Q2 2022 Jazz Pharmaceuticals PLC Earnings Call

August 3, 2022

Okay.

Ladies and gentlemen, thank you for standing by and welcome to the second quarter 2022 Jazz Pharmaceuticals earnings call.

Ladies and gentlemen, thank you for standing by and walked through the second quarter 2022 Jazz Pharmaceuticals earnings call. At this time all participants are in a listen only mode. After the speaker's presentation. That's a great question.

At this time, all participants are in a listen-only mode.

After the speaker's presentation, to ask a question during the session, you need to press, star 11 on your telephone.

Question to ask a question during the recession, when you're depressed star one on your telephone.

I would now like to turn the call over to your host, Andrea Flynn, Vice President, Head of Investor Relations.

I'd like to turn the call over to your host Andrea Flynn Vice President head of Investor Relations you may begin.

You may begin.

Thank you and good afternoon, everyone.

Thank you and good afternoon, everyone today Jazz Pharmaceuticals reported its second quarter 2022 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 closed.

Today, Jazz Pharmaceuticals reported its second quarter, 2022 financial results. The slide presentation accompanying this webcast is available on the Investors section of our website.

Investors may also refer to the press release we issued earlier, today, which is also posted on our website.

On the call today are Bruce Kozad, Chairman and Chief Executive Officer, Rene Gala, Executive Vice President and Chief Financial Officer, Dan, Swisher, President, and Rob Unown, Executive Vice President, Global Head of R&D.

It on our website.

On the call today are Bruce <unk>.

Chairman and Chief Executive Officer.

Renee Gala executive Vice President and Chief Financial Officer.

Kim Sablich,

Dan Swisher, President and Rob <unk>.

That gave vice President global head of R&D.

Kim <unk> Executive Vice President and General manager of North America will join the team for Q&A.

Executive Vice President and General Manager, North America, will join the team for Q&A.

On slide two, I'll remind you that today's webcast includes forward-looking statements, such as those related to our future financial and operating results, including expectations related to Vision 2025 and our guidance for 2022, 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.

On slide two I'll remind you that today's webcast includes forward looking statements such as those related to our future financial and operating results, including expectations related to vision 2025, and our guidance for 2022 growth potential and anticipated development and commercialization milestones and goals, which involve risks and uncertainties that could cause.

Actual events.

Foreman and results to differ materially from those contained in these forward looking statements.

We encourage you to review the statements contained in today's press release, in our slide deck, and in our latest SEC disclosure document, which identifies certain factors that may cause a company's actual events, performance, and results to differ materially from those contained in the forward-looking statements made on today's webcast.

We encourage you to review the statements contained in today's press release, and our slide deck and in our latest SEC disclosure document, which identifies certain factors that may cause the company's actual performance.

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.

We undertake no duty or obligation to update our forward looking statements.

Turning to slide three on this webcast, we'll discuss non-GAAP financial measures.

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 in the slide presentation available on the investors section of our website.

Reconciliations of GAAP to non-GAAP financial measures are included in today's press release and in the slide presentation available on the Investors section of our website.

I'll now turn the call over to Bruce.

Thank you Andrea good afternoon, everyone and thank you for joining us today I'll start on slide five we entered 2022 with substantial momentum and our team has continued to make notable advances across our business through the first half of the year, while delivering solid year over year top and bottom line growth in the first.

Thank you, Andrea.

Good, afternoon, everyone, and thank you for joining us today.

And second quarters.

Our productive second quarter reflect meaningful progress towards achieving vision 2025, which we introduced at the beginning of the year. We're pleased with our results in the first half of the year and are confident that we are on track to achieve our full year 2022 guidance, starting with our commercial business. Our Oxidate franchise is performing well and we remain.

I'll start on slide five.

We entered 2022 with substantial momentum, and our team has continued to make notable advances across our business through the first half of the year while delivering solid year-over-year top and bottom line growth in the first and second quarters. Our productive second quarter reflects meaningful progress towards achieving Vision 2025, which we introduced at the beginning of the year.

We're pleased with our results in the first half of the year and are confident that we are on track to achieve our full year 2022 guidance.

Starting with our commercial business, our Oxivate franchise is performing well, and we remain confident in the durability of XiWave, which we believe will be the Oxivate therapy of choice in the market, even following the entry of higher sodium-authorized, generics and potentially branded competition.

And the durability of sideways, which we believe will be the oxalate therapy of choice in the market even following the entry of higher sodium authorized generics and potentially branded competition.

We are pleased to see continued XiWave adoption in narcolepsy and are equally excited about the positive momentum of the launch of XiWave in idiopathic hypersomnia, or IH. There are a growing number of IH patients on XiWave therapy and a high level of engagement and receptivity in the market, all of which is underpinned by strong reimbursement.

We are pleased to see continued sideway or adoption in narcolepsy and are equally excited about the positive momentum of the launch of <unk> in idiopathic hypersomnia or IH.

Our growing number of IH patients on <unk> therapy at a high level of engagement and receptivity in the market all of which is underpinned by strong reimbursement.

Turning to Epidiolex, we continue to expand our prescriber base and are generating real, world evidence and data to further substantiate Epidiolex's broad effect across seizure types.

Turning to <unk>, we continue to expand our prescriber base and are generating real world evidence and data to further substantiate epidiorite as broad effect across seizure types. Our team has done an excellent job of launching the product ex U S and we remain confident we can achieve blockbuster status for <unk>.

Our team has done an excellent job of launching the product Ex-U.S. and we remain confident, we can achieve blockbuster status for Epidiolex.

<unk> remains a treatment of choice in second line small cell lung cancer and a robust development effort is aimed at identifying additional patient populations, who may benefit from therapy.

Xelka remains the treatment of choice in second line small cell lung cancer and our robust, development effort is aimed at identifying additional patient populations who may benefit from therapy.

Rilase has continued its strong launch and we are pleased to be able to deliver the only, therapy available to patients in the U.S. who experience a hypersensitivity reaction to E. coli derived asparaginose.

Riley's has continued its strong launch and we're pleased to be able to deliver the only therapy available to patients in the U S.

Experienced a hypersensitivity reaction to it.

Coli derived asparaginase.

Dan will provide a detailed overview of our performance across our commercial portfolio, later in the call.

Dan will provide a detailed overview of our performance across our commercial portfolio later in the call.

Our R&D team has remained very productive in the first half of 2022 advancing multiple clinical programs. In addition, we were pleased that the FDA cleared the IND application for <unk> hundred five, allowing this program to enter clinical development.

Our R&D team has remained very productive in the first half of 2022, advancing multiple, clinical programs. In addition, we were pleased that FDA cleared the IND application for JCP815, allowing this, program to enter clinical development.

As we highlighted on our last earnings call. We completed in licensing deals to add two new early stage molecules to our pipeline in the second quarter, including JCB $4 41, a potent highly selective orexin two agonist that has the potential to advance the treatment of narcolepsy and other sleep disorders.

As we highlighted on our last earnings call, we completed in-licensing deals to add two, new early stage molecules to our pipeline in the second quarter, including JCP441, a potent, highly selective orexin-2 agonist that has the potential to advance the treatment of narcolepsy and other sleep disorders, and JCP898, a differentiated, conditionally activated interferon-alpha endocrine molecule with the potential to minimize the toxicity associated with systemic interferon-alpha therapy, thereby expanding its clinical utility in treating cancer.

<unk> hundred 98.

Differentiated conditionally activated interferon alpha independent molecule with the potential to minimize the toxicity associated with systemic interferon alpha therapy, thereby expanding its clinical utility in treating cancer.

These transactions demonstrate our commitment to expanding our pipeline and diversifying, our revenue.

These transactions demonstrate our commitment to expanding our pipeline and diversifying our revenue consistent with these objectives. We are prioritizing the medicines in R&D programs, most likely to deliver value to patients and shareholders.

Consistent with these objectives, we are prioritizing the medicines and R&D programs most likely, to deliver value to patients and shareholders.

I'm also pleased to share that we've achieved our deleveraging target two quarters ahead, of our stated timeline, finishing the second quarter with a non-gap net leverage ratio of 3.2.

I'm also pleased to share that we've achieved our deleveraging target two quarters ahead of our stated timeline, finishing the second quarter with a non-GAAP net leverage ratio of three two.

The current macro environment is creating attractive options for corporate development, and our strong balance sheet provides us with flexibility to be active in identifying additional opportunities.

The current macro environment is creating attractive options for corporate development and our strong balance sheet provides us with flexibility to be active in identifying additional opportunities.

Turning to slide six, Vision 2025 provides us with a clear roadmap as we transform our, business and includes three components central to driving sustainable growth and enhanced value, commercial, pipeline, and operational excellence. Starting with commercial, after achieving over $3 billion in revenue in 2021, we're, positioned to grow revenue to $5 billion in 2025 through a combination of existing products as well as potential new therapies emerging from our pipeline and through corporate development.

Turning to slide six vision 2025 provides us with a clear roadmap as we transform our business and includes three components central to driving sustainable growth and enhance value.

Commercial pipeline and operational excellence.

Starting with commercial after achieving over $3 billion in revenue in 2021, we're positioned to grow revenue to $5 billion in 2025 through a combination of existing products as well as potential new therapies emerging from our pipeline and through corporate development.

Our R&D organization continues to advance key programs addressing significant patient, needs in neuroscience and oncology, and we anticipate delivering at least five novel product approvals by the end of the decade through a combination of existing pipeline programs and corporate development.

Our R&D organization continues to advance key programs addressing significant patient needs in neuroscience and oncology and we anticipate delivering at least five novel product approvals by the end of the decade through a combination of existing pipeline programs and corporate development.

And on Operational Excellence, our 2021 Adjusted Operating Margin was 43%, and we plan to improve, that by 5 percentage points from 2021 to 2025, delivering more of our top line through to the bottom line.

And on the operational excellence or <unk>.

2021, adjusted operating margin was 43% and we plan to improve that by five percentage points from 2021% to 2025, delivering more of our top line through to the bottom line.

I'll now turn the call over to Dan for an overview of our second quarter commercial, performance, after which Rob will share an update on the progress of our R&D programs.

I'll now turn the call over to Dan for an overview of our second quarter commercial performance after which Rob will share an update on the progress of our R&D programs.

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

<unk> will provide a financial overview and then we'll open the call to Q&A.

Dan?

Dan.

Thanks, Bruce I am encouraged by the progress we have made across our commercial portfolio in the second quarter.

Thanks, Bruce.

Starting with neuroscience on slide eight we are maintaining positive momentum in our <unk> franchise, continuing the robust launch NIH and driving adoption of XI width and narcolepsy.

With <unk>, we have meaningfully advance patient care with a lower sodium oxidate product.

Rest of our <unk> development efforts with recently highlighted by our presence in June at sleep 2020 to.

36th annual meeting of the associated professional sleep Society.

We and our partners debuted new data from 17 abstracts across narcolepsy NIH.

He was a well attended in person event, providing the opportunity to connect with customers.

And kols to gain valuable insights into their experience with <unk> in both narcolepsy NIH and we came away very encouraged by their feedback.

I'm encouraged by the progress we have made across our commercial portfolio in the second, quarter.

In the second quarter average active Oxford patients increased to approximately 17100.

Starting with neuroscience on slide eight, we are maintaining positive momentum in our, OxyBait franchise, continuing the robust launch in IH, and driving adoption of ZyWave and, Narcolepsy. With ZyWave, we have meaningfully advanced patient care with a lower sodium OxyBait, product. The breadth of our ZyWave development efforts was recently highlighted by our presence in, June at SLEAP 2022, the 36th annual meeting of the Associated Professional SLEAP Society.

An increase of nearly 8% compared to the same period last year.

We and our partners debuted new data from 17 abstracts across Narcolepsy and IH. It was a well-attended in-person event, providing the opportunity to connect with customers, and KOLs to gain valuable insights into their experience with ZyWave in both Narcolepsy and IH. And we came away very encouraged by their feedback.

And the highway for Narcolepsy, we continued to see strong performance in the second quarter, our efforts around educating physicians and patients about the lifelong burden of high sodium intake are resonating.

In the second quarter, average active OxyBait patients increased to approximately 17,100, an increase of nearly 8% compared to the same period last year.

In ZyWave for Narcolepsy, we continue to see strong performance in the second quarter.

We exited the second quarter with approximately 7550 narcolepsy patients taking <unk>.

Our efforts around educating physicians and patients about the lifelong burden of high, sodium intake are resonating.

And we exited the second quarter with approximately 7,550 Narcolepsy patients taking ZyWave. Looking ahead, we expect to see additional adoption of ZyWave from existing XyRM patients. And importantly, the large majority of new to OxyBait Narcolepsy patients are beginning, their therapy with ZyWave.

Looking ahead, we expect to see additional adoption of sideways from existing Xyrem patients and importantly, the large majority of needed to Oxidate narcolepsy patients are beginning their therapy was sideways.

For ZyWave and IH, we remain encouraged by the continued robust launch momentum and positive, feedback from prescribers and the IH community. Actually, in the second quarter, there were approximately 1,150 IH patients taking ZyWave.

For <unk> the NIH, we remain encouraged by the continued robust launch momentum.

And positive feedback from prescribers and the IH community.

Exiting the second quarter, there were approximately 1150 IH patients taking sideways.

We continue to focus on educating prescribers and patients about the compelling efficacy, and established safety profile of the first and only FDA-approved therapy for IH.

We continue to focus on educating prescribers and patients about the compelling efficacy and established safety profile of the first and only FDA approved therapy for IH.

And we are confident in our ability to maximize ZyWave's potential in this underserved market.

And we are confident in our ability to maximize <unk> potential in this underserved market.

We've achieved our goal of obtaining similar coverage to Narcolepsy with approximately, 90% of commercial lives covered.

We've achieved our goal of obtaining similar coverage to narcolepsy with approximately 90% of commercial lives covered.

We're pleased that payers have recognized the value that IH patients can realize from, initiating ZyWave therapy.

Pleased that payers have recognized the value that IH patients can realize from initiating the <unk> therapy.

Patients find our comprehensive and customized support valuable.

And we expect that educational efforts for prescribers and patients will increase, the awareness building this market over time. Stepping back, in each of the last four quarters, our commercial and medical education initiatives, around XyWave have translated into growth of approximately 900 active patients per quarter across both indications, and we achieved a significant milestone in the second quarter with more active OxyBait patients taking XyWave than XyREM.

And we expect that educational efforts for prescribers and patients will increase the awareness building this market over time.

Stepping back in each of the last four quarters, our commercial and medical education initiatives around sideways have translated into growth of approximately 900 active patients per quarter.

Both indications.

And we achieved a significant milestone in the second quarter with more active <unk> patients taking valuation than xyrem.

We have an integrated field sales team that is supporting both narcolepsy NIH.

We have an integrated field sales team that is supporting both narcolepsy and IH across, a concentrated call universe with significant overlap among narcolepsy and IH prescribers. Coupled with orphan drug exclusivity for both indications that extends to 2027 for narcolepsy, and 2028 for IH, as well as Orange Book listed patents that extend out to 2033, we believe, XyWave is well positioned to be a durable product and one of our core growth drivers.

Across our concentrated call universe with significant overlap among narcolepsy NIH prescribers.

Coupled with the orphan drug exclusivity for both indications that extend to 2027 for narcolepsy and 2028 for IH as well as Orange book listed patents that extend out to 2033, we believes that <unk> is well positioned to be a durable product and one of our core growth drivers.

Now turning to slide nine and Thats. The dialects net product sales grew by 12% in the second quarter of 2022.

Now turning to slide nine in Epidiolex, net product sales grew by 12% in the second quarter, of 2022, compared to the same period last year on a pro forma basis, as we continue to add Epidiolex prescribers. As we have previously highlighted, we expect that as new prescribers gain experience with, Epidiolex and see its clinical utility, they will more broadly adopt Epidiolex as a cornerstone therapy for their treatment-resistant patients.

Compared to the same period last year on a pro forma basis.

As we continue to add <unk> prescribers.

As we have previously highlighted we expect that as new prescribers gain experience with <unk> clinical utility they will more broadly adopt epidemics as a cornerstone therapy for their treatment resistant patients.

We are also committed to continuing to generate clinical study data and real world evidence to further support the utility of <unk> across a broad range of difficult to treat seizure types.

We are also committed to continuing to generate clinical study data and real-world evidence, to further support the utility of Epidiolex across a broad range of difficult-to-treat seizure types.

Our commercial team continues to focus on more in person engagement. This is the promotional sensitive market and we are encouraged that our field sales force has experienced increased access to physician offices and treatment centers in recent months.

Our commercial team continues to focus on more in-person engagement.

This is a promotionally sensitive market, and we are encouraged that our field sales, force has experienced increased access to physician offices and treatment centers in recent months.

And we're seeing continued adoption and growth ex U S. We remain on track to gain reimbursement for <unk> in France. This year at which point hepatitis would be launched and reimbursed in all five major European markets.

And we're seeing continued adoption and growth ex-US.

We remain on track to gain reimbursement for Epidiolex in France this year, at which point, Epidiolex will be launched and reimbursed in all five major European markets.

We also have opportunity for additional growth coming from a total of 10 anticipated new, market and indication launches throughout this year.

We also have opportunities for additional growth coming from a total of 10 anticipated new market and indication launches.

Throughout this year.

Given that <unk> unique mechanism of action efficacy and safety profile and the ability to be combined with other therapies. We are confident we can achieve a blockbuster status for <unk>.

Given Epidiolex's unique mechanism of action, efficacy, and safety profile, and ability, to be combined with other therapies, we are confident we can achieve a blockbuster status for Epidiolex as a global standard of care in treatment-resistant epilepsy.

The global standard of care and treatment resistant epilepsy.

Now moving to oncology and starting with <unk> on slide 10.

Now moving to oncology and starting with Zebzelka on slide 10.

Second quarter net product sales were $68.3 million.

Second quarter net product sales were $68 3 million as Bruce highlighted we have rapidly established <unk> as the treatment of choice in second line small cell lung cancer.

As Bruce highlighted, we have rapidly established Zebzelka as the treatment of choice in second-line, small cell lung cancer. To support our efforts to further grow market share in our current indication, we are investing, in additional real-world evidence and observational studies. We believe these data will add to the body of evidence around Zebzelka's positive benefit, risk profile for second-line small cell lung cancer patients and support increased adoption moving forward.

To support our efforts to further grow market share and our current indication we are investing in additional real world evidence and observational studies.

We believe these data will add to the body of evidence around zelle, because positive benefit risk profile for second line small cell lung cancer patients and support increased adoption moving forward.

