Q2 2021 Jazz Pharmaceuticals PLC Earnings Call

Good day and thank you for standing by welcome to the second quarter 2021, the jazz Pharmaceuticals earnings Conference call. At this time all the participants are in a listen only mode.

Operator: Thank you for standing by.

Operator: Welcome to the second quarter.

Operator: 2021 Jazz Pharmaceuticals Earnings Conference Call. At this time, all participants are in a listen-only mode.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1 on your telephone. I am pleased to advise that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Andrea Flynn. Please go ahead.

After the speaker's presentation, there will be a question and answer session jazz.

Ask the question. During this session you will need to press the star 1 on your telephone.

Please be advised the today's conference is being recorded.

If you require any further assistance. Please press star zero I would now like to enhance your conference over to your speaker today Andrea Flynn. Please go ahead.

Andrea Flynn: Thank you and good afternoon everyone. Today, Jazz Pharmaceuticals reported its second quarter 2021 financial results. The slide presentation accompanying this webcast is available in 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, Executive Vice President and Chief Financial Officer, Dan Swisher, President, and Rob Yannone, Executive Vice President of R&D and Chief Medical Officer.

Thank you and good afternoon, everyone today Jazz Pharmaceuticals reported its second quarter 2021 financial results. The slide presentation accompanying this webcast is available on the investors section of our web site 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 <unk>, Chairman and Chief Executive Officer, Renee Gala Executive Vice President and Chief Financial Officer, Dan Swisher, President and Rob You know executive Vice President of R&D, and Chief Medical Officer, Joe Johnson Neuroscience therapeutic head will also join the team for Q&A.

Andrea Flynn: Hill Jochelson, Neuroscience Therapeutic Head, will also join the team for Q&A. 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. We encourage you to review the statements contained in today's press release on slide two and in our latest SEC disclosure document, which identify certain factors that may cause the company's actual event 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 gross 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.

<unk>.

We encourage you to review of the statements contained in today's press release on slide 2 and in our latest SEC disclosure documents, 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.

The update our forward looking statements.

Andrea Flynn: Turning to slide three, on this webcast, we'll discuss non-GAAP financial measures. Reconciliations of GAAP to non-GAAP financial measures are included in today's press release and slide presentation, available on the Investors section of our website. With that, I'll now turn the call over to Bruce.

Turning to slide 3 on this webcast, we'll discuss non-GAAP financial measures reconciliations of GAAP to non-GAAP financial measures are included in today's press release and slide presentation available on the investors section of our website with that I'll now turn the call over to Bruce.

Bruce C. Cozadd: Thanks, Andrea. Good afternoon, everyone, and thank you for joining us today. I'll start on slide five. Looking back at the first half...

Thanks, Andrea good afternoon, everyone and thank you for joining us today I'll start on slide 5.

Looking back at the first half of the year I'm proud of how our team has continued to deliver operational excellence, we accomplish milestones across commercial R&D and corporate development. The collectively are driving our transformation into an innovative high growth Global Biopharma company.

Bruce C. Cozadd: I'm proud of how our team has continued to deliver operational excellence. We accomplish milestones across commercial, R&D, and corporate development that collectively are driving our transformation to an innovative, high-growth, global biopharma. Our recent acquisition of GW Pharmaceuticals, combined with progress across our existing businesses, is foundational to what we expect will be a period of sustained growth for Jazz, underpinned by our ability to deliver on our expanding pipeline and our corporate development as well as by leveraging our substantial commercial prowess and enhanced global footprint.

Our recent acquisition of GW pharmaceuticals.

Bind with progress across our existing business is foundational to what we expect will be a period of sustained growth for jazz underpinned by our ability to deliver on our expanding pipeline and our corporate development activities as well as part of leveraging our substantial commercial prowess and enhanced global footprint.

Bruce C. Cozadd: We continue to be impressed with the superb cultural fit between legacy jazz and GWT, and the successful completion of our integration will only further enhance our ability to innovate and. We are on track for another year of strong financial performance and sequential revenue growth, and for the first time, we expect to exceed $3 billion in annual revenue. But I also want to emphasize the makeup of this revenue.

We continue to be impressed with the superb cultural fit between legacy jazz GW teams and the successful completion of our integration will only further enhance our ability to innovate and execute.

We are on track for another year of strong financial performance and sequential revenue growth and for the first time, we expect to exceed $3 billion in annual revenue.

I also want to emphasize the makeup of this revenue several years ago, we made revenue diversification a key corporate objective with 41 per cent of net product sales in the second quarter from products launched or acquired since 2019, we are well positioned to reach our goal of at least.

Bruce C. Cozadd: Several years ago, we made revenue diversification a key Corporate objective, with 41% of net product sales in the second quarter from products launched or acquired since 2019. We are well positioned to reach our goal of at least 65% of net product sales from these newer products in 2022. And these newer products are not only innovative therapies that address critical needs for patients with neurologic disorders and cancer. They are also durable assets with high growth. In short, jazz has never been stronger.

65 per cent of net product sales from these newer products in 'twenty 'twenty 2.

And these newer products for not only innovative therapies that address critical needs for patients with neurologic disorders and cancer. They are also durable assets with high growth potential in short jazz has never been stronger.

Bruce C. Cozadd: It's particularly striking that we've been able to consistently operate at such a high level while navigating the challenges created by the global pandemic. This was only possible thanks to the dedication and engagement of our teams across Jazz. We are taking the lessons we learned about remote work and collaboration over the past 18 months to redefine the future of work at Jazz. We believe that a purpose-focused culture that delivers innovative therapies to patients.

It's particularly striking that we've been able to consistently execute at such a high level, while navigating the challenges created by the global pandemic.

This was only possible thanks to the dedication and engagement of our teams across jazz.

We are taking the lessons we learned about remote work and collaboration over the past 18 months to redefine the future of work of jazz. We believe that the combination of of purpose focused culture that delivers innovative therapies to patients the opportunity for rewarding professional experiences and of workplace, but at the.

Bruce C. Cozadd: The Opportunity for Rewarding Professional Experience and a workplace that adapts to meet employee expectations regarding flexibility, collaboration, Diversity, and Inclusion will make Jazz an even more attractive place to live, for both our existing teams and top talent across our industry.

<unk> to meet employee expectations regarding flexibility collaboration diversity and inclusion will make jazz an even more attractive place to work for both of our existing teams and top talent across our industry.

Bruce C. Cozadd: I'm not going to address every bullet on slide 5, as Dan, Rob, and Renee will provide greater detail, but I do want to note a few items that are key drivers of our future growth. We successfully closed the GW acquisition in early May, which has strengthened our position as a neuroscience leader with a global commercial and operational footprint. The acquisition is highly complementary to our existing business, further diversifying the commercial products we deliver to patients and adding the exciting GW cannabinoid platform to our R&D portfolio. We have also gained numerous talented colleagues, and Integration Remains a Key Factor.

I'm not going to address every bullet on slide 5 as Dan Robin Renee will provide greater detail, but I do want of note a few items that are key drivers of our future growth.

We successfully closed the GW acquisition in early May which has strengthened our position as of neuroscience leader with the global commercial and operational footprint. The acquisition is highly complementary to our existing business further diversifying the commercial products, we delivered of patients and adding the <unk>.

Exciting GW cannabinoid platform to our R&D portfolio.

We've also gained numerous talented colleagues and integration remains a key focus I'm pleased with our progress to date and we have successfully retained many GW of employees, who are enrolled that are crucial to our continued success the.

Bruce C. Cozadd: I'm pleased with our progress to date, and we have successfully retained many GW employees who are in roles that are crucial to our continued success. The GW acquisition was transformative for our business, and we are excited about the long-term value we believe it will deliver. We are very pleased with strong ZyWave adoption in the second quarter and that the benefits of a lower sodium oxygen are resonating with physicians and patients. It is our view that Zywave, as the only lower sodium oxidate product, will be the oxidate therapy of choice, even after other higher sodium oxidate products are available.

The GW acquisition was transformative for our business and we were excited about the long term value. We believe it will deliver.

We are very pleased with strong XI wave of adoption in the second quarter and that the benefits of of lower sodium ox abate are resonating with physicians and patients. It is our view. The July wave is the only lower sodium oxidate product will be the auction bait therapy of choice even after.

Other higher sodium ochs of based products are available.

Bruce C. Cozadd: We continue to expect that a majority of OxyBates patients across all approved indications will benefit from ZyWave in 2023. Looking ahead, we are preparing for the commercial launch of ZyWave and idiopathic hypersomnia, or IH, later this year pending FDA approval. This would be our fifth product launch since the beginning of 2020, achieving a key company objective while delivering a new treatment option to patients with IH. This hypersomnolence disorder has a profound effect on multiple aspects of daily life, and there currently are no approved therapies to treat IH.

We continue to expect of the majority of oxalate patients across all approved indications will benefit from XI wave in 2023.

Looking ahead, we are preparing for the commercial launch of XI wave in idiopathic hypersomnia or I. H later this year of pending FDA approval. This would be our fifth product launch since the beginning of 2020 achieving of key company objectives, while delivering a new treatment option to patients with IH.

This hypersomnia ones disorder has a profound effect on multiple aspects of daily life and there currently are no approved therapies to treat IH.

Bruce C. Cozadd: Turning to Zep Zelka, we saw strong underlying growth and demand for second-line treatment as we move toward our goal of establishing Zep Zelka as standard of care in that setting. Zapzolka is providing an important therapeutic option for patients with small cell lung cancer, and we are advancing a robust development plan for this therapy, including initiating a phase three trial this year in combination with immunotherapy in first-line small cell lung cancer.

Turning to the Zilkha, we saw strong underlying growth in demand in second line treatment as we move toward our goal of establishing the <unk> standard of care in that setting.

Does that silica is providing an important therapeutic option for patients with small cell lung cancer and we are advancing a robust development plan for this therapy, including initiating a phase III trial. This year in combination with immunotherapy in first line small cell lung cancer.

Bruce C. Cozadd: And continuing with our oncology portfolio, on June 30th, we were pleased to announce FDA approval of Riley, previously referred to as JZP 458 under FDA's real-time oncology review. Riley's became commercially available in July. This is a critical therapy for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who have developed hypersensitivity to E. coli-derived disparities, and we are excited to deliver a high quality therapeutic option with reliable supply to these patients.

And continuing with our oncology portfolio on June 30th we were pleased to announce FDA approval of Rai leases previously referred to as Jay Z P for 58 under F T as real time oncology review.

<unk> became commercially available on July 15th the.

This is of critical therapy for patients with acute lymphoblastic leukemia, and Lymphoblast <expletive> lymphoma, who have developed hypersensitivity to E. Coli derived asparaginase and we're excited to deliver a high quality therapeutic option with reliable supply to these patients.

Bruce C. Cozadd: Together with Zywave, Riley showcases our growing R&D capabilities and demonstrates our ability to bring medicines from concept to commercialization. I'll now turn the call over to Dan for an overview of our commercial performance, after which Rob will provide an update on progress across our R&D program. Rene will close our prepared remarks with a financial overview, and then we'll open the call to Q&A. Thanks, Bruce.

Together with XI wave Riley of showcases our growing R&D capabilities and demonstrates our ability to bring medicines from concept to commercialization.

I'll now turn the call over to Dan for an overview of our commercial performance after which Rob will provide an update on progress across our R&D programs Rene will close our prepared remarks with the financial overview and then we'll open the call to Q&A Dan.

Thanks Bruce.

Daniel N. Swisher: I'm excited to share the progress across our commercial portfolio. I'm going to begin with neuroscience on slide 7. Starting with our combined Oxybate franchise, including Xyrem and Xywave. Net product sales for the Oxybate franchise were $458.3 million, 3% higher than the same period last year. Average active OxyBate patients increased to approximately 15,900 in the quarter, an approximate 5% increase over the same period last year

I'm excited to share the progress across our commercial portfolio I'm going to begin with the neuroscience on slide 7.

