Q1 2021 Jazz Pharmaceuticals PLC Earnings Call

Welcome to the jazz Pharmaceuticals plc first quarter 2021 earnings conference call. Following on introduction from the company will open the call to questions.

Operator: Welcome to the Jazz Pharmaceuticals PLC first quarter 2021 earnings conference call. Following an introduction from the company, we will open the call to questions. I will now turn the call over to Andrea Flynn, Head of Investor Relations at Jazz Pharmaceuticals. Thank you.

I'll turn the call over to Andy <unk> head of Investor Relations at Jazz Pharmaceuticals. Thank you. Please go ahead.

Thank you and good afternoon, everyone. Today, we reported our first quarter 2021 financial results. The press release and slide presentation accompanying this webcast are available on the investors section of our web site.

Andrea Flynn: Thank you and good afternoon, everyone. Today we reported our first quarter 2021 financial results. The press release and slide presentation accompanying this webcast are available in the investors section of our website. On the call today are Bruce Cozadd, Chairman and Chief Executive Officer, Rene Gala, Executive Vice President and Chief Financial Officer, Dan Swisher, President and Chief Operating Officer, and Rob Iannone, Executive Vice President, R&D, and Chief Medical Officer. Joining the Q&A are Kim Sablich, Executive Vice President, General Manager of North America; Phil Jochelson, Neuroscience Therapeutic Head, and Ann Borgman, Hematology and Oncology Therapeutic Head.

On the call today are Bruce code that chairman and Chief Executive Officer, Renee Gala Executive Vice President and Chief Financial Officer, Dan Swisher, President and Chief operating Officer, and Rob you known Executive Vice President R&D and Chief Medical Officer.

Joining the Q&A or Kimzey book Executive Vice President General manager of North America fell Jakobsen neuroscience therapeutic head and Anne Borgman, hematology and oncology therapeutic head.

On slides two and three I'd like to remind you that today's webcast includes forward looking statements such as those related to our future financial and operating results and the transaction to acquire GW pharmaceuticals, which involve risks and uncertainties that could cause actual events performance and results to differ materially. We encourage you to review the statements contained in today's press release and on our latest.

Andrea Flynn: On slides two and three, I'd like to remind you that today's webcast includes forward-looking statements, such as those related to our future financial and operating results and the transaction to acquire GW Pharmaceuticals, which involve risks and uncertainties that could cause actual events, performance, and results to differ materially. We encourage you to review the statements contained in today's press release and in our latest SEC disclosure document, which identifies certain factors that may cause the company's actual results to differ materially from those projected. We undertake no duty or obligation to update our forward-looking statement.

C C disclosure document, which identify certain factors that may cause the company's actual results to differ materially from those projected.

We undertake no duty or obligation to update our forward looking statements on this webcast, we'll discuss non-GAAP financial measures reconciliations of GAAP to non-GAAP financial measures are included in today's press release and slide presentation on the.

Andrea Flynn: On this webcast, we'll discuss non-GAAP financial measures. Reconciliations of GAAP to non-GAAP financial measures are included in today's press release and slide presentation. I'll now turn the call over to Bruce.

Now I'll turn the call over to Bruce.

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

Bruce C. Cozadd: Thanks, Andrea. Good afternoon, everyone, and thank you for joining us today. I'll start with slide five.

I'll start on slide five.

Following an incredibly productive 'twenty 'twenty. We have continued this momentum into 2021 with sustained operational excellence across our commercial and R&D organizations.

Bruce C. Cozadd: Following an incredibly productive 2020, we have continued this momentum into 2021 with sustained operational excellence across our commercial and R&D organizations, positioning us to achieve multiple milestones during the remainder of the year. Our transformation to an innovative, high-growth biopharma company is well on its way. In February, we announced our planned acquisition of GW Pharmaceuticals, which is on track to close early this year. This acquisition positions Jazz as an industry leader in neuroscience with a global commercial and operational footprint.

Turning us to achieve multiple milestones during the remainder of the year.