Also, our robust development plan, which Rob will cover in more depth, has the potential, to identify additional patient populations who could benefit from this therapy.

Also our robust development plan, which Rob will cover in more depth has the potential to identify additional patient populations, who could benefit from this therapy, including treatment of first line small cell lung cancer and other tumor types, providing the opportunity for meaningful future growth.

Including treatment of first-line small cell lung cancer and other tumor types, providing the opportunity for meaningful future growth.

Turning to slide 11, second quarter net product sales for Rylase, our recombinant Erwinia asparaginase therapy, were $73 million. Rylase demand reflects increased brand awareness among customers and its position in the market as the only therapy available to patients in the U.S.

Turning to slide 11 second quarter net product sales for <unk>, our recombinant erwinia asparaginase therapy were $73 million.

Relates demand reflects increased brand awareness among customers and its position in the market is the only therapy available to patients in the U S. We have a hypersensitivity reactions to E coli derived asparaginase.

We have a hypersensitivity reaction to E. coli-derived asparaginase. Customer feedback continues to be positive and prescribers have indicated they are now returning to best clinical practice, switching to non-E. coli-derived asparaginase earlier when there has been an initial hypersensitivity reaction observed.

Customer feedback continues to be positive and prescribers have indicated they are now returning to best clinical practice switch.

Switching to non E coli derived asparaginase earlier when there has been an initial hypersensitivity reaction observed.

This is driven by the product profile, reliable supply of Rylase, and the suite of support services that we provide.

This is driven by the product profile reliable supply of <unk> and the suite of support services that we provide.

Looking ahead, the potential label updates in the U.S. to a Monday, Wednesday, Friday dosing schedule and IV administration have the potential to improve the Rylase experience for clinicians and patients.

Looking ahead, the potential label updates in the U S to a Monday Wednesday, Friday dosing schedule and IV administration that has the potential to improve the relates experience for clinicians and patients.

We've also completed our marketing authorization application or MAA submission to the European Medicines Agency with potential for approval in 2023.

We've also completed our marketing authorization application or MAA submission to the European medicines agency with potential for approval in 2023 now.

Now I will turn the call over to Rob to provide an R&D update.

Now I will turn the call over to Rob to provide an R&D update Rob.

Rob?

Thanks, Dan.

Slide 13 provides an overview of our R&D pipeline.

13 provides an overview of our R&D pipeline.

Looking across the pipeline, we are advancing a number of programs.

Looking across the pipeline.

We're advancing a number of programs with them.

Within neuroscience, we plan to initiate the phase 3 trial for epidiolex and epilepsy with myoclonic atonic seizures shortly. This would add a potential fourth indication to our label and provide the first clinical data on a fourth seizure type, myoclonic atonic seizures.

Neuroscience, we plan to initiate the phase III trial for <unk>.

OFC with my clients.

Seizures shortly.

This would add a potential fourth indication to our label and provide the first clinical data on our fourth seizure type Myoclonic atonic seizures.

We're also planning to initiate a pivotal phase 3 trial for epidiolex in Japan this year that would include DREVE, LGS, and TSC.

We're also planning to initiate a pivotal phase III trial for <unk> in Japan This year.

That would include your Weil Lgs and PSC.

In addition, enrollment in our trials for subacaltamide and JZP150 is ongoing.

Addition enrolled.

Enrollment in our trials for <unk> and <unk> is ongoing.

With respect to our Naviximals program, we announced top-line results from the phase 3 release MSS1 trial in June. The trial did not meet the primary endpoint of change in lower limb muscle tone 6 between baseline and day 21 as measured by the modified ASPR scale.

With respect to an <unk> program.

Topline results from the phase III release, MSS one trial in June .

The trial did not meet the primary endpoint is change in lower limb muscle tone sits between baseline and day 21.

<unk> by the modified Ashworth scale.

The goal of release MSS1 was to have an early look at the effect of Naviximals in patients with MS spasticity, and we continue to assess the trial results. In terms of safety, the profile was consistent with previously reported adverse events with no new safety signals attributable to Naviximals.

The goal of release amongst us one.

Have an early look at the effected in the midst of malls in patients with MF spasticity, and we continue to assess the trial results.

In terms of safety.

Profile was consistent with previously reported adverse events with no new safety signals attributable makes them all.

Moving to oncology, as Dan mentioned, we are advancing a robust development effort for DLIBZELKA for the treatment of lung cancer. This includes an ongoing phase 3 trial supported by JOWS and our partner, Roche, to evaluate DLIBZELKA in combination with Ticentric and first-line extensive stage small cell lung cancer.

Maintain apology as Dan mentioned, we are advancing a robust development airport.

<unk> for the treatment of lung cancer.

This includes an ongoing phase III trials supported by <unk> and our partner Roche.

Valuation and say, okay in combination with the centric first line extensive stage small cell lung cancer.

A confirmatory phase 3 trial and second-line small cell lung cancer being run by our partner, PharmaBot, and our own post-marketing observational trial in second-line small cell lung cancer. We recently presented data from four poster presentations at the ASCO annual meeting, evaluating Zypselka in a range of small cell lung cancer settings.

The confirmatory phase III trial in second line small cell lung cancer being run by our partner finally Maher.

And post marketing observational trial in second line small cell lung cancer.

We recently presented data from four poster presentations at the Ash annual meeting evaluating <unk> in a range of small cell lung cancer settings.

We're also exploring Zypselka and other solid tumors with the initiation of our Phase II BASQA trial, called eMERGE-201, earlier this year. This is a multicenter, open-label trial designed to assess the safety and efficacy of Zypselka as monotherapy, in three cohorts of patients with solid tumors, advanced urothelial carcinoma, large cell neuroendocrine carcinoma of the lung, and HRD tumors that have progressed following a platinum-containing regimen.

We're also exploring <unk> in other solid tumors with the initiation of our phase II basket trial.

Merged to alarm earlier this year.

This is a multicenter open label trial designed to assess the safety and efficacy.

<unk> as monotherapy in three cohorts of patients with solid tumors.

<unk> carcinoma.

Sumner and they couldnt carcinoma of the lung and HRD tumors.

Progress following a platinum containing regimen.

Turning to Rylase, in the second quarter, we completed an MAA submission to the European Medicines Agency, which included Monday, Wednesday, Friday, and every 48-hour dosing schedule, as well as IV and IM administration.

Turning to <unk> in the second quarter, we completed an MAA submission to the European Medicines Agency, which included Monday, Wednesday, Friday and are reporting at our dosing schedules.

Well Ivy and Im administration.

This followed our submission of a supplemental BLA for Rylase in the U.S. To update our label to a Monday, Wednesday, Friday dosing schedule, with patients receiving 25 milligrams per meter squared on Monday and Wednesday and 50 milligrams per meter squared on Friday. This schedule, which is more in line with current clinical practice to avoid weekend dosing, would allow patients to maintain a clinically meaningful level of serum asparaginase activity through the entire duration of treatment. Currently, the label dosing schedule is every 48 hours at 25 milligrams per meter squared. Clinical data using Monday, Wednesday, Friday dosing were presented at the recent ASCO annual meeting.

This solid our submission of a supplemental BLA for <unk> in the U S.

Our label to a Monday Wednesday Friday dosing schedule.

With patients receiving 25 milligrams per meter squared on Monday, Wednesday, and 50 milligrams per meter squared on Friday.

This schedule, which is more in line with the current clinical practice to avoid weekend dosing would allow patients to maintain a clinically meaningful level of serum asparaginase activity through the entire duration of treatment.

Currently the label dosing schedule every 48 hours at 25 milligrams per meter square.

Clinical data using Monday Wednesday, Friday dosing were presented at the recent <unk> annual meeting.

We also completed a separate SBLA to support intravenous dosing. Similar to the review of our original BLA, both the Monday, Wednesday, Friday, IM dosing schedule, and IV formulation SBLAs are being reviewed under the real-time oncology review process.

We also completed a separate SPN eight to support intravenous dosing.

Similar to the review of our original BLA, both the Monday, Wednesday, Friday, and dosing schedule IV formulations SPL as are being reviewed under the real time oncology review process.

In line with our anticipation of multiple INDs through 2023, FDA recently cleared the IND application for JZPA15, our pan-RAF inhibitor, for the treatment of solid tumors that contain mutations in the MAP kinase pathway, which will allow the product to enter clinical development. At the annual AACR meeting in April, we presented preclinical data demonstrating that JZPA15 selectively, and potently inhibits mutant A, B, and C-RAF kinases and also demonstrated robust anti-tumor activity in the RAS and RAF mutant phenograft models.

In line with our anticipation of multiple <unk> through 2023, FDA recently cleared the R&D application for <unk> five our Pan RAF inhibitor.

Treatment of solid tumors continue mutations in the map kinase pathway.

Which will allow the product to enter clinical development.

At the annual ACR meeting in April .

We presented preclinical data demonstrating the GBP eight five selectively and Potently inhibits.

<unk> kinase and <unk>.

Also demonstrated robust anti tumor activity in the Ras mutant geographic models.

Now I will pass the call off to Renee for a financial update.

Now I will pass the call off to Rene for financial update.

Renee?

Thanks, Rob I'll begin on slide 15.

Thanks, Rob.

Our impressive second quarter financial results demonstrate our progress so far in 2022.

I'll begin on slide 15.

We achieved strong top and bottom line growth with second quarter total revenues of $933 million representing growth of 24% compared to the same quarter in 2021.

Our impressive second quarter financial results demonstrate our progress so far in 2022. We achieved strong top and bottom line growth with second quarter total revenues of $933 million, representing growth of 24% compared to the same quarter in 2021. This included Neuroscience Net Product Sales of $697 million and Oncology Net Product Sales of $230 million, representing growth of 20% and 40% respectively, compared to the second quarter of 2021.

This included neuroscience net product sales of $697 million and oncology net product sales of $230 million, representing growth of 20% and 40% respectively compared to the second quarter of 2021.

Importantly, we are on track to meet our 2022 total revenue guidance of $3.5 to $3.7 billion.

Accordingly, we are on track to meet our 2022 total revenue guidance of three five to $3 7 billion.

With respect to operating expenses, we continue to focus on strategic, disciplined use of capital and expect to come in toward the lower end of our full year OPEX guidance ranges.

With respect to operating expenses, we continue to focus on strategic disciplined use of capital and expect to come in toward the lower end of our full year Opex guidance ranges.

Our continued focus on both the top and bottom line drove second quarter adjusted net income of $305 million, a 27% increase compared to the same period in 2021. Adjusted EPS was $4.30 in the second quarter, a 10% increase compared to the same period last year. Excluding the accounting change for convertible debt on a like-for-like basis, adjusted EPS growth would have been 23% compared to the same period in 2021.

Our continued focus on both the top and bottom line second quarter, adjusted net income of $305 million a.

27% increase compared to the same period in 2021.

Adjusted EPS was $4 30.

The second quarter, a 10% increase compared to the same period last year.

Excluding the accounting change for convertible debt on a like for like basis, adjusted EPS growth would have been 23% compared to the same period in 2021.

Based on the results from the first half of the year and our projections for the remainder of the year, we anticipate coming in toward the upper end of our 2022 non-GAAP ANI guidance range of $1.18 to $1.25 billion.

Based on the results from the first half of the year and our projections for the remainder of the year, we anticipate coming in toward the upper end of our 2022, non-GAAP <unk> guidance range of $1, one to $1 billion to $5 billion.

In summary, we're very pleased with our performance year to date.

We are affirming our non-GAAP adjusted guidance and have updated our GAAP guidance primarily to reflect the impact of foreign currency exchange movements on non-U.S. dollar denominated amortization and inventory step-up expense.

We are affirming our non-GAAP adjusted guidance and have updated our GAAP guidance, primarily to reflect the impact of foreign currency exchange movements on non U S. Dollar.

Denominated amortization and inventory step up expense.

Turning to slide 16, we committed to rapid deleveraging following the GW transaction, and I am pleased to report that we have achieved our goal of a net leverage ratio of less than 3.5 on a non-GAAP basis two quarters ahead of our stated timeline. Our non-GAAP net leverage ratio was approximately 3.2 at the end of the second quarter. This achievement has been underpinned by our disciplined capital allocation, focusing on both the top and bottom line, as well as our continued strong cash generation.

Turning to slide 16, we committed to rapid deleveraging following the GW transaction and I am pleased to report that we have achieved our goal of a net leverage ratio of less than three five on a non-GAAP basis.

Two quarters ahead of our stated timeline.

Our non-GAAP net leverage ratio was approximately $3 two at the end of the second quarter.

This achievement has been underpinned by our disciplined capital allocation focusing on both the top and bottom line as well as our continued strong cash generation.

Having achieved our deleveraging target, our focus will continue to be on managing the balance sheet through disciplined capital allocation and leveraging our strong cash flow, which provides us with meaningful flexibility for further corporate development initiatives.

Having achieved our deleveraging target our focus will continue to be on managing the balance sheet through disciplined capital allocation and leveraging our strong cash flow, which provides us with meaningful flexibility for further corporate development initiatives.

Corporate development is a foundational pillar of our strategy to deliver long-term growth and value for both patients and shareholders, and is important to our efforts to achieve Vision 2025. Consistent with that, our corporate development efforts remain focused on diversifying and enhancing our product portfolio and pipeline, leveraging our unique insights in commercial infrastructure, and strengthening the overall sustainability of our business. With our strategic investments, expanding product portfolio, and focus on operational excellence, we believe we are well positioned to achieve Vision 2025 and deliver further diversification, sustainable growth, and enhanced value to patients and shareholders.

Corporate development is a foundational pillar of our strategy to deliver long term growth and value for both patients and shareholders and is important to our efforts to achieve vision 2025.

Consistent with that our corporate development efforts remain focused on diversifying and enhancing our product portfolio and pipeline leveraging our unique insights and commercial infrastructure and strengthening the overall sustainability of our business.

With our strategic investments expanding product portfolio and focus on operational excellence. We believe we are well positioned to achieve vision 2025, and deliver further diversification sustainable growth and enhanced value to patients and shareholders I will now turn the call.

I will now turn the call back to Bruce for final remarks.

Back to Bruce for final remarks.

Thanks, Rene.

Thanks, Renee I'll conclude our prepared remarks on slide 18, we're pleased to be building on the strong momentum we've created over the previous quarters across commercial R&D and corporate development. Despite a challenging period in the biotech sector and global markets in general.

Our commercial efforts, we are focused on execution across our neuroscience and oncology portfolios, including maximizing the lightwave NIH and reilly's launches realizing the blockbuster potential of epic dialects, and continuing to drive adoption of <unk> in narcolepsy and <unk> in small cell lung cancer our R&D.

Team is advancing multiple mid and late stage programs and we expect to submit several <unk> through 2023.

Operational excellence also remains a key area of focus including maximizing our adjusted operating margin, while making strategic investments for future growth.

I'll conclude our prepared remarks on slide 18.

We're pleased to be building on the strong momentum we have created over the previous quarters across commercial, R&D, and corporate development, despite a challenging period in the biotech sector and global markets in general.

In summary, we remain on track to achieve vision 2025, and the affirmation of our top and bottom line guidance for 2022 underscores the confidence we have in our strategy and execution across the business that concludes our prepared remarks I'd now like to turn the call over to the operator to open the line for <unk>.

Q&A.

In summary, we remain on track to achieve Vision 2025, and the affirmation of our top and bottom line guidance for 2022 underscores the confidence we have in our strategy and execution across the business.

Ladies and gentlemen, if you have a question or comment at this time. Please press star one on your telephone we will pause for a moment to compile the Q&A roster.

That concludes our prepared remarks.

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

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

Hey, guys. Good afternoon. Thanks for taking my question now that you've exceeded your net leverage target early should we think of that as unlocking potentially larger business development transactions sooner than 2023.

Thanks for the question Josh.

Really pleased to have achieved this target so quickly through both pay down some debt but also.

<unk> growth and our profitability maybe for implications of this I'll turn it over to Renee for a couple of comments.

Yes, Thanks, Bruce and thanks for the question. So agree yes. This does provide us with greater flexibility with respect to corporate development.

<unk> mentioned the focus not just on paying down debt, but also increasing enhancing our EBITDA gives us greater flexibility because dollar for dollar we're getting more out of that net leverage ratio by improving the EBITDA and going forward. It also gives us greater capacity.

As we look at future targets, we've stated in the past and today on the call that we expect corporate development to be an important pillar for us going forward. Both on the commercial front and then also on the pipeline. So we're excited to be well positioned to continue to execute on that front.

Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone.

Thank you one moment for our next question.

Our next question comes from Marc Goodman with SBB Leerink. Your line is open.

We'll pause for a moment to compile our Q&A roster.

Yes, Hi, can you talk a little bit.

Page 11.

Our first question comes from Jessica Fye with JPMorgan.

11, 50, or they leave patients to date.

<unk>.

Have they used Oxford for these other products.

Just a sense of who these patients are and what they are doing are they dosed once a night or are.

Or are they being dosed twice a night and then just you didn't update the timeline on <unk> next study if you could just do that thanks.

Your line is open.

Yes, Mark let's start with your IH question.

We've said, we're very excited to enter this.

Hey, guys.

This segment, where there's been no FDA approved treatment. We know people have tried things off label historically, primarily at eight stimulates the wake promoting agents despite the relatively small impact on diseases.

Also note that historically there was some attempt to use ox debate to treat IH payer restrictions based that it's fairly uncommon.

Maybe I'll ask Kim to update you a little bit on how the launch is going from a patient acquisition perspective, and any comments she wants to make on the dose and then Rob can.

And to answer your Olympic smallest question Kim.

Good afternoon.

Sure Bruce.

Yeah, we continue to be very pleased with the uptake of the product the first and only FDA approved treatment for IH, we're really encouraged by the robust launch momentum and really especially by the feedback that we're getting from prescribers who are actually utilized.

Thanks for taking my question.

Now that you've exceeded your net leverage target early, should we think of that as unlocking potentially larger business development transactions sooner than 2023?

Thanks for the question, Jess.

You know, really pleased to have achieved this target so quickly through both pay down on some debt, but also, you know, continued growth in our profitability.

Maybe for implications of this, I'll turn it over to Renee for a couple of comments.

Evaluate and Theyre idiopathic hypersomnia patient population our focus today.

Yeah, thanks, Bruce, and thanks for the question.

So, agree, yes, this does provide us with greater flexibility with respect to corporate development. As Bruce mentioned, the focus not just on paying down debt, but also increasing, enhancing our EBITDA gives us greater flexibility because dollar for dollar, we're getting more out of that net leverage ratio by improving our profitability.