Starting with our combined Oxidate franchise, including Xyrem and XI wave.

Net product sales for the oxalate franchise for $4.58.3 million, 3% higher than the same period in 2020.

Average active oxy based patients increased to approximately 15900 in the quarter, an approximate 5% increase over the same period last year.

The strong adoption of XI wave continued through the second quarter with net product sales of $124.2 million, we exited the quarter with approximately 5100 active sideways patients up from approximately 3900 at the end of the first quarter.

Daniel N. Swisher: The strong adoption of ZyWave continued through the second quarter. We exited the quarter with approximately 5,100 active ZyWave patients, up from approximately 3,900 at the end of the first quarter. We remain focused on educating physicians and patients about the lifelong burden of high sodium intake, particularly in a patient population with an increased risk of cardiovascular comorbidities, and that Xi Wave is designed to enable patients to address this modifiable risk factor.

We remain focused on educating physicians and patients about the lifelong burden of high sodium intake, particularly in a patient population with an increased risk of cardiovascular comorbidities.

And that XI wave is designed to enable patients to address this modifiable risk factor.

This messaging is resonating with health care professionals and patients.

And the first 3 quarters since launch we have been successful at educating both high volume Xyrem prescribers and current xyrem patients to facilitate the adoption of XI wave, we are increasing our focus on health care providers, who have either not yet adopted XI wave or who have not transitioned the majority of.

Daniel N. Swisher: This messaging is responding well with health care professionals and patients. In the first three quarters since launch, we have been successful at educating both high-volume Xyrem prescribers and current Xyrem patients to facilitate their adoption of Xywave. We are increasing our focus on healthcare providers who have either not yet adopted Zywave or who have not transitioned the majority of their narcolepsy patients, as well as to oxybate-naive patients. While we anticipate that adoption rates will be slower in these groups compared to early adopters, we continue to make steady progress in expanding the prescriber base, and we've seen a continued preference for Zywave over Zyrum among

They are narcolepsy patients as well as to oxy bait naive patients.

While we anticipate that adoption rates will be slower in these groups compared to early adopters. We continued to make steady progress in expanding the prescriber base and we've seen of continued preference for XI wave over Xyrem among oxy bait naive patients.

We see a significant opportunity to continue to grow XI away of the narcolepsy and as Bruce noted. We are also planning for our fourth quarter commercial launch of XI ways, and idiopathic hypersomnia or IH pending FDA approval and following Rems implementation.

If approved for this additional indication XI of wave would be the first and only therapy indicated to treat IH.

Daniel N. Swisher: We see a significant opportunity to continue to grow ZyWave in narcolepsy, and as Bruce noted, we are also planning for a fourth quarter commercial launch of ZyWave in idiopathic hypersomnia, or IH, pending FDA approval and following REMS implementation. If approved for this additional indication, ZyWave would be the first and only therapy indicated to treat IH. So, as a reminder, the first Xyrem Authorized Generic or AG can enter the market on January 1, 2023 or earlier if triggered by a significant decline in Xyrem revenue.

So as a reminder of the first xyrem authorized generic or a G can enter the market on January 1.2023 or earlier, if triggered by a significant decline in xyrem revenue.

Well, we do not anticipate that this xyrem market acceleration clause will occur in 2021 given.

Given the strength of XI always adoption it could occur earlier than January 1.2023.

This would be of real mark of the success of the XI wave launch, we do have meaningful royalties on net sales of the AG products with the royalty rate increasing during the initial AG term based on increased AG sales.

Daniel N. Swisher: While we do not anticipate that this Xyron Market Acceleration Clause will occur in 2021, given the strength of Zywave adoption, it could occur earlier than January 1, 2023. This would be a real mark of the success of the XiWave launch.

I should note that generic xyrem will only be approved and narcolepsy as there is no data for Xyrem NIH.

Next we're exceptionally pleased to add at the dialects to our neuroscience portfolio with the close of the GW pharma acquisition in May.

The GW team has done a fantastic job on the launch of this product in both the U S and more recently in Europe and the growth. We've seen this quarter was in line with our expectations.

Daniel N. Swisher: We do have meaningful royalties on net sales of the AG products, with the royalty rate increasing during the initial AG term based on increased AG sales. I should note that generic Xyrem will only be approved for narcolepsy as there is no data for Xyrem in IH. Next, we're exceptionally pleased to add Epidiolex to our neuroscience portfolio with the close of the GW Pharma acquisition in May. The GW team has done a fantastic job on the launch of this product in both the U.S. and, more recently, in Europe, and the growth we've seen this quarter was in line with our expectations.

We view at the dialects as the durable product with near term blockbuster potential that addresses a significant unmet need to treat childhood onset of treatment resistant epilepsy.

In our press release today, we announced that we are planning to initiate a pivotal phase III trial of F. The dialogues for the treatment of epilepsy with Myoclonic atonic seizures or email us also known as doses syndrome.

This trial will expand the evaluation of Epidiorite and treating a broad range of seizure disorders, Rob will cover this trial in more detail shortly.

Daniel N. Swisher: We view Epidiolex as a durable product with near-term blockbuster potential that addresses a significant unmet need for the treatment of childhood-onset, treatment-resistant epilepsy. In our press release today, we announced that we are planning to initiate a pivotal Phase III trial of Epidiolex for the treatment of epilepsy with myoclonic atonic seizures, or EMOS, also known as DOSA syndrome. This trial will expand the evaluation of epidiolex in treating a broad range of seizure disorders. Rob will cover this trial in more detail shortly.

We continue to see Epidiorite growth coming from current indications of drove a Lennox gusto and T. S C as well as potential future indications such as email us at.

The dialogue has broad access to date AR has as broad access to date in the U S with more than 97% of all lives covered and there is a high persistency rate for patients who initiate therapy.

In the second quarter jazz recorded net product sales of 1 of $9.5 million for half the dialects.

This represents revenue from the close of the GW transaction on May 5 through the end of the quarter on an unaudited pro forma basis full second quarter net product sales were $1.55.9 million of 32% increase over the same quarter of 2020.

Daniel N. Swisher: We continue to see epidiolic growth coming from current indications of DREVE, Lennox-Gastaut, and TSC, as well as potential future indications such as EMAS. Epidiolex has broad access to date in the U.S., with more than 97% of all lives covered, and there is a high persistency rate for patients who initiate therapy. In the second quarter, Jazz recorded net product sales of $109.5 million for Epidiolex. This represents revenue from the close of the GW transaction on May 5th through the end of the quarter.

As COVID-19 restrictions ease and the U S. We are seeing an upturn in patients visiting their physicians.

Which we believe will drive additional growth of that the dialogues with new patient starts.

In addition, the European launch is progressing well with favorable pricing and access to date and reimbursement in place and for of the 5 largest markets.

Moving to Sanofi second quarter net product sales were $12.1 million of 41% increase over the same period last year.

Daniel N. Swisher: On an unaudited pro forma basis, full second quarter net product sales were $155.9 million, a 32% increase over the same quarter of 2020. As COVID restrictions ease in the U.S., we are seeing an upturn in patients visiting their physicians, which we believe will drive additional growth of epidiolex with new patient starts. In addition, the European launch is progressing well with favorable pricing and access to date, and reimbursement in place in four of the five largest markets. Moving to Synosy, second quarter net product sales were $12.1 million, a 41% increase over the same period last year.

Our expanded and dedicated Sanofi sales force has now had a full quarter in the field Sanofi is highly promotional sensitive and we believe that greater access to clinics and physicians will benefit the brand.

We are also continuing to make strides in our rolling European launch of Sanofi, including securing reimbursement in the key market of Germany.

So now I'm going to turn it over to the turn to the oncology portfolio on slide 8.

We continue to see strong growth in demand for <unk> with net product sales of $55.9 million in the second quarter of 2021 gross in the second line share and overall demand continues to increase in line with our expectations.

The sequential demand growth over the last 2 quarters of 8% and 9% respectively.

While we continue to have strong underlying growth I will note that there was lower sequential growth rate in net sales over the first 2 quarters of 2021. This was mainly the result of reduced inventory holdings by distributors in this early launch period.

Daniel N. Swisher: Our expanded and dedicated Synosy sales force has now had a full quarter in the field. Synosy is highly promotionally sensitive, and we believe that greater access to clinics and physicians will benefit the brand. We are also continuing to make strides in our rolling European launch of CENOSI, including securing reimbursement in the key market of Germany. Now, I'm gonna turn to the oncology portfolio on slide eight. We continue to see strong growth in demand for Zep Zelka with net product sales of $55.9 million in the second quarter of 2021. Growth in the second line share and overall demand continue to increase in line with our expectations, with sequential demand growth over the last two quarters of 8% and 9%, respectively.

We expect that as distributors gain more experience with customer demand levels our growth in net sales will be more closely aligned with the overall demand in future quarters.

As Bruce mentioned <unk>, providing an important therapeutic option for patients with small cell lung cancer, and we're making progress toward our goal of establishing <unk> as standard of care in the second line setting.

Turning to Asparaginase second quarter Irwin Ace net product sales were $28.3 million as previously disclosed we distributed our remaining supply of Irwin <unk> in the second quarter and we have discontinued selling this product.

We're very excited that our internally developed recombinant or linear spirit <unk> therapy or Riley's was approved at the end of June and is now commercially available.

Daniel N. Swisher: While we continue to have strong underlying growth, I will note that there was a lower sequential growth rate in net sales over the first two quarters of 2021. This was mainly the result of reduced inventory holdings by distributors in this early launch period.

Rob will discuss <unk> in more detail shortly.

<unk> net product sales in the second quarter were $31.5 million, an increase of 18% compared to the same period in 2020.

We continue to support the growth of <unk> see us with ongoing development and commercial activities as well as expansion into new International markets. We were pleased to gain the recent approval from health Canada in early July.

Daniel N. Swisher: We expect that as distributors gain more experience with customer demand levels, our growth in net sales will be more closely aligned with overall demand in future quarters. As Bruce mentioned, Xeb-Xelka is providing an important therapeutic option for patients with small cell lung cancer, and we're making progress toward our goal of establishing Xeb-Xelka as standard of care in the second line setting. Turning to asparaginase, second quarter Erwin Ace net product sales were $28.3 million.

For <unk>, we saw second quarter net product sales of $48.1 million. This was an increase of 13% over the same period last year.

So in summary, we remain focused on strong commercial execution across our neuroscience and oncology portfolios. We're excited about the opportunities in front of us, including the launch of <unk>. The anticipated launch of XI wave NIH. The continued rollout of XI wave of narcolepsy.

Daniel N. Swisher: As previously disclosed, we distributed our remaining supply of Erwin Ace in the second quarter, and we have discontinued selling this product. We're very excited that our internally developed recombinant Erwinia asparaginase therapy, or RYLASE, was approved at the end of June and is now commercially available. Rob will discuss RYLASE in more detail shortly.

The growth and development of the Zev Zilkha.

And working with our new colleagues from GW pharma to maximize the opportunity of the Epidiorite ex and realize its blockbuster potential.

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

Thanks, Dan.

I'll start on slide 10, with an important milestone because of all wave.

FCA recently granted orphan drug exclusivity for XI wave of narcolepsy.

Daniel N. Swisher: Vixios net product sales in the second quarter were $31.5 million, an increase of 18% compared to the same period in 2020. We continue to support the growth of Vixios with ongoing development and commercial activities, as well as expansion into new international markets. We were pleased to gain recent approval from Health Canada in early July. For Daffodilio, we saw second quarter net product sales of $48.1 million.

In connection with this.

The E also publish the summary of clinical superiority findings resign wave for the treatment of cataplexy.

Excessive daytime sleepiness in patients 7 years of age and older Narcolepsy I.

By means of greater safety compared to Xyrem.

FCA noted that quote.

<unk> is clinically superior to the Xyrem by means of greater of safety, because the <unk> provide the greater reduced chronic sodium burden compared to xyrem.

