: I am when they, you know, are available, they are dispersed quickly to help. Patients Who Need the Product, uh... so we think uh... you know it's even more important than we would have said a year or two ago that we have a reliable, high-quality Transcription by CastingWords, more modernly manufactured product that will reliably meet the needs of patients both in the U.S. and then, over time, in all markets. So we're we're doing everything we can I'm just uh... you know each batch takes quite some time to work it through the quality system with the FDA, in particular in the United States, and we do keep our customers updated on the supply website. We are anticipating a new batch. It's going to continue to be sporadic. Great, thank you. The next one is from Annabel Samy from SPIEFL. You are now live.

We're what we're penetrating into and there's still plenty of room for growth and so you know third line et cetera will fall off as more and more patients in second line have that exposure, but you shouldn't anticipate a quarter over quarter decline.

Any granularity on the cycles are patients or.

Average price per cycle not not so much right now I mean, it's a it's not a prescription data takes a little bit of time to collect.

Collect the claims based data so we've got some window on July and we'll have more as a each each month goes on but anecdotally. We're hearing you know good.

Good uptake in both platinum sensitive and platinum resistant patients and platinum sensitive, it's where you expect longer duration of therapy as well as.

You know better prognosis and better chance for response.

Great. So if I heard correctly, it's all bolus and not necessarily inventory.

Correct.

Correct. Thank you.

Next one on the Q is below 8% from Barclays you would all lives.

Hi, Thanks for taking my questions question. So falling opens up sell guys. So just wondering on time and more about your commercial of course, right now and how we should think about the cadence of accounts being converted as we think about the next couple of quarters. So clunky archstone agent rent a car.

Annabel Eva Samimy: Hi, thanks for taking my question. Congratulations on the launch of Celka. That was great.

Daniel N. Swisher: Can you maybe give us a sense if there was any initial stocking into the channels or if it was all demand, specifically pent-up demand? And does that mean that there's going to be a decline next quarter, and you know if you could just give us a little bit of granularity of what the underlying demand represents in terms of patient cycles per patient, average price per cycle, just how that looks. Thanks. So Dan, do you want to jump in on this? Yeah, if you listen carefully to the script, what we were saying is there was a bolus, as we expected, third line, fourth line.

Oh when would you go for a broader reach thanks.

Jim.

Hi, Yeah, I'm really we're calling on all the accounts and providers that we think are a valuable we're not starting you know with a subset so really what we're seeing in terms of.

Demand for that Delta is I believe driven by the whole sense that the accounts have ready ready to begin along with the awareness that we've created so not looking to really expand that to continue to try to educate and reach those accounts and generate awareness.

Yes.

Great next one on the Q is I guess two are you from Wolfe Research you know lives.

Daniel N. Swisher: And the good news was, you know, there was some benefit for those patients, but it's really... Getting Zipsel could be standard of care for relapsed second-line patients, and that we're what we're penetrating into, and there's still plenty of room for growth. So, you know, third line, et cetera, will fall off. There are more and more patients in second line have that But you shouldn't anticipate a quarter over quarter. Any granularity on the cycles or patients or average price per cycle? Not so much right now. I mean, it's not like prescription data.

I think that much. So for 2021, I think die wave estimates are about $280 million and that's kind of been buying a 50% switch from dimes and die wave onto next year, you mentioned that some patients we'll wait for a new script before switching over what percent of those late adopters make up that 1.7 billion of sodium oxybate sales right now.

What do you think about it implied switch cadence of about 50% and then just very quickly on GDP for you for your slide mentioned today still in phase, one where do we stand on enrollment and data read out for that program and when would we know whether you're taking it to phase three trial. Thanks.

Daniel N. Swisher: It takes a little bit of time to, you know, collect the claims-based data. So we've got some window for July, and we'll have more as each month goes on. But anecdotally, we're hearing... You know, good uptake in both platinum-sensitive and platinum-resistant patients. Platinum sensitive is where you expect a longer duration of therapy as well as a better prognosis and better chance of recovery

Yeah Kosh no no update on three to four today. So we don't have additional information to give on the Xyrem ASI wave dynamic for 2021, obviously, we have not given guidance for 2021, yet and we'll plan to do that in late February on our year end call.

The estimates that are out there you know didn't come from US I think you heard the comments in today's call about we expect this adoption to supply wave to happen overtime. We think it's important to educate both patients and physicians about the benefits of Flyways.