In addition to.

Sharing the impressive safety and efficacy profile of <unk> and yet idiopathic hypersomnia. We're also focused on continuing as we did prior to launch to educate prescribers and patients.

So, we're increasing the EBITDA.

And going forward, it also gives us greater capacity as we look at future targets.

We've stated in the past and today on the call that we expect corporate development to be an important pillar for us going forward, both on the commercial front and then also on the pipeline. So, we're excited to be well positioned to continue to execute on that front.

Thank you.

One moment for our next question.

About the disease.

And IH and particularly.

They understand the full breadth of symptoms not just excessive daytime sleepiness.

Our next question comes from Mark Goodman, with SVB Larynx.

So happy that Dan shared two via the places we had planned we are now 90% of commercial lives.

Our covered.

For idiopathic height.

And we are now 90% of commercial lives.

Our covered for.

Or idiopathic hypersomnia.

And I'm pleased with our customers are telling us that this offering.

Your line is open.

Meeting their needs both in terms of the product and the support services that we're offering.

Good morning, ladies and gentlemen, if you have a question of support services that we're offering.

Hi.

Good morning, ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone.

Can you talk a little bit about these IA patients that are 1150, are they naive patients to oxidate?

There was a.

There was a follow up question for Mark just on the timing of the two ongoing mixed small study so mark as you know when we when we last updated on this.

Are they, you know, have they used other products before?

Just give us a sense of who these patients are and what they're doing.

We're experiencing some I would say not unexpected challenges in getting those trials up and running related some logistical issues.

Ongoing pandemic and we're working through those would have some mitigation, but we're putting into place.

But we don't yet have a firm timeline on.

Those two trials at this time.

Then we also ask that you limit yourself to one question one moment for our next question.

Are they being dosed once a night or are they being dosed twice a night?

Great question, Ken Cacciatore Cowen Your line is open.

And then just, you didn't update the timeline on the Nabixamol's next study, if you could just do that.

His team great Great performance I wanted to just drill down a little bit more on the each launch. We are asked often this is bolus that we're seeing are warehoused patients can maybe Bruce or Kevin can you talk about how are we seeing normal demand and to what degree do we think the pace that we've been observing will be consistent or not.

Thanks.

And going forward and can you talk about to the degree in which the sales force is marketing versus still focus on the narcolepsy narcolepsy conversion is this something where the salesforce is indeed marketing aggressively or are we still kind of at a lower level. Then will have as we go forward and then just lastly any.

Yeah, Mark, let's start with your IH question.

You know, we've said we're very excited to enter, this segment where there's been no FDA approved treatment.

We know people have tried things off lately, historically, primarily daytime stimulants, the way promoting agents despite their relatively small impact on disease.

We also know that historically there was some attempt to use oxidate to treat IH, but payer restrictions made that fairly uncommon.

Early view on patient retention I know, it's very early days, but any thoughts on that thanks. So much.

Maybe I'll ask Kim to update you a little bit on how the launch is going from a patient acquisition perspective and any comments she wants to make on the dose.

Yes, Ken Thanks for the questions I'll start and then ask Ken to jump in.

And then Rob can chime in to answer your Nabixamol's question.

We don't think there was any bolus or warehousing of patients.

In any significant way.

Certainly true that there were some.

<unk> out there that were.

Waiting for the launch of the product have seen the strong phase III clinical data.

We saw our approval and we know that our actual launch.

Post stated our approval by a little bit while we completed rems implementation.

So there certainly was some.

Starting point.

If we're getting patients onto therapy.

We don't think of that as a bolus in the way you're suggesting here.

In terms of the pace of adding patients. So I'd just like to remind people are only a couple of quarters.

This launch so probably a little too early for a lot of.

Super accurate trending as.

Dan said in his remarks during the script.

Really pleased to be seeing growth in narcolepsy patients, whether that's patients coming over from xyrem or patients new to oxalate therapy, including newly diagnosed narcolepsy patients or whether they're IH patients getting the benefit of.

Sideways for the treatment of idiopathic hypersomnia.

Really strong growth in the overall <unk>.

Sideways franchise.

Kim?

Maybe Tim could comment on how.

She and the team are balancing our efforts across narcolepsy.

And by age and whether that will change in the future can.

Can add any comments on retention that she'd like.

Sure, Bruce.

Sure Bruce.

So I think as we've shared before this is a very efficient launch for us and that is largely the same base of customers is 90% overlap between.

Those hcp's that we're calling on for narcolepsy, NIH and really to your question kind of how we're balanced in that it is a balancing act, but I can say that we are out there fully supporting.

Both the continued transitions and new patient starts and narcolepsy as well as the launch of IH.

And our teams know that first and foremost you've got to keep the momentum going in narcolepsy, but I can't say that we've got a very strong full effort for.

Both in terms of patient retention.

I don't think we've shared specific numbers, but I would just instead comment and more of the qualitative feedback that we've gotten from HCP in terms of them being very pleased with the product and that they see that its performance and their patients.

Consistent with what they saw in the clinical study.

Thank you one of them before our next question.

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

Oh, Hey, guys. Thanks for taking my question.

Wanted to just drill in on a per dialects. If you can talk a little bit about <unk>.

These enhanced marketing efforts, it's going to be more more of a second half driven benefit and as we think about the performance. This quarter. Just curious are we seeing meaningful first time contribution ex U S. The U.

Growth is perhaps even lower than what was the overall reported number just wondering if you could help us sort of figure out like what's going on now and some of the marketing initiatives is the thinking about second half. Thanks.

Yes, Dan maybe I could ask you to jump in on F&I, Alex just globally, including the rollout ex U S. In recent quarters.

Sure Yes.

I mean, we're very pleased to see the growth and continue to.

Hear great feedback from the increase in prescriber base in the U S and the persistence remains strong and we saw.

Said this in the past that it is a promotional sensitive product and importantly, our field force is.

Increase in the level of face to face engagement.

Which is really important, especially for the smaller offices and the prescribers, who haven't had experience or much experience without the dialogues to move it more broadly into their treatment resistant epilepsy, yes regarding the ex U S. We don't breakout the sales but it.

We always view it as a meaningful growth driver to the overall franchise as a global brand.

Did reference that we've got 10.

New market and indication launches.

A couple of them have have already gone with Norway, and Ireland are successful to plan six indication launches and you still got a number of countries pending, especially France, which would be the last of the big the big countries. So.

Yes, so we're very confident about achieving ultimately the blockbuster status as a cornerstone of treatment resistant epilepsy.

Thank you one of them are for our next question.

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

Hi, Thanks for taking my question and congratulation on a good quarter.

Can you maybe just talk about the competitive dynamic you are seeing for new patient starts with narcolepsy.

It was a strong quarter on your part from new patient adds it looks like we saw a competitor out with a report strong new patient add so can you just elaborate a little bit on the market is this just sort of a normal step up post the <unk> headwind, yes, it's Brian .

Earlier this year or is it maybe just a bit more of a durable interest in the branded narcolepsy space given you have two branded competitors promoting aging.

Maybe just any commentary on in terms of getting in front of physicians and patients. Thank you.

Yes, Brandon.

I would say, we couldnt be more happy with the continued growth.

Sideways.

In narcolepsy as well as Joey these past quarters, but just the number of patients on therapy.

It's very gratifying, we think some of that is because we've come along with a truly differentiated.

<unk> product due to the low sodium with FDA has worked from drug exclusivity finding clinical superiority on the basis of safety because of this very large reduction in.

Nightly sodium intake in a chronic disease, where we know this patient population is at significant risk.

Vascular comorbidities.

Really got something that I think is attracting both.

<unk> xyrem obligations, but also potentially new patients.

Just generally true.

That ox of eight patients are on.

Not in all cases are generally true, but they are on the other regions.

Often ours are aging mistaken at night.

There are other daytime agents are taking them I think.

You referred to propose Hans falls into that category of the daytime treatment, but also having new patients.

So patients experiment with combinations that makes sense for them, but.

We've continued to see the kind of excellent growth, we've really wanted to see.

Again across existing oxalate patients and new OXXO vacations.

Thank you one moment for our next question.

Our next question comes from David <unk> with Piper Sandler Your line is open.

Hey, Thanks, So I wanted to drill down a little more.

About IH and I apologize if I missed this but in terms of I H.

Are these patients many diagnoses.

We're now getting treatment.

Or are these patients already been on wakefulness promoting agents like modafinil.

And then as a corollary to that question do you think that with the availability.

So that way, if youre going to Youre seeing more diagnoses in general.

Can you comment on that as well thanks.

Yes, David maybe I'll start with a broad picture and then let Tim go to a more current strategy broadly we do think the availability.

Yeah, we continue to be very pleased with the uptake of this product and first and, only, you know, FDA approved treatment for IH.

The first ever approved FDA and FDA approved agent NIH may well spur more diagnosis going forward.

It's often case often the case that when there is a reward for diagnosis and that it unlocks a treatment option and it unlocks reimbursement for a treatment option youll see doctors.

Move all the way to true diagnosis, where otherwise they might not but in terms of our current strategy for <unk>.

Penetrating the IH space, maybe I'll, let him make a few remarks.

You know, we're really encouraged by the robust launch momentum and really especially by the feedback that we're getting from prescribers who have actually utilized Zywave in their idiopathic hypersomnia patient population.

Yeah sure. So we've got a really nice sized market of diagnosed patients to go after and we're focusing our initial launch I think as we've said several times.

Our focus today, you know, remains in addition to sharing the impressive safety and efficacy profile of Zywave in the idiopathic hypersomnia.

Not only on our existing fleet call universe, but also on the 37000 adult patients who already not only have a formal diagnosis of idiopathic hypersomnia, but we're also in the health care system. We can see actively seeking health care. So that's why our strategy is really much more focused on.

Encouraging HCP to get appropriate patients started on <unk>.

What we really have a three pronged approach out there in the marketplace right now as I mentioned earlier, we're continuing our efforts to improve general understanding of the disease idiopathic hypersomnia, particularly as it relates to the breadth of patient symptoms experience given that we have a very broad indication.

We're also focused on continuing as we did prior to launch to educate prescribers and patients about the disease itself and IH and particularly ensuring they understand the full breadth of symptoms, not just excessive daytime sleepiness.

We're also happy, as Dan shared, to be at a place as we had planned where now 90 percent of commercial lives are covered for idiopathic hypersomnia.

And, you know, I've been pleased with our customers are telling us that this offering, you know, is meeting their needs both in terms of the product and the support services that we're offering.

Thanks.

Ladies and gentlemen, if you have a question about the support services that we're offering, please feel free to reach out to us.

And condition, we're also educating on the compelling efficacy and safety profile and we're helping hcp's identify.

Those patients in their practice, who are already diagnosed who maybe ready for xylene they've had many many years to figure out what that <unk>.

<unk> patient in narcolepsy looks like they are just getting started.

Case of idiopathic hypersomnia. So those are really the three key areas that we're focusing on in a very large population that already diagnosed.

We'll be happy to answer any questions Thank you.

Thank you one moment for our next question.

Our next question comes from Jeff Hung with Morgan Stanley . Your line is open.

Ladies and gentlemen, if you have a question about the support services, that we're offering.

Thanks for taking my question.

Thank you.

You've indicated for multiple quarters that youre, adding new prescribers for <unk> can you talk more about the new U S prescribers and do they tend to translate to multiple prescriptions fairly rapidly and have those dynamics changed much over time.

Yes.

Tim maybe I'll hand that over to you in terms of who the new epic Dialup prescribers are and what that means to our business.

Yes sure.

The newer prescribers I can really just say the characteristic is that theyre, obviously slower adapters as you see in any marketplace and we do believe the key is to get in their face to face educating them on the product profile and getting them to start using the product because what we see.

Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone.

There was a follow-up question for Mark just on the timing of the two ongoing, the mixed model study. So, Mark, as you know, when we last updated on this, we were experiencing some, I would say, not unexpected challenges in getting those trials up and running, you know, related to some logistical issues during the ongoing pandemic. And we're working through those. We have some mitigations that we're putting into place, but we don't yet have a firmer timeline on those two trials at this time.

From the beginning of the launch until now is that once a new prescriber gains experience with at the dialects and is able to see firsthand its clinical utility.

More broadly adopt at the Epidiorite as a cornerstone therapy.

For their treatment resistant patients.

I'd say as one of the approaches that we've been taking pretty much since the beginning of the year.

With Hcp's, who don't have experience with <unk>, we believe are under utilizing it in their practice and we're leveraging the fact that this is a category that naturally utilizes polypharmacy and we're highlighting data that we have on the synergistic effect of using <unk> in combination with <unk>.

Jim.

The product is already onboard and the vast majority of patients and we have found that by sharing these data with.

Hcp's that have yet to utilize epidiorite at all or robustly is that they've been highly impressed with the data as they demonstrate an ability to reduce the number of seizures and both lgs and dravet syndrome by more than 60%, which is a number on efficacy number that are very.

Common outcome and they recognize that at the moment, we share that data. So it's a very promotional <unk> sensitive market. We're encouraged that our sales force has had increased access to offices and treatment centers in recent months and we're really confident that our level of promotion is going to continue to increase.

Second half of the year and we've got a strong set of data to.

Really move those slower adopters.

And to try at the dialogues.

Then we also ask that you limit yourself to one question, one moment for our next question.

Thank you one moment for our next question.

Question from Akash Tewari with Cowen, your line is open.

Our next question comes from Gary Nachman with BMO. Your line is open.

Thanks. Good afternoon. So rallies was really strong in <unk> any unusual stocking in there in the quarter.

Does that all reflect demand you mentioned the thoughts of switching patients back earlier that they have.

Reaction to asparaginase, so could you expand on that dynamic.

And how should we think about that run rate from here, especially if you get Monday Wednesday Friday dosing.

Akash Tewari Hey team, great, great performance.

Yes, Gary Thanks for the question, we could not be more pleased with where we are just a couple of.

I want to just drill down a little bit more on the IH launch.

Quarters into the <unk> launch and how quickly we think physicians have moved to the best possible.

Treatments.

Paradigm for these patients Kim maybe I'll, let you answer as to whether there was any unusual stocking in.

How we think about this run rate for railways.

No I don't think we saw anything unusual in it going out this quarter and I think current utilization in the U S is outperforming and you can look at the numbers the peak that we experienced with <unk>.

Reinforcing the impact that in a supply constraint pad, providing optimal patient care.

We're asked often if this is bolus that we're seeing or warehouse patients, can maybe Bruce or Kim, can you talk about are we seeing normal demand and to what degree do we think the pace that we've been observing will be consistent or not consistent going forward?

And we think that really the demand trend were seeing reflects not only the increased brand awareness and familiarity of Riley with customers.

Its position in the market as the only available therapy right now for patients who have a hypersensitivity reaction.

E coli derived asparaginase.

Yes.

But really at this point, we think a lot of it has to do with the things that Dan highlighted in terms that we see customers who had put in place.

Paragon is sparing activity such as desensitization and re challenge practices are now telling us and we're seeing through ordering patterns that they are you know staffing those practices and they are starting to utilize.

Ladies instead, so all of that very positive signals.

The market is excited about reillys and ready to get back to you.

Optimal practices.

And Tim just to add on this is Dan we do have global rights to the product.

Yes, we update it on the call we did complete our submission to the EMA in the second quarter.

Market dynamics are a little different there <unk> on the market.

Then we think with our fully recombinant and.

<unk> to administer.

Already in a formulation that also.

Importantly, we studied it into a.

And updated $2525 50 dosing schedule that optimizes asparaginase levels through patients. So we look forward to that being on the market in 2023 in Europe , and then we're assessing other marketplaces, including Japan.

Thank you all remember for a next question.

Our next question comes from Madhu Kumar with Goldman Sachs. Your line is open.

And can you talk about to the degree in which the sales force is marketing versus still focus on narcolepsy conversion?

Is this something where the sales force is indeed marketing aggressively?

Hey, everyone. Thanks for taking our questions I want to follow up on some of the earlier discussion around that the dialogues and I guess kind of the question, where ultimately I think I'm curious about is.

What is that do you see further growth in the dialogue around geographic expansion indication expansion Youre kind of just like expansion of the onboard prescribers and use of the drug kind of off the lines of treatment resistant epilepsy.

And we wanted to take global opportunity for epic dialects, and where we see that go into the future.

Yes sure.

Yes to everything you just referenced I mean, theres plenty of headroom in the current indications as we think about the combination of the club at Sam Club exam is much more broadly used right now then.

Then.

<unk> and we do have continued data generation across different seizure types.

As well as sharing real world evidence from the Medical Records and then importantly, ex U S. We're at 14 of 34 countries in terms of launches France just.

Pending this year and opportunity for us to move more broadly into Asia as well. So we're super excited by what this brand can do long term its cornerstone unique mechanism very combinable.

And we've seen for example, with <unk> enhanced anti seizure activity, which is always.

The critical factor for these patients.

Thank you one moment for our next question.

Our next question comes from Amit <unk> with Needham Your line is open.

Hi, Good evening. Thanks for taking my question going back to hepatic hypersomnia can you give us some more color.

Around the market dynamics there are.

These patients coming from in terms of Florida prescribers.

Interesting.

Or by the prescribers for narcolepsy.

And if you could give us some color on what percent occur.

<unk> prescribers.

Narcolepsy has described.

Patient for an IX.

And also give us a sense of the patient journey, especially given the fact that.

There haven't been other treatment for iron it's available in the market.

Often these patients going back to the physicians seeking treatment or something new.

Would be helpful. Thank you.

Yes, Kim do you want to provide any additional information on overlap of prescribing physicians and.

Maybe pattern of whether patients see their physicians.

I don't believe we have that data to share Bruce maybe somebody can let me know if they feel otherwise in terms of how frequently patients are seeing their doctor, we see that typically out there in the marketplace. What we hear is they are an idiopathic hypersomnia visit there.

Doctor twice.

Twice a year.

Really the main statistic that we have about the HCP population is that in terms of potential.

And where the IH patients are receiving treatment, there's 90% overlap.

And in terms of where the patients reside in which HCP offices, if I don't have data at this time alternative what percentage of <unk>.

Physicians have prescribed.

Both IH and narcolepsy.

Thank you one moment for our next.

Yeah.

Our next question comes from Gregory <unk> with RBC. Your line is open.

Great. Thanks, Bruce and team for taking my question and congrats on the quarter Bruce I just wanted to touch back again, just once more an effort dialects.