And also stated quote the differences in the sodium content of the 2 products at the recommended doses will be clinically meaningful and reducing cardiovascular morbidity and a substantial proportion of patients for whom the drug is indicated.

Daniel N. Swisher: This was an increase of 13% over the same period last year. In summary, we remain focused on strong commercial execution across our neuroscience and oncology portfolios. We're excited about the opportunities in front of us, including the launch of Rylase, the anticipated launch of ZyWave and IH, the continued rollout of ZyWave and Narcolepsy, the growth and development of Zevzelka, and working with our new colleagues from GW Pharma to maximize the opportunity of Epidiolex and realize its blockbuster potential. I'm now going to turn the call over to Rob for an update Thanks, Dan.

We are encouraged that FDA recognized the benefits of reducing sodium and of chronic medication for narcolepsy patients.

And believe FDA summary will be meaningful to both physicians and patients.

Now turning to our neuroscience development program on Slide 11, I'll continue with Xilinx. The highlight that we are less than 2 weeks away from our August 12, due for action date for.

Our supplemental NDA filing with FDA for idiopathic hypersomnia.

Progressing as expected.

We are excited about the potential.

For whom currently no approved therapies.

Robert Iannone: I'll start on slide 10 with an important milestone for Zywik. The FDA recently granted orphan drug exclusivity for Zywave and Narcolepsy in connection with this. FDA also published its summary of clinical superiority findings for Zywave for the treatment of cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy by means of greater safety compared to placebo. FDA noted that, quote, ZyWave is clinically superior to Zyron by means of greater safety because ZyWave provides a greater reduced chronic sodium burden compared to Zyron and also stated, quote, the differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated.

Looking at other opportunities in our neuroscience pipeline I'm very pleased to report.

The integration between our jazz and GW R&D teams is progressing well and the combined organization is collaborating to advance multiple therapies across our neuroscience portfolio, including a number of programs emerging from the GW cannabinoid platform.

And the dialogues is currently approved in 3 of refractory seizure disorders, and we expect to initiate a registrational trial in the fourth.

Couple of FC with my acquired Atonic seizures or email us.

The first half of 2022.

Patients diagnosed with emails.

Also known as those of syndrome.

Experienced generalized myoclonic atonic seizures the.

The onset of the massacres commonly in the first 5 years of life with the mean age of onset being 3 years.

The chart provides the opportunity the study Epidiorite fourth childhood onset epileptic.

Philosophy of it.

The very high unmet need.

Hey, Myles is characterized by generalized micronic atonic seizures and this trial will provide the first randomized controlled clinical data with the epic dialects in the seizure type which.

Robert Iannone: We are encouraged that FDA recognizes the benefits of reducing sodium in a chronic medication for narcolepsy patients and believes its summary will be meaningful to both physicians and patients. Now turning to our Neuroscience Development Program on slide 11, I'll continue with XiWave to highlight that we are less than two weeks away from our August 12th PDUFA action date for our supplemental NDA filing with FDA for idiopathic hypersomnia Progressing as expected, and we're excited about the potential for patients for whom there are currently no approved therapies.

Which we believe will provide a more fulsome view of the potential of effectiveness.

Of the diabetics and treating a broad range of seizure disorders.

We also have a number of other near term pipeline milestones, including the initiation of a third multiple sclerosis related spasticity trial for the mixing malls.

Specificity occurs in up to 84 per cent per se.

<unk> of MS patients and approximately 1 third of those who experienced spasticity live with uncontrolled symptoms.

No new oral anti spasticity medications had been approved in the last 20 years and cash.

Robert Iannone: Looking at other opportunities in our neuroscience pipeline, I'm very pleased to report that the integration between our Jazz and GW R&D teams is progressing well, and the combined organization is collaborating to advance multiple therapies across our neuroscience portfolio, including a number of programs merging from the GW cannabinoid platform. Epidiolex is currently approved in three refractory seizure disorders, and we expect to initiate a registrational trial in a Epilepsy with Myoclonic Atonic Seizures, or EMAS, in the first half of 2022.

Current disease modifying treatment to no evidence in relieving the symptoms.

So we have an opportunity to deliver much needed therapeutic option.

For the multiple sclerosis community.

We are also planning to initiate phase II clinical trials for <unk> 3.5 GBP 150, the central tremor and PTSD, respectively.

We expect to initiate all 3 of these clinical trials this year.

Moving to oncology on slide 12, I'll start with Riley's were GBP 4 of 5.8.

Given the significant need we're very pleased the FDA approved <unk> for.

For the phase 2.3 trial was complete.

We believe the speaks to the need for relates to be available to patients as quickly as possible.

Robert Iannone: Patients Diagnosed with EMI, which is also known as Doza Syndrome, experienced generalized myoclonic atonic seizures. The onset of EMAS occurs commonly in the first five years of life, with the mean age of onset being three years.

Now that <unk> is approved in the U S. We are turning our attention to analyzing additional data from.

From the trial and submitting that information to FDA and other regulatory bodies.

Currently <unk> is approved for intramuscular administration dosed every 48 hours of 25 milligrams per meter squared.

Robert Iannone: The trial provides the opportunity to study epidiolex in a fourth childhood onset epileptic encephalopathy, with a very high unmet need. EMOS is characterized by generalized myoclonic atonic seizures, and this trial will provide the first randomized controlled clinical data with epidiolex in this seizure type, which we believe will provide a more fulsome view of the potential effectiveness. Epidiolex and treating a broad range of seizure disorders. We also have a number of other near-term pipeline milestones, including the initiation of a third multiple sclerosis-related spasticity trial for Naviximol. Spasticity occurs in up to 84% of MS patients, and approximately one third of those who experience spasticity live with uncontrolled symptoms.

We expect to submit.

A supplemental BLA to support of label update to include dosing intramuscularly at 25 milligrams per meter squared.

Day and Wednesday.

<unk> 50 milligrams per meter square and on Friday.

Giving a 2 fold higher dose on Friday resulted in a higher level of 72 hours and hours of news coverage between the Friday and Monday balances.

Our belief is that FCA will continue to move swiftly and its review process for.

Right.

The ongoing trial is also assessing intravenous administration of royalties, which is common in Europe and other geographies, we are continuing to advance our regulatory strategy for <unk>.

Outside of the U S.

We anticipate the data from our current development program will support regulatory filings in Europe in 'twenty 'twenty 2.

In addition, we are working with an in country partner to advance the program filing approval and launch in Japan.

Moving because of the zilkha.

Robert Iannone: No new oral antispasticity medications have been approved in the last 20 years, and Current Disease Modifying Treatments show no evidence of relieving the... So we have an opportunity to deliver a much needed therapeutic option to the Multiple Sclerosis Community. We are also planning to initiate Phase 2 clinical trials for JCP385 and JCP150 in essential tremor and PTSD, respectively. We expect to initiate all three of these clinical trials this year. Moving to oncology, on slide 12, I'll start with Riles or JZP458.

I'll take a few minutes to provide an update on our development plans in small cell lung cancer and other potential indications.

These plans include for trials.

The way for will be initiated in the next 12 months.

After the discussion with the FTA, our partner farmer <unk> plans to initiate a confirmatory trial in second line small cell lung cancer later this year.

This trial is expected to be a 3 arm trial comparing to himself up either as monotherapy or in combination with arena. He can.

Investigator's choice really T cannot cope with the U K.

Composite of this trial would confirm the benefit of the themselves.

For the treatment of small cell lung cancer when patients progressed following first line treatment with the platinum based regimen.

The second trial, which we announced in June of this year is the phase III trial to evaluate first line use the combination when the piece of lives amount for centric as maintenance therapy compared to centric alone.

Robert Iannone: Given the significant need, we're very pleased SBA approved Riley's once the Phase 2-3 trial was complete. We believe this speaks to the need for Riley's to be available to patients as quickly as possible. Now that RILAYS is approved in the U.S., we are turning our attention to analyzing additional data from the trial and submitting that information to FDA and other regulatory bodies. Currently, Riley's is approved for intramuscular administration just every 48 hours at 25 milligrams per meter square.

Patients with extensive stage small cell lung cancer after induction chemotherapy.

While which is expected to initiate later this year this in collaboration with Roche.

I am pleased to announce jazz is also planning to initiate another phase II basket trial in early 2022 to explore efficacy and safety of labor likely the monotherapy in patients with select the advanced or metastatic solid tumors.

Robert Iannone: We expect to submit a Supplemental BLA to support a label update to include dosing intramuscularly at 25 milligrams per meter squared on Monday and Wednesday and 50 milligrams per meter squared on Friday. Giving a two-fold higher dose on Friday results in higher-level, 72-hour asparaginase coverage between the Friday and Monday doses. Our belief is that FDA will continue to move swiftly in its review process for RIDA. The ongoing trial is also assessing the intravenous administration of bryolase, which is common in Europe and other geographies.

Cohorts will include enhanced <unk> filial cancer.

Large cell neuroendocrine tumor of the lung.

And my August recombination deficiency, or HRD positive cancers.

In addition, we have initiated a phase for observational study to collect safety and the outcome data in the real world setting.

Adult patients with extensive stage small cell lung cancer.

The primary objective of this study is to assess the effectiveness of said south of the monotherapy in terms of overall response rate in patients with small cell lung cancer.

Robert Iannone: We are continuing to advance our regulatory strategy for priorities outside of the US and anticipate the data from our current development program will support regulatory filings in Europe in 2022. In addition, we are working with an in-country partner to advance the program for filing approval and launch in Japan. Moving to Zabzalka.

<unk> on or after prior platinum containing chemotherapy the generate additional real world evidence data.

This robust development program will enable us to evaluate the Woodstock in a range of the settings and tumor types with the goal of identifying additional patient populations.

Robert Iannone: I'll take a few minutes to provide an update on our development plans for small cell lung cancer and other potential indications. These plans include four trials that are underway or will be initiated in the next 12 months. After discussion with FDA, our partner PharmaMar plans to initiate a confirmatory trial in second-line small cell lung cancer later this year. This trial is expected to be a three-arm trial comparing Zubzalka either as monotherapy or in combination with a renatecand to the investigator's choice of renatecand or topatecand. If positive, this trial would confirm the benefit of Zipselca in the treatment of small cell lung cancer when patients progress following first-line treatment with a platinum-based regimen.

We benefit from receiving themselves.

Part of their treatment regimen.

Turning to Vic CFS, and our continued effort to deliver our therapies to as many patients as possible and I am pleased to report the mixed sales is now approved in Canada and available to patients.

We're also continuing clinical program to evaluate additional patient populations and indications.

I'll conclude on slide 13.

At the beginning of the presentation Bruce stated that we're making notable progress in our transformation into an innovative high growth Global Biopharma company.

The significant component of that transformation is continuing to enhance our R&D day capable R&D capabilities and productivity.

Robert Iannone: The second trial, which we announced in June of this year, is a Phase III trial to evaluate first-line use in combination with atezolizumab or Ticentric as maintenance therapy compared to Ticentric alone in patients with extensive-stage small cell lung cancer after induction chemotherapy. The trial, which is expected to initiate later this year, is in collaboration with, I'm pleased to announce, Jazz is also planning to initiate another Phase 2 basket trial in early 2022 to explore efficacy and safety of lerbanectin monotherapy in patients with select advanced or metastatic solid tumors. Cohorts will include Advanced Urophelial Cancer Large Cell Neuroendocrine Tumor of the Lung and Homologous Recombination Deficiency, or HRD, positive cancer

Looking across our portfolio.

Slide really highlights the benefit I'm, sorry, the breath of our efforts.

7 mid to late stage trials are underway or will begin within the next 12 months, including 2 registrational trials designed to evaluate new indications for approved therapies.

We are making strategic and science driven investments across the neuroscience and oncology portfolio to deliver therapies to patients.

The GW cannabinoid platform adds exciting new direction for our development efforts.

And we remain focused on having the right talent and resources in place to advance innovative internally developed therapies.

Along with the expertise to identify promising external opportunities.