Our transformation to an innovative high growth Biopharma company is well on its way.

In February we announced our planned acquisition of GW Pharmaceuticals, which is on track to close early this month.

This acquisition positions jazz as an industry leader in neuroscience with a global commercial and operational footprint.

The addition of GW further diversifies, our commercial portfolio and pipeline with therapies that are complementary to our existing business jazz.

Bruce C. Cozadd: The addition of GW further diversifies our commercial portfolio and pipeline with therapies that are complementary to our existing business. Jazz and GW also share a common culture, built around the same mission, innovating to transform the lives of patients. We look forward to building an even stronger company together with our GW colleagues and are excited about the greater impact we will continue to drive for patients, customers, and shareholders. Rene and her team have secured financing to support the acquisition and done a fantastic job executing a very favorable debt structure.

So on G. W. Also share a common culture built around the same mission innovating to transform the lives of patients.

We look forward to building, an even stronger company together with our GW colleagues and are excited about the greater impact we will continue to drive for patients customers and shareholders.

Renee and her team have secured financing to support the acquisition and done a fantastic job in executing a very favorable debt structure she'll provide more color around that as well as our plans to provide updated guidance for the combined jazz GW enterprise later in the call.

Bruce C. Cozadd: She'll provide more color around that, as well as our plans to provide updated guidance for the combined jazz GW enterprise later in the call. As we progress toward the completion of the GW transaction, in parallel, we have delivered on key milestones in the first quarter. We continue to see strong adoption of Xiwa. Dan will discuss our commercial efforts in more detail shortly, but I want to highlight that there were approximately 3,900 active ZyWave patients exiting in the first quarter.

As we progress toward the completion of the GW transaction in parallel we have delivered on key milestones in the first quarter.

We continue to see strong adoption of sideways.

Dan will discuss our commercial efforts in more detail shortly but I want to highlight that there were approximately 3900 active XI ways patients exiting the first quarter.

We view this as a very positive indication that physicians and patients appreciate the benefits of a lower sodium oxidate option.

Bruce C. Cozadd: We view this as a very positive indication that physicians and patients appreciate the benefits of a lower sodium oxidate option. It is our view that ZyWave will be the oxibate therapy of choice as the only lower sodium product once multiple higher sodium oxibate products are available. And we continue to expect that a majority of oxibate patients across all approved indications will be on ZyWave in 2023. I specifically call out all indications because we are preparing for potential FDA approval and commercial launch of Zywave in idiopathic hypersomnia or IH later this year.

It is our view that sideways will be the oxalate therapy of choice as the only lower sodium product once multiple higher sodium oxo based products are available and we continue to expect that a majority of oxalate patients across all approved indications will be on XI wave in 2023.

I, specifically call out all indications because we are preparing for potential FDA approval and commercial launch of XI wave in idiopathic hypersomnia or I H later this year.

Bruce C. Cozadd: This is an area of high unmet need, with no FDA-approved therapy, and we are excited for this opportunity to bring a new treatment option to people with IH. Turning to Zepzelka, we are seeing continued growth in the second line setting in both platinum-sensitive and platinum-resistant patients as we move toward our target of Zepzelka becoming standard of care in the relapsed setting. Zepzelka is providing an important therapeutic option for patients with small cell lung cancer, and we expect to see continued growth over the course of the year.

This is an area of high unmet need with no F. D. A approved therapies and we're excited for this opportunity to bring a new treatment option to people with IH.

Turning to his up Zilkha, we're seeing continued growth in the second line setting in both platinum sensitive and platinum resistant patients as we move toward our target of Zips Orca, becoming standard of care in the relapsed setting.

Net zilkha is providing an important therapeutic option for patients with small cell lung cancer, and we expect to see continued growth over the course of the year.

Bruce C. Cozadd: As we exit the first quarter, Zywave and Zepzelka are making a significant contribution to our revenue diversification target, with 23% of product sales in the quarter already coming from recently launched products. Another important therapy in our oncology portfolio is JCP-458 for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who have developed hypersensitivity or silent inactivation to coli-derived asparaginase.