Daniel N. Swisher: Okay, so if I heard correctly, it's all bullets and not necessarily inventory. [inaudible] Next one on the queue is Balaji Prasad from Barclays. You are now live. Hi, thank you for taking my question. So following up on ZipZilk itself, I just want to understand more about your commercial efforts right now and how we should think about the cadence of accounts being converted as we think about the next couple of quarters. So currently, you're at around 800 accounts. When would you go for a broader reach?

Of course from a financial perspective, or whether we have patients on xyrem or Z wave next year is not as big a driver of our financial results relative to 2020 as for examples absaloka or the fortune 58 launch where the launch in idiopathic hyper samia or growth in Sanofi.

In our other assets show.

You know it will play out over time, we have shut the longer term goal of getting to a.

Balaji V. Prasad: Thanks. Kim, Hi, yeah, um, really, we are calling on all the accounts and providers that we think are valuable. We're not starting, you know, with a subset.

You know a majority of all Oxybate patients on July waves in 2023, but we have not yet given a specific target for 2021.

Thank you very helpful.

The next one on the Q is Gregg Gilbert from Treasury Securities you know lives.

Kim Sablich: So really, what we're seeing in terms of demand for that ZELTA is, I believe, driven by the patients that the accounts have ready and willing to begin along with the awareness that we've created. So not looking to really expand that, but to continue to try to educate and reach those accounts and generate awareness. Right, next one on the queue is Akash Tewari from Wolf Research. You are now live. Thanks so much.

Thank you up back to four or five years I think it's probably for Robyn for Dan to some degree I just would like you to confirm that all aspects of the four or five eight development or trial are on track and also how quickly can you make a product and are you already making product to meet demand and.

And when can you begin to play offense in terms of looking at additional geography is an indication that.

Thanks.

I mean short and robbing me, yes, we consider the program is is on track.

Akash Tewari: So for 2021, I think ZyWave estimates are about 280 million, and that's kind of implying a 50% switch from ZyWave to ZyWave Plus for next year. You mentioned that some patients will wait for a new script before switching over. What percent of those late adopters make up that 1.7 billion in sodium phosphate sales right now? And what do you think about an implied switch cadence of about 15%?

And Dan you want to talk about supplier, yeah, and that was a key factor in working out the recombinant system is to make sure we've got a a quality and modern process and.

We're already at commercial scale, and we have tens of thousands of vials.

Actually that have been generated would be available for a commercial launch that were part of will be part of the regulatory package.

Does that mean, you can meet all demand as soon as it's approved.

Bruce C. Cozadd: And then just very quickly on JCP324, as you mentioned in your slides today, it's still in phase one. Where do we stand on enrollment and data readout for that program? And when will we know whether you're taking it to phase three trials? Thanks. Yeah, Akash, no, no update on 324 today.

Yeah within reason, but yes.

Thank you.

Next one on the line is just people flying from JP Morgan.

No lives.

Hi, good afternoon, Thanks for taking my question.

For Q3.

3.5, you concluded the healthy volunteer study of the modified release formulation can you elaborate on those bulk there and in particular are you confident in the safety and Tolerability as this molecule.

Yeah, Rob are filled you want to take that.

That's great I can take that thank you Bruce.

Bruce C. Cozadd: So we don't have any additional information to give on the Xyrem and Xywave dynamic for 2021. Obviously, we have not given guidance for 2021 yet. We'll plan to do that in late February on our year-end call. The estimates that are out there, you know, didn't come from us.

Yes, so weve completed the study conduct but we don't have the results. He had actually you hope that to that.

That study.

And the the goal of the modified release formulation was to have a.

Product that could be taken once a day and be better tolerated, but we did not have results.

At this point in time.

Okay.

Keep your excellent on the Q is David Bruce Injure from Morgan Stanley. Your line is open.

Bruce C. Cozadd: I think you heard the comments in today's call about how we expect this adoption of ZyWave to happen over time. We think it's important to educate both patients and physicians about the benefits of ZyWave. Of course, from a financial perspective, whether we have patients on Xyrem or Xywave next year is not as big a driver of our financial results relative to 2020 as, for example, Zepzelka or the 458 launch or the launch in idiopathic hypersomnia or growth in Cenosi and our other assets. Uh... it'll play out over time. We have set the longer-term goal of getting to Thank you very much.

