Q1 2024 Jazz Pharmaceuticals PLC Earnings Call

May 1, 2024

Okay.

Krista: Thank you for standing by. My name is Krista, and I will be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals first quarter 2024 Earnings Conference Call. [Operator Instructions] I would now like to turn the conference over to Andrea Flynn; Vice President, Head of Investor Relations. Andrea, you may begin your conference. Thank you, Operator, and good afternoon, everyone.

Operator: Thank you for standing by, my name is Krista, and I will be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals First Quarter 2024 Earnings Conference Call. [Operator Instructions] I would now like to turn the conference over to Andrea Flynn; Vice President, Head of Investor Relations. Andrea, you may begin your conference.

Krista: Thank you for standing by my name is Krista and I will be your conference operator today at this time I would like to welcome everyone to the jazz Pharmaceuticals first quarter 'twenty 'twenty four earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.

Krista: After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during that time, simply press star followed by the number one on your telephone keypad. And if you'd like to withdraw that question, again, press star one.

Krista: Like to ask a question during that time simply press star followed by the number one on your telephone keypad and if you'd like to withdraw that question I got and press Star. One. Thank you I would now like to turn the conference over to Andrea Flynn Vice President head of Investor Relations. Andrea You May begin your conference.

Krista: Thank you. I would now like to turn the conference over to Andrea Flynn, Vice President, Head of Investor Relations. Andrea, you may begin your presentation. Thank you, Operator, and good afternoon, everyone.

Andrea Flynn: Thank you, Operator, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its first quarter 2024 financial results. The slide presentation accompanying this webcast is available on the investors section of our website. Investors may also refer to the press release we issued earlier today, which is also posted to our website. On the call today are Bruce Cozadd, Chairman and Chief Executive Officer, Renée Galá; President and Chief Operating Officer, Rob Iannone; Executive Vice President and Global Head of R&D, and Phil Johnson, Executive Vice President and Chief Financial Officer.

Andrea Flynn: Today, Jazz Pharmaceuticals reported its first quarter 2024 financial results. The slide presentation accompanying this webcast is available on the Investors section of our website. Investors may also refer to the press release we issued earlier today, which is also posted on our website. On the call today are Bruce Cozadd, Chairman and Chief Executive Officer, Rene Gala, President and Chief Operating Officer, Rob Iannone, Executive Vice President and Global Head of R&D, and Phil Johnson, Executive Vice President and Chief Financial Officer.

Andrea N. Flynn, Ph.D.: Thank you, operator, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its Q1 2024 financial results. The slide presentation accompanying this webcast is available on the investors section of our website. Investors may also refer to the press release we issued earlier today, which is also posted to our website. On the call today are Bruce Cozadd, Chairman and Chief Executive Officer, Renee Gala, President and Chief Operating Officer, Robert Iannone, Executive Vice President and Global Head of R&D, and Philip Johnson, Executive Vice President and Chief Financial Officer. On slide two, I'd like to remind you that today's webcast includes forward-looking statements, such as those related to our future financial and operating results, growth potential, and anticipated development and commercialization milestones and goals, which involve risks and uncertainties that could cause actual events, performance and results to differ materially from those contained in these forward-looking statements.

Andrea Flynn: Thank you, operator, and good afternoon, everyone. Today, Jazz Pharmaceuticals reported its Q1 2024 financial results. The slide presentation accompanying this webcast is available on the investors section of our website. Investors may also refer to the press release we issued earlier today, which is also posted to our website. On the call today are Bruce Cozadd, Chairman and Chief Executive Officer, Renee Gala, President and Chief Operating Officer, Robert Iannone, Executive Vice President and Global Head of R&D, and Philip Johnson, Executive Vice President and Chief Financial Officer. On slide two, I'd like to remind you that today's webcast includes forward-looking statements, such as those related to our future financial and operating results, growth potential, and anticipated development and commercialization milestones and goals, which involve risks and uncertainties that could cause actual events, performance and results to differ materially from those contained in these forward-looking statements.

Andrea Flynn: Thank you operator, and good afternoon, everyone today already jazz Pharmaceuticals reported its first quarter 2024 financial result.

Andrea Flynn: Slide presentation accompanying this webcast is available on the investors section of our website.

Andrea Flynn: Investors May also refer to the press release, we issued earlier today, which is also posted to our website.

Speaker Change: On the call today are Bruce <unk>, Chairman and Chief Executive Officer, Renee Gala, President and Chief Operating Officer, Rob You know executive Vice President and global head of R&D, and Phil Johnson, Executive Vice President and Chief Financial Officer.

Andrea Flynn: On slide 2, I'd like to remind you that today's webcast includes forward-looking statements, such as those related to our future financial and operating results, growth potential, and anticipated development and commercialization milestones and goals, which involve risks and uncertainties that could cause actual events, performance, and results to differ materially from those contained in these forward-looking statements. We encourage you to review the statements contained in today's press release in our slide deck and the risks and uncertainties described in our SEC filings, which identify certain factors that may cause the company's actual events, performance, and results to differ materially from those contained in the forward-looking statements made on today's webcast. We undertake no duty or obligation to update our forward-looking statements.

On slide 2, I'd like to remind you that today's webcast includes forward-looking statements, such as those related to our future financial and operating results, growth potential, and anticipated development and commercialization milestones and goals, which involve risks and uncertainties that could cause actual events, performance, and results to differ materially from those contained in these forward-looking statements.

Speaker Change: On slide two I'd like to remind you that today's webcast include forward looking statements such as those related to our future financial and operating result growth potential and anticipate a development and commercialization milestones and goals, which involve risks and uncertainties that could cause actual events performance and results to differ materially from those contained in these forward looking.

We encourage you to review the statements contained in today's press release in our slide deck and the risks and uncertainties described in our SEC filings, which identify certain factors that may cause the company's actual events, performance, and results to differ materially from those contained in the forward-looking statements made on today's webcast. We undertake no duty or obligation to update our forward-looking statements.

Andrea N. Flynn, Ph.D.: We encourage you to review the statements contained in today's press release, in our slide deck, and the risks and uncertainties described in our SEC filings, which identify certain factors that may cause the company's actual events, performance, and results to differ materially from those contained in the forward-looking statements made on today's webcast. We undertake no duty or obligation to update our forward-looking statements. As noted on slide 3, we will discuss non-GAAP financial measures on this webcast. Descriptions of these non-GAAP financial measures and reconciliations of GAAP to non-GAAP financial measures are included in today's press release and the slide presentation available on the investors section of our website. I'll now turn the call over to Bruce.

Andrea Flynn: We encourage you to review the statements contained in today's press release, in our slide deck, and the risks and uncertainties described in our SEC filings, which identify certain factors that may cause the company's actual events, performance, and results to differ materially from those contained in the forward-looking statements made on today's webcast. We undertake no duty or obligation to update our forward-looking statements. As noted on slide 3, we will discuss non-GAAP financial measures on this webcast. Descriptions of these non-GAAP financial measures and reconciliations of GAAP to non-GAAP financial measures are included in today's press release and the slide presentation available on the investors section of our website. I'll now turn the call over to Bruce.

Speaker Change: We encourage you to review the statements contained in today's press release, and our slide deck and the risks and uncertainties described in our SEC filings, which identify certain factors that may cause the company's actual events performance and results to differ materially from those contained in the forward looking statements made on today's webcast, we undertake no duty or.

Speaker Change: Nation to update our forward looking statements.

Bruce C. Cozadd: As noted on slide 3, we will discuss non-GAAP financial measures on this webcast. Descriptions of these non-GAAP financial measures and reconciliations of GAAP to non-GAAP financial measures are included in today's press release and the slide presentation available on the Investors section of our website. I'll now turn the call over to Bruce.

As noted on slide 3, we will discuss non-GAAP financial measures on this webcast. Descriptions of these non-GAAP financial measures and reconciliations of GAAP to non-GAAP financial measures are included in today's press release and the slide presentation available on the Investors section of our website.

Speaker Change: As noted on slide three we will discuss non-GAAP financial measures on this webcast descriptions of these non-GAAP financial measures and reconciliations of GAAP to non-GAAP financial measures are included in today's press release and the slide presentation available on the investors section of our website I will now turn the call over to Bruce.

I'll now turn the call over to Bruce.

Bruce C. Cozadd: Thanks, Andrea. Good afternoon, everyone, and thank you for joining us today to review our first quarter results. I want to begin by welcoming Phil Johnson, who joined Jazz in March as our Chief Financial Officer. We're very excited to have Phil on our executive team and look forward to his contributions to delivering value for patients and shareholders. Beginning on slide 5, we made important progress during the first quarter, including year-over-year combined double-digit revenue growth from our key growth drivers, XYWAV, EPIDIOLEX, and RYLAZE, along with meaningful advances in our pipeline.

Bruce Cozadd: Thanks, Andrea. Good afternoon, everyone, and thank you for joining us today to review our first quarter results. I want to begin by welcoming Philip Johnson, who joined Jazz in March as our Chief Financial Officer. We're very excited to have Phil on our executive team and look forward to his contributions to delivering value for patients and shareholders. Beginning on slide 5, we made important progress during the first quarter, including year-over-year combined double-digit revenue growth from our key growth drivers, XYWAV, Epidiolex, and Rylaze, along with meaningful advances in our pipeline. I'm also pleased to report that we are affirming our 2024 financial guidance. On the commercial front, we generated more than $900 million in total revenues across our growing and diversified portfolio of medicines. XYWAV revenues increased 14% year-over-year, reinforcing our confidence in its trajectory and durability.

Bruce: Thanks, Andrea good afternoon, everyone and thank you for joining us today to review our first quarter results.

Bruce: Want to begin by welcoming Phil Johnson, who joined <unk> in March as our Chief Financial Officer.

Bruce: Very excited to have Phil on our executive team and look forward to his contributions to delivering value for patients and shareholders.

Bruce: Beginning on slide five we made important progress during the first quarter, including year over year combined double digit revenue growth from our key growth drivers sideways, Epidiorite X and railways along with meaningful advances in our pipeline I'm also pleased to report that we are affirming our 2020 for finance.

Bruce C. Cozadd: Beginning on slide 5, we made important progress during the first quarter, including year-over-year combined double-digit revenue growth from our key growth drivers, XYWAV, EPIDIOLEX, and RYLAZE, along with meaningful advances in our pipeline. I'm also pleased to report that we are affirming our 2024 financial guidance.

Bruce C. Cozadd: I'm also pleased to report that we are affirming our 2024 financial guidance. On the commercial front, we generated more than $900 million in total revenues across our growing and diversified portfolio of medical products. Zywave revenues increased 14% year over year, reinforcing our confidence in its trajectory and durability.

I'm also pleased to report that we are affirming our 2024 financial guidance.

Bruce: Guidance.

On the commercial front, we generated more than $900 million in total revenues across our growing and diversified portfolio of medicines. XYWAV revenues increased 14% year over year, reinforcing our confidence in its trajectory and durability. EPIDIOLEX demand remains strong, and we continue to be confident in its blockbuster potential.

Bruce: On the commercial front, we generated more than $900 billion in total revenues across our growing and diversified portfolio of medicines.

<unk> revenues increased 14% year over year, reinforcing our confidence in its trajectory and durability epic dialects demand remains strong and we continue to be confident in its blockbuster potential.

Bruce C. Cozadd: Epidiolex demand remains strong, and we continue to be confident in its blockbuster potential. Our Oncology Therapeutic Area delivered another strong quarter with 13% year-over-year revenue growth. This continues the momentum we established last year when we surpassed $1 billion in annual oncology revenue for the first time. Moving to our R&D and pipeline efforts, 2024 is an important year for Jazz, with multiple late-stage catalysts for therapies targeting substantial market opportunities. We achieved a significant milestone for ZanyDataMap in March with the completion of our rolling VLA submission for the treatment of HER2-positive biliary tract cancer, or BTC, and we expect commercial launch in 2025 or earlier.

Epidiolex demand remains strong, and we continue to be confident in its blockbuster potential.

Bruce Cozadd: Epidiolex demand remains strong, and we continue to be confident in its blockbuster potential. Our oncology therapeutic area delivered another strong quarter, with 13% year-over-year revenue growth. This continues the momentum we established last year when we surpassed $1 billion in annual oncology revenue for the first time. Moving to our R&D and pipeline efforts, 2024 is an important year for Jazz, with multiple late-stage catalysts for therapies targeting substantial market opportunities. We achieved a significant milestone for zanidatamab in March, with the completion of our rolling BLA submission for the treatment of HER2-positive biliary tract cancer, or BTC, and we expect commercial launch in 2025 or earlier. If approved, zanidatamab would be the first HER2-targeted treatment specifically for BTC in the US.

Our oncology therapeutic area delivered another strong quarter with 13% year-over-year revenue growth. This continues the momentum we established last year when we surpassed $1 billion in annual oncology revenue for the first time. Moving to our R&D and pipeline efforts, 2024 is an important year for Jazz, with multiple late-stage catalysts for therapies targeting substantial market opportunities. We achieved a significant milestone for ZANIDATAMAB in March with the completion of our rolling VLA submission for the treatment of HER2-positive biliary tract cancer, or BTC, and we expect commercial launch in 2025 or earlier.

Bruce: Our oncology therapeutic area delivered another strong quarter with 13% year over year revenue growth.

Bruce: Continues the momentum we established last year, when we surpassed $1 billion in annual oncology revenue for the first time.

Moving to our R&D and pipeline efforts, 2024 is an important year for Jazz, with multiple late-stage catalysts for therapies targeting substantial market opportunities. We achieved a significant milestone for ZANIDATAMAB in March with the completion of our rolling VLA submission for the treatment of HER2-positive biliary tract cancer, or BTC, and we expect commercial launch in 2025 or earlier.

Bruce: Moving to our R&D and pipeline efforts 2024 is an important year for jazz with multiple late stage catalysts for therapies targeting substantial market opportunities.

Bruce: We achieved a significant milestone presenting data map in March with the completion of our rolling BLA submission for the treatment of her two positive biliary tract cancer or BTC, and we expect commercial launch in 2025 or earlier.

Bruce C. Cozadd: If approved, ZANIDATAMAB would be the first HER2-targeted treatment specifically for BTC in the U.S. We also expect important clinical data readouts in the near future for SUVECALTAMIDE in essential tremor, ZANIDATAMAB in gastroesophageal cancer, EPIDIOLEX in Japan, and ZEPZELCA in first-line small cell lung cancer. On the operational front, we are maintaining our focus on disciplined capital allocation.

If approves any data that would be the first her two targeted treatments specifically for PTC in the U S. We.

Bruce Cozadd: We also expect important clinical data readouts in the near future for suvecaltamide in essential tremor, zanidatamab in gastroesophageal cancer, Epidiolex in Japan, and Zepzelca in first-line small cell lung cancer. On the operational front, we are maintaining our focus on disciplined capital allocation. Our financial strength, including healthy operating cash flow, enables us to invest in the continued growth of our commercial portfolio and pipeline, while also positioning us to execute on corporate development opportunities. Turning to Slide 6, we remain focused on advancing the three core tenets of Vision 2025. This includes advancing leading therapies in sleep disorders and epilepsy, along with a growing oncology portfolio, investing in R&D to expand our capabilities and pipeline, and making disciplined capital allocation decisions to enhance value for shareholders as we realize our ambition to be a high-growth global biopharma leader.

Bruce: We also expect important clinical data readouts in the near future pursue the calcified and a central tremor zany data map and gastroesophageal cancer Epidiorite in Japan, and <unk> in first line small cell lung cancer.

Bruce: On the operational front, we are maintaining our focus on disciplined capital allocation.

Renee Gala: Our financial strength, including healthy operating cash flow, enables us to invest in the continued growth of our commercial portfolio and pipeline, while also positioning us to execute on corporate development opportunities. Turning to slide 6, we remain focused on advancing the 3 core tenets of Vision 2025. This includes advancing leading therapies in sleep disorders and epilepsy, along with a growing oncology portfolio, investing in R&D to expand our capabilities and pipeline, and making disciplined capital allocation decisions to enhance value to shareholders as we realize our ambition to be a high-growth global biopharma leader.

Our financial strength, including healthy operating cash flow, enables us to invest in the continued growth of our commercial portfolio and pipeline, while also positioning us to execute on corporate development opportunities.

Bruce: Our financial strength, including healthy operating cash flow enables us to invest in the continued growth of our commercial portfolio and pipeline, while also positioning us to execute on corporate development opportunities.

Turning to slide 6, we remain focused on advancing the 3 core tenets of Vision 2025. This includes advancing leading therapies in sleep disorders and epilepsy, along with a growing oncology portfolio, investing in R&D to expand our capabilities and pipeline, and making disciplined capital allocation decisions to enhance value to shareholders as we realize our ambition to be a high-growth global biopharma leader.

Bruce: Turning to slide six we remain focused on advancing the three core tenants of vision 2025. This includes advancing leading therapies and sleep disorders in epilepsy, along with a growing oncology portfolio investing in R&D to expand our capabilities and pipeline and making disciplined capital allocation.

Bruce: <unk> to enhance value for shareholders as we realize our ambition to be a high growth global Biopharma leader.

Renee Gala: I'll now turn the call over to Renée to review our commercial performance, after which Rob will share an update on our R&D progress. Phil will provide a financial overview, and then we'll open the call to Q&A. Renée?

Bruce Cozadd: I'll now turn the call over to Renee to review our commercial performance, after which Rob will share an update on our R&D progress. Bill will provide a financial overview, and then we'll open the call to Q&A. Renee?

Bruce: I'll now turn the call over to Renee to review, our commercial performance after which Rob will share an update on our R&D progress.

Bill will provide a financial overview and then we'll open the call to Q&A Rene.

Renee Gala: Thanks, Bruce. I'm excited to report on the continued progress across our commercial portfolio. We delivered strong first-quarter revenue, growing combined revenue from our key growth drivers, XYWAV, EPIDIOLEX, and RYLAZE, by 12% compared to the same period in 2023. As is typical of the first quarter of the year, revenue was impacted by seasonal headwinds from payer reauthorizations and inventory drawdown.

Renée Galá: Thanks, Bruce. I'm excited to report on the continued progress across our commercial portfolio. We delivered strong first quarter revenue, growing combined revenue from our key growth drivers, XYWAV, Epidiolex, and Rylaze, by 12% compared to the same period in 2023. As is typical of the first quarter of the year, revenue was impacted by seasonal headwinds from payer reauthorizations and inventory drawdown. Let's get into the details, starting on Slide 8 with our Sleep franchise. Total revenue from Sleep, which includes XYWAV and Xyrem net sales, plus royalties from high sodium oxybate, authorized generics, or AGs, was $430 million in the first quarter of 2024, and we remain confident in the growth and durability of XYWAV. In the first quarter of 2024, XYWAV revenue grew 14% year-over-year to $315 million.

Renee Gala: Thanks, Bruce. I'm excited to report on the continued progress across our commercial portfolio. We delivered strong first quarter revenue, growing combined revenue from our key growth drivers, XYWAV, Epidiolex, and Rylaze, by 12% compared to the same period in 2023. As is typical of the first quarter of the year, revenue was impacted by seasonal headwinds from payer reauthorizations and inventory drawdown. Let's get into the details, starting on Slide 8 with our Sleep franchise. Total revenue from Sleep, which includes XYWAV and Xyrem net sales, plus royalties from high sodium oxybate, authorized generics, or AGs, was $430 million in the first quarter of 2024, and we remain confident in the growth and durability of XYWAV. In the first quarter of 2024, XYWAV revenue grew 14% year-over-year to $315 million.

Renee: Bruce I'm excited to report on the continued progress across our commercial portfolio. We delivered strong first quarter revenue growing combined revenue from our key growth drivers <unk> at the dialects and realize by 12% compared to the same period in 2023.

Renee: As is typical of the first quarter of the year revenue was impacted by seasonal headwinds from payer reauthorization and inventory drawdown.

Renee Gala: Let's get into the details starting on slide 8 with our sleep franchise. Total revenue from sleep, which includes XYWAV and XYREM net sales, plus royalties from high sodium oxybate authorized generics, or AGs, was $430 million in the first quarter of 2024, and we remain confident in the growth and durability of XYWAV. In the first quarter of 2024, XYWAV revenue grew 14% year-over-year to $315 million.

Renee: Let's get into the details starting on slide eight with our sleep franchise.

Renee: Total revenue from fleet, which includes <unk> and Xyrem net sales plus royalties from high sodium oxidate authorized generics or Ags was $430 million in the first quarter of 2024, and we remain confident in the growth and durability in sideways in the first quarter of two.

Renee: 24, <unk> revenue grew 14% year over year to $315 million I'll take a few minutes to discuss our view of the overall oxidate market as well as several items of note from the quarter.

Renée Galá: I'll take a few minutes to discuss our view of the overall oxybate market, as well as several items of note from the quarter. In 2023, we saw the first competitive entrance to the oxybate market with the commercial availability of both high-sodium AG and branded fixed-dose high-sodium oxybate. We were pleased to deliver XYWAV revenue growth through this period and continue to expect XYWAV to remain the oxybate of choice, including the number one treatment for narcolepsy. As expected, at the start of 2024, Xyrem was excluded from certain commercial formularies based on the availability of multiple newer oxybate products, including XYWAV. Many of these patients and their physicians recognized the benefits of low sodium and chose to initiate treatment with XYWAV. I want to call out several downstream dynamics of this transition.

Renee Gala: I'll take a few minutes to discuss our view of the overall oxybate market, as well as several items of note from the quarter. In 2023, we saw the first competitive entrance to the oxybate market with the commercial availability of both high-sodium AG and branded fixed-dose high-sodium oxybate. We were pleased to deliver XYWAV revenue growth through this period and continue to expect XYWAV to remain the oxybate of choice, including the number one treatment for narcolepsy. As expected, at the start of 2024, Xyrem was excluded from certain commercial formularies based on the availability of multiple newer oxybate products, including XYWAV. Many of these patients and their physicians recognized the benefits of low sodium and chose to initiate treatment with XYWAV. I want to call out several downstream dynamics of this transition.

Renee: In 2023, we saw the first competitive entrance to the oxalate market with the commercial availability of both high sodium AG and branded fixed us high <unk>. We were pleased to deliver the <unk> revenue growth through this period and continue to expect <unk> to remain the Occidental.

Renee: Of choice, including the number one treatment for narcolepsy.

Renee Gala: As expected, at the start of 2024, XYREM was excluded from certain commercial formularies based on the availability of multiple newer oxybate products, including XYWAV. Many of these patients and their physicians recognize the benefits of low sodium and chose to initiate treatment with XYWAV. I want to call out several downstream dynamics of this transition.

Renee: As expected at the start of 2020 for Xyrem was excluded from certain commercial formularies based on the availability of multiple newer oximetry products, including sideways. Many of these patients and their physicians recognize the benefits of low sodium and chose to initiate.

Renee: <unk> met with sideways.

Renee: I want to call out several downstream dynamics of this transition.

Renee Gala: First, we saw a significant increase in the number of active narcolepsy patients benefiting from XYWAV at the end of the first quarter of 2024 compared to the fourth quarter of 2023. Second, we saw an increase in utilization of our patient support programs in the first quarter as patients navigated the transition from XYREM to XYWAV with their insurance providers. These programs provide free product for a limited duration, helping to ensure patients have uninterrupted access to therapy as they obtain XYWAV coverage.

Renée Galá: First, we saw a significant increase in the number of active narcolepsy patients benefiting from XYWAV at the end of Q1 2024, compared to Q4 2023. Second, we saw an increase in utilization of our patient support programs in Q1 as patients navigated the transition from Xyrem to XYWAV with their insurance providers. These programs provide free product for a limited duration, helping to ensure patients have uninterrupted access to therapy as they obtain XYWAV coverage. As a reminder, we have achieved benefit coverage in both narcolepsy and IH indications for approximately 90% of commercial lives. While we anticipate that other plans may exclude Xyrem from formulary going forward, we expect these changes will be less concentrated and spread out over time.

Renee Gala: First, we saw a significant increase in the number of active narcolepsy patients benefiting from XYWAV at the end of Q1 2024, compared to Q4 2023. Second, we saw an increase in utilization of our patient support programs in Q1 as patients navigated the transition from Xyrem to XYWAV with their insurance providers. These programs provide free product for a limited duration, helping to ensure patients have uninterrupted access to therapy as they obtain XYWAV coverage. As a reminder, we have achieved benefit coverage in both narcolepsy and IH indications for approximately 90% of commercial lives. While we anticipate that other plans may exclude Xyrem from formulary going forward, we expect these changes will be less concentrated and spread out over time.

Renee: First we saw a significant increase in the number of active narcolepsy patients benefiting from <unk> at the end of the first quarter of 2024 compared to the fourth quarter of 2023.

Renee: Second we saw an increase in utilization of our patient support programs in the first quarter as patients navigated the transition from Xyrem to XI wave with their insurance providers.

Renee: These programs provide free product for a limited duration, helping to ensure patients have uninterrupted access to therapy as they obtained XI with coverage.

Renee Gala: As a reminder, we have achieved benefit coverage in both narcolepsy and IH indications for approximately 90% of commercial lives. While we anticipate that other plans may exclude XYREM from formulary going forward, we expect these changes will be less concentrated and spread out over time. We view the large number of patient transitions that occurred from the fourth quarter of '23 to the first quarter of '24 as a one-time event. Finally, this transition resulted in a significant decrease in Xyrem branded revenue.

As a reminder, we have achieved benefit coverage in both narcolepsy and IH indications for approximately 90% of commercial lives. While we anticipate that other plans may exclude XYREM from formulary going forward, we expect these changes will be less concentrated and spread out over time. We view the large number of patient transitions that occurred from the fourth quarter of '23 to the first quarter of '24 as a one-time event.

Renee: As a reminder, we have achieved <unk> coverage in both narcolepsy NIH indications for approximately 90% of commercial lives.

Renee: While we anticipate that other plans may exclude xyrem from formulary going forward. We expect these changes will be less concentrated and spread out over time, we view the large number of patient transitions that occurred from the fourth quarter of 23 to the first quarter of 2004 as a one time.

Renée Galá: We view the large number of patient transitions that occurred from Q4 of 2023 to Q1 of 2024 as a one-time event. Finally, this transition resulted in a significant decrease in Xyrem-branded revenues. I'll note that all of these dynamics were accounted for in our 2024 neuroscience revenue guidance. Looking at our quarterly patient metrics, there were approximately 9,900 narcolepsy patients taking XYWAV exiting the first quarter, an increase of 375 patients from the prior quarter. Given the increased use of patient support programs, revenues for the quarter do not fully reflect these patient additions. We believe patient numbers are the best indicator of the long-term value and durability of this product and expect that revenues will be more aligned with patient numbers going forward, as newly transitioned patients revert to being fully covered by their insurance providers.