We are proud of it over the past several years, we have build a sustainable productive R&D engine the jazz the day.

<unk> innovative therapies for patients and also value for the company and its shareholders.

I'll now turn the call over to Rene.

Thanks, Rob.

On today's call I'll highlight several key items from the quarter full financial results are available in our press release and 10-Q.

Outlined on slide 15, our second quarter financial performance demonstrated continued top line revenue growth, including a meaningful and growing contribution from our recently launched and acquired products.

Robert Iannone: In addition, we have initiated a phase four observational study to collect safety and outcome data in the real world setting in adult patients with extensive stage small cell lung cancer. The primary objective of this study is to assess the effectiveness of Zilk and monotherapy in terms of overall response rate in patients with small cell lung cancer who progressed on or after prior platinum-containing chemotherapy to generate additional real world evidence data.

Total revenues in the second quarter were $751.8 million, an increase of 34% compared to the same period in 2020.

This double digit year over year revenue growth was driven by our Oxidate franchise the can.

<unk> success of the soccer and the addition of that the dial ex with the latter 2 clearly demonstrating our ability to put capital to work to build sustainable growth.

Robert Iannone: This robust development program will enable us to evaluate Zipf-Zalc in a range of settings and tumor types with the goal of identifying additional patient populations that can potentially benefit from receiving Zipselka as part of their treatment. Turning to Vixios, in our continued effort to deliver our therapies to as many patients as possible, I am pleased to report that Vixios is now approved in Canada and available to patients.

Consistent with this approach we continue to expect the GW transaction to be accretive in 2022 and substantially accretive thereafter and to provide accelerated double digit topline revenue growth.

We're on track for another year of strong financial performance and sequential revenue growth and we expect to exceed the significant milestone of $3 billion in annual revenue this year.

Robert Iannone: We're also continuing clinical programs to evaluate additional patient populations, and in this case, I'll conclude on slide 13. At the beginning of the presentation, Bruce stated that we're making notable progress in our transformation to an innovative, high-growth, global biopharma. A significant component of that transformation is continuing to enhance our R&D capabilities and productivity. Looking across our portfolio, this slide really highlights the benefit, I'm sorry, the breadth of our effort. Seven mid- to late-stage trials are underway or will begin within the next 12 months, including two registrational trials designed to evaluate new indications for approved. We are making strategic and science-driven investments across the neuroscience and oncology portfolio to deliver therapies to patients.

We've made substantial progress towards our goal of revenue diversification with 41% of net product sales in the second quarter coming from products that have been launched or acquired since 2019, and we're well on track to generate our target of at least 65% of.

Net product sales from these products in 2022.

Adjusted net income for the second quarter was $241 million, an increase of 16% over the same period in 2020.

Coupled with adjusted EPS growth of 5% year over year to $3.90, a share.

Maintaining strong cash generation remains a key focus as well as rapid deleveraging to meet our target of less than 3 and a half times net leverage by the end of 2022.

Robert Iannone: GW Cannabinoid Platform is an exciting new direction for development, and we remain focused on having the right talent and resources in place to advance innovative, internally developed therapies, along with the expertise to identify promising external operators. We are proud that, over the past several years, we have built a sustainable, productive R&D engine at Jazz that delivers innovative therapies for patients and also value for the company and its shareholders. I'll now turn the call over to Rene. Thanks, Rob.

We'll also continue to make disciplined investments to grow the business ink.

Including investments and the ongoing commercial launches of the sideways that soccer and railways.

The growth potential of at the dialects the anticipated launch of die wave NIH, our R&D pipeline and the GW cannabinoid platform.

We provided financial guidance in mid June following the close of the GW acquisition.

Rene D. Gal: On today's call, I'll highlight several key items from the quarter. Full financial results are available in our press release and 10-Q. As discussed on slide 15, our second quarter financial performance demonstrated continued top-line revenue growth, including a meaningful and growing contribution from our recently launched and acquired products. Total revenues in the second quarter were $751.8 million, an increase of 34% compared to the same period in 2020.

On a non-GAAP basis, we are reaffirming that guidance today.

Total revenue guidance is in the range of 3 point of 2 billion to $3, $1.8 billion and non-GAAP. Adjusted EPS is in the range of $13.40 to $14.70 per share.

This guidance includes the addition of GW from the date of closed the year end approximately 8 months.

We have updated our GAAP guidance, primarily to reflect the impact of the U K tax Act, which was enacted in June following our guidance update.

Rene D. Gal: This double-digit, year-over-year revenue growth was driven by our OxyBate franchise, the continuing success of Zepdelka, and the addition of Epidiolex, with the latter two clearly demonstrating our ability to put capital to work to build sustainable growth. Consistent with this approach, we continue to expect the GW transaction to be accretive in 2022 and substantially accretive thereafter, and to provide accelerated double-digit We're on track for another year of strong financial performance and sequential revenue growth, and we expect to exceed the significant milestone of $3 billion in annual revenue this year.

Turning to slide 16, we're pleased to be on track to deliver on the key objectives and milestones outlined for our business.

Our R&D organization continues to evolve and expand its capabilities with the recent FDA approval of reilly's, enabling our fourth new product launch since the beginning of 2020.

With Sideway the IH of approaching its produce the date next week, we are solidly on track to meet our goal of 5 product launches in 2 years.

And we are initiating multiple mid and late stage clinical trials in the next 12 months from both the legacy jazz and GW pipelines.

Rene D. Gal: We've made substantial progress towards our goal of revenue diversification, with 41% of net product sales in the second quarter coming from products that have been launched or acquired since 2019. And we're well on track to generate our target of at least 65% of net product sales from these products in 2022. Adjusted net income for the second quarter was $241 million, an increase of 16% over the same period in 2020, coupled with adjusted EPS growth of 5% year over year to $3.90 a share.

Our commercial teams have demonstrated strong performance on the launches of skywave of narcolepsy and <unk> and we expect that momentum to be carried forward and the launch of Riley and anticipated launch of XI way than IH as well as the continued growth of that the dialogue.

Ex <unk>.

We're pleased with the performance of that the dialects and continue to be impressed with the cultural fit and progress on integration.

Further increasing our confidence in the success of the GW of transaction.

Our disciplined capital allocation has enabled us to expand our pipeline and diversify our revenues and we are well positioned to continue to invest both internally and in our corporate development efforts to drive sustainable long term growth and shareholder value.

Rene D. Gal: Maintaining strong cash generation remains a key focus, as well as rapid deleveraging to meet our target of less than three and a half times net leverage by the end of 2022. We will also continue to make disciplined investments to grow the business, including investments in the ongoing commercial launches of Zywave, Zepselka, and Rileys. The growth potential of Epidiolex

Our transformation to an innovative high growth global biopharmaceutical company is well underway.

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

Rene D. Gal: The Anticipated Launch of Zywave NIH, Our R&D Pipeline, and GW Cannabinoid Plus. We provided financial guidance in mid-June following the close of the GW acquisition. On a non-GAAP basis, we are reaffirming that guidance today. Total Revenue Guidance is in the range of $3.02 billion to $3.18 billion, and Non-GAAP Adjusted EPS is in the range of $13.40 to $14.70 per share. This guidance includes the addition of GW from the date of closure to year end, approximately eight months. We have updated our GAAP guidance primarily to reflect the impact of the UK Tax Act, which was enacted in June following our guidance update.

As a reminder to ask a question you will need to press star 1 on your telephone to withdraw your question press the pound key.

A reminder, callers will be limited to 1 question only.

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

Your first question comes from the line of Ken cash.

<unk> of Cowen and company your line is open.

Oh, hi, Thanks team for the commentary around the generic xyrem and of triggering events just a couple of questions around it is this for all of the the settlements or is it for selected generics and then trying to understand if there are any volume restrictions or is the triggering event.

Rene D. Gal: Turning to slide 16, we're pleased to be on track to deliver on the key objectives and milestones outlined for our business. Our R&D organization continues to evolve and expand its capabilities, with the recent FDA approval of Rylase enabling our fourth new product launch since the beginning of 2020. With Zywave and IH approaching their PDUSA dates next week, we are solidly on track to meet our goal of five product launches in two years. And we are initiating multiple mid and late stage clinical trials in the next 12 months for both the Legacy Jazz and GW.

The limit for unleash all kind of volume restrictions that you may have and then obviously just would like to hear any commentary of how you think this would evolve the marketplace would evolve the language around sideways in the orphan designation clearly incredibly favorable so just trying to get a sense of how you think managed care would have.

The generic optionality with that type of language that the wave has thank you.

Yeah. Thanks, Ken for your question. So again as Dan mentioned in his remarks, we view it as upside if the XI way of launch is going so well that in fact xyrem revenues have dropped to the point that this kicks in but to your specific questions.

Rene D. Gal: Our commercial teams have demonstrated strong performance on

Rene D. Gal: Riley's has shown strong performance in the launches of ZyWave and Narcolepsy and Zepselka, and we expect that momentum to be carried forward in the launch of Riley's and the anticipated launch of ZyWave and IH, as well as the continued growth in Epidiolex. We're pleased with the performance of Epidiolex and continue to be impressed with the cultural fit and progress on integration, further increasing our confidence in the success of the GW transaction. Our disciplined capital allocation has enabled us to expand our pipeline and diversify our revenue. And we are well positioned to continue to invest both internally and in our corporate development efforts to drive sustainable long-term growth and shareholder value. Our transformation to an innovative, high-growth, global biopharmaceutical company is well underway.

That would trigger an earlier launch of the first AG, which is hikma. This.

The other Ags, which are all volume limited as you'll recall too.

Each of our low single digit percentage or a single digit percentage of prior year volume even collectively the 3 volume of limited Ags wouldn't add up to all of that much volume.

Those would track 6 months after hikma. So they are accelerated but not to the same dataset much of a day 6 months later.

And there would be no impact.

Of that acceleration of the AG launches to the generic launches which would be allowable.

As of the beginning of 2026.

So no impact on the volume restrictions 1 of your questions in terms of how the market will evolve.

Rene D. Gal: This concludes our prepared remarks. I'd now like to turn the call over to the operator to open the line for Q&A. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. As a reminder, callers will be limited to one question only. Please stand by while we compile the Q&A roster.

We're very pleased that the availability of a lower sodium product, which we believe is a healthier of lifelong treatment option for patients is being well received by physicians and patients.

And as we said as we look out into 2023, and we pick that year to be a year, where there could be multiple other oxidate products on the market. We still continue to believe sideways would be the dominant brand and have had the most of patients.

Operator: Your first question comes from the line of Ken Casciatori of Cowen & Company. Your line is open.

Ken Casciatori: Hi. Thanks, team, for the commentary around generic Xyrem and triggering events. I have just a couple questions around that.

We've got strong commercial coverage for both Xyrem and Z wave, we don't see that changing in the future.

Ken Casciatori: Is this for all of the settlements, or is it for selected generics? And then trying to understand if there are any volume restrictions or if the triggering event limits or unleashes all kinds of volume restrictions that you may have. And then, obviously, just wanted to hear any commentary on how you think this would evolve, the marketplace would evolve, the language around XyWave and the orphan designation, which is clearly incredibly favorable. So just trying to get a sense of how you think managed care would handle the generic optionality with that type of language that XyWave has. Thank you.

And and again, if you if you can imagine patients being well controlled on the slower sodium product and remember that that lowering as of 92% reduction to move those patients back to a product that would then have more than 10 times the sodium level.

A full up to a full gram and a half or more of extra sodium per night, when it's known that.

Sodium matters in terms of impact on cardiovascular comorbidity, and we know that the narcolepsy population is itself at higher risk on cardiovascular.

Bruce C. Cozadd: Yeah, thanks, Ken, for your question. So again, as Dan mentioned in his remarks, we view it as upside if the ZyWave launch is going so well that, in fact, ZyWave revenues have dropped to the point that this kicks in. But to your specific question, That would trigger an earlier launch of the first AG, which is Hikmas. The other AGs, which are all volume-limited, as you'll recall, to each a low single-digit percentage or a single-digit percentage of prior-year volume, even collectively, the three volume-limited AGs wouldn't add up to all that much volume.