As we exit the first quarters I wave ends up zilkha are making a significant contribution to our revenue diversification targets with 23% of product sales in the quarter already coming from recently launched products.

Another important therapy in our oncology portfolio is J C. P $4 58 for patients with acute lymphoblastic leukemia, and lymphoblastic lymphoma, who have developed hypersensitivity or silent in activation to E coli derived asparaginase.

We initiated a regulatory submission for <unk> would be 458 under F. D. A real time oncology review in December.

Bruce C. Cozadd: We initiated a regulatory submission for JCP-458 under FDA Real-Time Oncology Review in December. We believe that JCP-458 will enable us to provide a high-quality therapeutic option with reliable supply to these patients and are preparing for a mid-2021 launch upon FDA approval. It is important to note that in addition to successfully taking Zywave through development to commercialization in Narcolepsy, we have also advanced ZyWave NIH and JCP 458 from concept to commercial readiness.

We believe the J C. P for 58 will enable us to provide a high quality therapeutic option with reliable supply to these patients and are preparing for a mid 2021 launch upon FDA approval.

It is important to note that in addition to successfully taking XI waves through development to commercialization in narcolepsy. We have also advanced sideways in I H and J C. P for 58 from concept to commercial readiness, demonstrating our team's maturing R&D capabilities.

Bruce C. Cozadd: Demonstrating our team's maturing R&D capabilities. These capabilities are being leveraged across our robust pipeline, which will include several additional clinical stage development programs following the completion of the GW transaction. I'll now turn the call over to Dan for an overview of our commercial performance, after which Rob will provide an update on progress across our R&D program. Rene will close our prepared remarks with a financial overview, and then we'll open the call to questions. Ann?

These capabilities are being leveraged across our robust pipeline, which will include several additional clinical stage development programs. Following the completion of the GW transaction.

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

Thanks Bruce.

Daniel N. Swisher: Thanks, Bruce. I'm excited to share the progress across our commercial portfolio. I'm going to begin with neuroscience on slides 7 and 8, and then discuss our combined Octobate franchise, including Xyrem and Xywave. Net product sales for the Oxybate franchise were $411 million, 1% higher than the same period in 2020, including Zywave net product sales of $75 million. In the first quarter, average active Oxybate patients increased to approximately 15,700, a 4% increase over the same period last year and a 2% increase over the prior quarter. This quarter, we continue to see strong

I'm excited to share the progress across our commercial portfolio.

I'm going to begin with neuroscience on slides seven and eight.

And first discuss our combined oxidate franchise, including Xyrem and <unk> net.

Net product sales for the oxalate franchise were 411 million, 1% higher than the same period in 2020.

Including XI with net product sales of $75 million.

In the first quarter average active oxidate patients increased to approximately 15700, a 4% increase over the same period last year and a 2% increase over the prior quarter.

This quarter, we continued to see strong adoption of xylem as Bruce noted we ended the quarter with approximately 3900 active <unk> patients. This is up from approximately 1900 at the end of the year.

Daniel N. Swisher: As Bruce noted, we ended the quarter with approximately 3,900 active Zywave patients. This is up from approximately 1,900 at the end of the year. A key component of our launch initiatives is to educate physicians and patients about the lifelong burden of high sodium intake, as well as how the use of Zywave enables them to address what is a modifiable risk factor. We're pleased that this message is responding so well with both audiences. I'm going to stay on slide 7, but for reference, we've included further detail on why sodium intake matters on slide 8.

A key component of our launch initiatives is to educate physicians and patients about the lifelong burden of high sodium intake as well as how the use of XI wave enables them to address what is a modifiable risk factor.

We're pleased that this message is resonating so well with both audiences.

I'm going to stay on slide seven that for reference we've included further detail on why sodium intake matters on slide eight.

Importantly, we're seeing strong Z wave adoption among existing app.