Renee Gala: We view the large number of patient transitions that occurred from Q4 of 2023 to Q1 of 2024 as a one-time event. Finally, this transition resulted in a significant decrease in Xyrem-branded revenues. I'll note that all of these dynamics were accounted for in our 2024 neuroscience revenue guidance. Looking at our quarterly patient metrics, there were approximately 9,900 narcolepsy patients taking XYWAV exiting the first quarter, an increase of 375 patients from the prior quarter. Given the increased use of patient support programs, revenues for the quarter do not fully reflect these patient additions. We believe patient numbers are the best indicator of the long-term value and durability of this product and expect that revenues will be more aligned with patient numbers going forward, as newly transitioned patients revert to being fully covered by their insurance providers.

Renee: <unk> event.

Renee: Finally, this transition resulted in a significant decrease in Xyrem branded revenues I'll note that all of these dynamics were accounted for in our 2020 for neuroscience revenue guidance.

Finally, this transition resulted in a significant decrease in XYREM branded revenue. I'll note that all of these dynamics were accounted for in our 2024 Neuroscience Revenue Guidance. Looking at our quarterly patient metrics, there were approximately 9,900 narcolepsy patients taking XYWAV exiting the first quarter, an increase of 375 patients from the prior quarter. Given the increased use of patient support programs, revenues for the quarter do not fully reflect these patient additions. We believe patient numbers are the best indicator of the long-term value and durability of this product and expect that revenues will be more aligned with patient numbers going forward as newly transitioned patients revert to being fully covered by their insurance providers. Turning to IH, the transition dynamics associated with coverage for narcolepsy patients did not impact the IH market.

Renee Gala: I'll note that all of these dynamics were accounted for in our 2024 Neuroscience Revenue Guidance. Looking at our quarterly patient metrics, there were approximately 9,900 narcolepsy patients taking Zywave exiting the first quarter, an increase of 375 patients from the prior quarter. Given the increased use of patient support programs, revenues for the quarter do not fully reflect these patient additions. We believe patient numbers are the best indicator of the long-term value and durability of this product and expect that revenues will be more aligned with patient numbers going forward as newly transitioned patients revert to being fully covered by their insurance providers. Turning to IH, the transition dynamics associated with coverage for narcolepsy patients did not impact the IH market.

Renee: Looking at our quarterly patient metrics, there were approximately 9900 narcolepsy patients taking <unk> exiting the first quarter, an increase of 375 patients from the prior quarter.

Renee: Given the increased use of patient support programs revenues for the quarter do not fully reflect these patient additions.

Renee: We believe patient numbers are the best indicator of the long term value and durability of this product and expect that revenues will be more aligned with patient numbers going forward as newly transitioned patients revert to being fully covered by their insurance providers.

Renée Galá: Turning to IH, the transition dynamics associated with coverage for narcolepsy patients did not impact the IH market. We continue to view IH as the strongest growth opportunity for XYWAV, and exiting the quarter, there were approximately 3,050 active IH patients on XYWAV, an increase of 275 from the prior quarter. We are prioritizing investments to further build the market, and our expanded field force is now fully deployed. These additional field personnel are focused on increasing the depth and breadth of IH prescribers. Outside of the branded oxybate business, we recognized approximately $50 million in AG royalty revenue, which was driven by both patient transitions and our increased royalty rate.

Renee Gala: Turning to IH, the transition dynamics associated with coverage for narcolepsy patients did not impact the IH market. We continue to view IH as the strongest growth opportunity for XYWAV, and exiting the quarter, there were approximately 3,050 active IH patients on XYWAV, an increase of 275 from the prior quarter. We are prioritizing investments to further build the market, and our expanded field force is now fully deployed. These additional field personnel are focused on increasing the depth and breadth of IH prescribers. Outside of the branded oxybate business, we recognized approximately $50 million in AG royalty revenue, which was driven by both patient transitions and our increased royalty rate.

Turning to IH, the transition dynamics associated with coverage for narcolepsy patients did not impact the IH market. We continue to view IH as the strongest growth opportunity for XYWAV, and exiting the quarter, there were approximately 3,050 active IH patients on XYWAV, an increase of 275 from the prior quarter. We are prioritizing investments to further build the market, and our expanded field force is now fully deployed. These additional field personnel are focused on increasing the depth and breadth of IH prescribers.

Turning to IH, the transition dynamics associated with coverage for narcolepsy patients did not impact the IH market.

Renee Gala: We continue to view IH as the strongest growth opportunity for ZyWave, and exiting the quarter, there were approximately 3,050 active IH patients on ZyWave, an increase of 275 from the prior quarter. We are prioritizing investments to further build the market, and our expanded field force is now fully deployed. These additional field personnel are focused on increasing the depth and breadth of IH prescribers.

Renee: We continue to view IHS and the strongest growth opportunity for XI wave and exiting the quarter. There were approximately 3050 active IH patients on sideways, an increase of 275 from the prior quarter.

Renee: We are prioritizing investments to further build the market and our expanded field force is now fully deployed.

Renee: These additional field personnel are focused on increasing the depth and breadth of IH prescribers.

Renee Gala: Outside of the branded oxybate business, we recognized approximately $50 million in AG royalty revenue, which was driven by both patient transitions and our increased royalty rate. Given our results for the quarter and increased visibility into oxybate market dynamics since the entry of high sodium oxybates. We remain confident in the durability of XYWAV and believe that we are well positioned to achieve our Vision 2025 goal of $2 billion in sleep revenue. Moving to slide nine, we are pleased with the continued growth of Epidiolex with net product sales of approximately $200 million in the first quarter, representing a 5% increase compared to the same quarter in 2023. As a reminder, with Epidiolex, we typically see a build in inventory throughout the second half of the year, which then burns off in the first half of the following year, primarily in the first quarter.

Outside of the branded oxybate business, we recognized approximately $50 million in AG royalty revenue, which was driven by both patient transitions and our increased royalty rate. Given our results for the quarter and increased visibility into oxybate market dynamics since the entry of high sodium oxybates. We remain confident in the durability of XYWAV and believe that we are well positioned to achieve our Vision 2025 goal of $2 billion in sleep revenue.

Renee: Outside of the branded Oxidate business, we recognized approximately $50 million in AG royalty revenue, which was driven by both patient transitions and our increased royalty rates.

Renée Galá: Given our results for the quarter and increased visibility into oxybate market dynamics since the entry of high-sodium oxybates, we remain confident in the durability of XYWAV and believe that we are well-positioned to achieve our Vision 2025 goal of $2 billion in sleep revenue. Moving to Slide 9, we are pleased with the continued growth of Epidiolex, with net product sales of approximately $200 million in Q1, representing a 5% increase compared to the same quarter in 2023. As a reminder, with Epidiolex, we typically see a build in inventory throughout the second half of the year, which then burns off in the first half of the following year, primarily in Q1. We expect future growth to be driven by underlying demand and geographic expansion and remain confident in the blockbuster potential of Epidiolex.

Renee Gala: Given our results for the quarter and increased visibility into oxybate market dynamics since the entry of high-sodium oxybates, we remain confident in the durability of XYWAV and believe that we are well-positioned to achieve our Vision 2025 goal of $2 billion in sleep revenue. Moving to Slide 9, we are pleased with the continued growth of Epidiolex, with net product sales of approximately $200 million in Q1, representing a 5% increase compared to the same quarter in 2023. As a reminder, with Epidiolex, we typically see a build in inventory throughout the second half of the year, which then burns off in the first half of the following year, primarily in Q1. We expect future growth to be driven by underlying demand and geographic expansion and remain confident in the blockbuster potential of Epidiolex.

Renee: Given our results for the quarter and increased visibility into oxalate market dynamics since the entry of high sodium oxalates, we remain confident in the durability and sideways and believe that we are well positioned to achieve our vision 2025 goal of $2 billion and sweep revenue.

Moving to slide 9, we are pleased with the continued growth of EPIDIOLEX with net product sales of approximately $200 million in the first quarter, representing a 5% increase compared to the same quarter in 2023. As a reminder, with EPIDIOLEX, we typically see a build in inventory throughout the second half of the year, which then burns off in the first half of the following year, primarily in the first quarter.

Renee: Moving to slide nine we are pleased with the continued growth about the dialects with net product sales of approximately $200 million in the first quarter, representing a 5% increase compared to the same quarter in 2023.

Renee: As a reminder, with that the dialogues, we typically see a build in inventory throughout the second half of the year, which then burns off in the first half of the following year, primarily in the first quarter.

Renee Gala: We expect future growth to be driven by underlying demand and geographic expansion and remain confident in the blockbuster potential of EPIDIOLEX. Key drivers of increased demand in the U.S. included the positive response to data on the benefits of EPIDIOLEX beyond seizure control, such as language and communication, cognition, executive function, and emotional and social function, as well as synergies from treatment with EPIDIOLEX plus CLOBAZAM. We're also continuing to see increased penetration in the adult patient setting, which is supported in part by data showing that many patients may reach adulthood without a specific LGS diagnosis and by providing HCPs with clear diagnostic tools for adult patients.

Renee: We expect future growth to be driven by underlying demand and geographic expansion and remain confident in the blockbuster potential of the dialects.

Renée Galá: Key drivers of increased demand in the US included the positive response to data on the benefits of Epidiolex beyond seizure control, such as language and communication, cognition, executive function, and emotional and social function, as well as synergies from treatment with Epidiolex plus clobazam. We're also continuing to see increased penetration in the adult patient setting, which is supported in part by data showing that many patients may reach adulthood without a specific LGS diagnosis and by providing HCPs with clear diagnostic tools for adult patients. Further opportunities for growth include continued education to support optimal dosing, focused data generation, and geographic expansion beyond the more than 35 countries where Epidiolex is currently approved, with additional launches and market reimbursement expected in 2024.

Renee Gala: Key drivers of increased demand in the US included the positive response to data on the benefits of Epidiolex beyond seizure control, such as language and communication, cognition, executive function, and emotional and social function, as well as synergies from treatment with Epidiolex plus clobazam. We're also continuing to see increased penetration in the adult patient setting, which is supported in part by data showing that many patients may reach adulthood without a specific LGS diagnosis and by providing HCPs with clear diagnostic tools for adult patients. Further opportunities for growth include continued education to support optimal dosing, focused data generation, and geographic expansion beyond the more than 35 countries where Epidiolex is currently approved, with additional launches and market reimbursement expected in 2024.

Renee: Can you drivers of increased demand in the U S included the positive response to data on the benefits of that the dialects beyond seizure control.

Renee: Such as language and communication cognition executive function, and emotional and social function as well as synergies from treatment without the dialects plus club and Sam. We're also continuing to see increased penetration in the adult patient setting, which is supported in part by data showing that <unk>.

Renee: Many patients may reach adulthood, without a specific lgs diagnosis and by providing hcp's with clear diagnostic tools for adult patients.

Renee Gala: Further opportunities for growth include continued education to support optimal dosing, focused data generation, and geographic expansion beyond the more than 35 countries where EPIDIOLEX is currently approved, with additional launches and market reimbursement expected in 2024. Shifting to our oncology business on slide 10, total oncology revenue for the quarter was approximately $258 million, led by Rylase and Zepselka. Rylase delivered another strong quarter with net product sales of $103 million, representing a 20% increase from the first quarter of 2023.

Further opportunities for growth include continued education to support optimal dosing, focused data generation, and geographic expansion beyond the more than 35 countries where EPIDIOLEX is currently approved, with additional launches and market reimbursement expected in 2024.

Renee: Further opportunities for growth include continued education to support optimal dosing focused data generation and geographic expansion beyond the more than 35 countries, where <unk> is currently approved with additional launches and market reimbursement expected in 2024.

Shifting to our oncology business on slide 10, total oncology revenue for the quarter was approximately $258 million, led by RYLAZE and ZEPZELCA. RYLAZE delivered another strong quarter with net product sales of $103 million, representing a 20% increase from the first quarter of 2023.

Renée Galá: Shifting to our oncology business on Slide 10, total oncology revenue for the quarter was approximately $258 million, led by Rylaze and Zepzelca. Rylaze delivered another strong quarter, with net product sales of $103 million, representing a 20% increase from Q1 2023. Strong demand for Rylaze continues to be driven by several factors, including its near-universal adoption in pediatric asparaginase-based oncology protocols in the US and adoption of the Monday, Wednesday, Friday dosing regimen. We are also seeing usage of Rylaze in the first-line setting based on the benefits of its short-acting profile relative to current first-line asparaginase therapies. In addition, we remain focused on continued growth of Rylaze in the treatment of adolescents and young adults, or the AYA market.

Renee Gala: Shifting to our oncology business on Slide 10, total oncology revenue for the quarter was approximately $258 million, led by Rylaze and Zepzelca. Rylaze delivered another strong quarter, with net product sales of $103 million, representing a 20% increase from Q1 2023. Strong demand for Rylaze continues to be driven by several factors, including its near-universal adoption in pediatric asparaginase-based oncology protocols in the US and adoption of the Monday, Wednesday, Friday dosing regimen. We are also seeing usage of Rylaze in the first-line setting based on the benefits of its short-acting profile relative to current first-line asparaginase therapies. In addition, we remain focused on continued growth of Rylaze in the treatment of adolescents and young adults, or the AYA market.

Renee: Shifting to our oncology business on slide 10, total oncology revenue for the quarter was approximately $258 million led by Ray lease ends up soccer.

Renee: <unk> delivered another strong quarter with net product sales of $103 million, representing a 20% increase from the first quarter of 2023.

Renee Gala: Strong demand for RYLAZE continues to be driven by several factors, including its near universal adoption in pediatric asparaginase-based oncology protocols in the U.S. and adoption of the Monday, Wednesday, Friday dosing regimen. We are also seeing usage of RYLAZE in the first-line setting based on the benefits of its short-acting profile relative to current first-line asparaginase therapies. In addition, we remain focused on continued growth of RYLAZE in the treatment of adolescents and young adults, or the AYA market. Turning to slide 11 in Zepselka, net product sales for the first quarter increased 12% year-over-year to $75 million.

Strong demand for RYLAZE continues to be driven by several factors, including its near universal adoption in pediatric asparaginase-based oncology protocols in the U.S. and adoption of the Monday, Wednesday, Friday dosing regimen. We are also seeing usage of RYLAZE in the first-line setting based on the benefits of its short-acting profile relative to current first-line asparaginase therapies. In addition, we remain focused on continued growth of RYLAZE in the treatment of adolescents and young adults, or the AYA market.

Renee: Strong demand for <unk> continues to be driven by several factors, including its near Universal adoption in pediatric asparaginase based oncology protocols in the U S and adoption of the Monday Wednesday Friday dosing regimen.

Renee: We are also seeing usage of <unk> in the first line setting based on the benefits of its short acting profile relative to current first line asparaginase therapies.

Renee: In addition, we remain focused on continued growth of <unk> in the treatment of adolescence and young adults or the <unk> market.

Renée Galá: Turning to Slide 11 and Zepzelca, net product sales for Q1 increased 12% year-over-year to $75 million. We have established Zepzelca as the number one treatment for second-line small cell lung cancer patients, and we continue to hear positive feedback from healthcare providers on its clinical benefit, as well as ease of use and administration for patients and their healthcare practices. In addition to the second-line setting, there remains an unmet need for small cell lung cancer patients in earlier lines of therapy. We believe positive data from the ongoing Phase 3 trial in first-line small cell lung cancer is the biggest opportunity to drive significant growth and, most importantly, would provide a further opportunity to improve patient lives and outcomes. We expect data from that trial in late 2024 or early 2025.

Renee Gala: Turning to Slide 11 and Zepzelca, net product sales for Q1 increased 12% year-over-year to $75 million. We have established Zepzelca as the number one treatment for second-line small cell lung cancer patients, and we continue to hear positive feedback from healthcare providers on its clinical benefit, as well as ease of use and administration for patients and their healthcare practices. In addition to the second-line setting, there remains an unmet need for small cell lung cancer patients in earlier lines of therapy. We believe positive data from the ongoing Phase 3 trial in first-line small cell lung cancer is the biggest opportunity to drive significant growth and, most importantly, would provide a further opportunity to improve patient lives and outcomes. We expect data from that trial in late 2024 or early 2025.

Renee: Turning to slide 11, and <unk> net product sales for the first quarter increased 12% year over year to $75 million.

Turning to slide 11 in ZEPZELCA, net product sales for the first quarter increased 12% year-over-year to $75 million. We have established ZEPZELCA as the number one treatment for second-line small cell lung cancer patients, and we continue to hear positive feedback from healthcare providers on its clinical benefit, as well as its ease of use and administration for patients and their healthcare practices. In addition to the second-line setting, there remains an unmet need for small cell lung cancer patients in earlier lines of therapy. We believe positive data from the ongoing Phase III trial in first-line small cell lung cancer is the biggest opportunity to drive significant growth and, most importantly, would provide a further opportunity to improve patient lives and outcomes. We expect data from that trial in late 2024 or early 2025. With that, I'll turn it over to Rob for an update on our pipeline and upcoming milestones. Rob?

Renee Gala: We have established Zepselka as the number one treatment for second-line small cell lung cancer patients, and we continue to hear positive feedback from healthcare providers on its clinical benefit, as well as its ease of use for patients and their healthcare practices. In addition to the second-line setting, there remains an unmet need for small cell lung cancer patients in earlier lines of therapy. We believe positive data from the ongoing Phase 3 trial in first-line small cell lung cancer is the biggest opportunity to drive significant growth and, most importantly, would provide a further opportunity to improve patient lives and outcomes. We expect data from that trial in late 2024 or early 2025. With that, I'll turn it over to Rob for an update on our pipeline and upcoming milestones. Rob?

Renee: We have established <unk> as the number one treatment for second line small cell lung cancer patients and we continue to hear positive feedback from health care providers on its clinical benefit as well as ease of use and administration for patients and their health care practices.

Renee: In addition to the second line setting there remains an unmet need for small cell lung cancer patients and earlier lines of therapy. We believe positive data from the ongoing phase III trial in first line small cell lung cancer is the biggest opportunity to drive significant growth.

Renee: And most importantly would provide a further opportunity to improve patient lives and outcomes we.

We expect data from that trial in late 2024 or early 2025.

Renée Galá: With that, I'll turn it over to Rob for an update on our pipeline and upcoming milestones. Rob?

Renee Gala: With that, I'll turn it over to Rob for an update on our pipeline and upcoming milestones. Rob?

With that, I'll turn it over to Rob for an update on our pipeline and upcoming milestones. Rob?

Renee: With that I'll turn it over to Rob for an update on our pipeline and upcoming milestones Rob. Thank you Renee.

Robert Iannone: Thank you, Renee. 2024 represents an exciting time for our pipeline, and we anticipate multiple meaningful catalysts across oncology and neuroscience. On Slide 13, we've provided an overview of the key clinical programs in our diversified pipeline, and I'll highlight several milestones we expect to reach in the near term. Starting with oncology and zanidatamab, we have completed our BLA submission for second-line biliary tract cancer, or BTC, in the US, with potential for accelerated approval. Additionally, we are targeting late this year to report top-line data from the ongoing phase 3 first-line gastroesophageal adenocarcinoma, or GEA, trial. If positive, we expect this trial would support registration. I'll speak more to our zanidatamab development plan in just a moment. We're also pleased with the progress of the Zepzelca first-line trial, which completed enrollment in January.

Robert Iannone: Thank you, Renée. 2024 represents an exciting time for our pipeline, and we anticipate multiple meaningful catalysts across oncology and neuroscience. On slide 13, we provided an overview of the key clinical programs in our diversified pipeline. And I'll highlight several milestones we expect to reach in the near term, starting with Oncology and ZANIDATAMAB. We have completed our BLA submission for second-line Biliary Tract Cancer, or BTC, in the US, with potential for accelerated approval.

Rob: Only 24 represents an exciting time for our pipeline and we anticipate multiple meaningful catalysts across oncology and neuroscience.

Rob: On slide 13, we provided an overview of the key clinical programs and our diversified pipeline.

Rob: Highlights several milestones we expect to reach in the near term.

Robert Iannone: Additionally, we are targeting late this year to report top line data from the ongoing Phase III first-line gastroesophageal adenocarcinoma or GEA trial. If positive, we expect this trial would support registration. I'll speak more about our ZANIDATAMAB development plan in just a moment. Meanwhile, we're also pleased with the progress of the Zipselka first-line trial, which completed enrollment in January. Top-line progression-free survival data for Zubzelka in combination with Decentric in first-line, extensive-stage small cell lung cancer is expected at the end of 2024 or early 2025.

Additionally, we are targeting late this year to report top line data from the ongoing Phase III first-line gastroesophageal adenocarcinoma or GEA trial. If positive, we expect this trial would support registration. I'll speak more about our ZANIDATAMAB development plan in just a moment.

Rob: Starting with oncology presented data ma'am.

Rob: We have completed our BLA submission for second line biliary tract cancer or BTC in the U S.

Rob: Potential for accelerated approval.

Rob: Additionally, we are targeting late this year to report top line data from the ongoing phase III first line gastroesophageal adenocarcinoma.

Rob: Trial.

Rob: Positive we expect this trial would support registration.

We're also pleased with the progress of the ZEPZELCA first-line trial, which completed enrollment in January. Top-line progression-free survival data for ZEPZELCA in combination with TECENTRIQ in first-line, extensive-stage small cell lung cancer is expected at the end of 2024 or early 2025. If approved, this new indication would enable more patients with small cell lung cancer to potentially benefit from a longer duration of therapy with ZEPZELCA. Turning to neuroscience, we expect top-line data from our Phase III trial of EPIDIOLEX in Japan in the second half of 2024. We also have ongoing trials for SUVECALTAMIDE, or JZP385, in both essential tremor, or ET, and Parkinson's disease tremor. With top-line data from the ET trial expected late in the first half of 2024.

Rob: I'll speak more to our Zamin data Mab development plan in just a moment.

Rob: We're also pleased with the progress of the <unk> first line trial, which completed enrollment in January.

Robert Iannone: Top-line progression-free survival data for Zepzelca in combination with Tecentriq in first-line extensive-stage small cell lung cancer is expected at the end of 2024 or early 2025. If approved, this new indication would enable more patients with small cell lung cancer to potentially benefit from longer duration of therapy with Zepzelca. Turning to neuroscience, we expect top-line data from our phase 3 trial of Epidiolex in Japan in the second half of 2024. We also have ongoing trials for suvecaltamide, or JZP-385, in both essential tremor, or ET, and Parkinson's disease tremor, with top-line data from the ET trial expected late in the first half of 2024. If trial findings are positive, we believe this trial could serve as part of a pivotal regulatory package. I'd also like to provide an update on JZP-441, our clinical-stage orexin-2 receptor agonist.

Rob: Top line progression free survival data for <unk> in combination with centric and first line extensive stage small cell lung cancer is expected at the end of 2024 or early 2025, if approved this new indication would enable more patients with small cell lung cancer.

Robert Iannone: If approved, this new indication would enable more patients with small cell lung cancer to potentially benefit from a longer duration of therapy with Zubzelka. Turning to neuroscience, we expect top-line data from our Phase III trial of Epidiolex in Japan in the second half of 2024. We also have ongoing trials for subacalcamide, or JCP385, in both essential tremor, or ET, and Parkinson's disease tremor, with top line data from the ET trial expected late in the first half of 2024.

Rob: Potentially benefit from longer duration of therapy with <unk>, turning to neuroscience, we expect topline data from our phase III trial of <unk> in Japan in the second half of 2024.

Rob: We also have ongoing trials receive accounts in mind <unk> five in both essential tremor.

Rob: <unk> and Parkinson's disease tremor.

Rob: Top line data from the <unk> trial expected late in the first half of 2024.

Robert Iannone: If trial findings are positive, we believe this trial could serve as part of a pivotal regulatory package. I'd also like to provide an update on JZP441, our clinical stage RX2 OREXIN-2 receptor agonist. We paused the JZP441 Phase I trial last November after observing a signal for QTC interval prolongation on automated ECG recording. Since that time, we have engaged external experts for manual reads of ECGs.

Rob: If trials signings are positive we believe this trial could serve as part of the pivotal regulatory package.

Rob: I would also like to provide an update on GBP 441, our clinical stage <unk> receptor agonist.

Robert Iannone: We paused the JZP-441 phase I trial last November after observing a signal for QTc interval prolongation on automated ECG recordings. Since that time, we engaged external experts to perform manual reads of ECGs. That work was recently completed with the initial report indicating there may be a therapeutic index to exposures predicted to be efficacious in narcolepsy type 1 patients. We are reviewing this information with our alliance partner, Sumitomo Pharma, and Jazz will then make a decision on next steps, if any. I expect to be in a position to provide an update on our Q2 earnings call. Returning to zanidatamab, slide 14 provides more detail on our development plan.

Rob: We paused the GBP 401 phase one trial last November after observing a signal for Q T C interval prolongation, an automated ECG recordings.

Rob: Since that time, we engaged external experts to perform manual read <unk>.

Robert Iannone: That work was recently completed, with the initial report indicating there may be a therapeutic index to exposures predicted to be efficacious in narcolepsy Type 1 patients. We are reviewing this information with our alliance partner, Sumitomo Pharma, and Jazz will then make a decision on next steps, if any. I expect to be in a position to provide an update on our 2Q earnings call. Returning to Data Data Map.

That work was recently completed, with the initial report indicating there may be a therapeutic index to exposures predicted to be efficacious in narcolepsy Type 1 patients. We are reviewing this information with our alliance partner, Sumitomo Pharma, and Jazz will then make a decision on next steps, if any. I expect to be in a position to provide an update on our 2Q earnings call.

Rob: Network was recently completed with the initial report, indicating there may be a therapeutic index to exposures predicted to be efficacious in narcolepsy type one patients.

Rob: We are reviewing this information with our alliance partner Sumitomo Pharma and jazz will then make a decision on next steps if any.

Rob: I expect to be in a position to provide an update on our <unk> earnings call.

Returning to ZANIDATAMAB. Slide 14 provides more detail on our development plan. We have meaningfully progressed ZANIDATAMAB development across multiple indications since bringing it to Jazz. And based on emerging strong data across indications, we remain excited about the potential of ZANIDATAMAB to transform the current standard of care in multiple HER2-expressing cancers. As noted earlier, we completed our BLA submission for second line BTC at the end of March and anticipate a response from FDA within the usual 60 day window upon acceptance.

Rob: Returning to us out of the data man slide.

Robert Iannone: Slide 14 provides more detail on our development. We have meaningfully progressed on data map development across multiple indications since bringing it to JAG. And based on emerging strong data across indications, we remain excited about the potential of ZanaDataMap to transform the current standard of care in multiple HER2-expressing cancers. As noted earlier, we completed our BLA submission for second line BTC at the end of March and anticipate a response from FDA within the usual 60 day window upon acceptance.