Im just curious just in the context of the competitive landscape with respect to developmental therapies I'm. Just curious if you could comment a bit on epidiorite ex maybe longer term just given there have been some positive developments and some setbacks amongst the landscape.

Of late you certainly commented on on combination and cycling, but any added thought does that landscape even involved would be great. Thank you very much.

Yes, I would just remind people that the conditions, we're treating without the dialects are.

Very severe epilepsy very treatment refractory.

Patients have often tried a number of bankruptcies before they get to have the biologics of course, we've seen benefit.

And a good safety profile without the dialogue.

As patients their families and physicians continue to seek both better seizure control and just overall better results for their.

For their child.

They tend to stay on <unk>, even if they might rotate off work or try.

For therapy.

I personally heartened that there are continued developments that might offer additional relief.

So these patients give them more.

More things to put in to the arbitrary.

<unk> agents to try but we haven't seen anything yet on the horizon that strikes us as.

Reducing the opportunity for us to dial up so I think we may see benefits of combining treatment.

Much like you've heard touched on in Kim's comments.

Club example, a little bit earlier.

So lots of room for improvements.

On currencies.

<unk> from these patients.

Some of our evidence generation and additional trials is to continue to bring out that benefit whether that's been in other seizure types like E Mail us.

Or whether that's just better elucidating, what we are seeing in patients treated without the dialogues.

Rob maybe I could ask you to jump in.

Just from a physician perspective about.

Treatment of these.

Childhood onset seizure disorders, and how you see that going forward.

Sure happy to Bruce.

It's clear that <unk> has been very effective.

These groups of highly refractory epilepsy, both in terms of seizure reduction.

And other measures around seizure frequency seizure free days for example, but also in terms of overall wellbeing last year SaaS we showed.

Caretaker survey, where there's clearly benefits.

Observed outside of Jeff measures.

Epilepsy itself.

So becoming a cornerstone for therapy and as you mentioned the safety profile allows for combining with other therapies. So at the moment physicians practitioners continue to have a lot of enthusiasm about it and to the extent that there are new.

New drugs coming into these spaces.

<unk> thinking about it more in terms of another.

Another add on can be combined rather than to replace and what's a pretty highly.

Refractory set of conditions.

Operator, I think we probably have time for one more question.

Our last question comes from <unk> <unk> with UBS one moment.

Youre on it.

No.

Hi, Alex.

Can I take on the big small anything that you can share from the phase III. This release Msas one trial I understand that you didn't see significant statistically significant benefit.

Did you see that external benefit.

Yes, Rob do you want to.

Jumping on data from the recently.

Topline unblinded.

Small trial.

Okay.

We haven't given further details on that and we certainly are coming through.

David greater detail to understand what we could learn from this and how that might ultimately.

Impact the rest of the program if it does at all.

Nothing more to add at this time.

Yes.

Just to remind you that this was not the first trial ever done the big small so we're looking back across all trials with the Asia as well as our ongoing trials chart. The best course forward.

So with that maybe we'll wrap up the call and I'll, thank everyone for joining us.

We're really excited about the upcoming opportunities across our business.

As we continue to drive growth and shareholder value, we remain on track and focused on achieving vision 2025, and as always I'd love to close today's call by recognizing all of our jobs colleagues for their commitment to delivering new therapeutic options ladies.

Ladies and gentlemen, this does conclude so to thank our partners and our shareholders for their continued confidence and support. Thank you all for joining us today.

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.

Are we still kind of at a lower level than we'll have as we go forward?

The conference will begin shortly to raise your hand during Q&A you can dial one one.

[music].

Okay.

[music].

Yeah.

[music].

And then just lastly, any early view on patient retention?

I know it's very early days, but any thoughts on that?

[music].

Thanks so much.

Yeah, Kim, thanks for the questions.

I'll start and then ask Kim to jump in.

You know, we don't think there was any bolus or warehousing of patients.

In any significant way, you know, it's certainly true that there were some.

KOLs out there that were waiting for the launch of the product had seen the strong phase 3 clinical data, obviously saw our approval, you know, that our actual launch postdated our approval by a little bit while we completed REMS implementation.

So there certainly was some, you know, starting point for getting patients on the therapy, but we don't think of that as a bolus in the way you're suggesting it.

In terms of the pace of adding patients, I'd just like to remind people, we're only a couple quarters into this launch, so probably a little too early for a lot of super accurate trending, as Dan said in his remarks during the script.

You know, we're just really pleased to be seeing growth in narcolepsy patients, whether that's patients coming over from XyRM or patients new to Octavate therapy, including newly diagnosed narcolepsy patients, or whether they're IH patients getting the benefit of XyWave for the treatment of idiopathic hypersomnia. You know, we're seeing really strong growth in the overall XyWave franchise.

Maybe Kim could comment on how she and the team are balancing our efforts across narcolepsy and IH and whether that will change in the future and can add any comments on retention that she'd like.

Sure, Bruce.

So, I think as we've shared before, this is a very efficient launch for us in that it's largely the same base of customers. There's 90% overlap between those HCPs that we're calling on for narcolepsy and IH.

And, you know, really to your question, kind of how we're balancing that, it is a balancing act, but I can say that we are out there fully supporting both, you know, the continued transitions and new patients start from narcolepsy, as well as the launch of IH.

You know, and our teams know that, first and foremost, we've got to keep the momentum going on narcolepsy, but I can say that we've got a very strong, full effort for both.

In terms of patient retention, I don't think we've shared specific numbers, but I would just instead comment on more of the qualitative feedback that we've gotten from HCPs in terms of them being very pleased with the product and that they see that its performance in their patients is consistent with what they saw in the clinical studies.

Thank you.

One moment for our next question.

Our next question comes from Jason Gerberry, with Bank of America.

Your line is open.

Oh, hey, guys.

[music].

Thanks for taking my question.

Good question to ask a question during the session we need to press star one on your telephone.

I wanted to just drill in on Epidiolex.

I would now like to turn the call over to your host Andrea Flynn Vice President head of Investor Relations you may begin.

If, you can talk a little bit about the enhanced marketing efforts, is this going to be more of a second-half driven benefit?

Thank you and good afternoon, everyone today, Jonathan Masuda Golf reported its second quarter 2022 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 on our website.

On the call today are Bruce <unk>, Chairman and Chief Executive Officer.

<unk> Executive Vice President and Chief Financial Officer.

Dan Swisher, President and Rob <unk> Executive Vice President Global head of R&D.

Tim Statelets Executive Vice President and General manager of North America will join the team for Q&A.

On slide two I'll remind you that today's webcast includes forward looking statements such as those related to our future financial and operating results, including expectations related to vision 2025, and our guidance for 2022 growth potential and anticipate a development and commercialization milestones and goals, which involve risks and uncertainties that could cause.

Actual events performance and results to differ materially from those contained in these forward looking statements.

We encourage you to review the statements contained in today's press release, and our slide deck 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 to update or.

Forward looking statements.

Turning to slide three on this webcast, we'll discuss non-GAAP financial measures.

And as we think about the performance this quarter, just curious, are we seeing meaningful first-time contribution ex-U.S.?

Conciliations of GAAP to non-GAAP financial measures are included in today's press release and in the slide presentation available on the investors section of our website.

I'll now turn the call over to Bruce.

The U.S. growth is perhaps even lower than what was the overall reported number.

Just wondering if you could help us sort of figure out, like, what's going on now and some of the marketing initiatives as a thing about second half.

And second quarters.

Thanks.

Our productive second quarter reflects meaningful progress towards achieving vision 2020, which we introduced at the beginning of the year. We're pleased with our results in the first half of the year and are confident that we are on track to achieve our full year 2022 guidance, starting with our commercial business. Our Octavate franchise is performing well and we remain calm.

And the durability of <unk>, which we believe will be the oxalate therapy of choice in the market even following the entry of higher sodium authorized generics and potentially branded competition.

We are pleased to see continued sideway or adoption in narcolepsy and are equally excited about the positive momentum of the launch of <unk> in idiopathic hypersomnia, where IH. There are growing number of IH patients on <unk> therapy at a high level of engagement and receptivity in the market all of which is underpinned by strong <unk>.

<unk>.

Yeah, Dan, maybe I could ask you to jump in on Epidiolex just globally, including the, rollout ex-U.S. in recent quarters.

Turning catheter dialects, we continue to expand our prescriber base and are generating real world evidence and data to further substantiate epidiorite as broad effect across seizure types. Our team has done an excellent job of launching the product ex U S and we remain confident we can achieve blockbuster status for <unk>.

Sure.

Yeah, no, we're very pleased to see the growth and continue to hear great feedback, from the increasing prescriber base in the U.S. and the persistence remains strong.

<unk> remains a treatment of choice in second line small cell lung cancer and a robust development effort is aimed at identifying additional patient populations, who may benefit from therapy.

Riley's has continued its strong launch and we are pleased to be able to deliver the only therapy available to patients in the U S.

Experience of hypersensitivity reactions to E coli derived asparaginase.

We said this in the past, that it is a promotionally sensitive product.

And we will provide a detailed overview of our performance across our commercial portfolio later in the call.

As we highlighted on our last earnings call, we completed in licensing deals.

Two new early stage molecules to our pipeline in the second quarter, including JCB $4 41, a potent highly selective orexin two agonist that has the potential to advance the treatment of narcolepsy and other sleep disorders, and <unk> dollars 98, a differentiated conditionally activated interferon alpha.

Independent molecule with the potential to minimize the toxicity associated with systemic interferon alpha therapy, thereby expanding its clinical utility in treating cancer.

These transactions demonstrate our commitment to expanding our pipeline and diversifying our revenue.

Consistent with these objectives, we are prioritizing the medicines in R&D programs, most likely to deliver value to patients and shareholders.

I'm also pleased to share that we've achieved our deleveraging target two quarters ahead of our stated timeline, finishing the second quarter with a non-GAAP net leverage ratio of three two.

The current macro environment is creating attractive options for corporate development and our strong balance sheet provides us with flexibility to be active in identifying additional opportunities.

And importantly, our field force is increasing the level of face-to-face engagement, which is really important, especially for the smaller offices and the prescribers who haven't had experience or much experience with Epidiolex, to move it more broadly into their treatment-resistant epilepsy.

Turning to slide six vision 2025 provides us with a clear roadmap as we transform our business and includes three components samples to driving sustainable growth and enhanced value.

Commercial pipeline and operational excellence.

Yeah, regarding the ex-U.S., we don't break out the sales, but it has, you know, we always, view it as a meaningful growth driver to the overall franchise as a global brand.

And on the operational excellence, our 2021 adjusted operating margin was 43% and we plan to improve that by five percentage points from 2021% to 2025, delivering more of our top line through to the bottom line.

You know, did reference that we've got 10 new market and indication launches. A couple of them have already gone with Norway and Ireland, a successful two-plan, six indication launches.

I'll now turn the call over to Dan for an overview of our second quarter commercial performance after which Rob will share an update on the progress of our R&D programs Renee will provide a financial overview and then we'll open the call to Q&A Dan.

And, you know, we've still got a number of countries pending, especially France, which, would be the last of the big countries.

Thanks, Bruce I am encouraged by the progress we have made across our commercial portfolio in the second quarter.

Starting with neuroscience on slide eight we are maintaining positive momentum in our oxidative franchise, continuing the robust launch NIH and driving adoption of <unk> in narcolepsy.

With <unk>, we have meaningfully advance patient care with a lower sodium oxidate product the.

The breadth of our XI wave development efforts was recently highlighted by our presence in June at sleep 2022 to 30.

36 annual meeting of the associated professional fleets Society.

We and our partners debuted new data from 17 abstracts across narcolepsy NIH.

Was a well attended in person event, providing the opportunity to connect with customers.

And kols to gain valuable insights into their experience with <unk> in both narcolepsy NIH and we came away very encouraged by their feedback.

In the second quarter average active oxygen patients increased to approximately 17100.

An increase of nearly 8% compared to the same period last year.

And we exited the second quarter with approximately 7550 narcolepsy patients taking <unk>.

For us the highways NIH, we remain encouraged by the continued robust launch momentum.

And positive feedback from prescribers and the IH could use the.

Exiting the second quarter, there were approximately 1150 IH patients taking <unk>.

We continue to focus on educating prescribers and patients about the compelling efficacy and established safety profile of the first and only FDA approved therapy for IH.

And we are confident in our ability to maximize <unk> potential in this underserved market.

We've achieved our goal of obtaining similar coverage to narcolepsy with approximately 90% of commercial lives covered.

Pleased that payers have recognized the value that IH patients can realize from initiating the <unk> therapy.

Patients find our comprehensive and customized support valuable.

And we expect that educational efforts for prescribers and patients will increase the awareness building this market over time.

Stepping back and each of the last four quarters, our commercial and medical education initiatives around sideways have translated into growth of approximately 900 active patients per quarter across both indications.

And we achieved a significant milestone in the second quarter with more active <unk> patients taking <unk>.

Xyrem.

We have an integrated field sales team that is supporting both narcolepsy NIH across our concentrated call universe with significant overlap among narcolepsy NIH prescribers.

Now turning to slide nine and Thats. The dialects net product sales grew by 12% in the second quarter of 2022.

Compared to the same period last year on a pro forma basis.

As we continue to add <unk> prescribers.

As we have previously highlighted we expect that as new prescribers gain experience with us with Alex and <unk> clinical utility they will more broadly adopt epidemics as a cornerstone therapy for their treatment resistant patients.

We are also committed to continuing to generate clinical study data and real world evidence to further support the utility of <unk> across a broad range of difficult to treat seizure types.

Our commercial team continues to focus on more in person engagement. This is a promotional sensitive market and we are encouraged that our field sales force has experienced increased access to physician offices and treatment centers in recent months.

And we're seeing continued adoption and growth ex U S. We remain on track to gain reimbursement for <unk> in France. This year at which point hepatitis will be launched and reimbursed in all five major European markets.

We also have opportunities for additional growth coming from a total of 10 anticipated new market and indication launches.

Throughout this year.

Given that <unk> unique mechanism of action efficacy and safety profile and the ability to be combined with other therapies. We are confident we can achieve a blockbuster status throughout the dialects as the global standard of care and treatment resistant epilepsy.

So, yeah, so we're very confident about achieving ultimately the blockbuster status as a cornerstone of treatment-resistant epilepsy.

Thank you.

Now moving to oncology and starting with <unk> on slide 10.

One moment for our next question.

Quarter net product sales were $68 3 million as Bruce highlighted we have rapidly established <unk> as the treatment of choice in second line small cell lung cancer.

Our next question comes from Brandon Fulks with Cainter.

Your line is open.

Hi, thanks for taking my question, and congratulations on a good quarter.

To support our efforts to further grow market share and our current indication we are investing in additional real world evidence and observational studies.

Can you maybe just talk, about the competitive dynamic you're seeing for new patients start with inoculates?

Also our robust development plan, which Rob will cover in more depth has the potential to identify additional patient populations, who could benefit from this therapy <unk>.

Including treatment of first line small cell lung cancer and other tumor types, providing the opportunity for meaningful future growth.

Turning to slide 11 second quarter net product sales for <unk>, our recombinant erwinia asparaginase therapy were $73 million.

It was a strong quarter on your part from new patient ads, it looks like.

We saw a competitor with the report strong new patient ads.

So can you just elaborate a little bit on the market?

This demand reflects increased brand awareness among customers and its position in the market is the only therapy available to patients in the U S.

Is this just sort of the normal step-up post the 1Q headwind, you know, thrown in with, you know, we had Omicron earlier this year?

Or is there maybe just a bit more of a durable interest in the branded Noc lefty space, given you have two branded competitors out there promoting aging, and maybe just any commentary on in terms of getting in front of physicians in person?

Thank you.

Yeah, Brandon, I, you know, I would say we couldn't be more happy with the continued, growth of sideways in narcolepsy, as well as NIH over these past quarters, that just the number of patients on therapy.

We have a hypersensitivity reactions to E coli derived asparaginase.

Customer feedback continues to be positive and prescribers have indicated they are now returning to best clinical practice switching to non E. Coli derived asparaginase earlier when there has been an initial hypersensitivity reaction observed.

This is driven by the product profile reliable supply of <unk> and the suite of support services that we provide.

We've come along with a truly differentiated, better product due to the low sodium.

We've also completed our marketing authorization application or MAA submission to the European medicines agency with potential for approval in 2023.

With FDA's work in drug exclusivity, finding clinical superiority on the basis of safety, because of this very large reduction in nightly sodium intake in a chronic disease where we know this patient population is at significant risk of cardiovascular comorbidities, you know, we've really got something that I think is attracting both former Xyro patients but also potentially new patients.

It is generally true that Oxybate patients are on, not in all cases, but generally true, that they are on other agents.

Our agent is taken at night, and there are other daytime agents we're taking, and I think, that the product you're referring to, Potolosan, falls into that category of a daytime treatment that's also been adding new patients.

Now I will turn the call over to Rob to provide an R&D update Rob.

So you know, patients experiment with combinations that make sense for them, but we've continued, to see the kind of excellent growth we've really wanted to see, again, across existing, Oxybate patients and new Oxybate patients.

Thank you.

Thanks, Dan.

Slide 13 provides an overview of our R&D pipeline okay.

Looking across the pipeline, we are advancing a number of programs within neuroscience, we plan to initiate the phase III trial for Epidiorite.

One moment for our next question.

Our next question comes from David Amselen with Piper Sandler.

<unk> with my chronic atonic seizures shortly.

This would add a potential fourth indication to our label and provide the first clinical data on our fourth seizure type.

Your line is open.

Atonic seizures.

We're also planning to initiate a pivotal phase III trial for <unk> in Japan this year that.

That would include your Weil Lgs and PFC.

In addition enrollment.

Enrollment in our trials for <unk> and <unk> is ongoing.

With respect to <unk> program.

Topline results from the phase III release, NSS one trial in June .

The trial did not meet the primary endpoint of change in lower limb muscle tone sits between baseline and day 21.

<unk> by the modified Ashworth scale.

The goal of release MSS won.

Have an early look at the effect that in the midst of malls in patients with MF spasticity, and we continue to assess the trial results.

In terms of safety profile was consistent with previously reported adverse events with no new safety signals attributable can you make some models.

We maintain apology as Dan mentioned, we are advancing a robust development of airport.

<unk> for the treatment of lung cancer.

This includes an ongoing phase III trials supported by gels and our partner Roche.

Valuation and say, okay in combination with centric and first line extensive stage small cell lung cancer.

The confirmatory phase III trial in second line small cell lung cancer being run by our partner final remarks.