Yes, thanks, very much and congrats on the performance so.

Bruce I just wanted to ask you.

To basically paint a picture.

For how you see the 2023 time frame and the reason is that.

Jazz shares are trading at a high single digit P.E. unexpected 2021, EPS due to concerns about a feared xyrem cliff.

And I think it would be helpful for you to frame how you see the evolution of the company's financial performance as it faces Xyrem generics in a few years. Thank you.

Yeah, Thanks, David and really good question.

You know, we're we're really focused on a couple of things to diversify the business over time and while we have every.

Intention of performing well this year and next year a lot of what we're doing is designed to position us well in future years, including our goal to have about half of our total revenues come from newly launched products by 2022, and our goal to have a majority of all oxybate.

Greg Gilbert: Next one on the queue is Greg Gilbert from Tourist Securities. You are now live. Thank you. Back to 458. I think it's probably for Rob and for Dan to some degree. I just would like you to confirm that all aspects of the 458 development or trial are on track. And also, how quickly can you make a product? And are you already making product to meet demand? And when can you begin to play offense in terms of looking at additional geographies and indications?

Eight.

Patients.

Beyond July wave and 2023. So you can think about that Oxybate franchise is as a the first piece of value creation, which is how well do we do with high waves and continuing to grow the market.

Robert Iannone: I mean, short answer for me: yes, we consider the program is on track. And Dan, do you want to talk about supply? Yeah, that was a key factor in working up a recombinant system to make sure we've got a quality and modern process. We're already at commercial scale, and we have tens of thousands of vials. Actually, those have been generated and would be available for a commercial launch that will be part of the regulatory package. Does that mean you can meet all demand as soon as it's approved? Yeah, within reason, but yes.

As we've talked about with the potential of an IDH launch next year.

The second piece is what do we do with the rest of our portfolio how do we do with Selco.

And so no C and four or five eights.

And other opportunities in terms of growing those.

And then bringing force.

New products from our portfolio, including some mid stage programs that we featured in todays call, but I don't want people to Miss the third piece too which is continuing to put our.

Daniel N. Swisher: Next one on the line is Jessica Fye from JP Morgan. You are now live. Guys, good afternoon. Thanks for taking my question. For JCP385, you completed the healthy volunteer study of the modified release formulation. Can you elaborate on the results there? And, in particular, are you confident in the safety and tolerability of this molecule?

Capital to work in broadening our opportunity set both.

Things like is EPS, all called <unk>, where we did a deal on launched within months as well as things that are earlier in clinical development and while they might not be on the market in a few years could be generating key clinical data that will help people to value that pipeline. So I.

Jessica Fye: Yeah, Rob or Phil, do you want to take that? Great, I can take that. Thank you, Bruce. Yes, so we've completed the study conduct, but we don't actually have the results of that study yet. And the goal of the modified release formulation was to have a product that could be taken once a day and be better tolerated.

I really feel like in each of those buckets were performing well right now and all of those contribute in our mind to a sustainable growth strategy over the longer term.

Thank you.

Next question comes from the line of Gregg from Goldman Sachs Your normalized.

Great. Thank you thanks for taking my questions and congrats on a great quarter.

Robert Iannone: But we do not have results at this point in time. Okay, next one on the queue is David Rissinger from Morgan Stanley. Your line is now open.

I've got two if I could just one we've seen just from a BD perspective, obviously, some interesting earlier stage deals.

And I'm wondering having added Zilka witchcraft was more near term in terms of revenue.

David A. Amsellem: Yes, thanks very much. And congratulations on the performance. So, Bruce, I just wanted to ask you to basically paint a picture for how you see the 2023 timeframe. And the reason is that Jazz shares are trading at a high single-digit PE on expected 2021 EPS due to concerns about a feared Xyrem cliff. And I think it would be helpful for you to frame how you see the evolution of the company's financial performance as it faces Xyrem Generics in a few years. Thank you. Yeah, thanks, David. And a really good question.

How should we be thinking about the would be looking to fill across.

The different developmental stages or is there more of a.

A desire to focus maybe on the mid or early stage pipeline. So that's my first question is just on my second question and as you think about new products such as the spring works PTSD asset.

How do you think about the synergies.

Synergies from a commercialization perspective, so or PTSD I don't know what the natural.