Cardiovascular risk.

Just think that it will be cleared of people the better choice for ongoing therapy.

Great. Thank you.

Your next question comes from the line of Jessica Fye of Jpmorgan. Your line is open.

Hey, guys. Good afternoon, Thanks for taking my question.

1 short 1 so I'm going to try and keep it in the second 1 as well. The first 1 is what was the year over year change in the Octavate revenue bottle volume this quarter and the second 1 is can you frame for investors the reason for either confidence or caution heading into the index small phase III data in Ms Spasticity and he can you provide the timing for the REIT.

Bruce C. Cozadd: Those would track six months after HICMA, so they are accelerated, but not the same data segment to a date six months later, and there would be no impact of that acceleration of the AG launches to generic launches, which would be allowable as of the beginning of 2026. So there would be no impact on the volume restrictions, which is one of your questions.

Out of each of those trials.

So thanks gesture.

1 short and then 1 full question, we'll let you get away with that.

Maybe I could ask Dan to take the first part of your question, which was really around the auction volumes and then perhaps I could have Rob comment around your questions about the mix of malls clinical program Dan Yeah. Thanks Bruce.

Bruce C. Cozadd: In terms of how the market will evolve... You know, we're very pleased that the availability of a lower sodium product, which we believe is a healthier lifelong treatment option for patients, is being well received by physicians and patients. And as we said, as we look out into 2023, and we pick that year to be a year where there could be multiple other Oxybade products on the market, we still continue to believe Zywave would be the dominant brand and have, you know, the most patience. We've got strong commercial coverage for both Xyrem and XyWave.

So I mean, we were very pleased to see that the overall oxidate market share at a 5% year over year increase we referenced that are that.

That our sales were a 3% increase in so you can imagine as we had said with XI wave and as we were ramping up commercial coverage. We wanted to make sure. There was no inability for patients to access therapy. So we had a range of bridging programs. The good news is as we emerged from the second quarter, we have over 80%.

The coverage now and it's continuing to increase and so we expect.

That revenue bottles will be tracking to 2.2 patient growth and you'll see that in the coming quarters.

Bruce C. Cozadd: We don't see that changing in the future. And again, if you can imagine patients being well-controlled on this lower sodium product, and remember that that lowering is a 92% reduction, to move those patients back to a product that would then have more than 10 times the sodium level, you know, up to a full gram and a half or more of extra sodium per night, when it's known that sodium matters in terms of impact on cardiovascular comorbidity, and we know that the You know, we just think that it will be clear to people the better choice for ongoing therapy.

But the but we're not giving specific bottle volume numbers at this point.

Just for this quarter or going forward.

Going forward.

Okay.

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

Hey, just before we go on I think there was the question on the VIX the malls to and Rob If you want to address that that would be great.

Yeah. Thanks for the question, Jeff So we have a comprehensive program for <unk>.

The mix I'm also provide the bridging between the.

The already strong data and a lot of approval in many jurisdictions outside the U S.

That's in MFS 5 studies.

Final court into 2 studies and some of them are already underway and we expect that as the readout.

Operator: Your next question comes from the line of Jessica Fye.

Operator: Jessica Fye of J.P. Morgan said the airline is open.

Potentially the opportunity.

To provide enough breathing data for submission in the U S.

Jessica Fye: Hey guys, good afternoon. Thanks for taking my question.

I don't know that we've given specific timings on the wheat.

Jessica Fye: I have one short one, so I'm going to try and sneak in a second one as well. The first one is, what was the year-over-year change in OxyBate revenue bottle volume this quarter? And the second one is, can you frame for investors the reasons for either confidence or caution heading into VINBIX Model Space 3 data and MS specificity, and can you provide the timing for the readout of each of those trials?

Round the read out of each of those studies.

And just just to follow up we went back and checked all of the language in our Q, which you'll be able to see.

Soon and we did give a revenue bottles of figure of down less than 1%.

Year over year for the quarter across Octavate.

Operator, I think we're gonna go to Jason.

Yes, Hey, guys true.

Jessica Fye: So, thanks, Jess, for your one short and then one full question. We'll let you get away with that. Maybe I could ask Dan to take the first part of your question, which was really around oxybate volumes, and then perhaps I could have Rob comment on your questions about Namixomol's clinical program. Dan?

So I just wanted to follow up on Ken's question actually so Bruce is it your interpretation of the desired way of orphan exclusivity.

That would pertain to.

Essentially blocking approval of any high sodium composition of oxalate or.

Would seem to us that it's exclusive to kind of lower sodium composition since that was the basis of the clinical superiority of finding but I just wanted to.

Bruce C. Cozadd: Yeah, thanks, Bruce. So, Jess, we were very pleased to see that the overall oxybate market showed a 5% year-over-year increase. You know, we referenced that our sales were a 3% increase. And so you can imagine, as we had said with Zywave, and as we were ramping up commercial coverage, we wanted to make sure there was no inability for patients to access therapy. So, we had a range of bridging programs.

The run that by you.

So Jason my understanding is the orphan drug.

Drug exclusivity granted design wave means that no other oxidate product should be approved.

In narcolepsy.

Less FDA determines that it is superior to.

2 of the highway.

Which the FDA can do on a on a variety of measures potentially.

So it was about that interpretation generic and is of high sodium should not be approvable.

I think we're talking about new approvals.

Daniel N. Swisher: The good news is, as we emerge from the second quarter, we have over 80% coverage now, and it's continuing to increase. And so we expect that revenue bottles will be tracking, you know, patient growth, and you'll see that in the coming quarter. But we're not giving specific bottle volume numbers at this point, just for this quarter or going forward. Your next question comes from the line of Jason Gerberry of Bank of America. Your line is open. Hey, just before we go on, I think there was a question about the Bixomals too. And Rob, if you want to address that, that would be great.

So what can we sort of hasn't been down other than existing product.

Right, but I mean, we've only had hikma get approved and they've discontinued I think the approval. So there arent approvals technically of generic and does so I guess all of the others would technically be gated by the voting period.

I I think historically, it's been fda's views at orphan exclusivity does not block approval of generics too.

Our product on the market.

Okay alright, thank you.

Your next question comes from the line of Jeff Hung of Morgan Stanley. Your line is open.

Hi, This is only the central on for Jeff. Thanks for taking our question can.

Can you.

Operator: Yeah, thanks for the question, Jeff. So we have a comprehensive program for Nubixim that will also provide that bridging between the already strong data that allowed approval in many jurisdictions outside the U.S. That's in MS five studies and spinal cord injury two studies, and some of them are already underway. And we expect that as they read out.

What the breakout is of the dialect by indication and kind of what you see as the key growth driver going forward.

And also what kind of impact.

Youre expecting from off label indications. Thank you.

So Dan maybe I'll, let you talk to how the the evolving lawn show that the diodes continues to progress and where we see us coming from now and in the future.

Robert Iannone: They potentially will give us the opportunity to provide enough bridging data for submission. I don't know that we've given specific timings for the readout of each of those studies. And Jess, just to follow up, we went back and checked the language in our queue, which you'll be able to see. Soon, and we did give a revenue bottle of figure of down less than 1% year over year for the quarter across Oxobata. Operator, I think we were going to go to Jason. Yeah, hey guys.

Yeah. Thanks, Bruce so on the on the Epidiorite ex U S launch really pleased with the performance to date and what has been accomplished even in the midst of the COVID-19 pandemic that dampen down some of the new patient starts.

We see continued penetration into the current indications.

And then particular TFC, which was just recently launched in the fall of last year.

The number of patients available, but also higher doses.

Clearly, we see opportunity to go beyond the 3 indications and seizure types into <unk>. So we're excited to move into that area and as we referenced but didn't put a lot of.

Operator: So I just wanted to follow up on Ken's question, actually, Bruce. Is it your interpretation that the thioaborphine exclusivity would pertain to potentially blocking approval of any high sodium composition of Oxabate, or would it seem to us that it's exclusive to a kind of lower sodium composition since that was the basis of the clinical superiority finding? But I just wanted to run that by you. So Jason, my understanding is the orphan drug exclusivity granted to Zywave means that no other Oxybate product should be approved in narcolepsy unless FDA determines that it is superior to uh... tis, which the FDA can do on a variety of measures potentially.

The substance behind it of the European and international rollout continues to progress nicely too.

With recent reimbursement now in 4 of the 5 major European countries. So we also see continued contributions in growth from the international markets going forward.

Your next question comes from the line of David <unk> of Piper Sandler Your line is telephone.

Hi, Thanks, just wanted to continue on the theme.

Theme of epic dialogues.

Can you just talk about what your penetration is in the 3 approved indications even if you can't go into specifics just qualitatively.

What you're seeing and then secondly, how should we think about patient attrition.

Operator: So by that interpretation, generic andas of high sodium should not be approvable. I think we're talking about new..., for which there have been other existing products. Right, but we've only had HICMA get approved, and they've discontinued, I think, their approval. So there aren't any approvals, technically, for generic ANDAs. So I guess all the others wouldn't technically be gated by the ODE period. I think historically it's been FDA's view that orphan exclusivity does not block approval of generics for a product on the market.

Patient attrition rates.

For us the the approved indications or even just overall and do you expect that with the easing of the pandemic.

The Delta Covid notwithstanding the attrition.

Attrition rates.

The might attenuate to some extent with some more greater normalization of of the in office visits if you will maybe help us understand your thought process there. Thanks.

Thanks, David Dan do you want to take that sure. Yes. So persistency is definitely a hallmark of the brand and something we saw both in the diligence and continue to see in the market.

Makes up the dialects.

Jason Matthew Gerberry: Okay. All right. Thank you.

Particularly important in this refractory epilepsy setting is which is the polypharmacy is it's a unique mechanism of action relative to the other anti seizure medicines.

Operator: Your next question comes from the line of Jeff Hung of Morgan Stanley. Your line is open. Hi, this is Melina Santoro on behalf of Jeff.

And we really see it becoming a cornerstone of therapy for those patients and so often.

Operator: Thanks for taking our question. Can you give us what the breakout is for Epidiolex by indication and kind of what you see as the key growth driver going forward? And also, what kind of impact you're expecting from off-label indications? Thank you. So, Dan, maybe I'll let you...

If benefit is being drive from the drug.

It's continued and there may be some tinkering around the edges with other therapies. So.

With or without Covid, we think persistency is going to be a hallmark for the brand.

In terms of the penetration rates I know GW did give a number of last year by indication.

Those are the only numbers kind of out there and that was a single point in time.

Operator: So Dan, maybe I'll let you talk about how the evolving launch of Epidiolex continues to progress and where we see use coming from now and in the future. Yeah, thanks, Bruce.

I think we have an opportunities for going post COVID-19 and seeing patients return to the clinic that an increasing number of patients who will be available to access there is definitely a reluctance to put these.

Daniel N. Swisher: So on the, on the Epidiolex US launch, you know, really pleased with the performance to date and what has been accomplished, you know, even in the midst of the COVID pandemic that dampened down some of the new patient starts. We see continued penetration into the current indications. And in particular, TSC, which was just recently launched in the fall of last year, both the number of patients available but also higher doses. You know, clearly we see opportunity to go beyond the three indications and seizure types into EMOS.

These pediatric kids at risk to Tinker with their medicines, where there could be an ER visit or something else. If it doesn't go quite right. So kind of post COVID-19, we see a lot more opportunity for fine tuning those therapies without that concern.

And since I took the opportunity to clarify 1 of Dan's answers earlier I'm not going to take the opportunity to clarify 1 of my earlier answers and say that when I said that.

The <unk> would be unlikely to block.

And those 2 in the existing approved product I meant to Xyrem.

<unk> block and he and his to XI wave for the period of O'dea exclusivity, which is 7 years from sideways launch date.

Operator.