And our aim post marketing observational trial in second line small cell lung cancer.

We recently presented data from four poster presentations at the <unk> annual meeting evaluating <unk> in a range of small cell lung cancer settings.

We're also exploring <unk> in other solid tumors with the initiation of our phase II basket trial.

The merged two along earlier this year.

This is a multicenter open label trial designed to assess the safety and efficacy of <unk>.

<unk> as monotherapy in three cohorts of patients with solid tumors.

Vance Helio carcinoma.

Sumner and I couldnt carcinoma of the lung and HRD tumors that have progressed following a platinum containing regimen.

Turning to <unk> in the second quarter, we completed an MAA submission to the European Medicines Agency, which included Monday, Wednesday, Friday and are reporting at our dosing schedules.

Well as IV and Im administration.

This followed our submission of a supplemental BLA for <unk> in the U S. The.

Update on label to a Monday Wednesday, Friday dosing schedule with patients receiving 25 milligrams per meter squared on Monday, Wednesday, and 50 milligrams per meter squared on Friday.

This schedule, which is more in line with current clinical practice to avoid weekend dosing would allow patients to maintain a clinically meaningful level of serum asparaginase activity through the entire duration of treatment.

Currently the label dosing schedule is every 48 hours at 25 milligrams per meter square.

Clinical data using Monday Wednesday, Friday dosing were presented at the recent <unk> annual meeting.

We also completed a separate SPN eight to support intravenous dosing.

Similar to the review of our original BLA, both the Monday Wednesday, Friday, I am seeing schedule IV formulations <unk> are being reviewed.

The real time oncology review process.

In line with our anticipation of multiple <unk> through 2023.

Ta recently cleared the R&D application for <unk> five our Pan RAF inhibitor for the treatment of solid tumors that contain mutations in the map kinase pathway.

Which will allow the product to enter clinical development.

At the annual ACR meeting in April .

We presented preclinical data demonstrating that <unk>, five selectively and potently inhibits.

A b and C RAF kinases and also demonstrated.

<unk> anti tumor activity in the Ras and that you can see the graph models.

Now I will pass the call off to Rene for financial update.

Hey, thanks.

Okay.

Thanks, Rob I'll begin on slide 15.

So I wanted to drill down a little more about IH, and I apologize if I missed this, but, in terms of IH, are these patients new diagnoses who are now getting treatment, or are these patients who have already been on wakefulness-promoting agents like Modafinil?

And then as a corollary to that question, do you think that with the availability of, ZyWave, you're going to – you're seeing more diagnoses in general?

Our impressive second quarter financial results demonstrate our progress so far in 2022.

Can you comment on that as well?

We achieved strong top and bottom line growth with second quarter total revenues of $933 million representing growth of 24% compared to the same quarter in 2021.

Thanks.

Yeah, David, maybe I'll start with a broad picture and then let Kim go to our more current, strategy.

This concluded neuroscience net product sales of $697 million and oncology net product sales of $230 million, representing growth of 20% and 40% respectively compared to the second quarter of 2021.

Accordingly, we are on track to meet our 2022 total revenue guidance of three five to $3 7 billion.

With respect to operating expenses, we continue to focus on strategic disciplined use of capital and expect to come in towards the lower end of our full year Opex guidance ranges.

Our continued focus on both the top and bottom line second quarter, adjusted net income of $305 million.

<unk>, 7% increase compared to the same period in 2021.

Adjusted EPS was $4 30 in the second quarter, a 10% increase compared to the same period last year.

Excluding the accounting change for convertible debt on a like for like basis, adjusted EPS growth would have been 23% compared to the same period in 2021.

Based on the results from the first half of the year and our projections for the remainder of the year, we anticipate coming in toward the upper end of our 2022 non-GAAP <unk> guidance range of one one to one 5 billion.

In summary, we're very pleased with our performance year to date.

We are affirming our non-GAAP adjusted guidance and have updated our GAAP guidance, primarily to reflect the impact of foreign currency exchange movements on non U S. Dollar.

Denominated amortization and inventory step up expense.

Two quarters ahead of our stated timeline.

Our non-GAAP net leverage ratio was approximately $3 two at the end of the second quarter.

This achievement has been underpinned by our disciplined capital allocation focusing on both the top and bottom line as well as our continued strong cash generation.

Having achieved our deleveraging target.

We will continue to be on managing the balance sheet through disciplined capital allocation and leveraging our strong cash flow, which provides us with meaningful flexibility for further corporate development initiatives.

Corporate development is a foundational pillar of our strategy to deliver long term growth and value for both patients and shareholders and it's important to our efforts to achieve vision 2025.

Consistent with that our corporate development efforts remain focused on diversifying and enhancing our product portfolio and pipeline.

Leveraging our unique insights and commercial infrastructure and strengthening the overall facility of our business.

With our strategic investments expanding product portfolio and focus on operational excellence. We believe we are well positioned to achieve vision 2025, and deliver further diversification and sustainable growth and enhanced value to patients and shareholders I will now turn the call.

Back to Bruce for final remarks.

Thanks, Renee I'll conclude our prepared remarks on slide 18.

We're pleased to be building on the strong momentum we have created over the previous quarters across commercial R&D and corporate development. Despite a challenging period in the biotech sector and global markets in general.

In our commercial efforts, we are focused on execution across our neuroscience and oncology portfolios, including maximizing the XI wave NIH and Riley launches realizing the blockbuster potential of <unk> and continuing to drive adoption of <unk> in narcolepsy and <unk> in small cell lung cancer our <unk>.

Andy team is advancing multiple mid and late stage programs and we expect to submit several <unk> through 2023.

Operational excellence also remains a key area of focus including maximizing our adjusted operating margin, while making strategic investments for future growth.

<unk>.

Ladies and gentlemen, if you have a question or comment at this time. Please press star one on your telephone.

Just for a moment to compile our Q&A roster.

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

Thanks for the question Josh.

Really pleased to have achieved this target so quickly through both pay down some debt but also.

Continued growth in our profitability maybe for implications of this I'll turn it over to Renee for a couple of comments.

Yes, Thanks, Chris and thanks for the question.

I agree yes. This does provide us with greater flexibility with respect to corporate development.

As Bruce mentioned, the focus not just on paying down debt, but also increasing enhancing our EBITDA gives us greater flexibility because dollar for dollar we're getting more out of that net leverage ratio by improving the EBITDA and going forward. It also gives us greater capacity.

Thank you one moment for our next question.

Our next question comes from Marc Goodman with SBB Leerink. Your line is open.

Scott can you talk a little bit about these patient groups.

Yes.

11, 50, or they leave patients to Oxford dates.

Have they used akshay for these other products just a sense of who these patients are what they are doing are they dosed once a night or some.

You know, broadly, we do think the availability of the first-ever approved FDA agent – FDA-approved, agent in IH may well spur more diagnosis going forward.

They've been dosed twice a night and then just you didn't update the timeline on <unk> next study if you could just do that.

Yes, Mark let's start with your IH question.

We said, we're very excited to enter.

This segment, where theres been no FDA approved treatment.

People have tried things off label historically, primarily.

Eight stimulates the wake promoting agents despite the relatively small impact on diseases. We also know that historically there was some attempt to use ox debate.

IH payer restrictions made that fairly uncommon.

Maybe I'll ask Kim to update you a little bit on how the launch is going from a patient acquisition perspective.

Any comments she wants to make on the dose and then Rob can chime in.

To answer in the very smallest question Kim.

Sure Chris.

Yeah, we continue to be very pleased with the uptake of the product the first and only FDA approved treatment for IH, we're really encouraged by the robust launch momentum really especially by the feedback that we're getting from prescribers, who had actually utilized <unk>.

It's often the case that when there's a reward for diagnosis and that it unlocks a treatment, option and it unlocks reimbursement for a treatment option, you'll see doctors, you know, move all the way through that diagnosis where otherwise they might not.

<unk> eight in idiopathic hypersomnia patient.

Population our focus today remains.

But in terms of our current strategy for penetrating the IH space, maybe I'll let Kim make a few, remarks.

In addition to.

Sharing the impressive safety and efficacy profile of <unk> and yet idiopathic hypersomnia. We're also focused on continuing as we did prior to launch to educate prescribers all patient.

Yeah, sure.

About the disease.

And IH and particularly ensuring they understand the full breadth of symptoms not just excessive daytime sleepiness. We're also happy that Dan shared two via the places we had planned we are now 90% of commercial lives.

Our covered.

For idiopathic height.

And we are now 90% of commercial lives.

Our covered.

For idiopathic hypersomnia.

And I'm pleased with our customers are telling us that the <unk>.

Offering.

And meeting their needs both in terms of the product and the support services that we're offering.

It's a good one.

Ladies and gentlemen, if you have a question for support services.

What we're offering.

Good morning, ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone.

There was a.

There was a follow up question for Mark just on the timing of the two ongoing to make small study so mark as you know when we when we last updated on this we were experiencing some I would say not unexpected challenges in getting those trials up and running related some logistical issues.

Going pandemic and we're working through those could have some mitigation, but we're putting into place.

But we don't yet have a firm timeline.

Two trials at this time.

Then we also ask that you limit yourself to one question one moment for our next question.

Great question, Ken Cacciatore Cowen Your line is open.

So, you know, we've got a really nice-sized market of diagnosed patients to go after, you know, and we're focusing our initial launch, I think, as we've said several times, you know, not only on an existing sleep-call universe, but also on the 37,000 adult patients who already not only have a formal diagnosis of idiopathic hypersomnia, but who are also, you know, in the healthcare system, we can see actively seeking healthcare.

Consistent going forward and can you talk about to the degree in which the Salesforce is marketing versus.

We'll focus on the narcolepsy narcolepsy conversion is this.

Where the Salesforce is indeed marketing aggressively or are we still kind of at a lower level. Then will have as we go forward and then just lastly, any early view on patient retention I know, it's very early days, but any thoughts on that thanks. So much.

So, you know, that's why our strategy is really much more focused on encouraging HCPs, to get appropriate patients started on Zywave.

And, you know, we really have a three-pronged approach out there in the marketplace right, now.

Yes, Ken Thanks for the questions I'll start and then ask Ken to jump in.

We don't think there was any bolus or warehousing of patients.

In any significant way.

Certainly true that there were some.

<unk> out there that were.

Waiting for the launch of the product had seen the strong phase III clinical data obviously.

We saw our approvals we note that our actual launch.

Post stage of our approval by a little bit while we completed rems implementation.

There certainly was some.

Starting point.

We're getting patients onto therapy.

We don't think of that as a force in the way you're suggesting here.

In terms of the pace of adding patients. So I'd just like to remind people are only a couple of quarters into this launch so probably a little too early for a lot of super accurate trending.

<unk>.

Dan said in his remarks during the script, we're just really pleased to be seeing growth in narcolepsy patients, whether thats patients coming over from xyrem or patients new to oxalate therapy, including newly diagnosed narcolepsy patients or whether they're IH patients getting the benefit.

As I mentioned earlier, we're continuing our efforts to improve general understanding of, the disease of idiopathic hypersomnia, particularly as it relates to the breadth of patient symptoms experienced, given that we have a very broad indication in this condition.

We're also educating on the compelling efficacy and safety profile, and we're helping HCPs, identify those patients in their practice who are already diagnosed who may be ready for Zywave.

Sort of sideways for the treatment of idiopathic hypersomnia, we're seeing really strong growth in the overall sideways franchise.

Maybe Tim could comment on how.

She and the team are balancing our efforts across narcolepsy.

And by age and whether that will change in the future.

And add any confidence on retention that she'd like.

Sure Bruce.

So I think as we've shared before this is a very efficient launch for us and that it's largely the same base of customers is 90% overlap between.

Those hcp's that we're calling on for narcolepsy, NIH and really to your question kind of how we're balanced in that it is a balancing act, but I can say that we are out there fully supporting.

Both the continued transitions and new patient starts and narcolepsy as well as the launch of IH.

You know, they've had many, many years to figure out what that, you know, occibate patient, in narcolepsy looks like.

And our teams know that first and foremost you've got to keep the momentum going in narcolepsy, but I can't say that we've got a very strong full effort for.

They're just getting started in the case of idiopathic hypersomnia.

Both in terms of patient retention.

I don't think we've shared specific numbers, but I would just instead comment on more of the qualitative feedback that we've gotten from HCP in terms of them being very pleased with the product and that they see that performance and their patients.

Consistent with what they saw in the clinical study.

Thank you one of them before our next question.

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

Oh, Hey, guys. Thanks for taking my question.

Wanted to just drill in on a per dialects. If you can talk a little bit about.

In the U S growth is perhaps even lower than what was the overall reported number just wondering if you could help us sort of figure out like what's going on now and some of the marketing initiatives is to think about second half. Thanks.

Yes, Dan maybe I could ask you to jump in on F&I, Alex just globally, including the rollout ex U S. In recent quarters.

Sure Yes.

I mean, we're very pleased to see the growth and continue to.

Hear great feedback from the increase in prescriber base in the U S and the persistence remains strong and we said this in the past that it is a promotional sensitive product and importantly, our field force is.

The increase in the level of face to face engagement.

Which is really important, especially for the smaller offices and the prescribers, who haven't had experienced very much experience without the dialogues.

Is it more broadly into their treatment resistant epilepsy.

And the ex U S. We don't breakout the sales but.

It has we always view it as a meaningful growth driver to the overall franchise as a global brand.

It did reference that we've got 10.

New market and indication launches.

All of them have have already gone with Norway.

Ireland, a successful two planned six indication launches and you still got a number of countries pending, especially France, which would be the last of the big <unk>.

Countries. So.

Yes, so we're very confident about achieving ultimately the blockbuster status as a cornerstone of treatment resistant epilepsy.

Thank you one of them are for our next question.

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

Alright, Thanks for taking my question and congratulations on the good quarter.

Can you maybe just talk about the competitive dynamic youre seeing for new patient starts with narcolepsy.

It was a strong quarter on your part from new patient adds it looks like we saw competitors report strong new patient adds. So can you just elaborate a little bit on the market is this just sort of a normal step up post the <unk> headwind, yes, it's Brian .

I'll make one earlier this year or is it maybe just a bit more of a durable interest in the branded market ft space. Given you have two branded competitors promoting aging.

Maybe just any commentary on in terms of getting in front of physicians and patients. Thank you.

Yes, Brandon I would say, we couldnt be more happy with the continued growth.

Sideways.

In narcolepsy as well as when I drove in these past quarters, but just the number of patients on therapy.

It's very gratifying, we think some of that is because we've come along with a truly differentiated.

Better product due to the low sodium with FDA as work from drug exclusivity finding clinical superiority on the basis of safety because of this very large reduction.

Nightly sodium intake in a chronic disease, where we know this patient population is at significant risk of cardiovascular comorbidities.

Really got something that I think is attracting both.

Former xyrem organizations, but also potentially new patients.

It is generally true that ox of eight patients are on.

Not in all cases are generally true that they are on the other regions.

Often ours are aging mistaken at night and there are other daytime agents are taking them I think.

Youre, referring to proposing it falls into that category of the daytime treatment. That's also.

Having new patients.

So patients experiment with combinations that makes sense for them, but.

We've continued to see the kind of excellent growth, we've really wanted to see.

Across existing oxalate patients and new OXXO vacations.

Thank you one moment for our next question.

Our next question comes from David <unk> with Piper Sandler Your line is open.

Hey, Thanks, So I wanted to drill down a little more.

IH and I apologize if I missed this but in terms of H R.

Are these patients many diagnoses.

We're now getting treatment.

Or are these patients already been on wakefulness promoting agents like modafinil.

And then as a corollary to that question do you think that with the availability.

So that way, if youre going to Youre seeing more diagnoses in general.

Can you comment on that as well thanks.

Yes, David maybe I'll start with a broad picture and then let Tim go to a more current strategy broadly we do think the availability.

The first ever approved FDA and FDA approved agent NIH may well spur more diagnosis going forward.

It's often case often the case when there is a reward for diagnosis and that it unlocks a treatment option and unlocks reimbursement for treatment option, you'll see doctors.

Move all the way through the that diagnosis, where otherwise they might not but in terms of our current strategy for <unk>.

Penetrating the IH space, maybe I'll, let him make a few remarks.

Yeah.

Yes, sure. So we've got a really nice sized market of diagnosed patients to go after and we're focusing our initial launch I think as he said several times.

That's why our strategy is really much more focused on.

Encouraging HCP to get appropriate patients started on <unk>.

We really have a three pronged approach out there in the marketplace right now as I mentioned earlier, we're continuing our efforts to improve general understanding of the disease idiopathic hypersomnia, particularly as it relates to the breadth of patient symptoms experience given that we have a very broad indication.

So, those are really the three key areas that we're focusing on in a very large population, that's already diagnosed.

Thank you.

And condition. We're also educating on the compelling efficacy and safety profile and we're helping hcp's identify those patients in their practice, who are already diagnosed who may be ready for xylene they've had many many years to figure out what that.

Ask a bait patient in narcolepsy looks like they are just getting started in the case of idiopathic hypersomnia. So those are really the three key areas that we're focusing on in a very large population that's already diagnosed.

One moment for our next question.

Thank you one moment for our next question.

Our next question comes from Jeff Hung with Morgan Stanley . Your line is open thanks.

Our next question comes from Jeff Hung with, Morgan Stanley.

Thanks for taking my question.

Your line is open.

Yes.

Tim maybe I'll hand that over to you in terms of who the new Dialup prescribers are and what that means to our business.

Thanks for taking my question.

You've indicated for multiple quarters that you're adding new prescribers for Epidiolex.

Yes sure.

The newer prescribers I can really just say the characteristic is that theyre, obviously slower adapters as you see in any marketplace. Then we do believe the key is to get in their face to face educating them on the product profile and getting them to start using the product because what we see.

Can you talk more about the new U.S. prescribers, and do they tend to translate to multiple prescriptions fairly rapidly, and have those dynamics changed much over time?

From the beginning of the launch until now is that once a new prescriber gains experience with at the dialects and is able to see firsthand its clinical utility.

More broadly adopt epidiorite as a cornerstone therapy.

For their treatment resistant patients.

Thanks.

I'd say as one of the approaches that we've been taking pretty much since the beginning of the year.

Maybe I'll hand that over to you in terms of who the new Epidiolex prescribers are and, what that means to our business.

With HCP to don't have experience with <unk>, we believe are under utilizing it in their practice is we're leveraging the fact that this is a category that naturally utilizes polypharmacy and we're highlighting data that we have on the synergistic effect of using <unk> in combination with <unk>.