Selling capability is and whether you'd have to incrementally grow off of that so just any thoughts on how you think about that BT perspective. Thanks.

Bruce C. Cozadd: You know, we're really focused on a couple of things to diversify the business over time. And while we have every intention of performing well this year and next year, a lot of what we're doing is designed to position us well in future years, including our goal to have about half of our total revenues come from newly launched products by 2022. And our goal is to have a majority of all Oxybate patients, Beyond Zywave, in 2023.

Great I'll take that.

This is Renee great question, so with respect to corporate development, you know our strategy hasn't really changed in the sense that we're continuing to look at highly differentiated durable assets that can provide meaningful clinical benefit for patients as we think about than the stage of the pipeline we.

Bruce C. Cozadd: So you can think about that Oxibate franchise as the first piece of value creation, which is how well we do with Zywave and continue to grow the market, as we've talked about with the potential of an IH launch next year. The second piece is how do we do with the rest of our portfolio? How do we do with Epsilca and Sanosi and 458?

We're focused on different parts of the pipeline. So we you will probably see US continue to do some early deals as well as some mid stage deals being able to bring in a phase two ready asset in the fall inhibitor for for spring works with a nice strategic asset for us to continue to.

Bruce C. Cozadd: and other opportunities in terms of growing those, and then bringing forth new products from our portfolio, including some of the mid-stage programs that we featured in today's call. But I don't want people to miss the third piece too, which is continuing to put capital to work in broadening our opportunity set. Things like Zepzolco, where we did a deal and launched within months, as well as things that are earlier in clinical development, and while they might not be on the market in a few years, could be generating key clinical data that will help people to value that pipeline. So, I really feel like in each of those Thank you. The next question comes from the line of Craig from Goldman Sachs. You are now live. Great, thank you. Thanks for taking my questions and congrats on a great quarter. I've got two, but if I could, I'd have more.

Allow that midstage portfolio.

But I'd say, we're also looking specifically at transformative transactions, where we could leverage up our balance sheet leverage our balance sheet cash <unk> and infrastructure to acquire an on market assets were looking at M&A as well, but as you know those are larger deal opportunities are just.

Fewer in nature, and so were much more calculated in terms of how we think about what would be most strategically advantageous for us and also how do we most appropriately leverage our balance sheet in order to be able to take on something that can also.

Enhance the durability that Bruce described with respect to the long term diversified revenue base that we're trying to establish so I would say, we're looking fairly broadly both for pipeline augmentation and then also a mirror and on market.

Opportunities, where we could leverage that a commercial infrastructure that we have globally.

Craig: Just one, you know; we've seen Jazz, from a business development perspective, do some interesting earlier stage deals. And I'm wondering, having added Zilka, which perhaps was more near term in terms of revenue, how should we be thinking about BD? Will it be looking to fill across the different developmental stages, or is there more of a desire to focus maybe on the mid or early stage pipeline? So that's my first question and, just on my second question, and as you think about new products such as the SpringWorks PTSD asset, how do you think about synergies from a commercialization perspective? So, you know, for PTSD, I don't know what the natural...

To be able to continue to make it more effective and profitable from a financial perspective.

With respect to the commercial piece.

We do think that when we look at P.T.S.T. as Rob had described this is a high unmet need area and we have capabilities internally, where we've been focused on P.T.S.D. as an indication of interest.

And while we would need to to expand some of our commercial activities in order to support this in the future.

We look at this as something that if we get through a phase two study and this is positive then you can also build around that portfolio over time, because there is such a large unmet need and a meaningful market opportunity.

Renee Gala: Selling capabilities and whether you'd have to incrementally grow off of that. So just any thoughts on how you think about that from a business development perspective. Thanks. Great, I'll take that. This is Renee. Great question.

Okay.

And operator next question in the queue will be our last question.

Renee Gala: So with respect to corporate development, you know, our strategy hasn't really changed in the sense that we're continuing to look at highly differentiated durable assets that can provide meaningful clinical benefits for patients. As we think about the stage of the pipeline, we are focused on different parts of the pipeline. So you will probably see us continue to do some early deals as well as some mid-stage deals. Being able to bring in a phase two ready asset in the fall inhibitor for spring works was a nice strategic asset for us to continue to fill out that mid-stage portfolio. But I'd say we're also looking specifically at transformative transactions where we could leverage up our balance sheet, leverage our balance sheet cash flow and infrastructure to acquire an on-market asset. We're looking at M&A as well, but as you know, those larger deal opportunities are just fewer in nature.