Rob: 14 provides more detail on our development plan.

Robert Iannone: We have meaningfully progressed zanidatamab development across multiple indications since bringing it to Jazz, and based on emerging strong data across indications, we remain excited about the potential of zanidatamab to transform the current standard of care in multiple HER2 expressing cancers. As was noted earlier, we completed our BLA submission for second-line BTC at the end of March and anticipate a response from FDA within the usual 60-day window. Upon acceptance, FDA would also establish the priority of review and produce a timeline. I'll also note we are planning to present more mature data from the ongoing BTC trial at ASCO this year, including overall survival. Our development plan represents a robust investigation of this molecule in multiple tumor types, including an ongoing trial in GEA that we believe would support registration in that indication and several trials in breast cancer.

Rob: We have meaningfully progressed data mab development across multiple indications to bringing it to jazz.

Rob: Based on emerging strong data across indications.

Rob: We remain excited about the potentials that are data ma'am can transform the current standard of care in multiple <unk> expressing cancers.

Rob: As was noted earlier, we completed our BLA submission for second line BTC at the end of March.

Rob: Anticipated response from FDA within the usual 60 day window.

Rob: Upon acceptance.

Upon acceptance, FDA would also establish the priority overview and PDUFA timeline. I'll also note we are planning to present more mature data from the ongoing BTC trial at ASCO this year, including overall survival. Our development plan represents a robust investigation of this molecule in multiple tumor types, including an ongoing trial in GEA that we believe would support registration in that indication, and several trials in breast cancer.

Upon acceptance, FDA would also establish the priority overview and PDUFA timeline.

Robert Iannone: FDA would also establish the priority overview and PDUFA timeline. I'll also note we are planning to present more mature data from the ongoing BTC trial at ASCO this year, including overall survival. Our development plan represents a robust investigation of this molecule in multiple tumor types, including an ongoing trial in GEA that we believe would support registration in that indication, and several trials and press.

Rob: FTA would also establish the priority overview introduce your timeline.

I'll also note we are planning to present more mature data from the ongoing BTC trial at ASCO this year, including overall survival. Our development plan represents a robust investigation of this molecule in multiple tumor types, including an ongoing trial in GEA that we believe would support registration in that indication, and several trials in breast cancer. We recently announced plans to initiate the Phase III POWER trial in the second half of this year, which will evaluate ZANIDATAMAB in combination with chemotherapy after progression on HER2, where we have the opportunity to be the first HER2-targeted therapy to demonstrate efficacy and safety in breast cancer patients post-in HER2. In summary, we're executing a regulatory strategy that we believe will enable us to bring ZANIDATAMAB to the market in the near term with an initial indication in second-line BTC and the opportunity to rapidly advance other indications.

Rob: I'll also note we are planning to present more mature data from the ongoing BTC trial at <unk> this year, including overall survival.

Rob: Our development plan represents a robust investigation of this molecule in multiple tumor types, including an ongoing trial that.

Rob: That we believe would support registration in that indication.

Rob: In several trials in breast cancer.

Robert Iannone: We recently announced plans to initiate the Phase 3 POWER trial in the second half of this year, which will evaluate Xanadatamab in combination with chemotherapy after progression on an HER2, where we have the opportunity to be the first HER2-targeted therapy to demonstrate efficacy and safety in breast cancer patients post-inHER2. In summary, we're executing a regulatory strategy that we believe will enable us to bring ZanaDataMap to the market in the near term with an initial indication in second-line BTC and the opportunity to rapidly advance other indications.

Robert Iannone: We recently announced plans to initiate the phase 3 power trial in the second half of this year, which will evaluate zanidatamab in combination with chemotherapy after progression on Enhertu, where we have the opportunity to be the first HER2-targeted therapy to demonstrate efficacy and safety in breast cancer patients post-Enhertu. In summary, we're executing a regulatory strategy that we believe will enable us to bring zanidatamab to the market in the near term, with an initial indication in second-line BTC and the opportunity to rapidly advance other indications. In total, we believe our development program can deliver for patients in need and generate a significant commercial opportunity of more than $2 billion.

Rob: We recently announced plans to initiate the phase III powered trial in the second half of this year, which will evaluate examined data.

Rob: In combination with chemotherapy.

Rob: After progression on it hurt too.

Rob: We have the opportunity to be the first her <unk> targeted therapy to demonstrate efficacy and safety in breast cancer patients post 202.

Rob: In summary, we're executing our regulatory strategy that we believe will enable us to bring examine data map to the market in the near term with an initial indication in second line DTC.

Rob: And the opportunity to rapidly advance other indications.

Robert Iannone: In total, we believe our development program can deliver for patients in need and generate a significant commercial opportunity of more than $2 billion. I would encourage listeners to go to our IR website and access the R&D Day webcast be hosted on ZANIDATAMAB in March, which included a detailed overview of data demonstrating ZANIDATAMAB's differentiation from other HER2-targeted agents. How it would fit in the HER2 treatment landscape and perspectives from external thought leaders on the potential of ZANIDATAMAB to improve the quality of care for patients with HER2-expressing tumors.

Rob: In total we believe our development program can deliver for patients in need and generate a significant commercial opportunity of more than $2 billion.

Robert Iannone: I would encourage listeners to go to our IR website and access the R&D Day webcast we hosted on zanidatamab in March, which included a detailed overview of data demonstrating zanidatamab's differentiation from other HER2-targeted agents, how it would fit in the HER2 treatment landscape, and perspectives from external thought leaders on the potential of zanidatamab to improve the quality of care for patients with HER2-expressing tumors. Turning to slide 15, with the top line data readout from the essential tremor trial anticipated in Q2 of this year, I'd like to highlight suvecaltamide, which is a highly selective and state-dependent modulator of T-type calcium channels in clinical development for the treatment of ET and Parkinson's disease tremor. There is a high unmet need for ET treatment, with no new medicines approved in more than 50 years.

Rob: I would encourage listeners to go to our IR website and access to R&D day webcast. We hosted on data map in March which included a detailed overview of data demonstrating some of the data maps differentiation from other her two targeted agents.

Rob: How it would fit in the <unk> treatment landscape two perspectives from external thought leaders on the potential examined data map to improve the quality of care for patients with her two expressing tumors.

Robert Iannone: Turning to slide 15, with a top-line data readout from the essential tremor trial anticipated in the second quarter of this year, I'd like to highlight SUVECALTAMIDE, which is a highly selective state-dependent modulator of T-type calcium channels in clinical development for the treatment of ET and Parkinson's disease tremor. There is a high unmet need for ET treatment, with no new medicines approved in more than 50 years. ET can be highly debilitating, with significant negative effects on a patient's quality of life and activities of daily living, such as eating, drinking, dressing, shaving, and writing, and can lead to substantial impairment in physical functioning. Some patients also experience cognitive deficits, anxiety, social phobia, depression, and sleep disturbance in the U.S. and key European markets, there are approximately 2 million diagnosed patients, with a prevalence estimated at approximately 11 million patients.

Rob: Turning to slide 15.

Rob: With the topline data readout from the essential tremor trial anticipated in the second quarter of this year I'd like to.

Rob: Highlights of accounts in mind, which is a highly selective state dependent modulator of T type calcium channels in clinical development for the treatment of ETE in Parkinson's disease tremor.

Rob: There is a high unmet need for ETE treatment with no new medicines approved in more than 50 years.

Robert Iannone: ET can be highly debilitating, with significant negative effects on a patient's quality of life and activities of daily living, such as eating, drinking, dressing, shaving, and writing, and can lead to substantial impairment in physical functioning. Some patients also experience cognitive deficits, anxiety, social phobia, depression, and sleep disturbance. In the US and key European markets, there are approximately 2 million diagnosed patients with a prevalence estimated at approximately 11 million patients. Moving to slide 16, I want to touch on suvecaltamide's differentiated mechanism of action. While the exact underlying pathophysiology of ET is not clear, there is strong evidence to support the role of T-type calcium channels. T-type calcium channels regulate the balance of calcium ions, acting as a gatekeeper to help ions both enter and leave the cell membrane.

Rob: ETE can be highly debilitating with significant negative effects on a patient's quality of life and activities of daily living such as.

Rob: Eating drinking.

Rob: Shaving and writing.

Rob: And can lead to substantial impairment and physical functioning.

Rob: Some patients also experience cognitive deficits.

Rob: <unk>, social phobia depression sleep disturbance.

Robert Iannone: In the U.S. and key European markets, there are approximately 2 million diagnosed patients, with a prevalence estimated at approximately 11 million patients. Moving to slide 16, I want to touch on suvacaltamide's differentiated mechanism of action. While the exact underlying pathophysiology of ET is not clear, there is strong evidence to support the role of T-type calcium channels. These channels regulate the balance of calcium ions, acting as a gatekeeper to help ions both enter and leave the cell membrane.

In the U.S. and key European markets, there are approximately 2 million diagnosed patients, with a prevalence estimated at approximately 11 million patients.

Rob: In the U S and key European markets. There are approximately 2 million diagnosed patients with the prevalence estimated at approximately 11 million patients.

Moving to slide 16, I want to touch on SUVECALTAMIDE's differentiated mechanism of action. While the exact underlying pathophysiology of ET is not clear, there is strong evidence to support the role of T-type calcium channels. T-type calcium channels regulate the balance of calcium ions, acting as a gatekeeper to help ions both enter and leave the cell membrane.

Rob: Moving to slide 16.

Rob: I wanted to touch on two of the accounts <unk> differentiated mechanism of action.

Rob: While the exact underlying pathophysiology of ETE is not clear.

Rob: There is strong evidence to support the role of T type calcium channels T type calcium channels regulate the balance of calcium islands.

<unk> as a gatekeeper panel plans, both enter and leave the cell membrane.

Robert Iannone: In some pathological states, such as ET, increased activation of these channels leads to excessive rhythmic signals that prompt tremor. The high selectivity of SUVECALTAMIDE for T-type calcium channels makes it a promising candidate for the treatment of ET, which was demonstrated in the Phase II TECOM trial. Importantly, SUVECALTAMIDE is differentiated from other T-type calcium channel blockers in development as it is state dependent, meaning that it targets channels under conditions of hyper excitability while sparing the form of the channel, important for normal neuronal signaling. Now, I will turn the call over to Phil for a financial update. Phil?

In some pathological states, such as ET, increased activation of these channels leads to excessive rhythmic signals that prompt tremor. The high selectivity of SUVECALTAMIDE for T-type calcium channels makes it a promising candidate for the treatment of ET, which was demonstrated in the Phase II TECOM trial. Importantly, SUVECALTAMIDE is differentiated from other T-type calcium channel blockers in development as it is state dependent, meaning that it targets channels under conditions of hyper excitability while sparing the form of the channel, important for normal neuronal signaling.

Robert Iannone: In some pathological states, such as ET, increased activation of these channels leads to excessive rhythmic signals that prompt tremor. The high selectivity of suvecaltamide for T-type calcium channels makes it a promising candidate for the treatment of ET, which was demonstrated in the phase II TCOM trial. Importantly, suvecaltamide is differentiated from other T-type calcium channel blockers in development, as it is state-dependent, meaning that it targets channels under conditions of hyperexcitability while sparing the form of the channel important for normal neuronal signaling. Now I will turn the call over to Phil for a financial update. Phil?

Rob: And some pathological states.

Rob: Decreased activation of these channels leads to excessive rhythmic signals that prompt tremor.

Rob: The high selectivity of Subic Kalsomine for T type calcium channels makes it a promising candidate for the treatment of ETE.

Rob: Which was demonstrated in the phase two T com trial.

Rob: Importantly, Steve account Tonight is differentiated from other T type calcium channel blockers in development as it is state dependent meaning that it targets channels under conditions of hyper excitability, while sparing the form of the channel important for normal neuronal signaling.

Now, I will turn the call over to Phil for a financial update. Phil?

Rob: Now I will turn the call over to Phil for financial update.

Philip Johnson: Thanks, Rob. First, I'd like to express how excited I am to join Jazz. I came to the company because of its history of success, innovating to transform the lives of patients and their families, and because of the quality, integrity, and enthusiasm of its people. What Jazz has accomplished since its founding is impressive, and we have great opportunities ahead of us to enhance our impact on the lives of the patients we serve and to create significant shareholder value. Turning now to our Q1 2024 financial performance, slide 18 summarizes the highlights. As a reminder, more information on our financial results is available in our press release and 10-Q. We saw continued top-line growth in Q1 2024, with $902 million in total revenues, representing a 1% increase over the same period in 2023.

Phil Johnson: Thanks, Rob.

Phil Johnson: First I'd like to express how excited I am to join jazz.

Phil Johnson: Came to the company because it has a history of success innovating to transform the lives of patients and their families.

Phil Johnson: And because of the quality integrity and enthusiasm of its people.

Phil Johnson: With Janssen has accomplished since its founding is impressive and we have great opportunities ahead of us to enhance our impact on the lives of the patients we serve and to create significant shareholder value.

Phil Johnson: Turning now to our first quarter 2024 financial performance, slide 18 summarizes the highlights. As a reminder, more information on our financial results is available in our press release and 10-Q. We saw continued top line growth in the first quarter of 2024 with $902 million in total revenue, representing a 1% increase over the same period in 2023. As Renée noted, our first quarter revenues have historically been affected by several factors, including reauthorization, which drives the use of patient support programs and inventory build in the latter part of the prior year, which leads to inventory burn in Q1.

Speaker Change: Turning now to our first quarter 2024 financial performance Slide 18 summarizes the highlights.

Speaker Change: As a reminder, more information on our financial results is available in our press release and 10-Q.

Speaker Change: We saw continued top line growth in the first quarter of 2024 with $902 million in total revenues, representing a 1% increase over the same period in 2023.

Philip Johnson: As Renee noted, our first quarter revenues have historically been affected by several factors, including reauthorizations, which drive the use of patient support programs, and inventory build in the latter part of the prior year, which leads to inventory burn in Q1. Our Q1 results are in line with our expectations, and we are affirming our full-year revenue guidance of $4.0 to 4.2 billion, including our expectation for combined double-digit growth from our key growth drivers, XYWAV, Epidiolex, and Rylaze, and double-digit growth in our oncology therapeutic area. Moving to slide 19, non-GAAP adjusted SG&A reflected investments dedicated to our key growth drivers, including the XYWAV IH commercial initiatives, commercial support for Epidiolex in the US, where the market is promotionally sensitive, geographic expansion of Epidiolex outside the US, and educational efforts for Rylaze in AYA.

Speaker Change: As Rene noted our first quarter revenues have historically been affected by several factors, including re authorizations, which drive the use of patient support programs and inventory build in the latter part of the prior year, which leads to inventory burn in Q1.

Phil Johnson: Our Q1 results are in line with our expectations, and we are affirming our full-year revenue guidance of $4.0 billion to $4.2 billion, including our expectation for combined double-digit growth from our key growth drivers, XYWAV, EPIDIOLEX, and RYLAZE, and double-digit growth in our oncology therapeutic area. Moving to slide 19, non-gap adjusted SG&A reflected investments dedicated to our key growth drivers, including the Xywave IH commercial initiative. Commercial support for Epidiolex in the US, where the market is promotionally sensitive. Geographic Expansion of Epidiolics Outside the U.S. and Educational Efforts for RILAs and AYA

Our Q1 results are in line with our expectations, and we are affirming our full-year revenue guidance of $4.0 billion to $4.2 billion, including our expectation for combined double-digit growth from our key growth drivers, XYWAV, EPIDIOLEX, and RYLAZE, and double-digit growth in our oncology therapeutic area.

Speaker Change: Our Q1 results are in line with our expectations and we are affirming our full year revenue guidance of 4.0 to $4 2 billion, including our expectation for combined double digit growth from our key growth drivers as always at the dialogues and reillys and double digit growth in our oncology therapeutic area.

Speaker Change: Moving to slide 19, non-GAAP adjusted SG&A reflected investments dedicated to our key growth drivers.

Moving to slide 19, non-GAAP adjusted SG&A reflected investments dedicated to our key growth drivers, including the XYWAV IH commercial initiatives, commercial support for EPIDIOLEX in the U.S., where the market is promotionally sensitive. Geographic expansion of EPIDIOLEX outside the U.S. and educational efforts for RYLAZE and AYA.

Speaker Change: The design, we have IH commercial initiatives.

Speaker Change: Commercial support for <unk> in the U S, where the market is promotion sensitive geographic.

Speaker Change: <unk> expansion of epic dialogues outside the U S and educational efforts for railways and AIA.

Phil Johnson: Non-GAAP Adjusted R&D expense for the quarter was driven by investment in multiple late-stage programs, which we view as critical to enhancing the future value of our pipeline. We are executing on a robust development plan for ZANIDATAMAB with trials across multiple tumor types, as well as Phase II trials for SUVECALTAMIDE in 2 different disease areas, and programs for EPIDIOLEX and ZEPZELCA that have the potential to expand those products into new geographies and patient populations, respectively.

Philip Johnson: Non-GAAP adjusted R&D expense for the quarter was driven by investment in multiple late-stage programs, which we view as critical to enhancing the future value of our pipeline. We are executing on a robust development plan for zanidatamab, with trials across multiple tumor types, as well as Phase 2 trials for suvecaltamide in two different disease areas, and programs for Epidiolex and Zepzelca that have the potential to expand those products into new geographies and patient populations, respectively. I'll note that our operating margin and expenses are not linear, and we incur spend at the time that best supports strategic initiatives for our commercial business and pipeline. Investments in our commercial business to support our key growth drivers ramped up in the Q4 of 2023 and extended into the Q1 of 2024. We expect these investments to positively impact revenue as the year progresses.

Speaker Change: non-GAAP adjusted R&D expense for the quarter was driven by investment in multiple late stage programs, which we view as critical to enhancing the future value of our pipeline.

Speaker Change: We are executing on a robust development plan for is any data mab with trials across multiple tumor types as well as phase two trials for <unk> in two different disease areas and programs for other dialogues ends up blocker that have the potential to expand those products into new geographies and patient populations respectively.

Phil Johnson: I note that our operating margin and expenses are not linear, and we incur spend at the time that best supports strategic initiatives for our commercial business and pipeline. Investments in our commercial business to support our key growth drivers ramped up in the fourth quarter of 2023 and extended into the first quarter of 2024. We expect these investments to positively impact revenue as the year progresses. SG&A expenses in 1Q '24 also included a bad debt expenses and higher litigation costs, primarily related to the Avadel patent infringement trial.

Speaker Change: I will note that our operating margin and expenses are not linear.

Speaker Change: And we incur spend at the time, the best support strategic initiatives for our commercial business and pipeline.

Speaker Change: Investments in our commercial business to support our key growth drivers ramped up in the fourth quarter of 2023 and extended into the first quarter of 2024.

Speaker Change: We expect these investments to positively impact revenue as the year progresses.

Philip Johnson: SG&A expenses in Q1 2024 also included a bad debt expense and higher litigation costs, primarily related to the Abilade patent infringement trial. Our R&D expenses, along with clinical trial activity, ramped up in 2023, and we expect these expenses to remain at relatively consistent levels throughout 2024. Therefore, we are affirming our full year 2024 SG&A and R&D guidance. I'd also point out that we recorded a discrete tax expense related to expired stock options. While this significantly increased our non-GAAP effective tax rate for the quarter, we expect our full year 2024 non-GAAP effective tax rate to remain in the range of 10% to 13%. We continue to generate significant cash from our business, driven by the strength and diversity of our portfolio.

Speaker Change: SG&A expenses in the <unk> 24 also included a bad debt expense and higher litigation costs, primarily related to the avid El patent infringement trial.

Phil Johnson: Our R&D expenses, along with clinical trial activity, ramped up in 2023, and we expect these expenses to remain at relatively consistent levels throughout 2024. Therefore, we are affirming our full year 2024 SG&A and R&D guidance. I'd also point out that we recorded a discrete tax expense related to expired stock options. While this significantly increased our non-GAAP effective tax rate for the quarter, we expect our full year 2024 non-GAAP effective tax rate to remain in the range of 10% to 13%.

Speaker Change: Our R&D expenses, along with clinical trial activity ramped up in 2023, and we expect these expenses to remain at relatively consistent levels throughout 2024.

Speaker Change: Therefore, we are affirming our full year 2020 for SG&A and R&D guidance.

Speaker Change: Okay.

Speaker Change: I would also point out that we recorded a discrete tax expense related to expired stock options.

Speaker Change: This significantly increased our non-GAAP effective tax rate for the quarter, we expect our full year 2024, non-GAAP effective tax rate to remain in the range of 10% to 13%.

Phil Johnson: We continue to generate significant cash from our business, driven by the strength and diversity of our portfolio. We recorded approximately $267.2 million of cash from operations in the first quarter and ended the quarter with $1.8 million in cash on hand.

Speaker Change: We continue to generate significant cash from our business driven by the strength and diversity of our portfolio.

Philip Johnson: We recorded approximately $267.2 million of cash from operations in the first quarter and ended the quarter with $1.8 billion in cash on hand. Our strong financial position and operating cash flow provide flexibility to invest in priority commercial and R&D programs, as well as corporate development opportunities. Non-GAAP adjusted net income of $182 million and non-GAAP adjusted EPS of $2.68 were driven by our top-line growth, along with significant investment in our key growth drivers and pipeline, including multiple late-stage clinical programs for zanidatamab, Epidiolex, suvecaltamide, and Zepzelca, all of which have the potential to generate significant long-term value.

Speaker Change: We recorded approximately $267 $2 million of cash from operations in the first quarter and ended the quarter with $1 $8 million in cash on hand.

Phil Johnson: Our strong financial position and operating cash flow provide flexibility to invest in priority commercial and R&D programs, as well as corporate development opportunities. Non-GAAP adjusted net income of $182 million and non-GAAP adjusted EPS of $2.68 were driven by our top-line growth, along with significant investment in our growth drivers and pipeline, including multiple late-stage clinical programs for ZANIDATAMAB, EPIDIOLEX, SUVECALTAMIDE, and ZEPZELCA, all of which have the potential to generate significant long-term value. Based on our results from the quarter and our continued focus on discipline and strategic capital allocation, we are affirming our non-GAAP adjusted net income guidance of $1.275 billion to $1.35 billion.

Our strong financial position and operating cash flow provide flexibility to invest in priority commercial and R&D programs, as well as corporate development opportunities. Non-GAAP adjusted net income of $182 million and non-GAAP adjusted EPS of $2.68 were driven by our top-line growth, along with significant investment in our growth drivers and pipeline, including multiple late-stage clinical programs for ZANIDATAMAB, EPIDIOLEX, SUVECALTAMIDE, and ZEPZELCA, all of which have the potential to generate significant long-term value.

Speaker Change: Our strong financial position and operating cash flow provide flexibility to invest in priority commercial and R&D programs as well as corporate development opportunities.

Speaker Change: non-GAAP adjusted net income of $182 million and non-GAAP adjusted EPS of $2 68.

Speaker Change: Driven by our top line growth along with significant investment in our key growth drivers and pipeline, including multiple late stage clinical programs presenting data map dialogues Suva Kalsomine Enzo zilkha.

Speaker Change: All of which have the potential to generate significant long term value.

Based on our results from the quarter and our continued focus on discipline and strategic capital allocation, we are affirming our non-GAAP adjusted net income guidance of $1.275 billion to $1.35 billion. Since joining Jazz, I've spent considerable time speaking with investors and analysts and greatly appreciate the perspective and input they shared. In these conversations, I heard a concern that Jazz would overpay for an acquisition to meet our goal of corporate development, contributing $500 million to 2025 revenue. Here's how we're thinking about this. First, acquiring or licensing innovation from outside our walls is central to how we'll achieve our purpose of transforming the lives of patients and their families.

Philip Johnson: Based on our results from the quarter and continued focus on discipline and strategic capital allocation, we are affirming our non-GAAP adjusted net income guidance of $1.275 to 1.35 billion. Since joining Jazz, I've spent considerable time speaking with investors, analysts, and greatly appreciate the perspective and input they shared. In these conversations, I heard a concern that Jazz would overpay for an acquisition to meet our goal of corporate development, contributing $500 million to 2025 revenue. Here's how we're thinking about this. First, acquiring or licensing innovation from outside our walls is central to how we'll achieve our purpose of transforming the lives of patients and their families. Second, as we allocate capital to internal projects and to corporate development, we are focused on making investments that can deliver sustainable revenues and create value for shareholders.

Speaker Change: Based on our results from the quarter and continued focus on disciplined and strategic capital allocation. We are affirming our non-GAAP adjusted net income guidance of $1 75 to $1 35 billion.

Phil Johnson: Since joining Jazz, I've spent considerable time speaking with investors and analysts and greatly appreciate the perspective and input they shared. In these conversations, I heard a concern that Jazz would overpay for an acquisition to meet our goal of corporate development, contributing $500 million to 2025 revenue. Here's how we're thinking about this. First, acquiring or licensing innovation from outside our walls is central to how we'll achieve our purpose of transforming the lives of patients and their families.

Speaker Change: Since joining jazz I've spent considerable time speaking with investors and analysts and greatly appreciate the perspective and input they share.

Speaker Change: In these conversations.

Speaker Change: The concern that jazz and overpay for an acquisition to meet our goal of corporate development contributing $500 million to 2025 revenue.

Here's how we're thinking about this. First, acquiring or licensing innovation from outside our walls is central to how we'll achieve our purpose of transforming the lives of patients and their families. Second, as we allocate capital to internal projects and to corporate development, we are focused on making investments that can deliver sustainable revenues and create value for shareholders. We will remain disciplined on price and will not make an acquisition just to meet our Vision 2025 goal. I'll close by noting that while I'm still getting up to speed, I'm incredibly excited about the future of this company and the opportunities we have to deliver value to both patients and investors.

Speaker Change: Here's how we're thinking about this.

First acquiring and licensing innovation from outside our walls is central to how we will achieve our purpose of transforming the lives of patients and their families.

Phil Johnson: Second, as we allocate capital to internal projects and to corporate development, we are focused on making investments that can deliver sustainable revenues and create value for shareholders. We will remain disciplined on price and will not make an acquisition just to meet our Vision 2025 goal.

Speaker Change: As we allocate capital the interim of projects and a corporate development. We are focused on making investments that can deliver sustainable revenues and create value for shareholders.

Operator: ... We will remain disciplined on price and will not make an acquisition just to meet our Vision 2025 goal. I'll close by noting that while I'm still getting up to speed, I'm incredibly excited about the future of this company and the opportunities we have to deliver value to both patients and investors. With that, I'll turn the call back to Bruce for closing remarks.