Yeah, sure.

Jim.

The product is already onboard and the vast majority of patients and we have found that by sharing these data with.

Hcp's that have yet to utilize at the dialogue at all or robustly is that they've been highly impressed with the data as they demonstrate an ability to reduce the number of seizures and both lgs and dravet syndrome by more than 60%, which is a number on efficacy number that are very.

Common outcome and they recognize that at the moment, we share that data. So it's a very promotional sensitive market. We're encouraged that our sales force has had increased access to offices and treatment centers in recent months and we're really confident that our level of promotion is going to continue to increase.

Second half of the year and he's got a strong set of data to.

The newer prescribers, I can really just say the characteristic is that they're obviously slower adopters, as you see in any marketplace.

Really move those slower adopters.

And to try Epidiorite.

And we do believe the key is to getting in there face-to-face, educating them on the, product profile, and getting them to start using the product.

Thank you one moment for our next question.

Our next question comes from Gary Nachman with BMO. Your line is open.

Thanks. Good afternoon. So rallies was really strong in <unk> any unusual stocking in there in the quarter.

Does that all reflect demand you mentioned that docs are switching patients back earlier, let's say have a reaction to experiencing there. So could you expand on that dynamic.

And how should we think about that run rate from here, especially if you get Monday Wednesday Friday dosing.

Because what we see from the beginning of the launch until now is that once a new prescriber gains experience with Epidiolex and is able to see firsthand its clinical utility, they more broadly adopt Epidiolex as a cornerstone therapy for their treatment-resistant patients.

Yes, Gary Thanks for the question, we could not be more pleased with where we are just a couple.

What I'd say is one of the approaches that we've been taking pretty much since the beginning of the year with HCPs who don't have experience with Epidiolex, or we believe are underutilizing it in their practice, is we're leveraging the fact that this is a category that naturally utilizes polypharmacy, and we're highlighting data that we have on the synergistic effect of using Epidiolex in combination with Clobazam.

Quarters into the <unk> launch and how quickly we think physicians have moved to the best possible.

Treatment.

Paradigm for these patients Kim maybe I'll, let you answer as to whether there was any unusual stocking in.

How we think about this run rate for Riley's.

No I don't think we saw anything unusual in it going up and this quarter I think current utilization in the U S is outperforming and you can look at the numbers the peak that we experienced with <unk>.

Reinforcing the impact that in a supply constraint pad, providing optimal patient care.

And we think that really the demand trend were seeing reflects not only the increased brand awareness and familiarity of Riley with customers.

And its position in the market as the only available therapy right now for patients who have a hypersensitivity reactions to E coli derived asparaginase.

Yes.

But really at this point, we think a lot of it has to do with the things that Dan highlighted in terms that we see customers who had put in place.

Paragon is sparing activity such as desensitization and re challenge practices are now telling us and we're seeing through ordering patterns that they are you know.

Staffing those practices and they are starting to utilize.

Ladies instead, so all of that very positive signals.

Market is excited about reillys and ready to get back to you.

Yes.

Optimal practices.

And Tim just to add on this is Dan we do have global rights to the product.

As we update it on the call we did complete our submission to the EMA in the second quarter.

Market dynamics are a little different there <unk> on the market, but again, we think with our fully recombinant and.

As you are to administer.

Already in a formulation that also.

Importantly, we studied that into <unk>.

Yeah, and updated $2525 50 dosing schedule that optimizes the asparaginase levels.

<unk> patients. So we look forward to that being on the market in 2023 in Europe , and then we're assessing other marketplaces, including Japan.

Thank you one of them before our next question.

Our next question comes from Madhu Kumar with Goldman Sachs. Your line is open.

Hey, everyone. Thanks for taking our questions I want to follow up on some of the earlier discussion around at the dialogue and I guess kind of.

Clobazam is a product that's already on board in the vast majority of patients, and we have found that by sharing these data with these HCPs that have yet to utilize Epidiolex at all or robustly, is that they've been highly impressed with the data as they demonstrate an ability to reduce the number of seizures in both LGS and Dravet syndrome by more than 60 percent, which is an efficacy number that's a very uncommon outcome, and they recognize this the moment we share that data.

The question, where ultimately I think I'm curious about is.

So it's a very promotionally sensitive market.

What is that do you see further growth number dialogues around geographic expansion indication expansion youre kind of just like expansion of the onboard prescribers and use of the drug kind of off the lines of treatment resistant epilepsy.

We're encouraged that our sales force has had increased access to offices and treatment centers in recent months, and we're really confident that our level of promotion is going to continue to increase in the second half of the year, and we've got a strong set of data to try to really move those slower adopters, you know, into trying Epidiolex.

And we wanted to take global opportunity for up of dialects, and where we see that go out in the future.

Yes sure.

Yes to everything you just referenced I mean, theres plenty of headroom in the current indications as we think about the combination of the club Sam club's dam is much more broadly used right now then.

Then at the dialogues and we do have continued data generation across different seizure types.

As well as sharing real world evidence from the Medical Records and then importantly, ex U S. We're at 14 of 34 countries in terms of launches France just.

Pending this year and opportunity for us to move more broadly into Asia as well. So we're super excited by what this brand can do long term its cornerstone unique mechanism very combinable.

And we've seen for example, with club Sam enhanced anti seizure activity, which is always.

The critical factor for these patients.

Thank you one moment for our next question.

Thank you.

Our next question comes from Amit <unk> with Needham Your line is open.

One moment for our next question.

Hi, Good evening. Thanks for taking my question going back to the Pathic Hypersomnia can you give us some more color.

Our next question comes from Gary Nashman with BMO.

The market dynamics.

These patients coming from in terms of Florida prescribers.

Your line is open.

Existing xyrem Xyrem Xyrem prescribers for narcolepsy.

Thanks.

And if you could give us some color on what percent of her existing prescribers.

Good afternoon.

Narcolepsy have described.

Patient for <unk>.

And also give us a sense of the patient journey, especially given the fact that.

There haven't been other Cleveland branch available in the market.

Often these patients going back to the position seeking treatment or something new that could be.

Be helpful. Thank you.

Yes, Kim do you want to provide any additional information on overlap of prescribing physicians and.

Basically pattern of when patients see their physicians.

I don't believe we have that data to share Bruce maybe somebody can let me know if they feel otherwise in terms of how frequently patient. They are seeing their doctor, we see that typically out there in the marketplace. What we hear is they and idiopathic hypersomnia visit there.

Victor twice.

Twice a year.

Really the main statistic that we have about the HCP population is that in terms of potential.

And where the IH patients are receiving treatment there is 90% overlap.

In terms of where the patients reside in which HCP offices I don't have data at this time in terms of what percentage of <unk>.

Physicians have prescribed.

Both IH and narcolepsy.

Thank you one moment for next.

Yeah.

Our next question comes from Gregory <unk> with RBC. Your line is open.

So, Riley's was really strong in 2Q.

Great. Thanks, Bruce and team for taking my question and congrats on the quarter Bruce I just wanted to touch back again, just once more an effort dialects.

Any unusual stocking in there, in the quarter?

Does that all reflect demand?

Im just curious just in the context of the competitive landscape with respect to developmental therapies I'm. Just curious if you could comment a bit on at the dialects maybe longer term just given there have been some positive developments in some setbacks amongst the landscape.

You mentioned that docs are switching patients back earlier if they have a reaction to asparaginase.

Of late certainly commented on on combination and cycling, but any added thoughts as that landscape even involved would be great. Thank you very much.

So, can you expand on that dynamic, and how should we think about that run rate from here, especially if you get Monday, Wednesday, Friday dosing?

Yes, I would just remind people that the conditions, we're treating with <unk> are.

Very severe epilepsy very treatment refractory.

Patients have often tried a number of bankruptcies before they get to have the biologics of course, we've seen benefit.

And a good safety profile without the dialogues.

And as patients their families and physicians continue to seek both better seizure control and just overall better results for their.

For their trial.

They tend to stay on <unk>, even if they might rotate off work or try.

Different therapy.

I personally heartened that there are continued developments that might offer additional relief.

So these patients give them more.

More things to put in to the armamentarium of agents to try but we haven't seen anything yet on the horizon that strikes us as.

Hi.

Reducing the opportunity for up the dialogue. So I think we may see benefits of combining treatment.

Much like you've heard touched on in Kim's comments.

Club example, a little bit earlier.

So lots of room for improvements.

On currency.

Results from these patients.

Some of our evidence generation and additional trials.

Is to continue to bring out that benefit whether thats in and other seizure types like E Mail us.

Or whether that's just better elucidating, what we are seeing in patients treated without the dialogues.

Yeah, Gary, thanks for the question.

Rob maybe I could ask you to jump in.

You know, we could not be more pleased with where we, are just a couple of quarters into the Riley's launch and how quickly we think physicians have moved to the best possible treatment paradigm for these ALL patients.

Just from a physician perspective about.

Treatment of these.

Childhood onset seizure disorders.

And how you see that going forward.

Kim, maybe I'll let you answer as to whether there was any unusual stocking and how we think about, this run rate for Riley's.

Sure happy to Bruce.

No, I don't think we saw anything unusual, you know, going on this quarter.

You know, I think current utilization in the U.S. is, you know, outperforming.

We do have global rights to the product and as we updated on the call, we did complete our submission to the EMA in the second quarter.

It's clear that <unk> has been very effective.

If you look at the numbers, the peak that we experienced with IrwinAID, you know, reinforcing the impact that, you know, supply constraints had on providing optimal patient care.

You know, market dynamics are a little different there Erwin ACEs on the market, but again, we think with our fully recombinant and, you know, easier to administer and, you know, already in a formulation, but also, you know, importantly, we studied it into a, you know, an updated 25-25-50 dosing schedule that optimizes asparaginase levels through patients.

And we think that really the demand trend we're seeing, you know, reflects not only the increased brand awareness and familiarity of Riley's with customers, and its position in the market is the only available therapy right now for patients who have a hypersensitivity reaction to E. coli-derived asparaginase.

You know, but really at this point, we think a lot of it has to do with the things that Dan highlighted in terms of, you know, we see customers who had put in place, you know, asparaginase sparing activities such as desensitization and rechallenge practices are now telling us and we're seeing through ordering patterns that they are, you know, stopping those practices and they're starting to utilize Riley's instead.

So, all that very positive signals that the market is excited about Riley's and ready to get back to, you know, optimal practices.

And Kim, just to add on, this is Dan.

These groups of highly refractory epilepsy, both in terms of seizure reduction.

So, we look forward to that being on the market in 2023 in Europe and then we're assessing other marketplaces, including Japan.

And other managers around seizure frequency seizure free days for example, but also in terms of overall wellbeing last year say, yes, we showed.

Thank you.

One moment for our next question.

Sure take a survey where there was clearly benefits.

Served outside of just measures.

<unk> epilepsy itself.

So becoming a cornerstone for therapy and as you mentioned.

Safety profile allows for combining with other therapies so at the moment.

Physicians practitioners continue to have a lot of enthusiasm about it and to the extent that there are.

New drugs coming into these spaces, probably thinking about it more in terms of another.

Another add on to the combined rather than to replace what's a pretty highly.

Our next question comes from Madhu Kumar with Goldman Sachs.

Refractory set of conditions.

Operator, I think we probably have time for one more question.

Your line is open.

Our last question comes from <unk> <unk> with UBS one moment.

Hey, everyone.

I think in your wallet.

No.

I was going to take on the big symbol anything that you can share from the fee.

Thanks for taking our questions.

Relieves Msos one trial I understand that you didn't see significant statistically significant benefit but.

I want to follow up on some of the earlier, discussion around epidiolex and I guess kind of the question we're ultimately, I think, curious about is to what extent do you see further growth in epidiolex?

Is it around geographic expansion, indication expansion, or kind of just like expansion of the on-board prescribers' use of the drug kind of off the lines of treatment-resistant epilepsy?

Did you see that external benefit.

Dan, you want to take global opportunity for epidiolex and where we see that going on the, table?

Yeah, Rob do you want to.

Jumping on data from the recently.

Topline unblinded.

It's a small trial.

Yeah, I think that's a really good question.

Okay.

Haven't given further details on that and we certainly are coming through.

David greater detail to understand what we could learn from this and how that might ultimately.

Impact the rest of the program if it does at all.

So nothing more to add at this time.

I think that's a really good question.

Yes.

Just to remind you that this is not the first trial ever done the big small so we're looking back across all trials with the agent as well as our ongoing trials to chart the best course.

Yeah, sure.

I mean, I'd say yes to everything you just referenced.

I mean, there's plenty of headroom in the current indications as we think about the combination of the CLOVE exam.

CLOVE exam is much more broadly used right now than, you know, than epidiolex.

And we do have continued data generation across different seizure types, as well as sharing real world evidence from the medical records.

And then, importantly, ex-US, we're at 14 of 34 countries in terms of launches.

Sure.

So with that maybe we'll wrap up the call and I'll, thank everyone for joining us.

You know, France, just pending this year, and opportunity for us to move more broadly into Asia as well.

We're really excited about the upcoming opportunities across our business.

So, you know, we're super excited by what this brand can do long term.

It's a cornerstone unique mechanism, very combinable.

And we've seen, for example, with CLOVE exam, enhanced anti-seizure activity, which is always, you know, sort of the critical factor for these patients.

We continued to drive growth and shareholder value.

We remain on track and focused on achieving vision 2025, and as always I'd love to close today's call by recognizing all of our Johnson colleagues for their commitment to delivering new therapeutic options.

Thank you.

One moment for our next question.

Ladies and gentlemen, this does concludes what I think our partners and our shareholders for their continued confidence and support. Thank you all for joining us today.

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.

Our next question comes from Ami Fadia with Needham.

Your line is open.

Hi, good evening.

Thanks for taking my question.

Going back to adipathic hypersomnia, can you give us some more color around the market dynamics?

Where are these patients coming from in terms of who are the subscribers or the existing xyrem or xyway prescribers for narcolepsy?

And if you could give us some color of what percent of your existing prescribers for narcolepsy have prescribed a patient for IH?

And also, give us a sense of the patient journey, especially given the fact that there haven't been other treatments for IH available in the market.

So, how often are these patients going back to their physicians seeking treatment or something new?

That would be helpful.

Thank you.

Yeah, Kim, do you want to provide any additional information on overlap of prescribing positions and, you know, maybe pattern of when patients see their physicians?

Yeah, I don't believe we have that data to share, Bruce.

Maybe somebody can let me know if they feel otherwise.

But in terms of how frequently patients are seeing their doctor, we see that typically out there in the marketplace, what we hear is an idiopathic hypersomnia visits their doctor, you know, twice a year.

You know, really the main statistic that we have about the HCP populations is that in terms of potential and where the IH patients are receiving treatment, there's 90% overlap in terms of where the patients reside and which HCP offices.

But I don't have data at this time in terms of, you know, what percentage of physicians have prescribed for both IH and narcolepsy.

Thank you.

One moment for our next question.

Our next question comes from Gregory Renton with RBC.

Your line is open.

Great, thanks Bruce and team for taking my question and congrats on the quarter.

Bruce I just wanted to touch back again just once more on Epidiolex.

I'm just curious just in the context of the competitive landscape with respect to developmental therapies, I'm just curious if you could comment a bit on Epidiolex maybe longer term just given there have been some positive developments and some setbacks amongst the landscape of late.

You certainly commented on combination and cycling but any added thoughts, as that landscape even evolved would be great.

Thank you very much.

Yeah I would just remind people that the conditions we're treating with Epidiolex, are you know very severe epilepsies, very treatment refractory and patients have often tried a number of therapies before they get to Epidiolex.

Of course we've seen benefit and a good safety profile with Epidiolex so that is as patients, their families and physicians continue to seek both better seizure control and just overall better results for their for their child.

You know they tend to stay on Epidiolex even if they might rotate off or try a different therapy.

You know I'm personally heartened that there are continued developments that might offer additional relief to these patients, give them more you know more things to put into the armamentarium of agents to try but we haven't seen anything yet on the horizon that strikes us as you know reducing the opportunity for Epidiolex.

I think we may see benefits of combined treatment much like you heard touched on in Kim's comments about Clobazam a little bit earlier.

So lots of room for improvements on current you know results from these patients and you know some of our evidence generation and additional trials is to continue to bring out that benefit whether that's in another seizure type like EMOS or whether that's just better elucidating what we are seeing in patients treated with Epidiolex.

Rob maybe I could ask you to jump in just from a physician perspective about, treatment of these childhood onset seizure disorders and how you see that going forward.

Sure, happy to Bruce.

You know it's clear that Epidiolex has been very effective in, these groups of highly refractory epilepsy both in terms of seizure reduction and other measures around seizure frequency, seizure free days for example but also in terms of overall well-being.

Last year's AES we showed the caretaker survey where there was clearly benefits observed outside of just measures of epilepsy itself.

So becoming a cornerstone for therapy and as you mentioned the safety profile allows for combining with other therapies.

So at the moment physicians practitioners continue to have a lot of enthusiasm about it and to the, extent that there are new drugs coming into these spaces probably thinking about it more in terms of another add-on to be combined rather than to replace and what's a pretty highly Refractory Set of Conditions.

Operator, I think we probably have time for one more, question.

Our last question comes from Ashwani Verma with UBS.

One moment.

I was gonna ask like on the BixinMall, anything that you can share, from the Phase 3, this release MSS-1 trial?

I understand that you didn't see statistically significant benefits, but did you see directional benefits?

Yeah, Rob, do you want to jump in on data from the recently top-line unblinded BixinMall trial?

Yeah, we haven't given further details on that and we certainly are combing through the data in greater detail to understand what we can learn from this and how that might ultimately impact the rest of the program, if it does at all.

So nothing more to add at this time.

Yeah, Ash, I'll just remind you that this was not the first trial ever done at the, BixinMall, so we're looking back across all trials with the agent, as well as our ongoing trials to chart the best course forward.

So with that, maybe we'll wrap up the call and I'll thank everyone for joining us.

You know, we're really excited about the upcoming opportunities across our business as we continue to drive growth and shareholder value.

You know, we remain on track and focused on achieving Vision 2025, and as always, I'd love to close today's call by recognizing all of our JAZ colleagues for their commitment to delivering new therapeutic options.

Ladies and gentlemen, let's conclude today.

I'd like to thank our partners and our shareholders for their continued confidence and support.

Thank you all for joining us today.

Ladies and gentlemen, let's conclude today's presentation.

You may now disconnect and have a wonderful day.

The conference will begin shortly.

To raise your hand during Q&A, you can dial, The conference will begin shortly.