Daniel N. Swisher: So, you know, we're excited to move into that area. And as we referenced, but didn't put a lot of, you know, substance behind it, the European and international rollout continues to progress nicely, too, with recent reimbursement now in four of the five major European countries. So we also see continued contributions and growth from the international markets going forward.

Your next question comes from the line of Gary Nachman of BMO capital markets Your line of something.

The noon.

Given that it's the way of share of total lots of bit patience has accelerated nicely since launch now youre at about a third of total it sounds like we're reaching a point where that will level out more of perhaps there was some lower hanging fruit with the early adopters like Dan said earlier, so just walk through the next steps of the ramp in more detail of how you play.

Operator: Your next question comes from the line of David Amsellem from Piper Sandler.

Operator: of Piper Chandler, Yerlani. Thanks, just wanted to continue on the, Can you just talk about what your penetration is in the three approved indications, even if you can't go into specifics, just qualitatively what you're seeing? And then secondly, how should we think about patient attrition or patient attrition rates across the approved indications, or even just overall? And do you expect that with the easing of the pandemic, Delta COVID notwithstanding, that attrition rates might attenuate to some extent with some greater normalization of in-office visits? If you will, maybe help us understand your thought process there. Thanks. Thanks, David. Dan, do you want to take that?

To broaden the prescriber base and patients that are the xyrem naive versus switches from Xyrem.

And that was the IH if you get that approval do you think that's kind of further provide a tailwind for the narcolepsy indication as well.

Yeah, Gary Thanks for those questions and you know let me just be clear we think of.

XI wave is the better product for all patients and you know our goal would be.

To make that therapy is available to as many existing ox abate and new ochs of 8 patients as possible.

We're certainly ramping up our efforts as Dan talked about to go after.

Those physicians, who have not yet been as frequent prescribers or for prescribers at all of XI wave to date. So we've got some work to do.

Daniel N. Swisher: Sure. Yeah, so persistency is definitely, you know, a hallmark of the brand and something, you know, we saw both in the diligence and continue to see in the market. You know, it makes up the dialects.

But we're continuing that that effort.

Daniel N. Swisher: Uh, particularly important in this refractory epilepsy setting, which is polypharmacy, is that it has a unique mechanism of action relative to the other anti-seizure medicines. And we really see it becoming a cornerstone of therapy for those patients. And so often, if benefit is being derived from the drug, it's continued, and there may be some tinkering around the edges with other therapies. So with or without COVID, we think persistency is going to be a hallmark for the brand. In terms of penetration rates, I know GW did give a number last year by indication. Yeah, those are the only numbers kind of out there, and that was a single point in time.

You know to try to bring this product to them, maybe I'll, let Dan <unk>.

Comment on your point about whether IH provides any additional impetus moving forward Dan.

Yeah. Thanks, Bruce the I'm very very excited for the IH indication coming up and the physicians have seen the clinical results at some of the recent conferences and.

We've been doing disease education, among physicians and patients and as the only medication available with some outstanding clinical results. We do think that will make a difference.

Crosses offices, including those that may not have the fully adopted XI waves of narcolepsy, yet because this will be the 1 and only approved therapy are the good news is the markets concentrated it's the same physician audience that we're calling upon and so I do think of it 1 is it's an opportunity in and of itself. The 2 it does create.

Bruce C. Cozadd: I think we have an opportunity as we go post-COVID and see patients return to the clinic that an increasing number of patients will be available to access. There's definitely a reluctance to put these pediatric kids at risk to tinker with their medicines where there could be an ER visit or something else if it doesn't go quite right. So, kind of post-COVID, we see a lot more opportunity for fine-tuning those therapies without that concern.

The additional opportunity for interactions with the hcp's, including those that may not have fully embraced the.

As I waited for narcolepsy.

Great. Thank you.

Your next question comes from the line of Annabel Sammy of.

Stifel. Your line is open.

Hi, I had a quick question regarding the biggest malls that you have the phase III.

Bruce C. Cozadd: Since I took the opportunity to clarify one of Dan's answers earlier, I'm now going to take the opportunity to clarify one of my earlier answers and say that when I said that Zywave ODE would be unlikely to block, and those to an existing approved product I meant Xyron, it would block any and those to XyWave for the period of ODE exclusivity, which is seven years from XyWave launch date. Your next question comes from the line of Gary Nachman of BMO...

The study ongoing.

Is the is the goal to get a broad label with this MF study or are you also.

Seeking the Sci do you have to do additional studies there.

And.

When should we be expecting submission of this.

The program and just 1 other question on the books for malls.

You have a study.

There were some plans for PTSD as well, but you have the change of the people and 50 planned for.

Operator: Corporation of BMO Capital Markets, Airline Issue. Good afternoon.

It's true for initiation of the end of this year of coupon on the.

Operator: Good afternoon. Given that XyWave's share of total OxyBase patients has accelerated nicely since launch, now you're at about a third of total, it sounds like we're reaching a point where that will level out more. Perhaps there was some lower-hanging fruit with the early adopters, like Dan said earlier. So just walk through the next steps of the ramp in more detail, how you plan to broaden the prescriber base and patients that are XyWave versus switch from XyWave. I know with IAH. If you get that approval, do you think that's going to further provide a tailwind for the narcolepsy indication as well? Thank you.

The prioritizing the PTSD for him and Petsmart and prioritizing 150.

Thanks, Annabel, Rob let me come to you for the notebook smalls in the PTSD.

Thanks, Bruce So as we mentioned earlier, we have a comprehensive program which reflects.

Input from FDA around how best to bridge from all of the.

I would say of the voluminous data that already existed in support of approvals.

Around the globe, we chose to of study 2 indications in particular and whether ultimately of label would be other than that I think would be determined.

Upon review.

In terms of the earliest that we could possibly submit we do think there's meaningful data that will come out of each of those studies that are planned.

Gary Nachman: Yeah, Gary, thanks for those questions. And, you know, let me just be clear, we think Zywave is the better product for all patients, and you know our goal would be to make that therapy as available to as many existing Oxybate and new Oxybate patients as possible. You know, we're certainly ramping up our efforts, as Dan talked about, to go after those physicians who've not yet been frequent prescribers or prescribers at all of Zywave to date.

And with.

With several ongoing.

And that would mean that currently as possible.

To support an NDA submission could be within the next 1 or 2 years.

And then we haven't provided any details.

On prioritization of PTSD I mean, we are excited to be working in the steel, which where there's really a substantial unmet.

Medical need and now we have several mechanisms within our portfolio of that potentially could address it. So we've discussed the GBP 1.5 O program, but certainly.

We have significant expertise.

Gary Nachman: So we've got some work to do, but we're continuing that effort, you know, to try to bring this product to them. Maybe I'll let Dan comment on your point about whether IH provides any additional impetus moving forward. Dan?

In that space, and we'll be looking to leverage that further.

The 1.5 O program as I mentioned in my earlier remarks.

We're excited to be starting that trial this year.

Okay. Thank you.

Your next question comes from the line of Esther read the value of UBS. Your line is something.

Oh, Thank you for taking my question.

Bruce C. Cozadd: Yeah, thanks, Bruce. Yeah, we're very, very excited for the IH indication coming up, and physicians have seen the clinical results at some of the recent conferences, and we've been doing disease education among physicians and patients. And as the only medication available with some outstanding clinical results, we do think that will make a difference across those offices, including those that may not have fully adopted Zywave and narcolepsy yet, because this will be the one and only approved therapy.

Can you talk about inventory dynamics.

The quarter and also any color you can share on.

What you're seeing with regard to duration of therapy as you're moving more into the second line that would be helpful.

Yeah, So Dan do you want to take the.

Inventory and demand question, and then for Dan or Rob any comments on duration of of Zap topic of therapy.

Sure Yeah with the rapidly.

The rapidly adopted new therapy, it's not unusual for distributors to carry a little bit of excess inventory at the beginning and then as you start to see a little more of the real usage trends and a more consistent pattern of ordering to get them down to a lower level since we can ship.

Bruce C. Cozadd: The good news is the market's concentrated. It's the same physician audience that we're calling upon. And so I do think, one, it's an opportunity in and of itself, but two, it does create additional opportunities for interactions with the HCPs, including those that may not have fully embraced Zywave for narcolepsy.

2 the wholesaler into the clinic pretty quickly. So that's what we're saying is the underlying demand growth is whats relevant the 8.9% growth and that's going to be more reflective. We think of the ex factory growth will be closer to that demand growth. We're focused on of course is.

Daniel N. Swisher: Your next question comes from the line of Annabel Samimy of Stifel. Your line is open.

Operator: Hi, I had a quick question regarding the Bixomol that you have the phase 3 MS spasticity study ongoing for.

Establishing the standard of care.

Do look at monthly chart reviews, and we see continued penetration into all sectors.

Annabel Eva Samimy: Is the goal to get a broad label with this MS study, or are you also...

Of those of.

Annabel Eva Samimy: and the SCI. Do you have to do additional studies there?

Of those parts of second line therapy as you get to the patients who are have better prognosis, particularly platinum sensitive.

Annabel Eva Samimy: And when should we be expecting the submission of this program? And just one other question about Bixomals. You have a study, I guess there were some plans for PTSD as well, but you have JVP 150 planned, Phase 2 for initiation at the end of this year. Do you plan on reprioritizing PTSD in Bixomals and prioritizing 150? Thanks. Thanks, Annabel. Rob, let me come to you for the Nabixomals and the PTSD. Thanks, Bruce.

There is an opportunity to have much longer clinical benefit in more of a therapy.

Exactly the duration of therapy, we need a little more time to see that market mature, but we're happy to see is that the percentage increase in the standard of care in those settings is continuing to increase.

And and excited now for the additional data that will come from the trials that are pending.

Robert Iannone: So, you know, as we mentioned earlier, we have a comprehensive program that reflects input from FDA around how best to bridge from all the, I would say, voluminous data that already existed and supported approvals around the globe. We chose to study two indications in particular, and whether, ultimately, a label would be broader than that, I think would be determined upon review. In terms of the earliest that we could possibly submit, we do think there's meaningful data that will come out of each of those studies that are planned and with several ongoing, and that would mean that the earliest possible time to support an NDA submission could be within the next one or two years. And then we haven't provided any details, you know, on prioritizing PTSD.

Ryan I would just for you.

Of course.

Yeah. Thanks, Bruce I would just reinforce a few things here not speaking to specific data, but just what we're hearing in the field from our medical personnel is that.

What they're seeing as what we saw on clinical trials. So.

Good responses in patients and as Dan mentioned patients who had had initial good response in relapsed tend to do very well on the <unk> itself.

Also the Tolerability of it's been very good and the clinical trial that supported registration had less than 2% drop out due to toxicity and so that's all kinds of favorable tolerability profile can be continued without this continuation for the.

The great majority of the patients.

Until disease progression I would also just take the opportunity to to.

Operator: I mean, we are excited to be working in this field where there's really a substantial medical need, and now we have several mechanisms within our portfolio that potentially could address it. So, we've discussed the JCP 150 program, but, you know, certainly have significant expertise in that space, and we'll be looking to leverage that. The 150 program, as I mentioned in my earlier remarks, we're excited to be starting that trial this year. Your next question comes from the line of Esther Ragavellu of UBS. Your line is open.

To just comment on our excitement around the first line trial that we hope that we plan to initiate later this year. This is first line extensive stage small cell lung cancer, whereas itself will be add on.

To the standard of care and can that line, which includes the lives of Mt.

This gives us the chance to intervene on patients who have minimal residual disease.

Most commonly they do have the residual disease, but the experience of response of some benefits from the initial chemo.

I have to stop the chemo.

Operator: Hey, thank you for taking my question. Jessica, can you talk about the inventory dynamics for this quarter and also any color you can share on what you're seeing with regard to duration of therapy as you're moving more into the second line? That would be helpful.

It's an opportunity to intervene earlier before those patients progress and then off and on.