Philip Johnson: ... We will remain disciplined on price and will not make an acquisition just to meet our Vision 2025 goal. I'll close by noting that while I'm still getting up to speed, I'm incredibly excited about the future of this company and the opportunities we have to deliver value to both patients and investors. With that, I'll turn the call back to Bruce for closing remarks.

Speaker Change: We will remain disciplined on price and we will not make an acquisition just to meet our vision 2025 goal.

Phil Johnson: I'll close by noting that while I'm still getting up to speed, I'm incredibly excited about the future of this company and the opportunities we have to deliver value to both patients and investors. With that, I'll turn the call back to Bruce for his closing remarks. I'll conclude our prepared remarks on slide 21. We've made important progress towards delivering on our 2024 guidance and objectives and are pleased to be affirming our guidance. On the commercial side, we expect continued growth of our key products in 2024.

I'll close by noting that while I'm still getting up to speed, I'm incredibly excited about the future of this company and the opportunities we have to deliver value to both patients and investors. With that, I'll turn the call back to Bruce for his closing remarks.

I'll close by noting that while I'm still getting up to speed, I'm incredibly excited about the future of this company and the opportunities we have to deliver value to both patients and investors.

Speaker Change: I'll close by noting that while I'm still getting up to speed I'm incredibly excited about the future of this company and the opportunities we have to deliver value to both patients and investors.

Speaker Change: With that I'll turn the call back to Bruce for closing remarks.

Bruce Cozadd: I'll conclude our prepared remarks on slide 21. We've made important progress towards delivering on our 2024 guidance and objectives, and are pleased to be affirming our guidance today. On the commercial side, we expect continued growth of our key products in 2024, and on the R&D front, we continue to advance our pipeline and to invest in long-term growth. We see multiple catalysts in the near term, including data readouts for suvorexant, zanidatamab, Epidiolex, and Xywav. That concludes our prepared remarks. I would now like to turn the call over to the operator to open the line for Q&A.

Bruce: I'll conclude our prepared remarks on slide 21, we.

With that, I'll turn the call back to Bruce for his closing remarks.

Bruce: We've made important progress towards delivering on our 2020 for guidance and objectives and are pleased to be affirming our guidance today on.

Conclude our prepared remarks on slide 21. We've made important progress towards delivering on our 2024 guidance and objectives and are pleased to be affirming our guidance today. On the commercial side, we expect continued growth of our key products in 2024. And on the R&D front, we continue to advance our pipeline and to invest in long-term growth. We see multiple catalysts in the near term, including data readouts for SUVECALTAMIDE, ZANIDATAMAB, EPIDIOLEX, and ZEPZELCA. That concludes our prepared remarks. I would now like to turn the call over to the operator to open the line for Q&A.

Bruce C. Cozadd: Conclude our prepared remarks on slide 21. We've made important progress towards delivering on our 2024 guidance and objectives and are pleased to be affirming our guidance today. On the commercial side, we expect continued growth of our key products in 2024. And on the R&D front, we continue to advance our pipeline and to invest in long-term growth. We see multiple catalysts in the near term, including data readouts for SUVECALTAMIDE, ZANIDATAMAB, EPIDIOLEX, and ZEPZELCA. That concludes our prepared remarks.

Bruce: On the commercial side, we expect continued growth of our key products in 2024 and on the R&D front, we continued to advance our pipeline and to invest in long term growth.

Bruce: We see multiple catalysts in the near term, including data Readouts for Super Kalsomine Daily data Mab <unk> ends up Selco.

Bruce C. Cozadd: And on the R&D front, we continue to advance our pipeline and to invest in long-term growth. We see multiple catalysts in the near term, including data readouts for subacaltamide, zanydatamab, epidiolex, and zepsel. That concludes our prepared remarks. I would now like to turn the call over to the operator to open the line for Q&A.

That concludes our prepared remarks, I would now like to turn the call over to the operator to open the line for Q&A.

I would now like to turn the call over to the operator to open the line for Q&A.

Operator: [Operator Instructions] Your first question comes from the line of Jessica Fye with JP Morgan. Please go ahead. Hey guys, good afternoon.

Operator: [Operator Instructions] Your first question comes from the line of Jessica Fye with JP Morgan. Please go ahead.

Operator: Thank you. We will now begin the question-and-answer session. If you'd like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw that question, simply press star one again. If you are called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset to ensure that your phone is not on mute when asking your question. Please ask one question. The first question comes from the line of Jessica Fye with JP Morgan. Please go ahead.

Speaker Change: Thank you we will now begin the question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad to raise your hand and join the queue.

Operator: I would like to withdraw that question simply press Star. One again, if you are called upon to ask your question and our listening via loud speaker on your device. Please pickup your handset to ensure that your phone is not on mute when asking your question and please ask one question first question comes from the line of Jessica Fye with J P. Morgan.

Operator: And please ask one question. Your first question comes from the line of Jessica Fye with JP Morgan. Please go ahead. Hey guys, good afternoon.

Hey guys, good afternoon. Thanks for taking my two-part question on the oxybate narcolepsy dynamics in the quarter. First, can you quantify the headwind to 1Q from the increase in the use of patient support programs as those XYREM patients transition to XYWAV? And second, do you have an understanding of how many XYREM patients losing coverage transition to generic XYREM or once nightly and not to XYWAV? Thank you. Thanks, Jess, for the question. And Rene, maybe I'll let you take both parts of that.

Jessica Fye: Hey guys, good afternoon. Thanks for taking my two-part question on the oxybate narcolepsy dynamics in the quarter. First, can you quantify the headwind to 1Q from the increase in the use of patient support programs as those XYREM patients transition to XYWAV? And second, do you have an understanding of how many XYREM patients losing coverage transition to generic XYREM or once nightly and not to XYWAV? Thank you.

Jessica Fye: Please go ahead.

Jessica Fye: Hey, guys. Good afternoon. Thanks for taking my two-part question on the oxybate narcolepsy dynamics in the quarter. First, can you quantify the headwind to Q1 from the increase in use of patient support programs as those Xyrem patients transition to XYWAV? And second, do you have an understanding of how many Xyrem patients losing coverage transition to generic Xyrem or once nightly and not to XYWAV? Thank you.

Jessica Fye: Hey, guys. Good afternoon. Thanks for taking my two part question on oxalate narcolepsy dynamics in the quarter.

Jessica Fye: Thanks for taking my two-part question on the oxybate narcolepsy dynamics in the quarter. First, can you quantify the headwind to 1Q from the increase in the use of patient support programs as those XyRM patients transition to XyWave? And second, do you have an understanding of how many XyRM patients losing coverage transition to generic XyRM or once nightly and not to XyWave? Thank you. Thanks, Jess, for the question. And Rene, maybe I'll let you take both parts of that.

Jessica Fye: First can you quantify the headwind to <unk> from the increase in use of patient support programs as the xyrem patients transition to <unk>.

Jessica Fye: Second do you have an understanding of how many xyrem patients, losing coverage transitioned to generic xyrem or once nightly and not too sideways. Thank you.

Bruce C. Cozadd: Thanks, Jess, for the question. And Renée, maybe I'll let you take both parts of that.

Bruce Cozadd: Thanks, Jess, for the question, and Renee, maybe I'll let you take both parts of that.

Speaker Change: Thanks, Jess for the question Rene maybe I'll, let you take both parts of that.

Renee Gala: Sure. So, Jess, in terms of the--I'll take the second question first. We're not disclosing a breakdown of those patients, in part because that AG data is not our data to share. But with respect to being able to quantify how many patients came over, I would say there was a good portion of patients that made the decision, along with their HCPs, to adopt low-sodium XYWAV, and we did see and establish those patient support programs to ensure that we have uninterrupted access for those patients to be able to go from XYREM directly to XYWAV.

Renée Galá: Sure. So, Jess, in terms of the, I'll take the second question first. We're not disclosing a breakdown of those patients, in part because that AG data is not our data to share. But with respect to being able to quantify how many patients came over, I would say there was a good portion of patients that made the decision, along with their HCPs, to adopt low-sodium XYWAV. And we did see and establish those patient support programs to ensure that we have uninterrupted access for those patients to be able to go from Xyrem directly to XYWAV. So what we'll see in future quarters is you should see a better representation of those patients in the revenue and the net sales that come from XYWAV.

Renee Gala: Sure. So, Jess, in terms of the, I'll take the second question first. We're not disclosing a breakdown of those patients, in part because that AG data is not our data to share. But with respect to being able to quantify how many patients came over, I would say there was a good portion of patients that made the decision, along with their HCPs, to adopt low-sodium XYWAV. And we did see and establish those patient support programs to ensure that we have uninterrupted access for those patients to be able to go from Xyrem directly to XYWAV. So what we'll see in future quarters is you should see a better representation of those patients in the revenue and the net sales that come from XYWAV.

Rene: Sure. So just in terms of the I'll take the second question first we're not disclosing a breakdown of those patients in part because that AG data is not our data to share.

Renee Gala: We're not disclosing a breakdown of those patients, in part because that AG data is not ours to share. But with respect to being able to quantify how many patients came over, I would say there was a good portion of patients that made the decision, along with their HCPs, to adopt low-sodium ZyWave. And we did see and establish those patient support programs to ensure that we have uninterrupted access for those patients to be able to go from XyRim directly to ZyWave.

Rene: But with respect to being able to quantify.

Rene: How many patients came over I would say there was a good portion of patients that made the decision with their hcp's to adopt low sodium sideways and we did see and establish those patient support programs to ensure that we have uninterrupted access.

Rene: For those patients to be able to go from Xyrem directly to XI wave. So what we'll see in future quarters is you should see a better representation of those patients in the revenue and the net sales that come from.

Renee Gala: So what we'll see in future quarters is you should see a better representation of those patients in the revenue and the net sales that come from XYWAV. Your next question comes from Jason Gerberry with Bank of America. Please go ahead. Oh, hey guys.

So what we'll see in future quarters is you should see a better representation of those patients in the revenue and the net sales that come from XYWAV.

Rene: <unk>.

Your next question comes from Jason Gerberry with Bank of America. Please go ahead. Oh, hey guys.

Operator: Your next question comes from Jason Gerberry with Bank of America. Please go ahead.

Rene: Your next question comes from Jason <unk> with Bank of America. Please go ahead.

Hey, guys, thanks for taking my question. My question is about your Phase IIb Essential Tremor study. So, if this trial is successful, I'm wondering how you're thinking about the subsequent second confirmatory trial. Would it look something like this trial, which took roughly 2.5 years from start to data? Or could there be some sort of more abbreviated randomized withdrawal study that you could run to get yourself to goal line in a more expeditious manner? Thanks. Rob, do you want to jump in on that?

Jason Gerberry: Hey, guys, thanks for taking my question. My question is about your Phase IIb Essential Tremor study. So, if this trial is successful, I'm wondering how you're thinking about the subsequent second confirmatory trial. Would it look something like this trial, which took roughly 2.5 years from start to data? Or could there be some sort of more abbreviated randomized withdrawal study that you could run to get yourself to goal line in a more expeditious manner? Thanks.

Jason Matthew Gerberry: Thanks for taking my question. My question is about your Phase 2B essential tremor study. So, you know, if this trial is successful, I'm wondering how you're thinking about the subsequent second confirmatory trial. Would it look something like this trial, which took roughly two and a half years from start to data? Or could there be some sort of more abbreviated randomized withdrawal study that you could run to get yourself to the goal line in a more expeditious manner? Thanks. Rob, do you want to jump in on that?

Jason Gerberry: Oh, hey, guys. Thanks for taking my question. My question is about your phase IIb essential tremor study. So, you know, if this trial is successful, I'm wondering how you're thinking about the subsequent second confirmatory trial. Would it look something like this trial, which took, like, roughly 2.5 years from start to data, or could there be some sort of more abbreviated randomized withdrawal study that you could run to get yourself to goal line in a more expeditious manner? Thanks.

Jason: Oh, Hey, guys.

Jason: Thanks for taking my question.

Jason: My question is about your phase two be essential tremor study so.

Jason: If this trial is SaaS.

Jason: Seth fall Im wondering how youre thinking about.

Jason: The subsequent second confirmatory trial.

Jason: Would it look something like this trial, which took quick roughly two five years from start to data or could there be some sort of more abbreviated randomized withdrawal study that you could run to get yourself to go line in a more expeditious manner.

Thanks. Rob, do you want to jump in on that?

Thanks.

Bruce C. Cozadd: Rob, do you want to jump in on that?

Bruce Cozadd: Rob, you want to jump in on that?

Jason: Rob do you want to jump in on that.

Robert Iannone: Yes, happy to. So first of all, Jason, remember, this is a Phase IIb trial. It would count, we believe, or contribute to the pivotal regulatory package. But we call the Phase IIb because we included 3 dose levels of SUVECALTAMIDE, and when we would move to a, let's call it a, confirmatory Phase III trial, we wouldn't necessarily have to bring all those dose levels forward. And then ideally, we expect we would choose one dose level. So that creates a more streamlined design.

Robert Iannone: Yeah, happy to. So, first of all, Jason, remember, this is a phase IIb trial. It would count, we believe, or contribute to the pivotal regulatory package. But we call it a phase IIb because we included three dose levels of suvecaltamide. And when we would move to a, let's call it a confirmatory phase III trial, we wouldn't necessarily have to bring all those dose levels forward, and ideally, we expect we would choose one dose level. So that creates a more streamlined design. And to your point, when we, when we have data in hand and we engage regulatory authorities, we certainly, with compelling data, would be looking for the fastest path to approval and look at all possible trial designs to support that.

Rob: Yes happy to so.

Rob: First of all Jason remember this is a phase <unk> trial. It would count that we believe are contributing to that.

Rob: Pivotal regulatory package that we call the phase III, because we included three dose levels.

Rob: <unk> and when we would move to let's call. The confirmatory phase III trial, we wouldn't necessarily have to bring all of those dose levels for than ideally. We expect we would choose one dose level. So that creates a more streamlined design and <unk>.

Robert Iannone: So that creates a more streamlined design, and to your point, when we have data in hand and we engage regulatory authorities, we certainly, with compelling data, would be looking for the fastest path to approval and look at all possible trial designs. Your next question comes from the line of Mark Goodman with Lyrinc.

So that creates a more streamlined design,

And to your point, when we have data in hand and we engage regulatory authorities, we certainly, with compelling data, we'll be looking for the fastest path to approval and look at all possible trial designs to support that. Your next question comes from the line of Mark Goodman with Lyrinc.

Rob: Your fleet when we when we have data in hand, and we engage regulatory authorities, we certainly with compelling data would be looking for the fastest path.

Rob: Two approval and look at all possible trial designs to support that.

Operator: Your next question comes from the line of Mark Goodman with Leerink. Please go ahead.

Rob: Your next question comes from the line of Mark Goodman with Leerink. Please go ahead.

Operator: Your next question comes from the line of Marc Goodman with Leerink. Please go ahead.

Marc Goodman: Please go ahead. Bruce had a lot of discussions with investors over the past six months about what jazz.., wants to be and what it's transitioning from and to and just the whole big picture discussion and and a lot of investors believe you know you want to become an oncology company at least that's the perception out there I was curious, Can you talk about just what is it that you expect jazz to become what you're looking for jazz to be, you know, in five years, six years, seven years, just you know, because all the investments you're making today are obviously going to be reflected in five or six years and just talk about that and, and how maybe it's evolved since what you know, jazz was five, 10 years ago. Thanks. Yeah.

Please go ahead.

Operator: Bruce, had a lot of discussions with investors over the past six months about what Jazz wants to be and what it's transitioning from and to, and just the whole big picture discussion. And a lot of investors believe, you know, you want to become an oncology company. At least that's the perception out there. I was curious, can you talk about just what is it that you expect Jazz to become? What you're looking for Jazz to be, you know, in five years, six years, seven years? Just, you know, because all the investments you're making today are obviously going to be reflected in five or six years. And just talk about that and how maybe it's evolved since what, you know, Jazz was five, ten years ago. Thanks.

Marc Goodman: Bruce, had a lot of discussions with investors over the past six months about what Jazz wants to be and what it's transitioning from and to, and just the whole big picture discussion. And a lot of investors believe, you know, you want to become an oncology company. At least that's the perception out there. I was curious, can you talk about just what is it that you expect Jazz to become? What you're looking for Jazz to be, you know, in five years, six years, seven years? Just, you know, because all the investments you're making today are obviously going to be reflected in five or six years. And just talk about that and how maybe it's evolved since what, you know, Jazz was five, ten years ago. Thanks.

Marc Goodman: Bruce cut a lot of discussions with investors over the past six months about what Jess is wants to be and what it's transitioning from two and just the whole big picture discussion and a lot of investors believe you will want to become an oncology company at least that's the perception out there I was curious.

Bruce had a lot of discussions with investors over the past 6 months about what Jazz wants to be and what it's transitioning from and to and just the whole big picture discussion and a lot of investors believe you want to become an oncology company at least that's the perception out there. Just curious, can you talk about just what is it that you expect Jazz to become what you're looking for Jazz to be, in 5 years, 6 years, 7 years, just because all the investments you're making today are obviously going to be reflected in 5 or 6 years and just talk about that and how maybe it's evolved since what Jazz was 5, 10 years ago. Thanks. Yeah.

Marc Goodman: Bruce had a lot of discussions with investors over the past 6 months about what Jazz wants to be and what it's transitioning from and to and just the whole big picture discussion and a lot of investors believe you want to become an oncology company at least that's the perception out there. Just curious, can you talk about just what is it that you expect Jazz to become what you're looking for Jazz to be, in 5 years, 6 years, 7 years, just because all the investments you're making today are obviously going to be reflected in 5 or 6 years and just talk about that and how maybe it's evolved since what Jazz was 5, 10 years ago. Thanks.

Marc Goodman: Can you talk about just what is it that you expect <unk> to become what Youre looking for jazz to be.

Speaker Change: Five years six years seven years, just because all the investments you're making today are obviously kind of reflected in five or six years and just talk about that.

Marc Goodman: And how maybe it's evolve.

Marc Goodman: <unk> since what Josh was 510 years ago.

Yes. Thanks, Mark. So we're in a nice position of having growing assets on the neuroscience side of our business in XYWAV and EPIDIOLEX, with, we believe, promise in front of us, including pipeline programs like the 385 program we were just talking about. We're also excited about what's going on on the oncology side of the business, with double-digit growth coming from our current portfolio led by RYLAZE's, but also opportunities in front of us, with ZANIDATAMAB, where we've already got the submission complete and looking forward to a launch in '25 or earlier. ZEPZELCA data upcoming, but also an earlier stage pipeline, including particular expansion opportunities with ZANIDATAMAB and beyond. So we're excited about both those franchises.

Bruce C. Cozadd: Yes. Thanks, Mark. So we're in a nice position of having growing assets on the neuroscience side of our business in XYWAV and EPIDIOLEX, with, we believe, promise in front of us, including pipeline programs like the 385 program we were just talking about. We're also excited about what's going on on the oncology side of the business, with double-digit growth coming from our current portfolio led by RYLAZE's, but also opportunities in front of us, with ZANIDATAMAB, where we've already got the submission complete and looking forward to a launch in '25 or earlier. ZEPZELCA data upcoming, but also an earlier stage pipeline, including particular expansion opportunities with ZANIDATAMAB and beyond.

Bruce C. Cozadd: Thanks, Mark. So we're in a nice position of having growing assets on the neuroscience side of our business in Zywave and Epidiolex, with, we believe, Promise in front of us, including pipeline programs like the 385 program we were just talking about. We're also excited about what's going on on the oncology side of the business, with double-digit growth coming from our current portfolio led by Riley's, but also opportunities in front of us, with Sany Datamap, where we've already got the submission complete. I am looking forward to a launch in 25 or earlier. Zepselka Data The coming, but also an earlier stage pipeline, including particular expansion opportunities with ZanyDataMap and beyond. So we're excited about both those franchises.

Bruce Cozadd: Yeah. Thanks, Mark. So we're in a nice position of having growing assets on the neuroscience side of our business in XYWAV and Epidiolex, with, we believe, promise in front of us, including pipeline programs like the 385 program we were just talking about.

Speaker Change: Yes, thanks Mark.

Speaker Change: So we're in the nice position of having growing assets on the neuroscience side of our business in XI wave and <unk>.

Speaker Change: We believe promise in front of us.

Speaker Change: Including pipeline programs like the 385 program, we were just talking about.

Bruce Cozadd: ... But we're also excited about what's going on on the oncology side of the business, with double-digit growth coming from our current portfolio, led by Rylaze, but also opportunities in front of us, with zanidatamab, where we've already got the submission complete, and looking forward to a launch in 25 or earlier, Zepzelca data upcoming, but also an earlier stage pipeline, including particular, expansion opportunities with zanidatamab and beyond. So we're excited about both those franchises. While there has been a lot of focus on oncology, and certainly the single largest program in our R&D pipeline right now is zanidatamab, I would not say we're trying to turn the company into an oncology company. We'd like to have strength in both of our franchises.

Speaker Change: Also excited about what's going on on the oncology side of the business with double digit growth coming from our current portfolio led by <unk>, but also opportunities in front of us.

Speaker Change: With safety data Mab, where we've already got the submission complete.

Speaker Change: And looking forward to a launch in 'twenty five or earlier.

Speaker Change: So good data upcoming but also an earlier stage pipeline, including particular expansion opportunities was any data map and beyond so we're excited about both of those franchises.

So we're excited about both those franchises. While there has been a lot of focus on oncology, and certainly the single largest program in our R&D pipeline right now is ZANIDATAMAB, I would not say we're trying to turn the company into an oncology company. We'd like to have strength in both of our franchises.

Bruce C. Cozadd: While there has been a lot of focus on oncology, and certainly the single largest program in our R&D pipeline right now is AnyDataMap, I would not say we're trying to turn the company into an oncology company. We'd like to have strength in both of our franchises.

Speaker Change: There hasn't been a lot of focus on oncology.

Speaker Change: And certainly the single largest program in our R&D pipeline right now is any data Mab I would not say, we're trying to turn the company into an oncology company, we'd like to have strength in both of our franchises. The investments, we're making and I think Phil described it nicely in his comments are designed to both help the short term.

Bruce C. Cozadd: The investments we're making, and I think Phil described them nicely in his comments, are designed to both help the short term, particularly some of our commercial investments that we think can continue to generate great growth from our commercial portfolio, and R&D investments that will continue to broaden that pipeline and provide growth over both the near term and the medium and long term. But then also, those corporate development opportunities fueled by our strong cash flow and balance sheet and a history of doing transactions that continue to add to our portfolio allow us to impact more patients in more diseases, in more territories around the world. So I think about it as having to make smart investment decisions, which we're in a position to do given the financial strength of the company to fuel both the short and the long term to create value for our shareholders, so execution on the short term is important investment decisions, but I think that should give you a better sense for where we're headed. Your next question comes from the line of Annabel Samimy with CFL.

The investments we're making, and I think Phil described them nicely in his comments, are designed to both help the short term, particularly some of our commercial investments that we think can continue to generate great growth from our commercial portfolio, and R&D investments that will continue to broaden that pipeline and provide growth over both the near term and the medium and long term. But then also, those corporate development opportunities fueled by our strong cash flow and balance sheet and a history of doing transactions that continue to add to our portfolio allow us to impact more patients in more diseases, in more territories around the world. So

Bruce Cozadd: The investments we're making, and I think Phil described it nicely in his comments, are designed to both help the short term, particularly some of our commercial investments that we think can continue to generate great growth from our commercial portfolio, and R&D investments that will continue to broaden that pipeline and provide growth over both the near term and the medium and long term. But then also those corporate development opportunities, fueled by our strong cash flow and balance sheet and a history of doing transactions that continue to add to our portfolio, allow us to impact more patients in more diseases, in more territories around the world.

Speaker Change: Particularly some of our commercial investments that we think Ken.

Speaker Change: Continue to generate great growth from our commercial portfolio.

Speaker Change: And R&D investments that will continue to broaden that pipeline and provide growth over both the near term and the medium to long term, but then also those corporate development opportunities fueled by our strong cash flow and balance sheet and a history of doing transactions that continue to add to our portfolio allow us to impact.

Speaker Change: More patients and more diseases in more territories around the world. So I think about it as having to make smart investment decisions, which were in a position to do given the financial strength of the company.

Bruce Cozadd: So I think about it as having to make smart investment decisions, which we're in a position to do, given the financial strength of the company, to fuel both the short and the long term, to create value for our shareholders. So execution in the short term, important. Investment decisions, always important, but I think that should give you a better sense for where we're headed.

So I think about it as having to make smart investment decisions, which we're in a position to do given the financial strength of the company to fuel both the short and the long term to create value for our shareholders, so execution on the short term is important investment decisions always important, but I think that should give you a better sense for where we're headed. Your next question comes from the line of Annabel Samimy with CFL.

I think about it as having to make smart investment decisions, which we're in a position to do given the financial strength of the company to fuel both the short and the long term to create value for our shareholders, so execution on the short term is important investment decisions, but I think that should give you a better sense for where we're headed. Your next question comes from the line of Annabel Samimy with CFL.

Speaker Change: To fuel both the short and the long term to.

Speaker Change: To create value for our shareholders. So execution in the short term important investment decisions always important but I think that should give you a better sense for where we're headed.

Operator: Your next question comes from the line of Annabel Samimy with Stifel. Please go ahead.

Speaker Change: Your next question comes from the line of Annabel <unk> with Stifel. Please go ahead.

Operator: Your next question comes from the line of Annabel Samimy with Stifel. Please go ahead.

Annabel Eva Samimy: Please go ahead. Hi, thanks for taking my question. I had a two-part question on Zannie. I guess the first question is, how should we think about the opportunity for Zannie and GEA in light of the better Keynote Data OS that they announced today on KTRUDA? And secondly, where would Zannie fit into this paradigm? Separately, for the launch of ZANI, and as we think about all these indications, how should we think about how rapidly new cancer drugs with superior efficacy profiles can disrupt the mainstay standard of care? I guess, in other words, are these ramps going to be more rapid or just as challenging as, say, in other non-fatal conditions?

Please go ahead.

[Analyst] (Stifel): Hi, thanks for taking my question. I had a two-part in on Zani. I guess the first is, how should we think about the opportunity for Zani and GEA in light of the better, KEYNOTE, KEYNOTE data OS that they announced today on, on Keytruda? And I guess secondly, where would Zani fit into this paradigm? Separately, for launch of Zani, and as we think about all these indications, how should we think about how rapidly new cancer drugs with superior efficacy profiles can disrupt mainstay standard of care? I guess, in other words, are these ramps going to be more rapid, or just as challenging as, say, in other nonfatal conditions? So just wanted to get some characterization there. Thanks.