Okay. So for the last question, we do have David Steinberg from Jefferies. Your normalized.

Thanks, I have an additional question on Zipsor milk and want to drill down and some of the components of the 37 million you reported for Q3, specifically you highlighted the fact that when one of the reasons for that really strong initial quarterly sales.

Sure Pent up demand in third and fourth line.

And so but I don't recall that you gave us an actual split second line versus the others.

If not could you give us that break down or some rough approximation there. Thanks.

Yeah. David This is Bruce I'll, just I'll just come back and say we have data from like the first months of launch that would help us understand where the product was used and we don't have.

More recent data so we really can't give you a for the quarters your was the percentage.

Hi, as Kim said, we are seeing good use in second line.

Renee Gala: So we're much more calculated in terms of what would be most strategically advantageous for us and also how we most appropriately leverage our balance sheet in order to be able to take on something that can also enhance the durability that Bruce described with respect to the long-term diversified revenue base that we're trying to establish. So I would say we're looking fairly broadly, both for pipeline augmentation and then also near and on market opportunities where we could leverage that commercial infrastructure that we have globally to be able to continue to make it more effective and profitable from a financial perspective. With respect to the commercial piece, we do think that when we look at PTSD, as Rob described, this is a high unmet need area. We have capabilities internally where we've been focused on PTSD as an indication of interest.

Hi in growth in the number of accounts ordering so we feel good about where we are in the launch of this product as we continue.

Take the message out to the field, so really happy with.

How were doing just a few months into a new launch.

And I would just have to just have to wrap up my comments by saying really pleased with how the company overall is performing across the commercial portfolio and making rapid progress on our R&D programs. So I think you know.

We were pleased to give the update today, we've got a lot ahead of US was I waved just launching today and some near term.

Submissions coming.

In four or five eight and on the I.H. side. So still lot of work ahead of us.

Well, we finished the year, but you know a really great third quarter.

Yes, there are no further questions on the queue all of those turn the call back to Kathy was true.

Renee Gala: And while we would need to expand some of our commercial activities in order to support this in the future, we look at this as something that if we get through a phase two study and this is positive, then you can also build around that portfolio over time because there is such a large unmet need and a meaningful market opportunity. Operator, this next question in the queue will be our last question. Okay, so for the last question, we do have David Steinberg from Jefferies. You are now live. Thanks. I have an additional question about ZipZilk.

Well. Thank you Tina. Thank you again for joining US today, we will be participating in the Jefferies Virtual London Healthcare Conference later, this month and hope to speak with many of you. This now ends our call.

Ladies and gentlemen. This concludes today's conference call you may now disconnect.

[music].

David Steinberg: I want to drill down on some of the components of the $37 million you reported for Q3. Specifically, you highlighted the fact that one of the reasons for the really strong initial quarterly sales was pent-up demand in third and fourth lines. And so on, but I don't recall that you gave us an actual split of second line versus the others. If not, could you give us that breakdown or some rough approximation thereof?

Bruce C. Cozadd: Thanks. Yeah, David, this is Bruce. I'll just I'll just come back and say we have data from like the first month of launch that would help us. We don't have more recent data, so we really can't give you a percentage for the quarter here with the percentage. As Kim said, we are seeing good use on the second line with growth in the number of accounts ordering. So we feel good about where we are in the launch of this product as we continue to take the message out to the field. And we are really happy with how we are doing just a few months into a new launch. And I would just have to wrap up my comments by saying I am really pleased with how the company overall is performing across the commercial portfolio and making rapid progress on our R&D program. So I think we were pleased to give the update today. We've got a lot ahead of us with Zywave just launching today, and near-term submissions coming in 4, 5, 8 and on the IH side, so still a lot of work ahead of us before we finish the year. But a really great third quarter.

Kathy Wittron: Okay, and there are no further questions in the queue. I will now turn the call back to Kathy Wittron. Well, thank you, Gina. Thank you again for joining us today. We will be participating in the Jeffreys Virtual London Healthcare Conference later this month and hope to speak with many of you. This now ends our call. Ladies and gentlemen, this concludes today's conference. Call you may now disconnect. BF-WATCH TV 2021