The difficult situations to initiate a subsequent therapy and were hoping that setting the duration of therapy would be even longer.

Population of patients with <unk>.

Even higher really to extend that period of progression free survival of patients feel well and are experiencing of high quality of life.

Daniel N. Swisher: Yes, so Dan, do you want to take the inventory and demand question and then, for Dan or Rob, any comments on the duration of Zepselcatherapy? Sure. Yeah, with a rapidly adopted new therapy, it's not unusual for distributors to carry a little bit of excess inventory at the beginning and then, as you start to see a little more of the real usage trends and more consistent pattern of ordering, to get them down to a lower level since we can ship product to the wholesaler and to the clinic pretty quickly.

Awesome. Thank you.

Your next question comes from the line of Marc Goodman of SBB Leerink. Your line is open.

The marker either.

Hi can you hear me.

Can you hear me now.

Sorry about that I was wondering if you could comment on cost synergies, where we are.

With respect to how much we've achieved so far what we're thinking about for next year.

And if we found some other places for for some synergies. Thanks.

Renee.

Daniel N. Swisher: So that's what we're saying is the underlying demand growth is what's relevant, the 9% growth, and that's going to be more reflective, we think, of the ex-factory growth will be closer to that demand growth. What we're focused on, of course, is establishing a standard of care. We do look at monthly chart reviews, and we see continued penetration into all sectors of those parts of second-line therapy.

Yeah, Thanks, Bruce and Mark I'm happy to address that so when we announced the transaction, we announced that we expected to achieve about $45 million.

No.

Energy is in the first full year of following the transaction so that would be next year.

We've also started of course that this transaction is really not about cost synergies, but where we are today and as we're looking at 'twenty 'twenty 2 I feel very confident that we'll be able to achieve these synergies and as we've said in the past where we would expect these to come from some of the.

Daniel N. Swisher: As you get to the patients who have better prognosis, particularly platinum-sensitive ones, there's an opportunity to have much longer clinical benefit and more therapy. Exactly the duration of therapy, we need a little more time to see that market mature, but what we're happy to see is that the percentage increase in the standard of care in those settings is continuing to increase, and exciting now for the additional data that will come from the trials that are pending.

Typical overlap between functions that 2 public companies would have but you really wouldn't.

Need to duplicate and bringing them together and as we've been working through our integration.

Daniel N. Swisher: Yeah, I would just reinforce a couple of things... Yeah, thanks, Bruce. I would just reinforce a few things, not speaking to specific data, but just what we're hearing in the field from our medical personnel is that what they're seeing is what we saw in the clinical trial. So good responses in patients, and as Dan mentioned, patients who had an initial good response and relapsed tend to do very well on Zipfelka.

Being able to integrate the teams across the board, we've really had great success at being able to recruit recruit talent ensure that the teams are integrating well that we're able to get our R&D colleagues working together rapidly because we do see.

Good synergies there with respect to the ability to have the teams working together collaborating together and being able to accelerate some of our work on the pipeline side. The big picture, we're in great shape with respect to.

Daniel N. Swisher: Also, the tolerability has been very good, you know, in the clinical trial that supported registration, had less than 2% dropout due to toxicity, and so Zipfelka has a favorable tolerability profile and can be continued without this continuation for the great majority of the patients until disease progression. I would also just take the opportunity to... just comment on our excitement around the first-line trial that we plan to initiate later this year.

Being able to identify our cost synergies and as I as we've stated previously that's unlikely to come from them very much and the in in the tune of employee overlap, it's really more and some of the functional areas that you wouldn't.

Need to for 2 public companies, such as the board of directors and that sort of thing.

So you're basically saying that their G&A was about 45 million of that's what you were taking out of that's about it.

Daniel N. Swisher: This is first-line extensive stage small cell lung cancer, whereas Obcelca will be an add-on to the standard of care in that line, which includes tesolizumab. This gives us a chance to intervene on patients who have minimal residual disease. Most commonly, they do have active residual disease, but they've experienced a response or some benefit from their initial chemo, but have to stop that chemo.

No Mark I know, that's a little that's a little simplistic.

And as Renee said, there are lots of duplicate costs, we don't need.

And are eliminated she gave the example of the board of directors were not going to have 2 Ceos going forward for example.

There are places we can be more efficient as a combined company and essentially we were a growing company continuing to add employees GW is a growing company continuing to add employees, sometimes by putting the companies together, we're going to need to add still need to add employees, but not as many as we each would've needed.

Robert Iannone: It's an opportunity to intervene earlier before those patients progress and then often are in, you know, difficult situations to initiate subsequent therapy. And we hope in that setting, the duration of therapy would be even longer in a population of patients, and it's even higher really to extend that period of progression-free survival where patients feel well and are experiencing high quality. Awesome, thank you. Your next question comes from the line of Mark Goodman of SVV Lyric. Your line is open. Mark, are you there? Hi, can you hear me?

2.

AD.

Individually, so it's savings like that.

Thanks.

Your next question comes from the line of Greg Silvana Day of Goldman Sachs. Your line is open.

Okay.

Great. Good afternoon. Thanks for taking my question it sounds the zilkha and.

I just wanted to revisit.

The growth that youre seeing thus far so.

Operator: Yes, can you hear me now? Sorry about that. I was wondering if you could comment on cost synergies, where we are with respect to how much we've achieved so far, what we're thinking about for next year, and if we've found some other places for some synergies. Rene.

At 8% to 9% quarter over quarter growth over the past several quarters.

Is it fair to assume that has the steady state.

This case assumption, that's what we should be thinking about or perhaps even slightly moderating.

Operator: Yeah, thanks, Bruce. And Mark, I'm happy to address that. So when we announced the transaction, we announced that we expected to achieve about $45 million. We are looking for synergies in the first full year following the transaction. So that would be next year.

As we look over the next several quarters and as a follow up to that when would you suggest.

Just that we consider the potential for any meaningful potential acceleration in net growth dynamic.

Rene D. Gal: We've also said, of course, that this transaction is really not about cost synergies. But where we are today, and as we look at 2022, I feel very confident that we'll be able to achieve those synergies. And as we've said in the past, where we would expect these to come from is some of the typical overlaps between functions that two public companies would have that you really wouldn't need to duplicate in bringing them together.

And if I could sneak in another question just around expectations of around the launch trajectory of of Reillys and how would you suggest we consider modeling at least the initial uptake curve. Thanks, so much.

Yes, so Dan maybe I'll, let you take the.

ZIP Selco gross question first.

Sure Yeah, So I think we still see.

Rene D. Gal: And as we've been working through our integration, being able to integrate the teams across the board, we've really had great success at being able to recruit talent, ensure that the teams are integrating well, that we're able to get our R&D colleagues working together rapidly, because we do see it in the tune of an employee overlap. It's really more in some of the functional areas that you wouldn't need to have for two public companies, such as boards and directors and that sort of thing.

Growth and opportunity for penetration in the second line of course, as we move into the second line.

Patients, who then had prior exposure to <unk>. They go onto the third or fourth line will not be candidates and we did have the at the beginning of the launch of.

Some bolus of patients who are in later lines of therapy. The good news about increasing the yeah. The.

Our rate of adoption of second line is obviously those patients can benefit more from the therapy, particularly as we move into patients with with the more platinum sensitivity.

Bruce C. Cozadd: So you're basically saying that their DNA was about 45 million, and that's what you're taking out, and that's about it. No, Mark, I'd say that's a little simplistic. As Rene said, there are lots of duplicate costs we don't need and are eliminated. She gave the example of the board of directors.

And then even beyond that as we start to get clinical data from the first line study in the real World Studies, It will help give confidence.

To use the drug more broadly.

So that's what I would say is it's a little too early to it we're not giving forward guidance, but we do see continued growth in the brand.

Operator: We're not going to have two CEOs going forward, for example. There are places we can be more efficient as a combined company, and, essentially, we were a growing company continuing to add employees. GW is a growing company continuing to add employees. Sometimes, by putting the companies together, we're going to need to add, still need to add employees, but not as many as we each would have needed to add individually. So it's savings like that.

Going forward.

Yeah on on on Riley's expectations, you know, it's important that we know reestablish confidence in the marketplace that any patient that needs access to honor of winning spirit. After they show hypersensitivity.

The reaction to E coli derived asparaginase can get the product you know as Rob said, we're working to update the label over time with different dosing flexibility.

Operator: Your next question comes from the line of Gregg Silvanave of Goldman Sachs. Your line is open. Great. Good afternoon. Thanks for taking my question. It's about Zipzelka.

Operator: And I just wanted to revisit the growth that you're seeing thus far. So at 8% to 9% quarter over quarter growth over the past several quarters, is it fair to assume that, as a steady state base case assumption, that's what we should be thinking about or perhaps even slightly moderating as we look over the next several quarters? And as a follow-up to that, when would you suggest that we consider the potential for any meaningful potential acceleration in that growth? And if I could sneak in another question just around expectations around the Launch Trajectory of Rylase, and how would you suggest we consider modeling at least the initial uptake curve? Thanks so much.

But really we think we've given people the opportunity not only the treat their patients but to really treat them with the product that was designed to provide the best coverage.

Of active enzyme above threshold levels during the dosing interval that's been of our goal is the best therapy for patients.

We will work to establish that credibility quickly.

We mentioned at the time of launch we had of your supply available. So we want people to know they don't need to worry about it the ordering procedure is easier for railways than it had been with the predecessor product given some of the issues we had the deal with there.

Daniel N. Swisher: Yes. So, Dan, maybe I'll let you take the Zep Zelka growth question first. Sure. Yeah.

The N CCN, adding it so quickly the guidelines for was very helpful to us.

Daniel N. Swisher: So, I think we still see, you know, growth and opportunity for penetration in the second line. Of course, as we move into the second line, patients who have had prior exposure to Zep Zelka, if they go on to third or fourth line, will not be candidates. And we did have, at the beginning of the launch, some bolus of patients who were in later lines of therapy. The good news about increasing the, you know, the rate of adoption in second line is, obviously, those patients can benefit more from the therapy, particularly as we move into patients with more platinum sensitivity.

The partnership during development and their awareness through the clinical trials of where we were.

With cog.

Associated of physicians doing most of the of.

Prescribing for this product all will help.

But we're just getting started we will have more to say over the months to come.

Recall that at the time of our launch there was limited for.

When a supply in the marketplace that is out there now as well for at least a little while so we'll see we believe of transition here as people become aware of the new product.

And what we think are some of the benefits of of the way we developed the product.

Daniel N. Swisher: And then even beyond that, as we start to get clinical data from the first line study and the real world studies, it will help give confidence, you know, to use the drug more broadly. So, that's what I would say.

And it's a high quality and reliable supply.

Anything else you want to add on expectations in the near term.

No I think you covered it well I mean, obviously, we're gonna be supplementing the current indication with additional data as we expand to the Monday Wednesday Friday, IV, and then of course get the product to the market and outside.

Operator: It's a little too early to—we're not giving forward guidance, but, you know, we do see continued growth in the brand going forward. Yeah, on on on Riley's expectations, you know, it's important that we now reestablish confidence in the marketplace that any patient that needs access to Erwinia asparaginase after they show a hypersensitivity reaction to E. coli-derived asparaginase can You know, as Rob said, we're working to update the label over time with different dosing flexibility.

Outside the U S and Europe, Japan, and other regions and some of those regions like Japan, we never had product availability of the or the quality that could support the introduction into those markets.

Okay.

Thanks Sam.

Your next question comes from the line of Greg Fraser Your line is open.

Good afternoon folks thanks for taking my question.

For the physicians, who are not broadly adopted xylene has it been more about hesitancy the switch patients who are stable on xyrem or or some other reasons that you've heard.

Operator: But really, we think we've given people the opportunity, not only to treat their patients, but to really treat them with a product that was designed to provide the best coverage of active enzyme growth threshold levels during the dosing interval.

Dan do you want to take that or.

I mean, it's a little different for for everybody, but you know the new product launches there's obviously.