Annabel Samimy: Hi, thanks for taking my question. I had a two-part in on Zani. I guess the first is, how should we think about the opportunity for Zani and GEA in light of the better, KEYNOTE, KEYNOTE data OS that they announced today on, on Keytruda? And I guess secondly, where would Zani fit into this paradigm? Separately, for launch of Zani, and as we think about all these indications, how should we think about how rapidly new cancer drugs with superior efficacy profiles can disrupt mainstay standard of care? I guess, in other words, are these ramps going to be more rapid, or just as challenging as, say, in other nonfatal conditions? So just wanted to get some characterization there. Thanks.

Annabel: Hi, Thanks for taking my question.

Annabel Samimy: Hi, thanks for taking my question. I had a two-part on ZANI. I guess the first question is, how should we think about the opportunity for ZANI in GEA in light of the better KEYNOTE data OS that they announced today on KEYTRUDA? And I guess, secondly, where would ZANI fit into this paradigm? Separately, for the launch of ZANI, and as we think about all these indications, how should we think about how rapidly new cancer drugs with superior efficacy profiles can disrupt the mainstay standard of care? I guess, in other words, are these ramps going to be more rapid or just as challenging as, say, in other non-fatal conditions? So I just wanted to get some characterization there. Thanks.

Annabel: I had a two part and on <unk> I guess the first is how should we think about the opportunity to present, an GAA in light of the better.

Speaker Change: <unk> keynote data O S.

Speaker Change: You announced today on.

Speaker Change: Okay.

Speaker Change: And I guess, secondly, where where does that fit into this paradigm.

Speaker Change: Separately for.

Speaker Change: For launch and <unk> and as we think about all of these indications how should we.

Speaker Change: Think about how rapidly new cancer drives superior efficacy profiles.

Speaker Change: Can disrupt mainstay standard of care I guess in other words are these ramps going to be more rapid.

Speaker Change: Or just as challenging as say and other non fatal condition. So just wanted to get some characterization there. Thanks.

Bruce C. Cozadd: So I just wanted to get some characterization there. Thanks. Yeah, Annabel, thanks for the question. And on the ZANI data map, first question in GEA, you know, we had been expecting positive OS results at some point out of that trial, I think most people had, so I don't think that changes the landscape. But I'll let Rob comment on where ZANI could fit into the GEA landscape.

So I just wanted to get some characterization there. Thanks.

Bruce C. Cozadd: Yes, Annabel, thanks for the question. And on the ZANIDATAMAB, first question in GEA, we had been expecting positive OS results at some point out of that trial, I think most people had, so I don't think that changes the landscape. But I'll let Rob comment on where ZANI could fit into the GEA landscape.

Bruce Cozadd: Yeah, Annabel, thanks for the question. On the zanidatamab, first question, GEA, you know, we had been expecting positive OS results at some point out of that trial. I think most people had, so I don't think that changes the landscape, but I'll let Rob comment on where Zani could fit into the GEA landscape. On your second question, you know, it's all about results, uniqueness of mechanism of action, and benefit relative to other therapies that determine, you know, how fast you can make progress from launch.

Speaker Change: Yes, Annabel thanks for the question and on the on the Zany data map first question Gea.

Speaker Change: Had been expecting.

Annabel: Positive OS.

Speaker Change: Results at some point out of that trial I think most people had so I don't think that changes the landscape, but I'll, let rob comment on where.

Robert Iannone: And then on your second question, it's all about results and uniqueness of mechanism of action and benefit relative to other therapies that determine how fast you can make progress from launch and when we have the opportunity to bring something really new to patients in terms of benefit, particularly in the oncology space, where I think things can move sometimes even ahead of a regulatory approval, if there's strong data that's been presented that's picked up in the NCCN Guidelines and allows for reimbursement; you can get fairly rapid traction with a better option. Rob, do you want to talk about the landscape in GEA?

And then on your second question, it's all about results and uniqueness of mechanism of action and benefit relative to other therapies that determine how fast you can make progress from launch and when we have the opportunity to bring something really new to patients in terms of benefit, particularly in the oncology space, where I think things can move sometimes even ahead of a regulatory approval, if there's strong data that's been presented that's picked up in the NCCN Guidelines and allows for reimbursement; you can get fairly rapid traction with a better option.

Speaker Change: Is there any could fit into the gea landscape and then on your second question.

Rob: It's all about results and uniqueness of mechanism of action and benefit relative to other therapies to determine.

Rob: How fast you can make progress.

Rob: From launch and when we have the opportunity to bring something really new.

Bruce Cozadd: When we have the opportunity to bring something really new to patients in terms of benefit, particularly in the oncology space, where I think things can move sometimes even ahead of a regulatory approval, if there's strong data that's been presented, that's picked up in the NCCN guidelines and allows for reimbursement, you can get fairly rapid traction with a better option. Rob, you want to talk about the landscape in GEA?

Rob: Patients in terms of benefit.

Rob: Particularly in the oncology space, where I think things can move sometimes even ahead of a regulatory approval.

Rob: If theres strong data that's been presented Thats picked up in the NCC and guidelines and allows for reimbursement you can get fairly rapid traction with a better option. Rob do you want to talk about the landscape and GE.

Rob, do you want to talk about the landscape in GEA?

Robert Iannone: Yes, so in the context of HER2 positive overexpressed gastroesophageal adenocarcinoma, we think ZANIDATAMAB has the potential to be the HER2 antagonist of choice because of its differentiated mechanism of action and because of its differentiated efficacy and safety profile. Certainly in the PD-L1 negative population, which we think is sizable. There is no approved PD-1 agent, and so the comparator there is HERCEPTIN chemotherapy. But even in the PD-L1 positive population, where we think PD-1 agents are essentially interchangeable. We have the opportunity, in combination with TISLELIZUMAB, to show the benefit of ZANIDATAMAB, again, as a differentiated HER2 antagonist in combination with backbone chemotherapy and a PD-1 antagonism.

Robert Iannone: Yeah. So in the context of HER2-positive, overexpressed gastroesophageal adenocarcinoma, we think zanidatamab has the potential to be the HER2 antagonist of choice, because of its differentiated mechanism of action and because of the differentiated efficacy and safety profile. Certainly in the PD-L1 negative population, which we think is sizable, there is no approved PD-1 agent, and so the comparator there is Herceptin chemotherapy. But even in the PD-L1 positive population, where we think PD-1 agents are, essentially interchangeable, we have the opportunity in combination with tislelizumab to show the benefit of zanidatamab, again, as a differentiated HER2 antagonist in combination with backbone chemotherapy, and a PD-1 antagonist.

Rob: Yes, so in the context of her two positive over expressed gastroesophageal adenocarcinoma.

Rob: We think Santa data map has the potential to be the her two antagonist of choice.

Rob: Because of its differentiated mechanism of action and because of the differentiated efficacy and safety profile.

Rob: Certainly in the PD lone negative population, which we think is sizable.

Rob: There is no approved PD, one agents and so the comparator, there as herceptin and chemotherapy, but even in the PD Lone positive population, where we think PD one agents or.

Rob: Essentially interchangeable we have the opportunity in combination with <unk> Elisa lab to show the benefit of some of the data map again has a differentiated her two antagonists in combination with backbone chemotherapy.

Rob: The PD one antagonist.

Akash Tewari: Your next question comes from the line of Akash Tewari with Jeffreys. Please go ahead. Hey, thanks so much. You know, just going on the Horizon GA study, how should we really interpret the Jacob trial? Here we saw the addition of Progetta didn't provide any OS benefit in GA on top of TrasChemo.

Operator: Your next question comes from the line of Akash Tewari with Jeffreys. Please go ahead.

Operator: Your next question comes from the line of Akash Tewari with Jefferies. Please go ahead.

Speaker Change: Your next question comes from the line of attached to worry with Jefferies. Please go ahead.

Akash Tewari: Hey, thanks so much. Just going on the Horizon GEA study, how should we really interpret the JACOB trial? Here we saw the addition of PERJETA didn't provide any OS benefit in GEA on top of tras-chemo. And this is a large-scale Phase III trial. What gives your team confidence that ZW25's early data will hold up in this setting? And then maybe just on Essential Tremor, [JZP358] effectively showed no benefit on an accelerometer measurement in its Phase II trial.

Bruce C. Cozadd: And this is a large-scale phase three trial. What gives your team confidence that ZW25's early data will hold up in this setting? And then maybe just on essential tremor, JCP358 effectively showed no benefit on an accelerometer measurement in its phase two trial.

Akash Tewari: Hey, thanks so much. You know, just going on the Horizon GEA study, how should we really interpret the Jacob trial? Here we saw the addition of Perjeta didn't provide any OS benefit in GEA on top of chemo, and this is a large-scale Phase III. What gives your team confidence that ZW25's early data will hold up in this setting? And then, maybe just on essential tremor, DZNP-358 effectively showed no benefit on an accelerometer measurement in its Phase II trial. Do you feel like there was something about how the kits were administered in that study that may have skewed those results? And how confident do you feel in your ability to show a signal on the accelerometer endpoint with your upcoming data? Thank you.

Speaker Change: Hey, thanks, so much.

Speaker Change: Just going on the Horizons <unk> study, how should we really interpret the Jacobs trial here. We saw the addition of <unk> that didn't provide any OS benefit on top of the <unk> chemo and this is a large space.

Speaker Change: Large scale phase III, what gives you seem confident that GW 20, five's early data will hold up in the study.

Akash Tewari: And then maybe just on Essential Tremor, [JZP358] effectively showed no benefit on an accelerometer measurement in its Phase II trial. Do you feel like there was something about how the kits were administered in that study that may have skewed those results? And how confident do you feel in your ability to show a signal on the accelerometer endpoint with your upcoming data? Thank you. Yeah, Akash, thanks for asking the two questions. And maybe I'll start on the essential tremor and then let Rob add anything he'd like on the ongoing trial and then comment on your Zannie question.

Speaker Change: And then maybe just on essential tremor, <unk> 358, effectively showed no benefit on an accelerometer.

Speaker Change: Measurement and its phase III trial.

Bruce C. Cozadd: Do you feel like there was something about how the hits were administered in that study that may have skewed those results? And how confident do you feel in your ability to show a signal on the accelerometer endpoint with your upcoming data? Thank you. Yeah, Akash, thanks for asking the two questions. And maybe I'll start on the essential tremor and then let Rob add anything he'd like on the ongoing trial and then comment on your Zannie question.

Speaker Change: Do you feel like there was something about how the kits were administered in that study that may have skewed those results and how confident do you feel like.

Speaker Change: How confident you feel in your ability to show a signal on the accelerometer endpoint with your upcoming data. Thank you.

Bruce C. Cozadd: Yes, Akash, thanks for the 2 questions. And maybe I'll start on the Essential Tremor and then let Rob add anything he'd like on the ongoing trial and then comment on your ZANI question. Just to remember that the prior TCOM study for Essential Tremor did demonstrate a nice benefit on TETRAS 80 activities of daily living, which we believe is a measure that's actually more important to patients than the measurement of the quantity of Tremor. What patients want is to be able to live their life, to do the things they need to do, to be able to drink out of a cup, to be able to button and unbutton clothes, to be able to apply makeup, to do the things they care about, and we were very pleased that that became more of a focus for the pivotal endpoints in later stage trials. I think FDA too understands you want to do what's really going to provide a benefit to patients.

Bruce Cozadd: Yeah, Akash, thanks for, thanks for the two questions, and maybe I'll start on the essential tremor and then let Rob add anything he'd like on the ongoing trial and then comment on your Zani question. You know, just to remember that the prior TCOM study for essential tremor did demonstrate a nice benefit on TETRAS ADL activities of daily living, which we believe is a measure that's actually more important to patients than the you know, measurement of the you know, quantity of tremor. You know, what patients want is to be able to live their life, to do the things they need to do, to be able to drink out of a cup, to be able to button and unbutton clothes, to be able to apply makeup, to you know, to do the things they care about.

Speaker Change: Yes of course, thanks for thanks for the two questions and maybe I'll start on the essential tremor, and then I'll, let Rob add anything he'd like on the ongoing trial and then comment on that.

Bruce C. Cozadd: Just to remember that the prior TECOM study for essential tremor did demonstrate a nice benefit on Tetris 80 activities of daily living, which we believe is a measure that's actually more important to patients than the measurement of the quantity of tremor. You know, what patients want is to be able to live their life, to do the things they need to do, to be able to drink out of a cup, to be able to button and unbutton clothes, to be able to apply makeup, to, you know, do the things they care about, and we were very pleased that that became more of a focus for the pivotal endpoints in later stage trials.

Speaker Change: On your has any questions just to remember that the prior T Com study for essential tremor.

Speaker Change: Did demonstrate a nice benefit on.

Speaker Change: Tetris.

Speaker Change: <unk> activities activities of daily living which we believe is a measure that's actually more important to patients than the.

Rob: Measurement of the.

Speaker Change: Quantity of tremor, what patients want is to be able to live their life to do the things they need to do to be able to drink out of a cut to be able to button and unbutton close to be able to apply makeup.

Speaker Change: Makeup.

Speaker Change: Do the things they care about and we were very pleased that that became.

Bruce Cozadd: We were very pleased that that became more of a focus for the pivotal endpoints in later stage trials. I think, you know, FDA, too, understands you want to do what's really going to provide a benefit to patients. Rob, you want to talk a little bit about our ongoing trial and then pivot to zanidatamab?

Speaker Change: More of a focus for the pivotal endpoints in later stage trials I think.

Bruce C. Cozadd: I think FDA too understands you want to do what's really going to provide a benefit to patients. Rob, you want to talk a little bit about our ongoing trial and then pivot to ZANI? Yeah, happy to.

I think FDA too understands you want to do what's really going to provide a benefit to patients. Rob, you want to talk a little bit about our ongoing trial and then pivot to ZANI?

I think FDA too understands you want to do what's really going to provide a benefit to patients.

Speaker Change: FDA to understand you want to do what's really going to provide a benefit to patients.

Rob, you want to talk a little bit about our ongoing trial and then pivot to ZANI?

Speaker Change: Rob do you want to talk a little bit about our ongoing trial and then <unk>.

Robert Iannone: Yes, happy to. And so I would agree, Bruce, that the endpoints that we prioritize as primary, not only the most meaningful to patients but endorsed by FDA. And on those endpoints, we have confidence from the TCOM trial. And I would just add to that in the current Phase IIb trial with a new daily formulation, we've been able to push that dose to exposures that would be higher than in the TCOM trial itself because we have 10, 20, and 30-milligram doses in that trial. So we think based on that, we're positioned for success.

Robert Iannone: And so I would agree, Bruce, that the endpoints that we prioritize are primary, not only the most meaningful to patients but endorsed by FDA. And on those endpoints, we have confidence from the TCOM trial. And I would just add to that in the current phase 2b trial with a new daily formulation, we've been able to push that dose to exposures that would be higher than in the TCOM trial itself because we have 10, 20, and 30 milligram doses in that trial.

Robert Iannone: Yeah, happy to. And so I would agree, Bruce, that the endpoints that we prioritize as primary are not only the most meaningful to patients, but endorsed by FDA. And on those endpoints, we have confidence from the TCOM trial. And I would just add to that, that in the current Phase IIb trial with a new once-daily formulation, we've been able to push that dose to exposures that would be higher than in the TCOM trial itself, because we have 10mg, 20mg, and 30mg doses in that trial. So we think based on that, we're positioned for success. And then coming back to the question on zanidatamab and GEA, the key point I'd like to make is we really believe that zanidatamab is differentiated from even the combination of Herceptin and Perjeta.

Rob: Yes, happy too and so I would I would agree with Bruce.

Rob: The endpoints that we prioritize as primary and not only the most meaningful to patients, but endorsed by FDA and on those endpoints, we have confidence from the <unk> trial.

Rob: Just add to that in the current phase <unk> trial with a new once daily formulation.

Rob: We've been able to push that dose.

Rob: Two exposures that would be higher than in the telecom trial itself. Because we have 10 2030 milligram doses in that trial. So we think based on that we are positioned for success.

Robert Iannone: So, based on that, we think we're positioned for success. And then, coming back to the question about JACOB and GEA, the key point I'd like to make is we really believe that XANA DataMap is differentiated from even the combination of Perceptive and Projeta. As we presented at our R&D day, we went through some important data that were published in Nature Communication, showing how XANA DataMap is differentiated. The two epitopes necessarily bind to distinct receptors, causing more effective receptor clustering and internalization and have demonstrated better immune function, for example, complement fixation.

So, based on that, we think we're positioned for success.

Speaker Change: Then coming back to the question on Jacob and Gea. The key point I would like to make is we really believe that <unk> is differentiated from even the combination of herceptin and <unk> as we presented at our R&D day, we step through some important data that were published in nature communications showing how is that data mab is deferred.

And then, coming back to the question about JACOB and GEA, the key point I'd like to make is we really believe that ZANIDATAMAB is differentiated from even the combination of HERCEPTIN and PERJETA. As we presented at our R&D day, we stepped through some important data that were published in Nature Communication, showing how ZANIDATAMAB is differentiated with 2 epitopes necessarily bind to distinct receptors, causing more effective receptor clustering and internalization and have demonstrated better immune function, for example, complement fixation.

Robert Iannone: As we presented at our R&D day, we stepped through some important data that were published in Nature Communications, showing how zanidatamab is differentiated. The two epitopes necessarily bind to distinct receptors, causing more effective receptor clustering and internalization, and have demonstrated better immune function, for example, complement fixation. And so in that paper, head-to-head and preclinical experiments, better than Herceptin and Perjeta, and the clinical data bear that out without going into great detail. If you look at the BTC data, where the response rates are over 40% and duration of response greater than 12 months, that compares very favorably to prior data with the combination of Herceptin and Perjeta. And of course, we have data in breast cancer showing activity of zanidatamab, even after patients have failed frontline therapy with Perceptin and Perjeta as part of a Cleopatra regimen.

Rob: Sure so two epitopes necessarily buying.

Rob: Two distinct receptors, causing more effective receptor clustering and internalization.

Rob: <unk> has demonstrated.

Rob: Better immune function for example, complement fixation and so in that paper head to head in preclinical experiments better than herceptin, and <unk> and the clinical data bear that out without going into great detail. If you look at the BTC data, where the response rates are over 40% and duration of response greater.

Robert Iannone: And so in that paper, head-to-head and preclinical experiments better than HERCEPTIN and PERJETA, and the clinical data bear that out without going into great detail. If you look at the BTC data, where the response rates are over 40% and the duration of response is greater than 12 months, that compares very favorably to prior data with the combination of HERCEPTIN and PERJETA. And, of course, we have data in breast cancer showing activity on ZANIDATAMAB even after patients have failed frontline therapy with HERCEPTIN and PERJETA as part of a [Inaudible] regimen.

Rob: 12 months that compares very favorably to prior data with the combination of Herceptin and <unk> and of course, we have.

Rob: Data in breast cancer, showing activity data map, even after patients who failed frontline therapy.

Rob: With.

Rob: Herceptin and <unk> as part of a Cleopatra regiment, so that in combination with the data that you referred to signing of chemo and then separately or is that a cumulative elisa <unk> showing very promising not only response rates very very durable responses.

Robert Iannone: So that, in combination with the data that you referred to, zanidatamab and chemo, and then separately, a cohort of zanidatamab, chemo, tislelizumab, showing very promising, not only response rates, but very, very durable responses. That's what gives us confidence that our phase 3 trial will be successful.

Robert Iannone: So, in combination with the data that you referred to, ZANI and chemo, and then separately a cohort of ZANI, chemo, TISLELIZUMAB showing very promising not only response rates, but very, very durable responses. That's what gives us confidence that our Phase III trial will be successful. Your next question comes from the line of Ami Fadia with Needham and Company. Please go ahead. Hi, good evening.

So, in combination with the data that you referred to, ZANI and chemo, and then separately a cohort of ZANI, chemo, TISLELIZUMAB showing very promising not only response rates, but very, very durable responses. That's what gives us confidence that our Phase III trial will be successful.

Rob: What gives us confidence.

Rob: That our phase III trial will be successful.

Your next question comes from the line of Ami Fadia with Needham & Company. Please go ahead. Hi, good evening.

Operator: Your next question comes from the line of Ami Fadia with Needham & Company. Please go ahead.

Rob: Your next question comes from the line of Amy <unk> with Needham <unk> Company. Please go ahead.

Ami Fadia: Hi, good evening. Thanks for taking my question. Perhaps I had a question for Phil, just with regard to his comments around business development. And that's a question that we get often from investors as well. Can you talk about some of the metrics that you would use to really evaluate potential deals, in terms of kind of what really could meet the bar in terms of what Jazz would be interested in executing on? And also, can you talk about capital--the use of capital across R&D, business development, but also perhaps buyback of shares? Thank you.

Ami Fadia: Thanks for taking my question. Perhaps I had a question for Phil, just with regard to his comments around business development. And you know, that's a question that we get often from investors as well. Can you talk about some of the metrics that you would use to really evaluate potential deals, in terms of kind of what really would meet the bar in terms of what Jazz would be interested in executing on? And also, can you talk about capital, the use of capital across?

Ami Fadia: Hi, good evening. Thanks for taking my question. Perhaps I had a question for Phil, just with regards to his comments around business development, and, you know, that's a question that we get often from investors as well. Can you talk about some of the metrics that you would use to really evaluate potential deals, in terms of kind of what really would meet the bar in terms of what Jazz would be interested in executing on? And also, can you talk about capital use of capital across R&D business development, but also perhaps buyback of shares? Thank you.

Amy: Hi, good evening, Thanks for taking my question.

Amy: Just a question for so just with regards to his comments around.

Amy: This development.

Amy: The question that we get often from investors as well.

Amy: Can you talk about some of the metrics that.

Amy: You would use to really evaluate potential deals.

Amy: In terms of kind of what they need to meet the bar in terms of what jazz.

Amy: Be interested in executing on.

Amy: And also can you tell us about capital use of capital across.

Phil Johnson: R&D, Business Development, but also perhaps a buyback of shares. Thank you. Thanks Ami. Phil, go ahead and jump right in.

R&D, Business Development, but also perhaps a buyback of shares.

Amy: R&D business development, but also perhaps.

Amy: Buyback of shares thank you.

Thank you. Thanks Ami. Phil, go ahead and jump right in.

Thank you.

Bruce C. Cozadd: Thanks Ami. Phil, go ahead and jump right in.

Bruce Cozadd: Thanks, Ami. Phil, go ahead and jump right in.

Phil Johnson: Thanks, Tommy Phil go ahead and jump right in.

Philip Johnson: Great, Ami, thank you for the question. My first one on a Jazz earnings call, and even though I've been around for a while, my mom is to listen to these. So thanks for giving her early Mother's Day present. In terms of our corporate development evaluation, first and foremost, there are a number of non-financial criteria that we would look at. Primarily, these are things like, is there an area with significant unmet need with the medicine that we're looking at acquiring our medicines really meaningfully impact patients? Is there an efficient commercial call point?

Philip Johnson: Great, Ami. Thank you for the question. My first one on a Jazz earnings call, and even though I've been around for a while, my mom still listens to these, so thanks for giving her early Mother's Day present. In terms of our corporate development evaluation, first and foremost, there are a number of non-financial criteria that we would look at. Primarily, they're things like, is there an area with significant unmet need? Would the medicine that we're looking at acquiring or medicines really meaningfully impact patients? Is there an efficient commercial call point? We do have a relatively focused business and want to make sure that we're set up for success to commercialize the assets that we're bringing in.

Phil Johnson: Great. Thank you for the question My first one on a jazz earnings call and even though I've been around for a while my mouth to listen to the so thanks for getting her early mother's day present.

Phil Johnson: So thanks for giving her early. In terms of our corporate development evaluation, first and foremost, there are a number of non-financial criteria that we would look at. Primarily, these are things like, is there an area with significant unmet need for the medicine that we're looking at acquiring your medicines really meaningfully impact patients? Is there an efficient commercial call point?

Tommy: In terms of our corporate development evaluation first and foremost there are a number of non financial criteria that we wouldn't look at.

Tommy: Primarily they are things like is there an area with significant unmet need with the medicine that we're looking at acquiring your medicines really meaningfully impact patients.

Tommy: Is there an efficient commercial call point, we do have a relatively focused business and want to make sure that we're set up for success to commercialize the assets that we're bringing in.

Phil Johnson: We do have a relatively focused business and want to make sure that we're set up for success to commercialize the assets that we're bringing in. Will it allow us to leverage the expertise we've got in-house, the commercial footprint we've built out and continue to build out, for example, with Japan coming soon? And we'll stay largely focused, as we talked about in the past, in neuroscience as well as oncology, but we have looked at things in the rare orphan space as well, given the kinds of capabilities that we've built up selling products with these types of limited patient populations. From a financial perspective, it really, I think, some of the traditional things that you would expect.

We do have a relatively focused business and want to make sure that we're set up for success to commercialize the assets that we're bringing in. Will it allow us to leverage the expertise we've got in-house, the commercial footprint we've built out and continue to build out, for example, with Japan coming soon? And we'll stay largely focused, as we talked about in the past, in neuroscience as well as oncology, but we have looked at things in the rare orphan space as well, given the kinds of capabilities that we've built up selling products with these types of limited patient populations.

Philip Johnson: Will it allow us to leverage the expertise we've got in-house, the commercial footprint we've been built out and continue to build out, for example, with Japan coming soon? We'll stay largely focused, as we talked in the past, in neuroscience as well as oncology, but we have looked at things in the rare orphan space as well, given the kinds of capabilities that we've built up selling products with these types of limited patient populations. From a financial perspective, it really is, I think, some of the traditional things that you would expect. We do want to have line of sight to getting a good return on the investment.

Tommy: It will allow us to leverage the expertise we've got in house. So commercial footprint, we've been built out and continue to build out for example, with Japan coming soon.

Tommy: And we will stay largely focused as we've talked in the past.

Tommy: Neuroscience as well as oncology, but we have looked at things in the rare orphan space as well given the kinds of.

Tommy: Capabilities that we've built up selling products with these types of limited patient populations.

From a financial perspective, it really, I think, some of the traditional things that you would expect. We do want to have line of sight to getting a good return on the investment. We'll look at things that would vary some of the key assumptions, not only draft launch label and competitive landscape, but also timeline to continue to make a return on investment in the marketplace, different options for exclusivity, be that through orphan drug exclusivity, through patent life or other extensions. So, I think, by nothing unusual in terms of the, financial evaluation that we'd have there. But first and foremost we need to figure out is this just a jazz asset and one where there can be a significant value proposition for patients. In terms of capital priorities, I'd say first and foremost, very consistent what you've heard in the past from Bruce, Renée and the team. We're focused on driving the commercial opportunities for the in-market products that we have and are dedicating significant monies to get those to as many patients as possible that can benefit from those medicines.