To raise your hand during Q&A, you can dial star 1-1.

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Kasper, A. K. Arnold, A. T.

...

Ladies and gentlemen, thank you for standing by and welcome to the second quarter 2022 jazz pharmaceutical earnings call.

At this time all participants are on a listen only mode.

After the speaker's presentation there will be a information session.

To ask a question during the session you'll need to press star one one on your telephone.

I would like to turn the call over to your host, Andrea Flynn, vice president, head of investor relations.

You may begin.

Thank you and good afternoon everyone today.

Jazz pharmaceuticals reported at second quarter 2022 financial results. The slide presentation accompanying this webcast is available on the investors section of our website.

Investors may also refer to the press release. We issued earlier today, which is also posted on our website.

On the call today are Bruce Cozad, chairman and chief executive officer.

Rene Galah, executive vice president and chief financial officer.

Dan Swisher, president.

And Rob Unone, executive vice president, global head of R&D.

Kim Sablich, executive vice president and general manager, North America, will join the team for Q&A.

On slide two, I'll remind you that today's webcast includes forward looking statements. Such as those related to our future financial and operating results.

Including expectations related to vision 2025 and our guidance for 2022.

Growth potential in anticipated development and commercialization milestones and goals. Which involves risks and uncertainties that could cause actual events.

Performance and results to differ materially from those contained in these forward looking statements.

We encourage you to review the statements contained in today's press release, in our slide deck, and in our latest SEC Disclosure Document, which identifies certain factors that may cause the company's actual events, performance, and results to differ materially from those contained in the forward-looking statements made on today's webcast.

We undertake no duty or obligation to update our forward-looking statements.

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 in the slide presentation available on the Investors section of our website.

I'll now turn the call over to Bruce.

Thank you, Andrea.

Good afternoon, everyone, and thank you for joining us today.

I'll start on slide five.

We entered 2022 with substantial momentum, and our team has continued to make notable advances across our business through the first half of the year, while delivering solid year-over-year top and bottom line growth in the first and second quarters. Our productive second quarter reflects meaningful progress towards achieving Vision 2025, which we introduced at the beginning of the year.

We're pleased with our results in the first half of the year and are confident that we are on track to achieve our full year 2022 guidance.

Starting with our commercial business, our Oxibate franchise is performing well, and we remain confident in the durability of XyWave, which we believe will be the Oxibate therapy of choice in the market, even following the entry of higher sodium-authorized generics and potentially branded competition.

We are pleased to see continued XyWave adoption in narcolepsy and are equally excited about the positive momentum of the launch of XyWave in idiopathic hypersomnia, or IH. There are a growing number of IH patients on XyWave therapy and a high level of engagement and receptivity in the market, all of which is underpinned by strong reimbursement.

Turning to Epidiolex, we continue to expand our prescriber base and are generating real-world evidence and data to further substantiate Epidiolex's broad effect across seizure types.

Our team has done an excellent job of launching the product XUS, and we remain confident we can achieve blockbuster status for Epidiolex.

Axelka remains the treatment of choice in second-line small-cell lung cancer, and a robust development effort is aimed at identifying additional patient populations who may benefit from therapy.

Rilase has continued its strong launch, and we are pleased to be able to deliver the only therapy available to patients in the U.S. who experience a hypersensitivity reaction to E. coli-derived asparaginase.

Dan will provide a detailed overview of our performance across our commercial portfolio later in the call.

Our R&D team has remained very productive in the first half of 2022, advancing multiple clinical programs. In addition, we were pleased that FDA cleared the IND application for JCP815, allowing this program to enter clinical development.

As we highlighted on our last earnings call, we completed in-licensing deals to add two new early-stage molecules to our pipeline in the second quarter, including JCP441, a potent, highly selective orexin-2 agonist that has the potential to advance the treatment of narcolepsy and other sleep disorders.

Disorders, and JCP-898, a differentiated, conditionally-activated interferon-alpha-endocrine, molecule with the potential to minimize the toxicity associated with systemic interferon-alpha therapy, thereby expanding its clinical utility in treating cancer.

These transactions demonstrate our commitment to expanding our pipeline and diversifying, our revenue.

Consistent with these objectives, we are prioritizing the medicines and R&D programs most likely, to deliver value to patients and shareholders.

I'm also pleased to share that we've achieved our deleveraging target two quarters ahead, of our stated timeline, finishing the second quarter with a non-gap net leverage ratio of 3.2.

The current macro environment is creating attractive options for corporate development, and our strong balance sheet provides us with flexibility to be active in identifying additional opportunities.

And on operational excellence, our 2021 adjusted operating margin was 43%, and we plan to improve, that by five percentage points from 2021 to 2025, delivering more of our top line through to the bottom line.

I'll now turn the call over to Dan for an overview of our second quarter commercial, performance, after which Rob will share an update on the progress of our R&D programs.

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

Dan?

Thanks, Bruce.

I'm encouraged by the progress we have made across our commercial portfolio in the second, quarter.

Starting with neuroscience on slide eight, we are maintaining positive momentum in our, OxyBait franchise, continuing the robust launch in IH, and driving adoption of ZyWave and, Narcolepsy. With ZyWave, we have meaningfully advanced patient care with a lower-sodium OxyBait product. The breadth of our ZyWave development efforts was recently highlighted by our presence in, June at SLEAP 2022, the 36th annual meeting of the Associated Professional SLEAP Society.

In the second quarter, average active OxyBay patients increased to approximately 17,100, an increase of nearly 8% compared to the same period last year.

In XyWave for narcolepsy, we continue to see strong performance in the second quarter.

Our efforts around educating physicians and patients about the lifelong burden of high, sodium intake are resonating.

And we exited the second quarter with approximately 7,550 narcolepsy patients taking XyWave.

Looking ahead, we expect to see additional adoption of XyWave from existing XyRim patients.

And importantly, the large majority of new to OxyBay narcolepsy patients are beginning, their therapy with XyWave.

For XyWave and IH, we remain encouraged by the continued robust launch momentum and positive, feedback from prescribers and the IH community. Actually, in the second quarter, there were approximately 1,150 IH patients taking XyWave.

We continue to focus on educating prescribers and patients about the compelling efficacy, and established safety profile of the first and only FDA-approved therapy for IH.

And we are confident in our ability to maximize XyWave's potential in this underserved market.

We've achieved our goal of obtaining similar coverage to narcolepsy with approximately, 90% of commercial lives covered.

We're pleased that payers have recognized the value that IH patients can realize from, initiating XyWave therapy.

Patients find our comprehensive and customized support valuable.

And we expect that educational efforts for prescribers and patients will increase the, awareness building this market over time. Stepping back, in each of the last four quarters, our commercial and medical education initiatives, around XyWave have translated into growth of approximately 900 active patients per quarter across both indications.

We achieved a significant milestone in the second quarter with more active OxyBate patients, taking XyWave than XyREM. We have an integrated field sales team that is supporting both narcolepsy and IH across, a concentrated call universe with significant overlap among narcolepsy and IH prescribers. Coupled with orphan drug exclusivity for both indications that extends to 2027 for narcolepsy, and 2028 for IH, as well as Orange Book listed patents that extend out to 2033, we believe, XyWave is well positioned to be a durable product and one of our core growth drivers.

Now turning to slide nine in Epidiolex, net product sales grew by 12% in the second quarter, of 2022, compared to the same period last year on a pro forma basis. As we continue to add Epidiolex prescribers, as we have previously highlighted, we expect, that as new prescribers gain experience with Epidiolex and see its clinical utility, they will more broadly adopt Epidiolex as a cornerstone therapy for their treatment resistant patients.

We are also committed to continuing to generate clinical study data and real-world evidence, to further support the utility of epidiolics across a broad range of difficult-to-treat seizure types.

Our commercial team continues to focus on more in-person engagement.

This is a promotionally sensitive market, and we are encouraged that our field sales, force has experienced increased access to physician offices and treatment centers in recent months.

And we're seeing continued adoption and growth ex-U.S. We remain on track to gain reimbursement for epidiolics in France this year, at which point, epidiolics will be launched and reimbursed in all five major European markets.

We also have opportunity for additional growth coming from a total of 10 anticipated new, market and indication launches throughout this year.

Given epidiolics' unique mechanism of action, efficacy, and safety profile, and ability, to be combined with other therapies, we are confident we can achieve a blockbuster status for epidiolics as a global standard of care in treatment-resistant epilepsy.

Now moving to oncology and starting with Zeph Zelka on slide 10.

Second quarter net product sales were $68.3 million.

As Bruce highlighted, we have rapidly established Zeph Zelka as the treatment of choice in second, line small cell lung cancer. To support our efforts to further grow market share in our current indication, we are investing, in additional real-world evidence and observational studies. We believe these data will add to the body of evidence around Zeph Zelka's positive benefit, risk profile for second line small cell lung cancer patients and support increased adoption moving forward.

Also, our robust development plan, which Rob will cover in more depth, has the potential, to identify additional patient populations who could benefit from this therapy, including treatment of first line small cell lung cancer and other tumor types, providing the opportunity for meaningful future growth.

Turning to slide 11, second quarter net product sales for Rylase, our recombinant Erwinia, asparaginase therapy, were $73 million. Rylase demand reflects increased brand awareness among customers and its position in the market, as the only therapy available to patients in the U.S.

We have a hypersensitivity reaction to E. coli-derived asparaginase. Customer feedback continues to be positive and prescribers have indicated they are now, returning to best clinical practice, switching to non-E. coli-derived asparaginase earlier when there has been an initial hypersensitivity reaction observed.

This is driven by the product profile, reliable supply of Rylase, and the suite of support, services that we provide.

Looking ahead, the potential label updates in the U.S. to a Monday, Wednesday, Friday, dosing schedule and IV administration have the potential to improve the Rylase experience for clinicians and patients.

We've also completed our marketing authorization application or MAA submission to the European, Medicines Agency with potential for approval in 2023.

Now I will turn the call over to Rob to provide an R&D update.

Rob?

Thanks, Dan.

Slide 13 provides an overview of our R&D pipeline.

Looking across the pipeline, we are advancing a number of programs.

We're also planning to initiate a pivotal phase 3 trial for epidiolex in Japan this year that would include DREVE, LGS, and TSC.

In addition, enrollment in our trials for subacaltamide and JZP150 is ongoing.

With respect to our, Naviximals program, we announced top-line results from the phase 3 release MSS1 trial in June. The trial did not meet the primary endpoint of change in lower limb muscle tone 6 between, baseline and day 21, as measured by the modified OSWR scale.

The goal of release MSS1 was to have an early look at the effect of Naviximals in patients with MS spasticity, and we continue to assess the trial results. In terms of safety, the profile was consistent with previously reported adverse events, with no new safety signals attributable to Naviximals.

Moving to oncology, as Dan mentioned, we are advancing a robust development effort for Dlibzelka for the treatment of lung cancer.

This includes an ongoing phase 3 trial supported by JOWS and our partner Roche to evaluate Dlibzelka in combination with Tecentric in first-line extensive stage, small cell lung cancer, a confirmatory phase 3 trial in second-line small cell lung cancer being run by our partner PharmaMAR, and our own post-marketing observational trial in second-line small cell lung cancer. We recently presented data from four poster presentations at the ASCO annual meeting evaluating Dlibzelka in a range of small cell lung cancer settings.

We're also exploring Dlibzelka and other solid tumors with the initiation of our phase 2 basket, trial called eMERGE-201 earlier this year. This is a multi-center, open-label trial designed to assess the safety and efficacy of Dlibzelka as monotherapy in three cohorts of patients with solid tumors. Advanced urothelial carcinoma, large cell neuroendocrine carcinoma of the lung, and HRD tumors that have progressed following a platinum-containing regimen.

Turning to Rilase, in the second quarter, we completed an MAA submission to the European, Medicines Agency, which included Monday, Wednesday, Friday, and every 48-hour dosing schedule, as well as IV and IM administration.

This followed our submission of a supplemental BLA for Rilase in the U.S. to update our label to a Monday, Wednesday, Friday dosing, Schedule with patients receiving 25 milligrams per meter squared on Monday and Wednesday and 50 milligrams per meter squared on Friday. This schedule, which is more in line with current clinical practice to avoid weekend, dosing, would allow patients to maintain a clinically meaningful level of serum asparaginase activity through the entire duration of treatment. Currently, the label dosing schedule is every 48 hours at 25 milligrams per meter squared. Clinical data using Monday, Wednesday, Friday dosing were presented at the recent ASCO annual, meeting.

We also completed a separate SBLA to support intravenous dosing. Similar to the review of our original BLA, both the Monday, Wednesday, Friday IM dosing, schedule and IV formulation SBLAs are being reviewed under the real-time oncology review process.

In line with our anticipation of multiple INDs through 2023, FDA recently cleared the, IND application for JCPA 1.5, our pan-RAF inhibitor for the treatment of solid tumors that contain mutations in the MAP kinase pathway, which will allow the product to enter clinical development. At the annual AACR meeting in April, we presented preclinical data demonstrating that JCPA 1.5, selectively and potently inhibits mutant A, B, and C-RAF kinases, and also demonstrated robust anti-tumor activity in the RAS and RAP mutant phenograph models.

Now I will pass the call off to Renee for a financial update.

Renee?

Thanks, Rob.

I'll begin on slide 15.

Our impressive second quarter financial results demonstrate our progress so far in 2022. We achieved strong top and bottom line growth with second quarter total revenues of $933, million, representing growth of 24% compared to the same quarter in 2021. This included neuroscience net product sales of $697 million and oncology net product sales, of $230 million, representing growth of 20% and 40% respectively compared to the second quarter of 2021.

Importantly, we are on track to meet our 2022 total revenue guidance of $3.5 to $3.7 billion.

With respect to operating expenses, we continue to focus on strategic disciplined use of capital, and expect to come in toward the lower end of our full year OPEX guidance ranges.

Our continued focus on both the top and bottom lines drove second quarter adjusted net income, of $305 million, a 27% increase compared to the same period in 2021. Adjusted EPS was $4.30 in the second quarter, a 10% increase compared to the same period, last year. Excluding the accounting change for convertible debt on a like-for-like basis, adjusted EPS, growth would have been 23% compared to the same period in 2021.

Based on the results from the first half of the year and our projections for the remainder, of the year, we anticipate coming in toward the upper end of our 2022 non-GAAP ANI guidance range of $1.18 to $1.25 billion. In summary, we're very pleased with our performance here to date.

We are affirming our non-GAAP adjusted guidance and have updated our GAAP guidance primarily, to reflect the impact of foreign currency exchange movements on non-U.S. dollar denominated amortization and inventory step-up expense.

Turning to slide 16, we committed to rapid deleveraging following the GW transaction, and I am pleased to report that we have achieved our goal of a net leverage ratio of less than, 3.5 on a non-GAAP basis, two quarters ahead of our stated timeline. Our non-GAAP net leverage ratio was approximately 3.2 at the end of the second quarter. This achievement has been underpinned by our discipline capital allocation, focusing on, both the top and bottom line, as well as our continued strong cash generation.

Having achieved our deleveraging target, our focus will continue to be on managing, the balance sheet through discipline capital allocation and leveraging our strong cash flow, which provides us with meaningful flexibility for further corporate development initiatives. Corporate development is a foundational pillar of our strategy to deliver long-term growth, and value for both patients and shareholders, and is important to our efforts to achieve, Vision 2025. Consistent with that, our corporate development efforts remain focused on diversifying and, enhancing our product portfolio and pipeline, leveraging our unique insights in commercial infrastructure, and strengthening the overall sustainability of our business. With our strategic investments, expanding product portfolio, and focus on operational, excellence, we believe we are well-positioned to achieve Vision 2025 and deliver further diversification, sustainable growth, and enhanced value to patients and shareholders.

I will now turn the call back to Bruce for final remarks.

Thanks, Renee.

I'll conclude our prepared remarks on slide 18.

We're pleased to be building on the strong momentum we've created over the previous quarters, across commercial, R&D, and corporate development, despite a challenging period in the biotech sector and global markets in general.

In our commercial efforts, we are focused on execution across our neuroscience and oncology, portfolios, including maximizing the ZyWave and IH and Rylaze launches, realizing the blockbuster potential of epidiolex, and continuing to drive adoption of ZyWave and narcolepsy and Zepzelka in small cell lung cancer.

Our R&D team is advancing multiple mid- and late-stage programs, and we expect to submit, several INDs through 2023.

Operational excellence also remains a key area of focus, including maximizing our adjusted, operating margin while making strategic investments for future growth.

That concludes our prepared remarks.

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

Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone.

We'll pause for a moment to compile our Q&A roster.

Our first question comes from Jessica Fye with JPMorgan.

Your line is open.

Hey, guys.

Good afternoon.

Thanks for taking my question.

Now that you've exceeded your net leverage target early, should we think of that as unlocking potentially larger business development transactions sooner than 2023?

Thanks for the question, Jess.

You know, really pleased to have achieved this target so quickly through both pay down on some debt, but also, you know, continued growth in our profitability.

Maybe for implications of this, I'll turn it over to Renee for a couple of comments.

Yeah, thanks, Bruce, and thanks for the question.

And going forward, it also gives us greater capacity as we look at future targets.

Thank you.

1 moment for our next question.

Our next question comes from Mark Goodwin with SVB Larynx.

Your line is open.

Yes, hi, can you talk a little bit about these IA patients that are the 1150?

Are they naive patients to Oxidate?

Are they, you know, have they used Oxidate before?

Have they used other products before?

Just give us a sense of who these patients are and what they're doing.

Are they being dosed once a night or are they being dosed twice a night?

And then just, you didn't update the timeline on the nebixomol next study, if you could just do that.

Thanks.

Yeah, Mark, let's start with your IH question.

You know, we've said we're very excited to enter this segment where there's been no FDA approved treatment.

We know people have tried things off labeled historically, primarily a daytime stimulants, the way promoting agents, despite their relatively small impact on the disease.

We also know that historically there was some attempt to use Oxidate.

We know that people have tried things off labeled historically, primarily a daytime stimulants, the way promoting agents, despite their relatively small impact on the disease.

FDA-approved treatment for IH, you know, we're really encouraged by the robust launch momentum, and really, especially by the feedback that we're getting from prescribers who have actually utilized Zywave in their idiopathic hypersomnia patient population.

Our focus today, you know, remains in addition to sharing the impressive safety and efficacy profile of Zywave in the idiopathic hypersomnia.

We're also focused on continuing, as we did prior to launch, to educate prescribers and patients about the disease itself and IH, and particularly ensuring they understand the full breadth of symptoms, not just excessive daytime sleepiness.