Slow adopters and faster adopters. The good news is that the faster adopters were high volume.

Prescribers of more associated with the the Kols and aware of the benefits with the O D. E. It's clearly give some win that the sales as we go into offices, including kind of the lower volume offices.

Bruce C. Cozadd: That's been our goal, the best therapy for patients. We will work to establish that credibility quickly. You know, we mentioned at the time of launch that we had a year's supply available, so we want people to know they don't need to worry about it. The ordering procedure is easier for Riley's than it had been with the predecessor product, given some of the issues we had to deal with there.

And then some of these physicians are a little more reluctant to take a stable patient or at least wait till of the patients up for a prescription.

Think as ER physicians are gaining increasing experience and we have these high volume practices, some of which of largely adopted XI wave or they can see the same great efficacy and it's easy to transition the patients dose for dose over and so the peer to peer discussion. We will also be beneficial for penetrating into the office.

Daniel N. Swisher: You know, the NCCN adding it so quickly to guidelines was very helpful to us. COG's partnership during development and their awareness through the clinical trials of where we were, you know, with COG-associated physicians doing most of the prescribing for this product will all help, but we're just getting started. We'll have more to say over the months to come. But you know, recall that at the time of our launch, there was limited Irwinase supply in the marketplace that is out there now as well for at least a little while.

As ware.

<unk> has not yet been adopted or hasn't been fully adopted.

Rob anything you want to add on this 1.

Yes, I would just say from the.

The anecdotes that we're hearing from the medical staff in the field is that.

Daniel N. Swisher: So, we'll see, we believe, a transition here as people become aware of the new product and what we think are some of the benefits of the way we developed the product and its high quality and reliable supply. Dan, anything else you want to add? Expectations in the near term. Now, I think you covered it well. I mean, obviously, we're going to be supplementing the current indication with additional data as we expand to Monday, Wednesday, Friday, IV, and then, of course, get the product to the market and, you know, outside the U.S. and Europe, Japan, and other regions. In some of those regions, like Japan, we never had product availability or the quality that could support the introduction into those markets. Okay, thanks Bruce, thanks Annabel.

There's no issues when they talk to physicians about the importance of lowering sodium in narcolepsy patients for this lifelong therapy, there's a lot of receptivity.

And especially I would say since the granting of Audi and the Fda's statements.

Just really resonating well and it's probably a matter of time.

Great. Thank you.

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

Thanks, I have 2 questions 1 very near term related 1 longer term. So first of kind of near term question next week as you produce the date for sny wave of NIH and I was just curious.

Are you in labeling discussions or have you concluded labeling discussions I assume you are in them are of conclude them can you confirm that and then and then secondly, just the longer term tax rate question.

Operator: Your next question comes from the line of Greg Fraser.

Operator: This question comes from the line of Greg Fraser. Your line is open. Good afternoon, folks. Thanks for taking my questions. For the physicians who have not broadly adopted ZyWave, has it been more about hesitancy to switch patients who are stable on Zyram or some other reasons that you've heard? Dan, do you want to take that? Sure. Yeah.

At the beginning of the year you guided to.

16% to 18% pre GW and upon closing the pretty significant cut in the range of 300 basis points to 13% to 15% at least for this year, obviously that reflects the mix shift to at the dial ex with the U K based tax jurisdiction, but obviously with.

Operator: I mean, it's a little different for everybody, but, you know, new product launches, there are obviously slow adopters and faster adopters. The good news is that the faster adopters were high volume prescribers, more associated with the KOLs, and aware of the benefits. With the ODE, it clearly gives them wind in their sails as we go into offices, including kind of the lower volume offices. And then some of these physicians are a little more reluctant to take a stable patient or at least wait until, you know, the patient's up for a prescription.

XI way of growing rapidly and again, the more favorable tax jurisdiction as well as.

Of the Nols from DW should we assume that the 13% to 15% tax rate as the new normal longer term or were there. Some 1 off just for this year and that that tax rate will be above the 13% to 15% starting next year. Thanks.

Operator: I think as, you know, physicians are gaining increasing experience and we have these high-volume practices, some of which have largely adopted ZyWave, they can see the same great efficacy, and it's easy to transition the patient's dose for dose over. And so the peer-to-peer discussion will also be beneficial for penetrating into offices where ZyWave has not yet been adopted or hasn't been fully Rob, anything you want to add to this?

Yeah.

David I'll take the first part about the.

The Paducah date upcoming and then turn it over to Renee on on tax matters.

As Rob said, we think we're right on track, we're not going to get into and generally don't get into the back and forth with FDA, specifically, but things are progressing the way, we expected and we're looking forward to.

Operator: Yeah, I would just say from the anecdotes that we're hearing from the medical staff in the field, that there are no issues when they talk to physicians about the importance of lowering sodium in narcolepsy patients for this lifelong therapy, there's a lot of receptivity. And especially, I would say, since the granting of ODE and the FDA's statements, just really responding well, and it's probably a matter of time.

Bringing XI wave to patients by age is as soon as we can.

Renee.

Yeah and on the tax side. So we have stated previously that when we look at our future product mix as we continue to diversify this groups of products that we're diversifying into is expected to have the paypal and favorable impact to our ETR.

Operator: Your next question comes from the line of David Steinberg of...

And that's based on a number of factors IP, where product of manufacturer of other impacts related to our business and there was as we shifted from the beginning of the year.

Operator: David Steinberg of Jefferies Irlanis. Thanks.

Operator: I have two questions, one very near-term related and one longer-term. So first, on the near-term question, next week is your PDUFA date for ZyWave and IAH. I'm just curious, are you in labeling discussions, or have you concluded labeling discussions? I assume you are in them or have concluded them. Can you confirm that?

To coming out with our updated guidance in June this shift downward to reflect both the addition of that the dialects and then as we continue to look at that shift into our newer products with those products coming together of those other ones that.

Operator: And then secondly, just a longer-term tax rate question. At the beginning of the year, you guided us to... 13-15% tax rate is the new normal longer term, or were there some one-offs just for this year and that that tax rate will be above that 13-15% starting next year. Yeah, David, I'll take the first part about the, uh...

That carry a more favorable ETR.

And of course, we also continue to look longer term, while we're not going to give a specific range here today.

I would just say going forward as we continue to diversify and we're building that portfolio of future products will continue to look at how we structure of those and the most economically favorable way.

Operator: The PDUFA date is upcoming, and then I'll turn it over to Rene on tax matters. You know, as Rob said, we think we're right on track. We're not going to get into and generally don't get into back and forth with FDA specifically, but things are progressing the way we expected, and we're looking forward to bringing Zywave to patients with IH as soon as we can.

Great. Thanks.

Your next question comes from the line of Blahyi Prasad of Barclays. Your line.

Hi, good afternoon. Thanks for the question.

Just a couple for me firstly on.

Sanofi you Rejig the sales sales team around February March and.

Bruce C. Cozadd: Yeah, and on the tech side, so we have stated previously that when we look at our future product mix, as we continue to diversify, this group of products that we're diversifying into is expected to have a favorable impact on our ETR. And that's based on a number of factors, IP, where the product is manufactured, other impacts related to our business. And there was, as we shifted from the beginning of the year to coming out with our updated guidance in June, this shift downward to reflect both the addition of Epidiolex and then as we continue to look at that shift into our newer products.

And I also commented that the highly promotional and staffs all of the thinking that we would probably see stronger numbers.

But could you maybe take us for the progress achieved in the background on this and also maybe revisit the overall market growth on the longer term out of the trough of 2025.

Sure I'll take a sanofi yes.

Yes. So we are we reformed our field teams and made sure that we've got a dedicated for.

Field team to call upon the Sanofi doctors, and we do think its promotional sensitive and with increasing restrictions getting lifted and more.

Rene D. Gal: with those products coming together, those are the ones that carry a more favorable ETR.

Rene D. Gal: And of course, we also continue to look longer term. While we're not going to give a specific range here today, I would just say going forward, as we continue to diversify and we're building that portfolio of future products, we'll continue to look at how we structure those in the most economically favorable way. Great, thanks. Your next question comes from the line of Balaji Prasad of Barclays. Your line is open. Hi, good afternoon. Thanks for the questions. Just a couple from me. Firstly,

I used the face interaction, we're still below our COVID-19 levels in terms of the percentage of.

In person versus virtual so we're seeing that of continuing to increase them and making sure that there is real the awareness of Sanofi for those physicians, who have adopted it and for patients who have gone on the clinical profile really fits with what we saw in the clinical study.

I think we are seeing sometimes for physicians, who haven't had experienced yet that there is a just the general reluctance or concern about market access.

Operator: Your next question comes from the line of Balaji Prasad of Barclays. Your line is open. Hi, good afternoon. Thanks for the questions.

With new branded therapies and given that we've got very good market access it's something we're trying to address with more in.

Operator: Sure, I'll take Sanosi. Yeah, so we reformed our field teams and made sure that we've got a dedicated field team to call upon the Sanosi doctors. And we do think it's promotionally sensitive, and with increasing restrictions getting lifted and more face-to-face interaction, we're still below COVID levels in terms of the percentage of in-person versus virtual. So we're seeing that continue to increase and making sure that there's real awareness of Sanosi. Yeah, for those physicians who've adopted it, and for patients who've gone on, the clinical profile really fits with what we saw in the clinical study. I think sometimes for physicians who haven't had experience yet, there's just a general reluctance or concern about market access with new branded therapies.

In field education, so overall, 25% prescription growth.

Continue to think that there's room for upside.

Not updating kind of longer term potential, but we do think it's got a sort of meaningful clinical benefits relative to the current wake promoting agents and stimulants that are being used.

Okay, operator, I think that was the last question.

So on the there are no conclude.

Just conclude by saying we remain focused on our key.

<unk> for 2021, and we're excited about the progress of our transformation.

I would say the for 6 months of this year have been of good demonstration of the power of our products our platform and our people and we're looking forward to continuing the momentum I'd like to close today's call by recognizing our jazz colleagues, including those who recently joined us for GW for their creativity commitment and the strong.

Daniel N. Swisher: And given that we've got very good market access, it's something we're trying to address with more in-field education. Overall, 25% prescription growth, we continue to think that there's room for upside. We don't know the kind of longer-term potential, but we do think it has sort of meaningful clinical benefits relative to the current weight-promoting agents and stimulants that are being used.

Sense of urgency the continues to fuel our success I also want to thank our patients partners and shareholders for their continued confidence and support we look forward to speaking with many of you at upcoming fall investor conferences, Thanks, everyone for joining us today and stay well.

Operator: Okay, operator, I think that was the last question, so I'm going to conclude. Just conclude by saying we remain focused on our key objectives for 2021 and we're excited about the progress of our transformation in the first six months.

I will turn the call over to Dan Swisher for closing remarks of smell.

No those were those were the closing remarks, operator, sorry for any confusion, we're all set.

Thank you. So much. This concludes today's conference call. Thank you for participating you may now disconnect.

Bruce C. Cozadd: This year has been a good demonstration of the power of our products, our platform, and our people, and we're looking forward to continuing the momentum. I'd like to close today's call by recognizing our jazz colleagues, including those who recently joined us from GW, for their creativity, commitment, and the strong sense of urgency that continues to fuel our success. I also want to thank our patients, our partners, and shareholders for their continued confidence and support.

Yes.

Okay.

[music].

During the day.

[music].

Bruce C. Cozadd: We look forward to speaking with many of you at upcoming fall investor conferences. Thanks, everyone, for joining us today, and stay well. I will turn the call over to Dan Swisher for the closing remarks. Nope, those were the closing remarks operators. Sorry for any confusion. We're all, Thank you so much. This concludes today's conference call. Thank you for participating. You may now disconnect.

Yes.

Yeah.

Yeah.

[music].

Yes.

Yes.

Okay.

Moving forward.

[music].

Yes.

Operator: © BF-WATCH TV 2021 ??? ???

Yes.

[music].

Okay.

[music].