Tommy: From a financial perspective, it really is I think some of the traditional things that you would expect we do have line of sight to getting a good return on the investment we will look at things that would vary some of the key assumptions not only draft launch label and competitive landscape, but also timeline.

Phil Johnson: We do want to have line of sight to getting a good return on the investment. We'll look at things that would vary some of the key assumptions, not only, you know, draft launch label and competitive landscape, but also, you know, timeline to continue to make a return on investment in the marketplace, different options for exclusivity, be that through orphan drug exclusivity, through patent life or other extensions. So, I think, by nothing unusual in terms of the, financial evaluation that we'd have there but first and foremost we need to figure out is this a jazz asset and one where there can be a significant value proposition for for patients, In terms of capital priorities, you know, I'd say first and foremost, very consistent what you've heard in the past from Bruce, Renee and the team, we're focused on driving the commercial opportunities for the in-market products that we have and are dedicating significant monies to get those to as many patients as possible that can benefit from those medicines.

Philip Johnson: We'll look at things that would vary some of the key assumptions, not only in a draft launch label and competitive landscape, but also, you know, timeline to continue to make a return on investment in the marketplace, different options for exclusivity, be that through orphan drug exclusivity, through patent life or other extensions. So I think probably nothing unusual in terms of the financial evaluation that we'd have there, but first and foremost, we need to figure out, is this a Jazz asset and one where there can be a significant value proposition for, for patients?

Tommy: And to continue to make a return on investment in the marketplace different options for exclusivity be that through orphan drug exclusivity through patent life for other extensions. So I think by nothing unusual in terms of the.

Tommy: Financial evaluation that we'd have there first and foremost we need to figure out is this the jazz asset and one where there can be a significant value proposition for for patients.

In terms of capital priorities, I'd say first and foremost, very consistent what you've heard in the past from Bruce, Renée and the team. We're focused on driving the commercial opportunities for the in-market products that we have and are dedicating significant monies to get those to as many patients as possible that can benefit from those medicines. We then are looking to rapidly progress the existing pipeline that we have; obviously, we're making significant investments behind ZANIDATAMAB given the data that we've generated post the licensing deal, and then looking at business development to further augment our growth prospects for the future. Once we've exhausted those possibilities, then we'll look to return excess cash to shareholders. So I hope that gives you a sense for how we're looking at prioritizing capital going forward.

Renée Galá: ...In terms of capital priorities, you know, I'd say first and foremost, very consistent what you've heard in the past from Bruce, Renee, and the team, we're focused on driving the commercial opportunities for the in-market products that we have and are dedicating significant monies to get those to as many patients as possible that can benefit from those medicines. We then are looking to rapidly progress the existing pipeline that we have. Obviously, we're making significant investments behind zanidatamab, given the data that we've generated post the licensing deal, and then looking at business development to further augment our growth prospects for the future. Once we've exhausted those possibilities, then we'd look to return excess cash to shareholders. So hopefully that gives you a sense for how we're looking at prioritizing capital going forward.

Philip Johnson: ...In terms of capital priorities, you know, I'd say first and foremost, very consistent what you've heard in the past from Bruce, Renee, and the team, we're focused on driving the commercial opportunities for the in-market products that we have and are dedicating significant monies to get those to as many patients as possible that can benefit from those medicines. We then are looking to rapidly progress the existing pipeline that we have. Obviously, we're making significant investments behind zanidatamab, given the data that we've generated post the licensing deal, and then looking at business development to further augment our growth prospects for the future. Once we've exhausted those possibilities, then we'd look to return excess cash to shareholders. So hopefully that gives you a sense for how we're looking at prioritizing capital going forward.

Tommy: In terms of capital priorities.

Tommy: First and foremost very consistent what you've heard in the past from Bruce Renee and the team were focused on driving the commercial opportunities for the in market products that we have and are dedicating significant monies.

Tommy: To get those to as many patients as possible that can benefit from those medicines.

Phil Johnson: We are then looking to rapidly progress the existing pipeline that we have; obviously, we're making significant investments behind ZanyDataMap given the data that we've generated post the licensing deal, and then looking at business development to further augment our growth prospects for the future. Once we've exhausted those possibilities, then we'll look to return excess cash to shareholders.

Tommy: We then are looking to rapidly progressed the existing pipeline that we have obviously, we're making significant investments behind any data math given the data that we've generated post the licensing deal and then looking at business development to further augment our growth prospects for the future. Once we've exhausted those possibilities then we'd look.

Tommy: To return excess cash to shareholders. So I hope that gives you a sense for how we're looking at priorities prioritizing capital going forward.

Tommy: Okay.

Phil Johnson: So hopefully that gives you a sense for how we're looking at prioritizing capital going forward. Your next question comes from the line of Joseph Thome with TD Cowan. Please go ahead. Hi there.

So hopefully that gives you a sense for how we're looking at prioritizing capital going forward.

Operator: Your next question comes from the line of Joseph Thome with TD Cowen. Please go ahead.

Tommy: Your next question comes from the line of Joseph <unk> with TD Cowen. Please go ahead.

Your next question comes from the line of Joseph Thome with TD Cowen. Please go ahead. Hi there.

Operator: Your next question comes from the line of Joseph Thome with TD Cowen. Please go ahead.

Please go ahead. Hi there. Good afternoon, and thank you for taking my question. Maybe one on the upcoming essential tremor readout, what is the sort of bar for clinical meaningfulness on the TETRAS endpoint, or I guess what is your internal bar, you think, for kind of taking the program forward? And then one point of clarification, because in response to one of the earlier questions, the phase three trial for essential tremor was referred to as a confirmatory trial. So I just want to make sure that was actually confirming the dose and not that this phase two B could potentially be used for approval, and then you would do a phase three confirmatory study. Thanks.

Please go ahead.

Joseph Thome: Hi, there. Good afternoon, and thank you for taking my question. Maybe one on the upcoming Essential Tremor readout, what is sort of the bar for clinical meaningfulness on the TETRAS endpoint? Or I guess what is your internal bar, you think, for kind of taking the program forward? And then one just point of clarification, because in response to one of the earlier questions, the Phase III trial for Essential Tremor was referred to as a confirmatory trial. So I just want to make sure that was actually confirming the dose and not that this Phase IIb could potentially be used for approval, and then you would do a Phase III confirmatory study? Thanks.

Joseph Thome: Good afternoon, and thank you for taking my question. Maybe one on the upcoming essential tremor readout, what is the sort of bar for clinical meaningfulness on the TETRAS endpoint, or I guess what is your internal bar, you think, for kind of taking the program forward? And then one point of clarification, because in response to one of the earlier questions, the phase three trial for essential tremor was referred to as a confirmatory trial. So I just want to make sure that was actually confirming the dose and not that this phase two B could potentially be used for approval, and then you would do a phase three confirmatory study. Thanks.

Joe Thome: Hi there. Good afternoon, and thank you for taking my question. Maybe one on the upcoming essential tremor readout. What is sort of the bar for clinical meaningfulness on the TETRAS endpoint? Or, I guess, what is your internal bar, you think, for kind of taking the program forward? And then one, just point of clarification, because I think in response to one of the earlier questions, the phase 3 for essential tremor was referred to as a confirmatory trial. So just want to make sure that was actually confirming the dose and not that this phase 2b could potentially be used for approval, and then you would do a phase 3 confirmatory study. Thanks.

Joseph Thome: Hi there. Good afternoon, and thank you for taking my question. Maybe one on the upcoming essential tremor readout. What is sort of the bar for clinical meaningfulness on the TETRAS endpoint? Or, I guess, what is your internal bar, you think, for kind of taking the program forward? And then one, just point of clarification, because I think in response to one of the earlier questions, the phase 3 for essential tremor was referred to as a confirmatory trial. So just want to make sure that was actually confirming the dose and not that this phase 2b could potentially be used for approval, and then you would do a phase 3 confirmatory study. Thanks.

Joseph: Hi, there good afternoon, and thank you for taking my question, maybe one on the upcoming essential tremor readout, what is sort of the bar for clinical meaningfulness on the <unk> endpoint or I guess, what is your internal bar you think for kind of taking the program forward and then one.

Joseph: Just point of clarification I think in response to one of the earlier questions. The phase III for a central tremor was referred to us.

Joseph: Confirmatory trials. So just wanted to make sure that was actually confirming the dose and not that this phase <unk> could potentially be used for approval and then you would do a phase III confirmatory study. Thanks.

Robert Iannone: Yes. Thanks for giving me the opportunity to clarify. I didn't mean to imply that we would get approval based on Phase IIb, just that it would be part of a package, and typically, in this space, FDA would be looking for independent studies to confirm efficacy. I did want to point out that when we go to that second efficacy study, we're likely to only use 1 dose, which would be a streamlined design, because I think the earlier question had to do with, could you move more quickly than you did with the Phase IIb study.

Robert Iannone: Yeah, thanks for giving me the opportunity to clarify. I didn't mean to imply that we would get approval based on the phase 2B, just that it would be part of a package. And typically in this space, FDA would be looking for independent studies to confirm efficacy. I did want to point out that when we go to that second efficacy study, we're likely to only use one dose, which would be a streamlined design, because I think the earlier question had to do with, you know, could you move more quickly than you did with the phase 2B study? You know, we haven't said in particular or specifically, you know, what level of difference on the ADS or the performance scale, you know, that would be meaningful enough for approval or for patients.

Speaker Change: Yes, thanks for giving me the opportunity to clarify I didn't mean to imply that we would get approval based on the phase II B just that it will be part of a package and typically in this space FDA would be looking for independent.

Speaker Change: Studies to confirm efficacy.

Speaker Change: I did want to point out that when we go to that second efficacy study, we're likely to only use one dose which would be a streamlined design because I think the earlier question has to do with could you move more quickly than you did.

Speaker Change: With the phase <unk>.

Speaker Change: <unk> study.

Robert Iannone: We haven't said in particular or specifically what level of difference on the ADS or the performance scale that would be meaningful enough for approval or for patients. But I would just highlight that there really hasn't been any therapies for this disease, almost ever, even though things like PROPRANOLOL and PRIMIDONE are used. They really have minimal efficacy. So there's a substantial unmet need. And I would just say, based on what we saw from the TCOM study, we think that, The tubercalatomide really has an opportunity to make a meaningful difference on the endpoints that matter to patients. And overall, in terms of its provability, it'll be based on that, you know, the effect size of those primary and secondary endpoints, as well as the overall tolerability, which we think, you know, will be good given the once daily extended release and the titration that we did in the trial. Your next question comes from the line of Ash Verma with UBS. Please go ahead. Hi there.

We haven't said in particular or specifically what level of difference on the ADS or the performance scale that would be meaningful enough for approval or for patients. But I would just highlight that there really hasn't been any therapies for this disease, almost ever, even though things like PROPRANOLOL and PRIMIDONE are used. They really have minimal efficacy. So there's a substantial unmet need.

Speaker Change: We haven't said in particular, our specifically what level of difference.

Speaker Change: The.

Speaker Change: After the performance scale that would be meaningful enough for approval or for patients.

Robert Iannone: But I would just highlight that there really hasn't been any therapies for this disease, you know, almost ever, even though things like propranolol and primidone, you know, are used, they really have minimal efficacy. So there's a substantial unmet need. And I would just say, based on what we saw from the TCOM study, we think that we think that suvecaltamide really has an opportunity to make a meaningful difference on the endpoints that matter to patients. And overall, in terms of its approvability, it'll be based on that, you know, the effect size of those primary and secondary endpoints, as well as the overall tolerability, which we think, you know, will be good, given the once daily extended release and the titration that we did in the trial.

Speaker Change: And I would just highlight that there really hasnt been any therapies for this disease.

Speaker Change: Almost ever even though.

Speaker Change: On slide propranolol perimeter.

And I would just say, based on what we saw from the TCOM study, we think that SUVECALTAMIDE really has an opportunity to make a meaningful difference on the endpoints that matter to patients. And overall, in terms of its provability, it'll be based on that, the effect size of those primary and secondary endpoints, as well as the overall tolerability, which we think will be good given the once daily extended release and the titration that we did in the trial. Your next question comes from the line of Ash Verma with UBS. Please go ahead. Hi there.

Speaker Change: Used really have minimal efficacy. So there is a substantial unmet need and I would just say based on what we saw from the <unk> study we think.

Speaker Change: That.

Speaker Change: <unk> really has an opportunity to make a meaningful difference on the endpoints that matter to patients and overall in terms of its probability it'll be based on that.

Speaker Change: Size of those primary and secondary endpoints as well as the overall tolerability, which we think.

Speaker Change: We will be good given given the once daily extended release in the titration that we did in the trial.

Your next question comes from the line of Ash Verma with UBS. Please go ahead. Hi there.

Operator: Your next question comes from the line of Ash Verma with UBS. Please go ahead.

Speaker Change: Your next question comes from the line of Ash, Vermont with UBS. Please go ahead.

Ash Verma: Hi there. Yes, thanks for taking my question. I just wanted to get a sense, like in the long term for narcolepsy, I understand from your perspective that you believe that XYWAV will remain an oxybate choice. But in your view, like what percentage of patients do you think may ultimately switch to a once-nightly or generic XYREM? And then, as you're trying to extend your leadership in the sleep arena, are you committed to potentially pursuing another OREXIN or trying to internally develop a once-nightly candidate? Thanks.

Ashwani Verma: Yeah, thanks for taking my question. I just wanted to get a sense, like in the long term for narcolepsy, I understand from your perspective that you believe that Zyvee will remain an oxidative choice, but in your view, like what percentage of patients do you think may ultimately switch to a once nightly or generic Zydem? And then, as you're trying to extend your leadership in the sleep arena, are you committed to potentially pursuing another orexin or trying to internally develop a once nightly? Can you do it?

Ashwani Verma: Hi there. Yeah, thanks for taking my question. I just wanted to get a sense, like in the long term for narcolepsy, I, I understand from your perspective that you believe that XYWAV will remain an oxybate of choice, but in your view, like, what percentage of patients do you think may ultimately switch to a once-nightly or generic Xyrem? And then as, as you're trying to extend your leadership in the sleep arena, are you committed to potentially pursuing another orexin or try to internally develop a once-nightly candidate? Thanks.

Ash Verma: Hi there. Yeah, thanks for taking my question. I just wanted to get a sense, like in the long term for narcolepsy, I, I understand from your perspective that you believe that XYWAV will remain an oxybate of choice, but in your view, like, what percentage of patients do you think may ultimately switch to a once-nightly or generic Xyrem? And then as, as you're trying to extend your leadership in the sleep arena, are you committed to potentially pursuing another orexin or try to internally develop a once-nightly candidate? Thanks.

Ash: Hi, there thanks.

Ash: Thanks for taking my question I, just wanted to get a sense like in the long term for narcolepsy I understand from your perspective that you believe that JV.

Ash: In an oxidative choice, but in your view like what percent database and do you think ultimately switched to a once nightly.

Ash: Genetics item.

Ash: And then as Youre trying to extend your leadership into sleep arena, our new committed to potentially pursuing another <unk> or tried to internally develop once and IP.

Ash: Thanks.

Bruce C. Cozadd: Thanks. Yeah, Ash, maybe I'll take the second part of your question first. And then Renee, maybe you can hop in on the narcolepsy side. You know, Rob gave you a little bit of an update on the 441 program; we're doing a little more work there and conferring with our partner before we announce next steps. We have previously said we have other, backup programs behind that as well. We find this an interesting area, certainly with a lot of promise, though development remains early in the Erexon space. But in terms of a new mechanism of action, it already has proof of concept, and we're definitely interested in the benefit that it can bring to patients. Rene?

Thanks.

Bruce Cozadd: Yeah, Ash, maybe I'll take the second part of your question first, and then Renee, maybe you can hop in on the narcolepsy side. You know, Rob gave you a little bit of an update on the 441 program. We're doing a little more work there and conferring with our partner before we announce next steps. We have previously said we have other backup programs behind that as well. We find this an interesting area, certainly with a lot of promise, though development remains early in the orexin space. But in terms of a new mechanism of action, it already has proof of concept, and we're definitely interested in the benefit that can bring to patients. Renee?

Speaker Change: Yeah Ash, maybe I'll take the second part of your question first and then Renee maybe you can hop in on the on the narcolepsy side.

Bruce C. Cozadd: Yes, Ash, maybe I'll take the second part of your question first. And then Renée, maybe you can hop in on the narcolepsy side. Rob gave you a little bit of an update on the 441 program; we're doing a little more work there and conferring with our partner before we announce next steps. We have previously said we have other, backup programs behind that as well. We find this an interesting area, certainly with a lot of promise, though development remains early in the OREXIN space. But in terms of a new mechanism of action, it already has proof-of-concept, and we're definitely interested in the benefit that it can bring to patients. Renée?

Ash: Rob gave you a little bit of an update on the four for one program.

Speaker Change: We're doing a little more work there and conferring with our partner before we announce next steps. We have previously said we have other.

Speaker Change: Backup programs behind that as well.

Speaker Change: We find this an interesting area.

Speaker Change: Certainly with a lot of promise, though development remains early in the Orexin space, but in terms of a new mechanism of action. It already has proof of concept in and we are definitely interested in the benefits that can bring to patients.

Speaker Change: Renee.

Renee Gala: Yes, thanks, Bruce. So I would say with respect to XYWAV, clearly, we saw both strong patient growth and net sales growth year-over-year, that was 14% in terms of net sales growth. And we believe that reflects XYWAV as being a differentiated therapy, the only low sodium oxybate on the market, and the #1 treatment for narcolepsy. I would say with respect to people trying a fixed dose high sodium oxybate, we've said we do expect some patients to try that branded therapy. We do expect that certain patients and HCPs will want to get experience with a fixed dose regimen. What we are hearing anecdotally and also seeing with respect to patients is that we are seeing some patients not get a full night's coverage.

Renée Galá: Yeah, thanks, Bruce. So I would say with respect to XYWAV, clearly we saw both strong patient growth and net sales growth. Year-over-year, that was 14% in terms of net sales growth, and we believe that reflects XYWAV as being a differentiated therapy, the only low-sodium oxybate on the market and the number one treatment for narcolepsy. I would say with respect to people trying a fixed-dose, high-sodium oxybate, we've said we do expect some patients to try that branded therapy. We do expect that certain patients and HCPs will want to get experience with a fixed-dose regimen. What we are hearing anecdotally and also seeing with respect to patients is that we are seeing some patients not get a full night's coverage.

Renee Gala: Yeah, thanks, Bruce. So I would say with respect to XYWAV, clearly we saw both strong patient growth and net sales growth. Year-over-year, that was 14% in terms of net sales growth, and we believe that reflects XYWAV as being a differentiated therapy, the only low-sodium oxybate on the market and the number one treatment for narcolepsy. I would say with respect to people trying a fixed-dose, high-sodium oxybate, we've said we do expect some patients to try that branded therapy. We do expect that certain patients and HCPs will want to get experience with a fixed-dose regimen. What we are hearing anecdotally and also seeing with respect to patients is that we are seeing some patients not get a full night's coverage.

Renee: Yeah. Thanks, Bruce So I would say with respect to sideways at clearly we saw both strong patient growth and net sales growth.

Renee: Year over year that was 14% in terms of net sales growth and we believe that reflects dilated as being a differentiated therapy. The only low sodium <unk> stayed on the market and the number one treatment for narcolepsy.

Speaker Change: I would say with respect to <unk>.

Speaker Change: People trying it fixed dose high sodium oxalate.

Renee Gala: And we believe that reflects XyWave as being a differentiated therapy, the only low sodium oxidate on the market, and the number one treatment for narcolepsy. I would say with respect to people trying a fixed dose high sodium oxidate, we've said we do expect some patients to try that branded therapy. We do expect that certain patients and HCPs will want to get experience with a fixed dose regimen. However, what we are hearing anecdotally and also seeing with respect to patients is that some patients do not get a full night's coverage.

Speaker Change: Said, we do expect some patience to try that branded therapy, we do expect that.

Speaker Change: Certain ph patients in Hcp's will want to get experience.

Speaker Change: With a fixed dose regimen, what we are hearing anecdotally and also seeing with respect to patients is that we are seeing some patients not get a full night's coverage. We believe that there is benefit to being able to have.

Renee Gala: We believe that there is a benefit to being able to have a full night's coverage in terms of sleep and the flexibility that comes with the twice-nightly dosing. But more importantly, as the only low-sodium oxybate on the market, we are seeing that educating on the benefits of low-sodium, publishing, and investing in evidence generation on this front, that message is resonating with HCPs. We have seen data showing the faster-than-expected negative impact from a cardiovascular perspective that patients have when they start high-sodium oxybate therapy.

We believe that there is a benefit to being able to have a full night's coverage in terms of sleep and the flexibility that comes with the twice-nightly dosing. But more importantly, as the only low-sodium oxybate on the market, we are seeing that educating on the benefits of low-sodium, publishing, and investing in evidence generation on this front, that message is resonating with HCPs.

Renée Galá: We believe that there is benefit to being able to have a full night's coverage in terms of sleep and the flexibility that comes with the twice-nightly dosing. But more importantly, as the only low-sodium oxybate on the market, we are seeing that educating on the benefits of low sodium, publishing and investing in evidence generation on this front, that message is resonating with HCPs. We have seen data showing the faster than expected negative impact from a cardiovascular perspective that patients have when they start a high sodium oxybate therapy. And we believe that patients and HCPs will ultimately continue to prioritize long-term health when it comes to their oxybate therapy with respect to narcolepsy. These are both chronic conditions, and that gives us continued confidence in the long-term growth and durability of XYWAV.

Renee Gala: We believe that there is benefit to being able to have a full night's coverage in terms of sleep and the flexibility that comes with the twice-nightly dosing. But more importantly, as the only low-sodium oxybate on the market, we are seeing that educating on the benefits of low sodium, publishing and investing in evidence generation on this front, that message is resonating with HCPs. We have seen data showing the faster than expected negative impact from a cardiovascular perspective that patients have when they start a high sodium oxybate therapy. And we believe that patients and HCPs will ultimately continue to prioritize long-term health when it comes to their oxybate therapy with respect to narcolepsy. These are both chronic conditions, and that gives us continued confidence in the long-term growth and durability of XYWAV.

Speaker Change: Full night's coverage in terms of sleep and the flexibility that comes with the twice nightly dosing, but more importantly, as the only low sodium oxidate on the market. We are seeing that educating on the benefits of low sodium <unk>.

Speaker Change: Publishing and investing in evidence generation on this front.

Speaker Change: That message is resonating with Hcp's.

Speaker Change: We have seen data showing the faster than expected negative impact from a cardiovascular perspective.

We have seen data showing the faster-than-expected negative impact from a cardiovascular perspective that patients have when they start high-sodium oxybate therapy. And we believe that patients and HCPs will ultimately continue to prioritize long-term health when it comes to their oxybate therapy with respect to narcolepsy. These are both chronic conditions, and that gives us continued confidence in the long-term growth and durability of XYWAV. Your next question comes from June Lee with Truist Securities. Please go ahead.

Speaker Change: That patients have when they start a high sodium oxidate therapy, and we believe that patients in Hcp's will ultimately continue to prioritize long term health when it comes to their oxidate therapy with respect to narcolepsy.

Renee Gala: And we believe that patients and HCPs will ultimately continue to prioritize long-term health when it comes to their OxyBate therapy with respect to narcolepsy. These are both chronic conditions, and that gives us continued confidence in the long-term growth and durability of XyWave. Your next question comes from June Lee with Truist Securities. Please go ahead.

Speaker Change: These are both chronic conditions and that gives us continued confidence in the long term growth and durability in sideways.

Operator: Your next question comes from June Lee with Truist Securities. Please go ahead.

Speaker Change: Your next question comes from Joon Lee with Truest Securities. Please go ahead.

June Lee: Hey, thanks for the updates and for taking our questions. You had a lot of presentations at AN, and one in particular was on the efficacy of EPIDIOLEX in focal onset seizures in the context of an expanded access program. And the study showed a median seizure reduction in the mid-70% range. How prevalent is the off-label use of EPIDIOLEX? And what sort of growth opportunities do you think you have there? There's a lot of investor interests in focal-onset seizures these. Renee, do you want to take that?

Joon Lee: Hey, thanks for the update and for taking our questions. You had a lot of presentations at AN, and one in particular was on the efficacy of Epidiolex in focal onset seizures in the context of an expanded access program. The study showed, you know, immediate seizure reduction in the mid-70% range. How prevalent is the off-label use of Epidiolex, and what sort of growth opportunities do you think you have there? There's a lot of investor interest in focal onset seizures these days. Thank you.

Joon Lee: Hey, Thanks for the update and for taking our questions you had a lot of presentations.

Joon Lee: And one in particular was on the efficacy of <unk> and focal onset teachers in the context of expanded access program and the study showed immediate deduction in the mid 70% range.

Speaker Change: <unk> is the off label use of after dialogues and what sort of gross growth opportunities do.

Speaker Change: Do you think you have there.

Speaker Change: Investor interest in focal onset seizures. These days thank you.

Bruce Cozadd: Renee, you want to take that?

Speaker Change: Renee you want to take that.

Bruce C. Cozadd: Renee, do you want to take that?

Renee Gala: Sure. Well, clearly, with respect to our promotional activities, we focus our promotional activities on those indications where we are approved, that is, LGS, Dravet, and TSC. However, we do see continued use based on seizure type, and we do see continued use in other refractory epilepsies, and that is an area that we assume will continue to provide growth for EPIDIOLEX. The reality, when you think about the overall benefits of EPIDIOLEX in terms of being a highly differentiated treatment, it has broad-spectrum efficacy, working through a novel MOA, and in an area which is characterized by polypharmacy, having a favorable and well-characterized safety profile means that the product lends itself well to being combined with multiple other therapies, in particular, for physicians that see patients that are refractory with respect to seizures.

Renée Galá: Sure. Well, clearly, with respect to our promotional activities, we focus our promotional activities on those indications where, you know, we are approved, that being LGS, Dravet, and TSC. However, we do see continued use, based on seizure type, and we do see continued use in other refractory epilepsies, and that is an area that we assume will continue to provide growth for Epidiolex. The reality when you think about the overall benefits of Epidiolex in terms of being a highly differentiated treatment, it has broad spectrum efficacy, working through a novel MOA and in an area which is characterized by polypharmacy. Having a favorable and well-characterized safety profile means that the product lends itself well to being combined with multiple other therapies, in particular, for physicians that see patients that are refractory with respect to seizures.

Renee Gala: Sure. Well, clearly, with respect to our promotional activities, we focus our promotional activities on those indications where, you know, we are approved, that being LGS, Dravet, and TSC. However, we do see continued use, based on seizure type, and we do see continued use in other refractory epilepsies, and that is an area that we assume will continue to provide growth for Epidiolex. The reality when you think about the overall benefits of Epidiolex in terms of being a highly differentiated treatment, it has broad spectrum efficacy, working through a novel MOA and in an area which is characterized by polypharmacy. Having a favorable and well-characterized safety profile means that the product lends itself well to being combined with multiple other therapies, in particular, for physicians that see patients that are refractory with respect to seizures.