We're also happy to be at a place, as Dan shared, where 90% of commercial lives are covered for idiopathic hypersomnia.

There was a follow-up question from Mark just on the timing of the two ongoing, the mixed model study.

So, Mark, as you know, when we last updated on this, we were experiencing some, I would say, not unexpected challenges in getting those trials up and running, you know, related to some logistical issues during the ongoing pandemic.

And we're working through those.

We have some mitigations that we're putting into place, but we don't yet have a firmer timeline on those two trials at this time.

And we also ask that you limit yourself to one question, one moment for our next question.

I have a question.

Can I catch it over to Calvin?

Your line is open.

Hey, team.

Great, great performance.

I want to just drill down a little bit more on the IH launch.

We're asked often if this is bolus that we're seeing or warehouse patients.

Maybe, Bruce or Kim, can you talk about are we seeing normal demand and to what degree do we think the pace that we've been observing will be consistent or not consistent going forward?

And can you talk about to the degree in which the sales force is marketing versus still focus on narcolepsy conversion?

Is this something where the sales force is indeed marketing aggressively?

Are we still kind of at a lower level than we'll have as we go forward?

And then just lastly, any early view on patient retention?

I know it's very early days, but any thoughts on that?

Thanks so much.

Yeah, Kim, thanks for the questions.

I'll start and then ask Kim to jump in.

You know, we don't think there was any bolus or warehousing of patients in any significant way.

You know, it's certainly true that there were some KOLs out there that were waiting for the launch of the product, had seen the strong Phase 3 clinical data, obviously saw our approval. You know that our actual launch postdated our approval by a little bit while we completed REMS, implementation.

So there certainly was some, you know, starting point for getting patients on to therapy, but we don't think of that as a bolus in the way that you're suggesting it.

In terms of the pace of adding patients, I'd just like to remind people we're only a couple quarters, into this launch, so probably a little too early for a lot of super accurate trending.

As Dan said in his remarks during the script, you know, we're just really pleased to be seeing growth in narcolepsy patients, whether that's patients coming over from Xyrom or patients new to oxybate therapy, including newly diagnosed narcolepsy patients, or whether they're IH patients getting the benefit of XyWave for the treatment of idiopathic hypersomnia.

You know, we're seeing really strong growth in the overall XyWave franchise.

Maybe Kim could comment on how she and the team are balancing our efforts across narcolepsy and IH and whether that will change in the future and can add any comments on retention that she'd like.

Sure, Bruce.

So, I think as we've shared before, this is a very efficient launch for us in that it's largely the same base of customers. There's 90 percent overlap between those HCPs that we're calling on for narcolepsy and IH.

And, you know, really to your question, kind of how we're balancing that, it is a balancing act, but I can say that we are out there fully supporting both, you know, the continued transitions and new patient starts in narcolepsy, as well as the launch of IH.

You know, and, you know, our teams know that first and foremost, we've got to keep the momentum going on narcolepsy, but I can say that we've got a very strong full effort for both.

In terms of patient retention, I don't think we've shared specific numbers, but I would just instead comment on more of the, qualitative feedback that we've gotten from HCPs in terms of them being very pleased with the product and that they see that its performance in their patients is consistent with what they saw in the clinical studies.

Thank you.

One moment for our next question.

Our next question comes from Jason Gerber, Bank of America.

Your line is open.

Oh, hey, guys.

Thanks for taking my question.

I wanted to just drill in on Epidiolex.

If you can, talk a little bit about these enhanced marketing efforts, is this going to be more of a second half driven benefit?

And as we think about the performance this quarter, just curious, are we seeing meaningful first-time contribution ex-U.S. since the U.S. growth is perhaps even lower than what was the overall reported number?

Just wondering if you could help us sort of figure out, like, what's going on now and some of the marketing initiatives as a thing about second half.

Thanks.

Yeah, Dan, maybe I could ask you to jump in on Epidiolex just globally, including the, rollout ex-U.S. in recent quarters.

Sure.

Yeah, no, we're, I mean, we're very pleased to see the growth and continue to, you know, hear great feedback from the increasing prescriber base in the U.S. and the persistence remains strong.

You know, we've said this in the past, that it is a promotionally sensitive product and, importantly, our field force is, you know, increasing the level of face-to-face engagement, which is really important, especially for the smaller offices and the prescribers who haven't had experience or much experience with Epidiolex to move it more broadly into their treatment resistant epilepsy.

You know, regarding the ex-U.S., we don't break out the sales, but it has, you know, we always view it as a meaningful growth driver to the overall franchise as a global brand.

You know, I did reference that we've got 10 new market and indication launches. A couple of them have already gone with Norway and Ireland successful, two planned, six indication, launches, and, you know, we've still got a number of countries pending, especially France, which would be the last of the big countries.

So, you know, so we're very confident about achieving ultimately the blockbuster status, as a cornerstone of treatment resistant epilepsy.

Thank you.

One moment for our next question.

Our next question comes from Brandon Fulks with Cainter.

Your line is open.

Hi.

Thanks for taking my question and congratulations on a good quarter.

Can you maybe just talk about the competitive dynamic you're seeing for new patients start, with narcolepsy?

It was a strong quarter on your part from new patient ads, it looks like.

We saw a competitor with the report strong new patient ads.

So can you just elaborate a little bit on the market?

Is this just sort of the normal step up post the 1Q headwind, you know, thrown in with, you know, we had Omicron earlier this year?

Or is there maybe just a bit more of a durable interest in the branded narcolepsy space, given you had two branded competitors out there promoting aging?

And maybe just any commentary on in terms of getting in front of physicians in person?

Thank you.

Yeah, Brandon, I, you know, I would say we couldn't be more happy with the continued, growth of Zywave in narcolepsy as well as in IHO in these past quarters. Just the number of patients on therapy is very gratifying.

You know, we think some of that is because we've come along with a truly differentiated, better product due to the low sodium.

You know, with FDA's work in drug exclusivity, finding clinical superiority on the basis, of safety, because of this very large reduction in nightly sodium intake in a chronic disease where we know this patient population is at significant risk of cardiovascular comorbidities.

You know, we've really got something that I think is attracting both former Zywave, patients, but also potentially new patients.

It is generally true that oxidation, patients are on, not in all cases, but generally true, that they are on other agents.

Often ours, our agent was taken at night, and there are other daytime agents who are taking them.

I think that the product you're referring to, PatolaSan, falls into that category of a daytime treatment that's also been having new patients.

So, you know, patients experiment with combinations that make sense for them, but, you know, we've continued to see the kind of excellent growth we've really wanted to see, again, across existing OxyBate patients and new OxyBate patients.

Thank you.

One moment for our next question.

Our next question comes from David Anselm with Piper Sandler.

Your line is open.

Hey, thanks.

So, I wanted to drill down a little more about IH, and I apologize if I missed this, but in terms of IH, are these patients new diagnoses who are now getting treatment, or are these patients who have already been on wakefulness-promoting agents like modafinil?

And then as a corollary to that question, do you think that with the availability of ZyWave, you're going to – you're seeing more diagnoses in general?

Can you comment on that as well?

Thanks.

Yeah, David, maybe I'll start with a broad picture and then let Kim go to our more current strategy.

Broadly, we do think the availability of the first-ever approved FDA-approved agent, NIH, may well spur more diagnosis going forward.

It's often the case that when there's a reward for diagnosis and that it unlocks a treatment option and it unlocks reimbursement for a treatment option, you'll see doctors, you know, move all the way through that diagnosis where otherwise they might not.

But in terms of our current strategy for penetrating the IH space, maybe I'll make – let Kim make a few remarks.

Yeah, sure.

So, you know, we've got a really, nice-sized market of diagnosed patients to go after, you know, and we're focusing our initial launch, I think as we've said several times, you know, not only on an existing sleep call universe, but also on the 37,000 adult patients who already not only have a formal diagnosis of idiopathic hypersomnia, but who are also, you know, in the healthcare system, we can see actively seeking healthcare.

So, you know, that's why our strategy is really much more focused on encouraging HCPs to get appropriate patients started on Zywave.

And, you know, we really have a three-pronged approach out there in the marketplace right now.

As I mentioned earlier, we're continuing our efforts to improve general understanding of the disease of idiopathic hypersomnia, particularly as it relates to the breadth of patient symptoms experienced, given that we have a very broad indication in this condition.

We're also educating on the compelling efficacy and safety profile.

And we're helping HCPs identify those patients in their practice who are already diagnosed, who may be ready for Zywave.

You know, they've had many, many years to figure out what that, you know, occibate patient and narcolepsy looks like.

They're just getting started in the case of idiopathic hypersomnia.

So, those are really the three key areas that we're focusing on in a very large population that's already diagnosed.

Thank you.

One moment for our next question.

Our next question comes from Jeff Hung with, Morgan Stanley.

Your line is open.

Thanks for taking my question.

You've indicated for multiple quarters that you're adding new prescribers for Epidiolex.

Can you talk more about the new U.S. prescribers, and do they tend to translate to multiple prescriptions fairly rapidly, and have those dynamics changed much over time?

Thanks.

Kim, maybe I'll hand that over to you in terms of who the new Epidiolex prescribers, are and what that means to our business.

Yeah, sure.

The newer prescribers, I can really just say the characteristic is that they're, obviously slower adopters, as you see in any marketplace.

We do believe the key is to getting in there face-to-face, educating them on the product profile, and getting them to start using the product.

What I'd say is one of the approaches that we've been taking pretty much since the beginning, of the year with HCPs who don't have experience with Epidiolex, or we believe are under-utilizing it in their practice, is we're leveraging the fact that this is a category that naturally utilizes polypharmacy. We're highlighting data that we have on the synergistic effect of using Epidiolex in combination with Clobazam. Clobazam is a product that's already on board in the vast majority of patients.

We have found that by sharing these data with these HCPs that have yet to utilize Epidiolex at all or robustly, is that they've been highly, impressed with the data as they demonstrate an ability to reduce the number of seizures in both LGS and Dravet syndrome by more than 60%, which is an efficacy number that's a very uncommon outcome, and they recognize this the moment we share that data.

It's a very promotionally sensitive market. We're encouraged that our sales force has had increased access to offices and treatment centers in recent months, and we're really confident that our level of promotion is going to continue to increase in the second half of the year.

We've got a strong set of data to try to really move those slower adopters into trying Epidiolex.

Thank you.

One moment for our next question.

Our next question comes from Gary Nashman, with DMO.

Your line is open.

Thanks.

Good afternoon.

So, Riley's was really strong in 2Q.

Any unusual stocking in there in the quarter?

Does that all reflect demand?

You mentioned that docs are switching patients back earlier if they have a reaction to asparagine, so can you expand on that dynamic?

And how should we think about that run rate from here, especially if you get Monday, Wednesday, Friday, those things?

Yeah, Gary, thanks for the question.

You know, we could not be more pleased with where we, are just a couple quarters into the Ryleigh's launch and how quickly we think physicians have moved to the best possible treatment paradigm for these ALL patients.

Kim, maybe I'll let you answer as to whether there was any unusual stocking and how we think about, this run rate for Ryleigh's.

No, I don't think we saw anything unusual, you know, going on this quarter.

You know, I think current utilization in the U.S. is, you know, outperforming.

If you look at the numbers, the peak that we experienced with Erwin AIDS, you know, reinforcing the impact that, you know, supply constraints had on providing optimal patient care.

And we think that really the demand trend we're seeing, you know, reflects not only the increased brand awareness and familiarity of Ryleigh's with customers, and its position in the market is the only available therapy right now for patients who have a hypersensitivity reaction to E. coli-derived asparaginase.

You know, but really at this point, we think a lot of it has to do with the things that Dan, highlighted in terms of, you know, we see customers who had put in place, you know, asparaginase sparing activities such as desensitization and re-challenge practices are now telling us and we're seeing through ordering patterns that they are, you know, stopping those practices and they're starting to utilize Ryleigh's instead.

So, all that very positive signals that the market is excited about Ryleigh's and ready to get back to, you know, optimal practices.

And Kim, just to add on, this is Dan.

We do have global rights to the product and, as we updated on the call, we did complete our submission to the EMA in the second quarter.

You know, market dynamics are a little different there, Erwin AIDS is on the market.

But again, we think with our fully recombinant and, you know, easier to administer and, you know, already in a formulation but also, you know, importantly, we studied it into a, you know, an updated 25-25-50 dosing schedule that optimizes asparaginase levels through patients.

So, we look forward to that being on the market in 2023 in Europe and then we're assessing other marketplaces including Japan.

Thank you.

One moment for our next question.

Our next question comes from Madhu Kumar with Goldman Sachs.

Your line is open.

Hey, everyone.

Thanks for taking our questions.

Is it around geographic expansion, indication expansion, or kind of just like expansion of the on-board prescriber's use of the drug kind of off the lines of tumor resistant epilepsy?

Dan, you want to take global opportunity for epidiolex and where we see that going?

Yeah, sure.

I mean, I'd say yes to everything you just referenced.

I mean, there's plenty, of headroom in the current indications as we think about the combination of Clovisam.

Clovisam is much more broadly used right now than, you know, than Epidiolex.

And we do, have continued data generation across different seizure types, as well as sharing real world evidence from the medical records.

And then importantly, ex US, we're at 14 of 34 countries in terms of launches, you know, France, just pending this year and opportunity for us to move more broadly into Asia as well.

So, you know, we're super excited by what this brand can do long term.

It's a cornerstone unique mechanism, very combinable.

And we've seen, for example, with Clovisam, enhanced anti-seizure activity, which is always, you know, sort of the critical factor for these patients.

Thank you.

One moment for our next question.

Our next question comes from Ami Fadia with Needham.

Your line is open.

Hi, good evening.

Thanks for taking my question.

Going back to adipathic hypothermia, can you, give us some more color around the market dynamics?

Where are these patients coming from in terms of who are the prescribers?

Are they existing Xyrem or Xyve prescribers for narcolepsy?

And if you could give us some color of what percent of your existing prescribers for narcolepsy have prescribed a patient for IH.

And also give us a sense of the patient journey, especially given the fact that there haven't been other treatments for IH available in the market.

So how often are these patients going back to their physicians seeking treatment or something new?

That would be helpful.

Thank you.

Yeah, Kim, do you want to provide any additional information on overlap of prescribing positions, and maybe pattern of when patients see their physicians?

Yeah, I don't believe we have that data to share, Bruce.

Maybe somebody can let me know if they, feel otherwise.

But in terms of how frequently patients are seeing their doctor, we see that typically out there in the marketplace, what we hear is an idiopathic hypersomnia visits their doctor twice a year.

Really the main statistic that we have about the HCP populations is that in terms of potential and where the IH patients are receiving treatment, there's 90% overlap in terms of where the patients reside and which HCP offices.

But I don't have data at this time in terms of what percentage of physicians have prescribed for both IH and narcolepsy.

Thank you.

One moment for our next question.

Our next question comes from Gregory Renton with RBC.

Your line is open.

Great, thanks Bruce and team for taking my question and congrats on the quarter.

Bruce, I just wanted to touch back again just once more on Epidiolex.

I'm just curious, just in the context of the competitive landscape with respect to developmental therapies, I'm just curious if you could comment a bit on Epidiolex, maybe longer term, just given there have been some positive developments and some setbacks amongst the landscape of late.

You certainly commented on combination and cycling, but any added thoughts as that landscape even evolved would be great.

Thank you very much.

Yeah, I would just remind people that the conditions we're treating with Epidiolex are very severe epilepsies, very treatment refractory, and patients have often tried a number of therapies before they get to Epidiolex.

Of course, we've seen benefit and a good safety profile with Epidiolex, so that is patients, their families, and physicians continue to seek both better seizure control and just overall better results for their child.

They tend to stay on Epidiolex even if they might rotate off or try a different therapy.

I'm personally heartened that there are continued developments that might offer additional relief to these patients, give them more things to put into the armamentarium of agents to try, but we haven't seen anything yet on the horizon that strikes us as reducing the opportunity for Epidiolex.

We may see benefits of combined treatment, much like you heard touched on in Kim's comments about Clobazam a little bit earlier.

Lots of room for improvements on current results from these patients, and some of our evidence generation and additional trials is to continue to bring out that benefit, whether that's in another seizure type like EMOS or whether that's just better elucidating what we are seeing in patients treated with Epidiolex.

Rob, maybe I could ask you to jump in just from a physician perspective about treatment of these childhood-onset seizure disorders, and how you see that going forward.

Sure.

Happy to, Bruce.

It's clear that Epidiolex has been very effective in these groups of highly refractory epilepsy, both in terms of seizure reduction and other measures around seizure frequency, seizure-free days, for example, but also in terms of overall well-being.

Last year's AES, we showed a caretaker survey where there was clearly benefits observed outside of just measures of epilepsy itself, so becoming a cornerstone for therapy. As you mentioned, the safety profile allows for combining with other therapies.

So at the moment, physicians, practitioners continue to have a lot of enthusiasm about it, and to the extent that there are new drugs coming into these spaces, probably thinking about it more in terms of another add-on to be combined rather than to replace, and what's a pretty highly...

Operator, I think we probably have time for one more question.

Our last question comes from Ashwani Verma with UBS.

One moment.

Sorry, I was going to ask, like, on Libixymol, anything that you can share from the Phase, 3, this release MSS-1 trial?

I understand that you didn't see statistically significant benefits, but did you see directional benefits?

Yeah, Rob, do you want to jump in on data from the recently top-line unblinded Libixymol, trial?

Yeah, we haven't given further details on that, and we certainly are combing through, the data in greater detail to understand what we can learn from this and how that might ultimately impact the rest of the program, if it does at all.

So, nothing more to add at this time.

Yeah, Nash, I'll just remind you that this is not the first trial ever done at Libixymol, so we're looking back across all trials with the agent, as well as our ongoing trials to chart the best course forward.

So, with that, maybe we'll wrap up the call, and I'll thank everyone for joining us.

You, know, we're really excited about the upcoming opportunities across our business as we continue to drive growth and shareholder value.

You know, we remain on track and focused on achieving Vision 2025, and, as always, I'd love to close today's call by recognizing all of our Jazz, colleagues for their commitment to delivering new therapeutic options.

Ladies and gentlemen, this concludes today's presentation.

I'd like to thank our partners and our shareholders for their continued confidence and support.

Thank you all for joining us today.

Ladies and gentlemen, this concludes today's presentation.

You may now disconnect and have, a wonderful day.

Q2 2022 Jazz Pharmaceuticals PLC Earnings Call

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