Renee: Sure well clearly with respect to our promotional activities.

Renee: Our promotional activities on those indications where.

Renee: We are approved that being lgs dravet and TSP. However, we do see continued views based on seizure type and we do see continued use in.

Renee: Other refractory epilepsies and that is an area that we assume we will continue to provide growth for at the dialects.

Renee: The reality when you think about the overall benefits that the dialects in terms of being a highly differentiated treatment. It has broad spectrum efficacy working through a novel MLA and in an area, which is characterized by a polypharmacy.

Renee: A favorable and well characterized safety profile it means that the product lends itself well to being combined with multiple other therapies in particular for physicians that see patients that are refractory with respect to seizures and on top of that there really <unk>.

Renee Gala: In particular, for physicians that see patients that are refractory with respect to seizures, and on top of that, they're really starting to understand even more based on the data that we continue to generate and present around the benefits beyond seizures, and this also underpins our further investment in generating additional data, such as the EpiCom study that we're getting underway. So, we do believe we'll continue to see growth with Epidiolex, both in our approved indications and also in other refractory epilepsies, which, again, we do not promote.

In particular, for physicians that see patients that are refractory with respect to seizures,

And on top of that, they're really starting to appreciate even more based on the data that we continue to generate and present around the benefits beyond seizures, and also underpins our further investment in generating additional data, such as the EpiCoM study that we're getting underway. So, we do believe we'll continue to see growth with EPIDIOLEX, both in our approved indications and also in other refractory epilepsies, which, again, we do not promote for. This is a long-lived, durable asset for us that we will continue to look at as a global growth product with additional growth opportunities outside the U.S.

Renée Galá: And on top of that, they're really starting to appreciate even more based on the data that we continue to generate and present around the benefits beyond seizures. And also underpins our further investment in generating additional data, such as the Epicom study that we're getting underway. So we do believe we'll continue to see growth with Epidiolex, both in our approved indications and also in other refractory epilepsies, which, again, we do not promote for. This is a long-lived, durable asset for us that we will continue to look at as a global growth product with additional growth opportunities outside the US.

Renee Gala: And on top of that, they're really starting to appreciate even more based on the data that we continue to generate and present around the benefits beyond seizures. And also underpins our further investment in generating additional data, such as the Epicom study that we're getting underway. So we do believe we'll continue to see growth with Epidiolex, both in our approved indications and also in other refractory epilepsies, which, again, we do not promote for. This is a long-lived, durable asset for us that we will continue to look at as a global growth product with additional growth opportunities outside the US.

Renee Gala: <unk> two.

Renee: Appreciate even more based on the data that we continue to generate and present around the benefits beyond seizures.

Renee Gala: And it also underpins our further investment in generating additional data such as the <unk> study that were getting underway. So we do believe we will continue to see growth without the dialects. Both on our approved indications and also and other refractory epilepsies, which again, we do not.

Renee Gala: <unk> four this is a long lived durable asset for us.

Renee Gala: This is a long-lived, durable asset for us that we will continue to look at as a global growth product with additional growth opportunities outside the U.S. Your next question comes from the line of Gregory Renza with RBC Capital Markets. Please go ahead. Hey, good afternoon, Bruce.

This is a long-lived, durable asset for us that we will continue to look at as a global growth product with additional growth opportunities outside the U.S.

Gregory Renza: We will continue to look at as a global growth product with additional growth opportunities outside the U S.

Your next question comes from the line of Gregory Renza with RBC Capital Markets. Please go ahead. Hey, good afternoon, Bruce.

Operator: Your next question comes from the line of Gregory Renza with RBC Capital Markets. Please go ahead.

Renee: Your next question comes from the line of Gregory <unk> with RBC capital markets. Please go ahead.

Gregory Renza: Hey, good afternoon, Bruce and team. Thanks for taking my question. Bruce, we certainly appreciate all the color you and Philip provided on the strategic thinking as well as capital allocation, especially when it comes to internal investments. And just aside from the diversification of top line when it comes to neuroscience and sleep, as well as the oncology portfolios. Can you just speak to the synergies, the benefits and even the cross talk that you think is important for us to know when it comes to keeping both portfolios under the Jazz umbrella?

Gregory Renza: Hey, good afternoon, Bruce and team. Thanks for taking my question. Bruce, we certainly appreciate all the color you and Phil have provided on the strategic thinking as well as capital allocation, especially when it comes to internal investments. And just aside from the diversification of top line when it comes to neuroscience and sleep, as well as the oncology portfolios, can you just speak to the synergies, the benefits, and even the crosstalk that you think is important for us to know when it comes to keeping both portfolios under the Jazz umbrella? Thanks so much.

Gregory Renza: Hey, good afternoon, Bruce and team. Thanks for taking my question Bruce We certainly appreciate all the color you and Philip provided on the strategic thinking as well as the capital allocation, especially when it comes to internal investments and just aside from the diversification of top line when it comes to neuroscience and.

Gregory Renza: Thank you for taking my question. Bruce, we certainly appreciate all the color you and Philip provided on thinking as well as Capital Allocation, especially when it comes to internal Neuroscience and Sleep, as well as the Oncology Portfolios. Can you just speak to the synergies, the benefits? Crosstalk.

Gregory Renza: Sleep as well as the oncology portfolios can you just speak to the synergies the benefit and even a cross talk that that you think is important for us to know when it comes to keeping both portfolios under the jazz umbrella. Thanks, so much.

Bruce C. Cozadd: Yes, well, Greg, we're fortunate to have growth opportunities on both sides, places that are worth investing, whether that's commercial or R&D. And I also believe there's a benefit in being able to look across these 2 therapeutic areas on the corporate development side. As we've all seen, over the past few decades, there are times when an area heats up, and valuations get high. And if you can look more broadly across therapeutic categories and across stages of development, I think you're often more likely to find an opportunity that's both a strategic fit but also offers a nice return profile. There are a number of services we provide across the company that are centralized and may provide some marginal benefit by not having to reproduce things across multiple therapeutic areas. I wouldn't say that's the strategic driver, but again, we're in a position where we've got nice opportunities in front of us for the short and long term on both sides of the business. Your next question comes from the line of David Amsellem with Piper Sandler. Please go ahead.

Yes, well, Greg, we're fortunate to have growth opportunities on both sides, places that are worth investing, whether that's commercial or R&D. And I also believe there's a benefit in being able to look across these 2 therapeutic areas on the corporate development side. As we've all seen, over the past few decades, there are times when an area heats up, and valuations get high. And if you can look more broadly across therapeutic categories and across stages of development, I think you're often more likely to find an opportunity that's both a strategic fit but also offers a nice return profile. There are a number of services we provide across the company that are centralized and may provide some marginal benefit by not having to reproduce things across multiple therapeutic areas. I wouldn't say that's the strategic driver, but again, we're in a position where we've got nice opportunities in front of us for the short and long term on both sides of the business.

Bruce Cozadd: Yeah, well, Greg, we're fortunate to have, you know, growth opportunities on both sides, places that are worth investing, whether that's commercial or R&D. I also believe there's benefit in being able to look across these two therapeutic areas on the corporate development side. As we've all seen over the past few decades, there are times when an area heats up and valuations get high. And if you can look more broadly across therapeutic categories and across stages of development, I think you're often more likely to find an opportunity that's both a strategic fit, but also offers a nice return profile. You know, there are a number of services we provide across the company that are centralized and, you know, may provide some marginal benefit by not having to reproduce things across multiple therapeutic areas.

Renee: Yeah.

Gregory Renza: We're fortunate to have.

Rob Iannone: Growth opportunities on both sides places that are worth investing.

Phil Johnson: Thats commercial or R&D and I also believe there's benefit in being able to look across these two therapeutic.

Bruce C. Cozadd: Areas on the corporate development side as we've all seen over the past few decades, there are times when an area heats up in valuations get high.

Bruce C. Cozadd: And if you can look more broadly across therapeutic categories and across stages of development, I think you're often more likely to find an opportunity that's both a strategic fit but also offers a nice return profile. For example, there are a number of services we provide across the company that are centralized and may provide some marginal benefit by not having to reproduce things across multiple therapeutic areas. I wouldn't say that's the strategic driver, but again, we're in a position where we've got nice opportunities in front of us for the short and long term on both sides of the business. Your next question comes from the line of David Amsellem with Piper Sandler. Please go ahead.

Bruce C. Cozadd: And if you can look more broadly across therapeutic categories and across stages of development. I think you are often more likely to find an opportunity that is both a strategic fit but also offers.

David A. Amsellem: Nice return profile there.

David A. Amsellem: There are a number of services, we provide across the company that.

There are a number of services we provide across the company that are centralized and may provide some marginal benefit by not having to reproduce things across multiple therapeutic areas. I wouldn't say that's the strategic driver, but again, we're in a position where we've got nice opportunities in front of us for the short and long term on both sides of the business.

David A. Amsellem: Our centralized and may provide some marginal benefit by not having to reproduce things across.

David A. Amsellem: Multiple therapeutic areas I would say that's the strategic driver, but again, we're in a position where we've got.

Bruce Cozadd: I wouldn't say that's the strategic driver, but again, we're in a position where we've got nice opportunities in front of us, short and long term, on both sides of the business.

David A. Amsellem: Nice opportunities in front of us short and long term on both sides of the business.

Operator: Your next question comes from the line of David Amsellem with Piper Sandler. Please go ahead.

David A. Amsellem: Your next question comes from the line of David <unk> with Piper Sandler. Please go ahead.

Operator: Your next question comes from the line of David Amsellem with Piper Sandler. Please go ahead.

David A. Amsellem: Hey, just have a quick question on the balance sheet and the cap structure. Can you talk to any potential long-term leverage targets that you have? You've done a lot of deleveraging in the years since the GW transaction. Obviously, you're active in biz dev, but are you thinking about perhaps, accelerating debt paydown as a means of potentially supporting the equity? Is that something you're contemplating? And just help us better understand how you're thinking about leverage ratios over time? Thank you. Jill, do you want to jump in on that?

David Amsellem: Hey, just have a quick question on the balance sheet and the cap structure. Can you talk to any potential long-term leverage targets that you have? You've done a lot of deleveraging in the years since the GW transaction. Obviously, you're active in biz dev, but are you thinking about perhaps, accelerating debt paydown as a means of potentially supporting the equity? Is that something you're contemplating? And just help us better understand how you're thinking about leverage ratios over time? Thank you.

[Analyst] (Aiera): Hey, just have a quick question on the balance sheet and the cap structure. Can you talk to any potential long-term leverage targets that you have? You've done a lot of deleveraging in the years since the GW transaction. Obviously, you're active on biz dev. But are you thinking about perhaps accelerating debt paydown as a means of potentially supporting the equity? Is that something you're contemplating? And just help us better understand how you're thinking about leverage ratios over time. Thank you.

David Amsellem: Hey, just have a quick question on the balance sheet and the cap structure. Can you talk to any potential long-term leverage targets that you have? You've done a lot of deleveraging in the years since the GW transaction. Obviously, you're active on biz dev. But are you thinking about perhaps accelerating debt paydown as a means of potentially supporting the equity? Is that something you're contemplating? And just help us better understand how you're thinking about leverage ratios over time. Thank you.

David A. Amsellem: Hey, just had a quick question on the balance sheet in the cap structure.

Jill: Can you talk to.

Jill: Any potential long term leverage targets.

Jill: That you have done.

Jill: Done a lot of deleveraging in the year since the GW transaction, obviously you were active on <unk>.

Jill: But are you thinking about perhaps.

Jill: Celebrating debt Paydown.

Jill: As a means of potentially supporting the equity is that something you are contemplating and just help us better understand how you're thinking about leverage ratios over time. Thank you.

Bruce C. Cozadd: Phil, do you want to jump in on that?

David A. Amsellem: Okay.

Bruce Cozadd: Phil, you want to jump in on that?

David A. Amsellem: Sure.

Phil Johnson: Yes, happy to. So, David, as you mentioned, when we had the GW acquisition, there was a really strong interest in communication that we would rapidly de-lever down to about 3.5 turns by the end of 2022. You saw us actually beat that by about 6 months. We currently sit with about 2.5x in that leverage. I think still a very strong position at this point in time, and feel very good about the overall debt complex that we've got with about 60% of that being fixed, only about 40% of that being variable, exposed to interest rate movements, and with the weighted average cost of debt of south of 5.5% at this point in time. As you're probably aware, we do have an upcoming maturity of our 2024 convert that we're actively planning as you'd expect, looking at some alternatives for how we might approach that particular financing opportunity or repayment opportunity.

Philip Johnson: Yes, happy to. So, David, as you mentioned, when we had the GW acquisition, there was a really strong interest in communication that we would rapidly de-lever down to about 3.5 turns by the end of 2022. You saw us actually beat that by about 6 months. We currently sit with about 2.5x in that leverage. I think still a very strong position at this point in time, and feel very good about the overall debt complex that we've got with about 60% of that being fixed, only about 40% of that being variable, exposed to interest rate movements, and with the weighted average cost of debt of south of 5.5% at this point in time.

Philip Johnson: Yeah, happy to. So, David, as you mentioned, you know, when we had the GW acquisition, there was a really strong, interest and communication that we would rapidly delever down to about 3.5 turns by the end of 2022. You know, you saw us actually, beat that by about six months. We currently sit with about 2.5 times net leverage. I think still a very, strong position at this point in time, and feel very good about the overall, debt complex that we've got, with about 60% of that being fixed, only about 40% of that being variable, exposed to interest rate movements. And with the weighted average cost of debt of south of, of 5.5% at this point in time.

Jill: Yes happy to do so.

Phil Johnson: David as you mentioned when we had the CW acquisition, there was a really strong inter.

Phil Johnson: Interest and communication that we would rapidly delever down to about three five turns by the end of 2022.

Phil Johnson: You saw us actually.

Phil Johnson: Beat that by about six months.

Phil Johnson: We currently sit with about two and a half times in that leverage, I think still a very strong position at this point in time, and feel very good about the overall debt complex that we've got with about 60% of that being fixed, only about 40% of that being variable, exposed to interest rate movements, and with the weighted average cost of debt south of five and a half percent at this point in time. As you're probably aware, we do have an upcoming maturity of our 2024 convert that we're actively planning for, as you'd expect, looking at some alternatives for how we might approach that particular financing opportunity or repayment opportunity.

Phil Johnson: We currently sit with about two five times net leverage I think still a very strong position at this point in time I feel very good about the overall debt complex that we've got.

Phil Johnson: With about 60% of that being six only about 40% of that being variable exposed to interest rate movements and with a weighted average cost of debt of south of five 5% at this point in time as.

Philip Johnson: As you're probably aware, we do have an upcoming maturity of our 2024 convert that we're in active planning, as you'd expect, looking at some alternatives for how we might approach that particular financing opportunity or repayment opportunity. I would say if we were to engage in additional business development that had the debt increase in the near term, I think like we did with GW, we'd have a strong plan to reduce that quickly to get back into the kind of levels that we've currently got or below, where we've got significant flexibility to continue to look at ways to build the business through business development or corp dev opportunities.

Phil Johnson: As you are probably where we do have an upcoming maturity of our 2024 convert.

Phil Johnson: In active planning as you would expect looking at some alternatives for how we might approach that particular.

Phil Johnson: Financing opportunity or repayment opportunity I would say if we were to engage in additional business development that had the <unk>.

As you're probably aware, we do have an upcoming maturity of our 2024 convert that we're actively planning as you'd expect, looking at some alternatives for how we might approach that particular financing opportunity or repayment opportunity. I would say if we were to engage in additional business development, we have the debt increase in the near term, I think like we did with GW, we have a strong plan to reduce that quickly to get back into the kind of levels that we currently got or below where we've got significant flexibility to continue to look at ways to build the business through business development or CorpDev opportunities. To date, we have not specified any kind of specific targets below where we're currently sitting and where we'd like to get to, but this will be actively discussed and worked through as we move forward, looking at the investment opportunities in front of us, both internal as well as external. I'm not sure, Bruce, if you want to comment additionally. No, Phil, I think you covered it well. I, you know, I think we've seen some recent positive commentary from the rating agencies, in general, about the financial profile of the company. You know, we've used leverage to do transactions when we thought that was the best thing for shareholders. But, as Phil said, we've always tried to de-lever rapidly after that.

Phil Johnson: That increase in the near term I think like we did with GW, we'd have a strong plan to reduce that quickly to get back into the kind of levels that we've currently got are below where we've got significant flexibility to continue to look at ways to build the business through.

Phil Johnson: Does this development our Corp Dev opportunities to date, we have not specified any kind of.

Phil Johnson: To date, we have not specified any kind of specific targets below where we're currently sitting and where we'd like to get to, but this will be actively discussed and worked through as we move forward, looking at the investment opportunities in front of us, both internal as well as external. I'm not sure, Bruce, if you want to comment additionally. No, Phil, I think you covered it well. I, you know, I think we've seen some recent positive commentary from the rating agencies, in general, about the financial profile of the company. You know, we've used leverage to do transactions when we thought that was the best thing for shareholders. But, as Phil said, we've always tried to de-lever rapidly after that.

Philip Johnson: To date, we have not specified any kind of a specific target below where we're currently sitting and where we'd like to get to, but this will be actively discussed and worked through as we move forward, looking at the investment opportunities in front of us, both internal as well as external. Not sure, Bruce, if you want to comment, additionally? No.

Bruce: Specific targets below where we're currently sitting at where we'd like to get to.

Phil Johnson: But this will be actively discussed to work through as we move forward looking at the investment opportunities in front of us both internal as well as external Bruce do you want to comment. Additionally.

To date, we have not specified any kind of specific targets below where we're currently sitting and where we'd like to get to, but this will be actively discussed and worked through as we move forward, looking at the investment opportunities in front of us, both internal as well as external. I'm not sure, Bruce, if you want to comment additionally. No, Phil, I think you covered it well. I, you know, I think we've seen some recent positive commentary from the rating agencies, in general, about the financial profile of the company. You know, we've used leverage to do transactions when we thought that was the best thing for shareholders. But, as Phil said, we've always tried to de-lever rapidly after that.

Bruce Cozadd: No, Phil, I think you covered it well. I, you know, I think we've seen some recent positive commentary from the rating agencies in general about the financial profile of the company. You know, we've used leverage to do transactions when we thought that was the best thing for shareholders, but as Phil said, we've always tried to delever rapidly after that.

Bruce: No Phil I think you covered it well.

I'm not sure, Bruce, if you want to comment additionally. No, Phil, I think you covered it well. I, you know, I think we've seen some recent positive commentary from the rating agencies, in general, about the financial profile of the company. You know, we've used leverage to do transactions when we thought that was the best thing for shareholders. But, as Phil said, we've always tried to de-lever rapidly after that.

I'm not sure, Bruce, if you want to comment additionally?

Bruce: We've seen some recent positive commentary from the rating agencies in general.

Bruce C. Cozadd: No, Phil, I think you covered it well. I think we've seen some recent positive commentary from the rating agencies, in general, about the financial profile of the company. We've used leverage to do transactions when we thought that was the best thing for shareholders. But, as Phil said, we've always tried to de-lever rapidly after that.

Bruce: About the financial profile of the company.

Bruce: We've used leverage to do transactions when we felt that was the best thing for shareholders, but as Phil said, we've always tried to delever rapidly after that.

Bruce C. Cozadd: Your next question comes from the line of Gary Nachman with Raymond James. Please go ahead. Thanks. Good afternoon.

Operator: Your next question comes from the line of Gary Nachman with Raymond James. Please go ahead.

Speaker Change: Your next question comes from the line of Gary Nachman with Raymond James. Please go ahead.

Gary Nachman: Thanks. Good afternoon. So, on XYWAV, understanding the patient support program was a key factor for the lower revenue in 1Q. Is XYWAV also still getting a lot of the oxybate-naive patients in narcolepsy? And is that a factor that can impact revenue in coming quarters to consider?

Bruce C. Cozadd: Yes.

Gary Nachman: So, on Zywave, you know, understanding the patient support program was a key factor for the lower revenue in OneQ. Is Zywave also still getting a lot of oxidate-naive patients in narcolepsy? And, you know, is that a factor that can impact revenue in coming quarters to consider?

Gary Nachman: Thanks. Good afternoon. So on XYWAV, you know, understanding the, the patient support program was a key factor for the lower revenue in Q1. Is XYWAV also still getting a lot of the oxybate-naive patients in narcolepsy? And, you know, is that a factor that can impact, impact revenue in coming quarters to consider? And then IH, are physicians staying strictly on label, or are you hearing there could be some off-label use with Lumryz if it's with younger patients, I guess, in particular? And maybe talk about the competitive dynamics, IH going forward, since that space is going to get a lot more crowded, I guess, in the, in the coming years. Thank you.

Gary Nachman: Thanks, Good afternoon, so in some ways.

Gary Nachman: Standing the patient support program was a key factor for the lower revenue and <unk> <unk> also still getting a lot of the oxidate naive patients in narcolepsy and.

Gary Nachman: Is that a factor that can impact impact revenue in coming quarters to consider.

Bruce C. Cozadd: And then NIH, are physicians staying strictly on-label, or are you hearing there could be some off-label use with LUMRYZ, if it's with younger patients, I guess, in particular? And maybe talk about the competitive dynamics in NIH going forward, since that space is going to get a lot more crowded, I guess, in the coming years. Thank you. Yeah, thanks for the question. I'll hop right in there

And then NIH, are physicians staying strictly on-label, or are you hearing there could be some off-label use with LUMRYZ, if it's with younger patients, I guess, in particular? And maybe talk about the competitive dynamics in NIH going forward, since that space is going to get a lot more crowded, I guess, in the coming years. Thank you.

Gary Nachman: And then the NIH.

Speaker Change: Our physician staying strictly on label or are you hearing there could be some off label use with Luna, Brian if it's with younger patients I guess in particular.

Speaker Change: And maybe talk about the competitive dynamics NIH going forward.

Speaker Change: Since that space is going to get a lot more crowded I guess in the coming years. Thank you.

Rene Gala: Yes, thanks for the question. I'll hop right in there. So with respect to oxybate-naive patients starting on XYWAV for narcolepsy, while we don't have full visibility into the new to oxibate patient numbers, based on our estimates, we do believe we continue to capture more of those new to oxybate narcolepsy patients than any other currently available therapy. And I would say that speaks to the differentiation of the product. It speaks to our host of patient support services more broadly, and being a leader in sleep, the high overlap when we're looking at narcolepsy and IH, being in front of physicians and continuing to be able to educate them on the benefits of low sodium.

Bruce C. Cozadd: Okay.

Renee Gala: So with respect to oxibate naive patients starting on Xywave for narcolepsy, while we don't have full visibility into the new to oxibate patient numbers, based on our estimates, we do believe we continue to capture more of those new to oxibate narcolepsy patients than any other currently available therapy. And I would say that speaks to the differentiation of the product. It speaks to our host of patient support services more broadly. And being a leader in sleep, you know, the high overlap when we're looking at narcolepsy and IEH, of being in front of physicians and continuing to be able to educate them on the benefits of low sodium.

Renée Galá: Yeah, thanks for the question. I'll hop right in there. So with respect to oxybate naive patients starting on XYWAV for narcolepsy, while we don't have full visibility into the new to oxybate patient numbers, based on our estimates, we do believe we continue to capture more of those new to oxybate narcolepsy patients than any other available therapy. And I would say that speaks to the differentiation of the product. It speaks to our host of patient support services more broadly, and being a content leader in sleep, you know, the high overlap when we're looking at narcolepsy and IH of being in front of physicians and continuing to be able to educate them on the benefits of low sodium.

Renee Gala: Yeah, thanks for the question. I'll hop right in there. So with respect to oxybate naive patients starting on XYWAV for narcolepsy, while we don't have full visibility into the new to oxybate patient numbers, based on our estimates, we do believe we continue to capture more of those new to oxybate narcolepsy patients than any other available therapy. And I would say that speaks to the differentiation of the product. It speaks to our host of patient support services more broadly, and being a content leader in sleep, you know, the high overlap when we're looking at narcolepsy and IH of being in front of physicians and continuing to be able to educate them on the benefits of low sodium.

Speaker Change: Yes. Thanks for the question I'll hop right in there so with respect to <unk>.

Renee Gala: <unk> naive patients starting on sideways for narcolepsy, while we don't have full visibility into that new to oxalate patient numbers based on our estimates. We do believe we continue to capture more of that is new to Oxidate narcolepsy patients.

Renee Gala: And any other.

Renee Gala: Available therapy.

Renee Gala: And I would say that speaks to the differentiation of the product it speaks to our.

Renee Gala: Host of patient support services more broadly.

Renee Gala: And.

Renee Gala: Being a.

Renee Gala: Leader in sleep.

Renee Gala: You know that the high overlap when we're looking at in narcolepsy and IH of being in front of physicians and continuing to be able to educate them on the benefits of low sodium with respect to I H, we don't we're not.

Renee Gala: With respect to IH, we don't, we're not really seeing much, if any, off-label use with LUMRYZ, given the payer restrictions on these products and the need for a validated week test for either narcolepsy or for IH. We tend to see that being required in order to receive a prescription. And so it would be pretty unusual to be able to see a prescription for the AG or for LUMRYZ for idiopathic hypersomnia.

Renée Galá: With respect to IH, we don't-- we're not really seeing, much, if any, off-label use with Lumryz, given the payer restrictions on these products and the need for a validated sleep test for either narcolepsy or for IH. We tend to see, we tend to see that being required in order to receive a prescription, and so it would be, pretty unusual to be able to see a prescription for the AG or for Lumryz for idiopathic hypersomnia. And then with respect to competitive dynamics, I think we'll continue to probably see, wake-promoting agents studied for idiopathic hypersomnia.

Renee Gala: With respect to IH, we don't-- we're not really seeing, much, if any, off-label use with Lumryz, given the payer restrictions on these products and the need for a validated sleep test for either narcolepsy or for IH. We tend to see, we tend to see that being required in order to receive a prescription, and so it would be, pretty unusual to be able to see a prescription for the AG or for Lumryz for idiopathic hypersomnia. And then with respect to competitive dynamics, I think we'll continue to probably see, wake-promoting agents studied for idiopathic hypersomnia.

Renee Gala: Really seeing much if any off label use with limb rise.

Renee Gala: Given the <unk>.

Renee Gala: Payer restrictions on these products and the need for a validated test for either narcolepsy or for I H.

Renee Gala: We tend to see.

Renee Gala: We tend to see that being required in order to receive a prescription and so it would be.

Renee Gala: Pretty unusual to be able to see a prescription for the AG or for limb rise for idiopathic hypersomnia.

Renee Gala: And then with respect to competitive dynamics, I think we'll continue to probably see wake-promoting agents studied for idiopathic hypersomnia. Keep in mind, we had a rather large percentage of patients that came into our idiopathic hypersomnia study on wake-promoting agents and continued to see meaningful benefits while on therapy with XYWAV in addition to being on that wake-promoting agent as part of their baseline. Very much like we've seen the wake-promoting agents end up being complementary to XYWAV in narcolepsy, we would expect a very similar dynamic in idiopathic hypersomnia. For example, with WAKIX coming onto the market for narcolepsy. We saw little to no impact on our oxybate franchise and would expect the same, largely the same dynamic with respect to IH. Your next question comes from the line of Charles Duncan with Cantor Fitzgerald. Please go ahead.

And then with respect to competitive dynamics, I think we'll continue to probably see wake-promoting agents studied for idiopathic hypersomnia. Keep in mind, we had a rather large percentage of patients that came into our idiopathic hypersomnia study on wake-promoting agents and continued to see meaningful benefits while on therapy with XYWAV in addition to being on that wake-promoting agent as part of their baseline. Very much like we've seen the wake-promoting agents end up being complementary to XYWAV in narcolepsy, we would expect a very similar dynamic in idiopathic hypersomnia. For example, with WAKIX coming onto the market for narcolepsy. We saw little to no impact on our oxybate franchise and would expect the same, largely the same dynamic with respect to IH.

Renee Gala: And then with respect to competitive dynamics I think we will continue to probably see a wake promoting agent studied for idiopathic hypersomnia keep in mind, we had a rather large percentage of patients that came into our idiopathic hypersomnia.

Renée Galá: Keep in mind, we had, you know, a rather large percentage of patients that came into our idiopathic hypersomnia study on wake-promoting agents and continued to see meaningful benefit while on therapy with XYWAV, in addition to being on that, wake-promoting agent as part of their baseline. Very much like we've seen the wake-promoting agents end up being complementary to XYWAV in narcolepsy, we would expect a very similar dynamic in idiopathic hypersomnia. For example, with Wakix coming onto the market for narcolepsy, narcolepsy, we saw little to no impact to our oxybate franchise... and would expect the same, largely the same dynamic with respect to IH.

Renee Gala: Keep in mind, we had, you know, a rather large percentage of patients that came into our idiopathic hypersomnia study on wake-promoting agents and continued to see meaningful benefit while on therapy with XYWAV, in addition to being on that, wake-promoting agent as part of their baseline. Very much like we've seen the wake-promoting agents end up being complementary to XYWAV in narcolepsy, we would expect a very similar dynamic in idiopathic hypersomnia. For example, with Wakix coming onto the market for narcolepsy, narcolepsy, we saw little to no impact to our oxybate franchise... and would expect the same, largely the same dynamic with respect to IH.

Renee Gala: Study on wake promoting agents and continue to see meaningful benefit while on therapy with sideways. In addition to being on that wake promoting agent as part of their baseline very much like we've seen the wake promoting.

Renee Gala: Agents end up being complementary to <unk> in narcolepsy, we would expect a very similar dynamic and.

Renee Gala: Idiopathic Hypersomnia for example, with wake X coming onto the market for narcolepsy.

Renee Gala: For example, with Wakex coming onto the market for narcolepsy, we saw little to no impact on our Oxivate franchise and would expect the same, largely the same dynamic with respect to IH. Your next question comes from the line of Charles Duncan with Cantor Fitzgerald. Please go ahead.

Charles Duncan: Narcolepsy, we saw little to no impact to our Oxidate franchise and would expect the same largely the same dynamic with respect to IH.

Operator: Your next question comes from the line of Charles Duncan with Cantor Fitzgerald. Please go ahead.

Robert Iannone: Your next question comes from the line of Charles Duncan with Cantor Fitzgerald. Please go ahead.

Operator: Your next question comes from the line of Charles Duncan with Cantor Fitzgerald. Please go ahead.

Renee Gala: Your next question comes from the line of Charles Duncan with Cantor Fitzgerald. Please go ahead.

Charles Duncan: Thank you. Good afternoon, Bruce and team. Thanks for taking our question. And congrats on the BLA submission being completed with ZANI. That said, the next data read is actually Neuro with SUVECALTAMIDE and Essential Tremor. And so I'm going to ask for a little bit more granularity. I know others have tried, but I'm really wondering what would you like to see out of the Phase IIb to move forward? If it's supportive of a registration strategy, it definitely seems like stat sig is important, but will you be looking at certain effect sizes and responder analysis? And of the 2 composites, which of the 2 are important to you? Thanks.

Charles Duncan: Thank you. Good afternoon, Bruce and team. Thanks for taking our question, and congrats on the BLA submission being completed with zanidatamab. That said, the next data read is actually neuro with suvecaltamide and essential tremor. So I'm gonna ask for a little bit more granularity. I know others have tried, but I'm really wondering, what would you like to see out of the phase 2b to move forward? Is it, if it's supportive of a registrational strategy, it definitely seems like stat sig is important, but will you be looking at certain effect sizes and responder analysis? And of the two composites, which of the two are important to you? Thanks.

Charles Duncan: Thank you good afternoon, Bruce and team thanks for taking our questions and congrats on the BLA submission being completed husseini.

Charles Duncan: That said the next data read is actually neuro was super Kalsomine and essential tremor, and so I'm going to ask for a little bit more granularity I know others have tried but I'm really wondering what would you like to see the phase to be to move forward is that if a if it's a <unk>.

Charles Duncan: Supportive of registration strategy. It definitely seems like stat Sig is important but will you be looking at certain effect sizes and responder analysis and of the two composites, which of the two are important too. Thanks.

Bruce C. Cozadd: Yes, Charles, I'll start with the dangerously general comments and then and then let Rob jump in if he wants to provide more specifics. What we want, aside from a package that would generate a regulatory approval is something that really adds value, something that is of value to patients, that patients and prescribers and payers will all see as providing a really meaningful benefit. And certainly our trials are designed with perspective key endpoints that we need to hit, but we measure lots of things in these trials that really go to establishing that benefit profile for patients against a backdrop, as Rob said, of really nothing that's currently available that's providing that kind of benefit. Rob, do you want to talk about anything specific?

Bruce Cozadd: Yeah, Charles, I'll start with the dangerously general comments and then let Rob jump in if he wants to provide more specifics. You know what we want, aside from a package that would generate a regulatory approval, is something that really adds value. Something that is of value to patients, that patients, prescribers, and payers will all see as providing a really meaningful benefit. And, you know, certainly our trials are designed with prospective key endpoints that we need to hit. But we measure lots of things in these trials that really go to establishing that benefit profile for patients against a backdrop, as Rob said, of really nothing that's currently available that's providing that kind of benefit. Rob, do you wanna talk about anything specific?

Speaker Change: Yeah, Charles I'll start with the dangerously General comments, and then and then let Rob jump in if he wants to provide more specifics.

Rob: We want a aside from.

Rob: Our package that would generate a regulatory approval is something that really adds value.

Rob: That is a value to patients that.

Rob: Patients and prescribers and payers were all see is providing a really meaningful benefit.

Rob: And certainly our trials are designed with perspective.

Rob: Key endpoints that.

Rob: We need to hit but.

Rob: We measure lots of things in these trials that really go to establishing.

Rob: That benefit profile for patients.

Rob: Against the backdrop.

Bruce C. Cozadd: As Rob said of really nothing.

Rob: That's currently available that's providing that kind of benefit.

Bruce C. Cozadd: Rob, do you want to talk about anything specific?

Bruce C. Cozadd: you want to talk about anything specific?

Bruce C. Cozadd: Rob do you want to talk about anything specific.

Robert Iannone: Well, again, I don't want to necessarily specify an effect size that we think is meaningful because it really is the overall picture that matters. But what I would say is when you look at the TCOM data, we thought there was an important effect there. We've optimized our trial in many respects, honing the primary endpoint in agreement with FDA, optimize the dose, made some changes to how we measure to be sure we get more accurate measurements. And I think all of that would bode well for the trial. I think the other reference point you would have is other T-type calcium channel inhibitors in development. We certainly think SUVECALTAMIDE is differentiated in a couple of respects.

Robert Iannone: Well, again, I don't wanna necessarily specify an effect size that we think is meaningful, 'cause it really is the holistic picture that matters. But I... What I would say is, you know, when you look at the TCOM data, we thought there was an important effect there. We've optimized our trial in many respects, you know, honing the primary endpoint and agreement with FDA, optimized the dose, made some changes to how we measure to be sure we get more accurate measurements. And I think all of that would, you know, would bode well for the trial. I think the other reference point you would have is, you know, other T-type calcium channel inhibitors in development. We certainly think suvecaltamide is differentiated in a couple of respects.

Rob: Well again, I don't want to unnecessarily specified effect size that we think is meaningful because it really is the holistic picture that matters.

Robert Iannone: What I would say is when you look at the telecom data we thought there was an important effect there.

Robert Iannone: <unk> optimized our trial in many respects.

Robert Iannone: Honing the primary endpoint in agreement with FDA optimize the dose made some changes to how we measure to be sure we get more accurate measurements and I think all of that.

Robert Iannone: And it would bode well for the trial I think the other reference point you have is.

Robert Iannone: I think the other reference point you would have is other T-type calcium channel inhibitors in development. We certainly think supra-calcimide is differentiated in a couple of respects. It's a state-dependent inhibitor, which means it really targets the hyperactive iron channels that are pathologic in the essential tremor condition. And with that, we think it potentially gives us a better therapeutic index, which is why we've been able to push the dose even to doses and exposures that are higher than we would have achieved in T. So again, it's the totality of the data around the primary and secondary endpoints that Your next question comes from Balaji Prasad with Barclays. Please go ahead. Good evening, everyone. Just a couple from me.

I think the other reference point you would have is other T-type calcium channel inhibitors in development. We certainly think supra-calcimide is differentiated in a couple of respects.

Robert Iannone: Other.

Balaji V. Prasad: T type calcium channel inhibitors in development, we certainly think similar kalsomine differentiate it as a couple of respects. This is state dependent and inhibitor, which means it really targets.

It's a state-dependent inhibitor, which means it really targets the hyperactive iron channels that are pathologic in the Essential Tremor condition. And with that, we think it potentially gives us a better therapeutic index, which is why we've been able to push the dose even to doses and exposures that are higher than we would have achieved in TCOM. So again, it's the totality of the data around the primary and secondary endpoints that we've included that will be meaningful to patients and we know acceptable to FDA. Your next question comes from Balaji Prasad with Barclays. Please go ahead. Good evening, everyone. Just a couple from me.

It's a state-dependent inhibitor, which means it really targets the hyperactive iron channels that are pathologic in the essential tremor condition. And with that, we think it potentially gives us a better therapeutic index, which is why we've been able to push the dose even to doses and exposures that are higher than we would have achieved in T. So again, it's the totality of the data around the primary and secondary endpoints that Your next question comes from Balaji Prasad with Barclays. Please go ahead. Good evening,

Robert Iannone: It's a state-dependent inhibitor, which means it really targets the hyperactive ion channels that are pathologic in the essential tremor condition. And with that, we think it potentially gives us a better therapeutic index, which is why we've been able to push the dose even to doses and exposures that are higher than we would have achieved in TCOM. So again, it's the totality of the data around the primary and secondary endpoints that we've included that will be meaningful to patients and we know acceptable to FDA. Your next question comes from Balaji Prasad with Barclays. Please go ahead.

Balaji V. Prasad: Hyperactive ion channels that a pathologic in essential tremor condition.

Robert Iannone: Condition.

Balaji V. Prasad: With that we think could.

Balaji V. Prasad: Essentially it gives us a better therapeutic index, which is why we've been able to push the dose even to doses and exposures that are higher than we would've achieved in telecom.

Balaji V. Prasad: Again, it's the totality of the data around the primary and secondary endpoints that we've included that will be meaningful to patients and we know acceptable to FDA.

Operator: Your next question comes from Balaji Prasad with Barclays. Please go ahead.

Your next question comes from Balaji Prasad with Barclays. Please go ahead. Good evening,

Operator: Your next question comes from Balaji Prasad with Barclays. Please go ahead.

Balaji V. Prasad: Your next question comes from <unk> Prasad with Barclays. Please go ahead.

Balaji V. Prasad: Good evening, everyone. Just a couple from me. On EPIDIOLEX, can you comment on the adult opportunity, either quantified or qualified? Primarily asking because I'm curious; at most, I thought the primary indications approved were childhood diseases that patients tend to outgrow. And also, when do you expect to see this additional data, and what is the data that you're expecting? Secondly, on the 2024 guide, can you help us understand the double-digit per stage growth that you provided for Zywave, Epidiolex, and Rylase combined?

everyone. Just a couple from me. everyone. Just a couple from me. On Epidiolex, can you comment on the adult opportunity, either quantified or qualified? Primarily asking because I'm curious; at most, I thought the primary indications approved were childhood diseases that patients tend to outgrow. And also, when do you expect to see this additional data, and what is the data that you're expecting? Secondly, on the 2024 guide, can you help us understand the double-digit per stage growth that you provided for Zywave, Epidiolex, and Rylase combined?

everyone. Just a couple from me. On Epidiolex, can you comment on the adult opportunity, either quantified or qualified? Primarily asking because I'm curious; at most, I thought the primary indications approved were childhood diseases that patients tend to outgrow. And also, when do you expect to see this additional data, and what is the data that you're expecting? Secondly, on the 2024 guide, can you help us understand the double-digit per stage growth that you provided for Zywave, Epidiolex, and Rylase combined?

Balaji V. Prasad: On Epidiolex, can you comment on the adult opportunity, either quantified or qualified? Primarily asking because I'm curious; at most, I thought the primary indications approved were childhood diseases that patients tend to outgrow. And also, when do you expect to see this additional data, and what is the data that you're expecting? Secondly, on the 2024 guide, can you help us understand the double-digit per stage growth that you provided for Zywave, Epidiolex, and Rylase combined?

[Analyst] (Barclays): Hi, good evening, everyone. Just a couple from me. On Epidiolex, can you comment on the adult opportunity, either quantify it or qualify it? Primarily asking because I'm curious, at most, I thought the primary indications approved were childhood diseases that patients tend to outgrow. And also, when do you expect to see these additional data, and what is the data that you're expecting? Secondly, on the 2024 guide, can you help us understand the double-digit percentage growth that you provided for XYWAV, Epidiolex, and Rylaze combined? Since all three are in different categories, it would be helpful if you could dissect this further. Thanks.

Balaji Prasad: Hi, good evening, everyone. Just a couple from me. On Epidiolex, can you comment on the adult opportunity, either quantify it or qualify it? Primarily asking because I'm curious, at most, I thought the primary indications approved were childhood diseases that patients tend to outgrow. And also, when do you expect to see these additional data, and what is the data that you're expecting? Secondly, on the 2024 guide, can you help us understand the double-digit percentage growth that you provided for XYWAV, Epidiolex, and Rylaze combined? Since all three are in different categories, it would be helpful if you could dissect this further. Thanks.

Balaji V. Prasad: Hi, Good evening, everyone just a couple from me.

Balaji V. Prasad: On <unk> can you comment on the adult opportunity quantify it or quantify it.

Balaji V. Prasad: Primarily asking because I'm curious that most I thought the primary indications appeal their childhood diseases patients tend to outgrow.

Balaji V. Prasad: And also when do you expect to see these additional data and what is the data that you're expecting.

Balaji V. Prasad: Secondly on the 2020 full guide can you help us understand the double digit plus stage growth that you provided for.

Balaji V. Prasad: I've, even heard Alex and Ryan as combined since ultimately it in different categories. It would be helpful. If you could dissect. This further thanks.

Balaji V. Prasad: Secondly, on the 2024 guide, can you help us understand the double-digit per stage growth that you provided for XYWAV, EPIDIOLEX and RYLAZE combined since all 3 are in different categories, it would be helpful if you could dissect this further. Thanks. Yeah, Balaji, on the first part of your question, we often refer to these childhood-onset seizure disorders to point out they're not only childhood disorders; they do persist into adulthood.

Secondly, on the 2024 guide, can you help us understand the double-digit per stage growth that you provided for XYWAV, EPIDIOLEX and RYLAZE combined since all 3 are in different categories, it would be helpful if you could dissect this further. Thanks.

Bruce Cozadd: Yeah, Balaji, on the first part of your question, you know, we often refer to these childhood-onset seizure disorders to point out they're not only childhood disorders. They do persist into adulthood, and we think there's substantial opportunity there that I'm gonna let Renee jump in on if she wants to. But let me also hit the second part of your question and say we're emphasizing the double-digit combined growth of our key growth drivers, XYWAV, Epidiolex and Rylaze, just because we don't provide single product guidance for the year, as you know, and that's not different this year from any other year. That's why we do it on that basis. Obviously, each quarter we're reporting actual results for each of those products. Renee, anything you want to add on adult opportunity for Epidiolex?

Speaker Change: Yeah, but largely on the.

Balaji V. Prasad: On the first part of your question, we often refer to these childhood onset seizure disorders to point out theyre not only childhood disorders. They do persist into adulthood, and we think there's substantial opportunity there.

Bruce C. Cozadd: Yes, Balaji, on the first part of your question, we often refer to these childhood-onset seizure disorders. To point out, they're not only childhood disorders; they do persist into adulthood. And we think there's substantial opportunity there that I'm going to let Renee jump in on if she wants to. But let me also hit the second part of your question and say we are emphasizing the double-digit combined growth of our key growth drivers, XYWAV, EPIDIOLEX, and RYLAZE, just because we don't provide single-product guidance for the year, as you know, and that's not different this year from any other year. That's why we do it on that basis. Obviously, each quarter, we're reporting actual results for each of those products.

Speaker Change: Kind of let Renee jump in on if she wants to but let me also hit the second part of your question and say we.

Bruce C. Cozadd: And we think there's substantial opportunity there that I'm going to let Renee jump in on if she wants to. But let me also hit the second part of your question and say we are emphasizing the double-digit combined growth of our key growth drivers, Zywave, Epidiolex, and Rylase, just because we don't provide single-product guidance for the year, as you know, and that's not different this year from any That's why we do it on that basis.

Speaker Change: Emphasizing the double digit combined growth of our key growth drivers XI wave up of dialects and relays, just because we don't provide.

Bruce C. Cozadd: Single product guidance for the year as you know and that's not different this year from any other year. That's why we do it on that basis, obviously each quarter, we were reporting actual results.

Bruce C. Cozadd: Obviously, each quarter, we're reporting actual results for each of those products. Rene, anything you want to add on the adult opportunity for Epidiolex? Yeah, I'm not sure if we'll quantify it here, Balaji, but I would just say that as we look at the broader growth drivers, we do see the adult population, the long-term care environment, one that is currently underserved with respect to epidiolex, which is weight-based dosing. So you do end up with higher dosages when it comes to that population.

Obviously, each quarter, we're reporting actual results for each of those products.

Rene: Each of those products.

Renee, anything you want to add on the adult opportunity for EPIDIOLEX? Yeah, I'm not sure if we'll quantify it here, Balaji, but I would just say that as we look at the broader growth drivers, we do see the adult population, the long-term care environment, one that is currently underserved with respect to epidiolex, which is weight-based dosing. So you do end up with higher dosages when it comes to that population.

Renee, anything you want to add on the adult opportunity for EPIDIOLEX?

Bruce C. Cozadd: Ray anything you want to add on adult opportunity for <unk>.

Renée Galá: Yeah, I'm not sure if we'll quantify it here, Balaji, but I would just say that as we look at the broader growth drivers, we do see the adult population, the long-term care environment, one that is currently underserved. With respect to Epidiolex, Epidiolex is weight-based dosing, so you do end up with higher dosing when it comes to that population. But at times when you move from an environment of pediatric care into long-term care, there is, I would say, perhaps less attention placed on the actual indication of what the adult has. You would have heard in my prepared remarks, a focus on ensuring that we have the right diagnostic tools....

Renee Gala: Yeah, I'm not sure if we'll quantify it here, Balaji, but I would just say that as we look at the broader growth drivers, we do see the adult population, the long-term care environment, one that is currently underserved. With respect to Epidiolex, Epidiolex is weight-based dosing, so you do end up with higher dosing when it comes to that population. But at times when you move from an environment of pediatric care into long-term care, there is, I would say, perhaps less attention placed on the actual indication of what the adult has. You would have heard in my prepared remarks, a focus on ensuring that we have the right diagnostic tools....

Speaker Change: Yeah, I'm not sure if we'll quantify adhere velocity, but I would just say that as we look at the broader growth drivers. We do see the adult population. The long term care environment. One that is currently underserved with respect to other dialects.

Yes, I'm not sure if we'll quantify it here, Balaji, but I would just say that as we look at the broader growth drivers, we do see the adult population, the long-term care environment, one that is currently underserved. With respect to EPIDIOLEX. EPIDIOLEX is weight-based dosing. So you do end up with higher dosages when it comes to that population. But at times, when you move from an environment of pediatric care into long-term care, there is, I would say, perhaps less attention placed on the actual indication of what the adult has, you would have heard in my prepared remarks, a focus on ensuring that we have the right diagnostic tools with respect to long-term care centers and continuing to ensure whether it's getting the right diagnosis. Or getting to the right level of dosing where you can optimize results or better educating on the combined impact of CLOBAZAM and EPIDIOLEX,

Renee Gala: Yes, I'm not sure if we'll quantify it here, Balaji, but I would just say that as we look at the broader growth drivers, we do see the adult population, the long-term care environment, one that is currently underserved.

With respect to EPIDIOLEX. EPIDIOLEX is weight-based dosing. So you do end up with higher dosages when it comes to that population. But at times, when you move from an environment of pediatric care into long-term care, there is, I would say, perhaps less attention placed on the actual indication of what the adult has, you would have heard in my prepared remarks, a focus on ensuring that we have the right diagnostic tools with respect to long-term care centers and continuing to ensure whether it's getting the right diagnosis, or getting to the right level of dosing where you can optimize results or better educating on the combined impact of CLOBAZAM and EPIDIOLEX, those are all opportunities that we see going forward.

Bruce C. Cozadd: <unk> is weight based dosing.

Bruce C. Cozadd: Do end up with higher dosing when it comes to that population.

Bruce C. Cozadd: But at times when you move from.

Bruce C. Cozadd: An environment of.

Bruce C. Cozadd: But at times, when you move from an environment of pediatric care into long-term care, there is, I would say, perhaps less attention placed on the actual indication of what the adult has. You would have heard in my prepared remarks, a focus on ensuring that we have the right diagnostic tools with respect to long-term care centers and continuing to ensure whether it's getting the right diagnosis. Or getting to the right level of dosing where you can optimize results or better educate patients on the combined impact of Clobizam and Epidiolex.

Bruce C. Cozadd: Pediatric care into long term care.

Bruce C. Cozadd: There is a I would say, perhaps less attention placed on the actual indication of what the adult has you would have.

Bruce C. Cozadd: Heard in my prepared remarks, a focus on ensuring that we have the right diagnostic tools with respect to long term care centers and continuing to ensure whether it's getting the right diagnosis or getting to the right level of dosing, where you can optimize results or better.

Renée Galá: with respect to long-term care centers and continuing to ensure whether it's getting the right diagnosis or getting to the right level of dosing, where you can optimize results or better educating on the combined impact of clobazam and Epidiolex. Those are all opportunities that we see going forward.

Renee Gala: with respect to long-term care centers and continuing to ensure whether it's getting the right diagnosis or getting to the right level of dosing, where you can optimize results or better educating on the combined impact of clobazam and Epidiolex. Those are all opportunities that we see going forward.

Renee Gala: Those are all opportunities that we see going forward. Ladies and gentlemen, that concludes our question and answer session, and I will now turn the call over to Bruce Cozadd for closing remarks. Thanks, Operator. As always, I'd like to close today's call by recognizing our jazz colleagues for their efforts on behalf of patients and their families and thank our partners and shareholders for their continued confidence and support. Thank you all for joining us today. This concludes today's conference call. Thank you for your participation, and you may now disconnect.;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;

Those are all opportunities that we see going forward.

Ladies and gentlemen, that concludes our question and answer session, and I will now turn the call over to Bruce Cozadd for closing remarks. Thanks, Operator. As always, I'd like to close today's call by recognizing our jazz colleagues for their efforts on behalf of patients and their families and thank our partners and shareholders for their continued confidence and support. Thank you all for joining us today. This concludes today's conference call. Thank you for your participation, and you may now disconnect.;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;

Operator: Ladies and gentlemen, that concludes our question and answer session, and I will now turn the call over to Bruce Cozadd for closing remarks.

Thanks, Operator. As always, I'd like to close today's call by recognizing our Jazz colleagues for their efforts on behalf of patients and their families and thank our partners and shareholders for their continued confidence and support. Thank you all for joining us today. This concludes today's conference call. Thank you for your participation, and you may now disconnect.;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;

Bruce C. Cozadd: Thanks, Operator. As always, I'd like to close today's call by recognizing our Jazz colleagues for their efforts on behalf of patients and their families and thank our partners and shareholders for their continued confidence and support. Thank you all for joining us today.

Operator: This concludes today's conference call. Thank you for your participation, and you may now disconnect.

Renee Gala: Educating on the.

Renee Gala: Combined impact of club exam at the dialects.

Bruce C. Cozadd: Those are all opportunities that we see going forward.

Operator: Ladies and gentlemen, that concludes our question and answer session, and I will now turn the call over to Bruce Cozadd for closing remarks.

Bruce C. Cozadd: Ladies and gentlemen that concludes our question and answer session and I will now turn the call over to Bruce <unk> for closing remarks.

Bruce Cozadd: Thanks, operator. As always, I'd like to close today's call by recognizing our Jazz colleagues for their efforts on behalf of patients and their families, and thank our partners and shareholders for their continued confidence and support. Thank you all for joining us today.

Speaker Change: Thanks, operator.

Bruce C. Cozadd: As always I'd like to close today's call by recognizing our jazz colleagues for their efforts on behalf of patients and their families and thank our partners and shareholders for their continued confidence and support. Thank you all for joining us today.

Operator: This concludes today's conference call. Thank you for your participation, and you may now disconnect.

Renee Gala: This concludes today's conference call. Thank you for your participation and you may now disconnect.

Renee Gala: [music].

Renee Gala: Yeah.

Renee Gala: Yes.

Renee Gala: [music].

Renee Gala: Thanks.

Renee Gala: Okay.

Renee Gala: [music].

Renee Gala: Okay.

Renee Gala: [music].

Q1 2024 Jazz Pharmaceuticals PLC Earnings Call

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