Daniel N. Swisher: Importantly, we're seeing strong Zywave adoption among existing and new-to-oxibate patients. Specific to existing Oxivate patients, our market research and reports from the field highlight that many physician offices are comfortable with seamlessly transitioning patients over to Zywave. For existing XyRim patients, they are receiving information about XyWave availability along with their product shipments from the specialty pharmacy. We have also seen an increase in in-person field engagement with our target HTPs recently.

And new to activate patients.

Specific to the existing obsidian patients our market research and reports from the field highlights that many physician offices are comfortable with seamlessly transitioning patients over to <unk> for.

For existing Xyrem patients, they're receiving information about XI with availability along with their product shipments from the specialty pharmacy.

We have also seen an increase of in person field engagement with our target Hcp's recently.

Daniel N. Swisher: Coupled with strong adoption, we've made excellent progress with payers. Meeting our goal to obtain broad payer coverage within six months of launch, we now have agreements in place with multiple payers, including three major PBMs.

Coupled with strong adoption, we've made excellent progress with payers.

Meeting our goal to obtain broad payer coverage within six months of launch.

We now have agreements in place with multiple payers.

Holding three major Pbms are coverage overall is currently at 80% of covered commercial lives.

Daniel N. Swisher: Our coverage overall is currently at 80% of covered commercial lives, and our team is working with payers to continue to expand coverage. So looking ahead, we are preparing for the planned fourth quarter launch of Zywave and Idiopathic Hypersomnia. There are no FDA-approved treatments for IH, and we have the opportunity to improve treatment for people with a debilitating sleep disorder.

Our team is working with payers to continue to expand coverage.

So looking ahead, we are preparing for the planned fourth quarter launch of XI wave in idiopathic hypersomnia.

There are no FDA approved treatments for IH, and we have the opportunity to improve treatment for people with this debilitating sleep disorder.

Daniel N. Swisher: For a more detailed discussion of the opportunity in IH, I would refer investors to our April 20th webcast where we provided a review of the Phase III Zywave IH data presented at this year's American Academy of Neurology Annual Meeting and commentary around the IH opportunity. Moving with Synosy, first quarter net product sales were $12 million compared to $2 million in the same period last year and $9 million in the fourth quarter of 2020.

For a more detailed discussion of the opportunity and IH I wouldn't I would refer investors to our April 20th webcast well, we provided a review of the phase III XI wave IH data presented at this year's American Academy of Neurology annual meeting.

And commentary around the IH opportunity.

Moving to Sanofi first quarter net product sales were 12 million compared to $2 million on the same period last year and $9 million in the fourth quarter of 2020.

Daniel N. Swisher: Prescriptions in the first quarter increased 10% in the U.S. compared to the prior quarter, and we are encouraged by recent demand and growth trends, including an increase in first-time prescribers and an increase in patients new to Cynosi therapy. We're continuing to invest in the promotion of Sanosi, including our expanded and dedicated sales force in the ongoing direct-to-consumer TV campaign, which began early this year in the U.S. We're also pleased with the progress of our ongoing rolling European launches of CENOSI.

Prescriptions in the first quarter increased 10% in the U S compared to the prior quarter.

We're encouraged by recent demand and growth trends, including an increase in first time prescribers and an increase in patients new to Sanofi therapy.

We're continuing to invest in the promotion of Sanofi, including our expanded and dedicated sales force and the ongoing direct to consumer television campaign, which began early this year in the U S.

We're also pleased with the progress of our ongoing rolling European launches of Sanofi.

So now turning to our oncology portfolio on slide nine we continue to see strong demand for <unk> with net product sales of $54 million in the first quarter.

Daniel N. Swisher: So now turning to our oncology portfolio on slide nine, we continue to see strong demand for Zep Zelka with net product sales of $54 million in the first quarter. There has been significant patient growth and uptake across both community and academic settings and in both platinum sensitive and platinum resistant patients.

There has been significant patient growth in uptake across both community and academic settings and in both the platinum sensitive and platinum resistant patients.

Notably we are seeing continued strong growth in second line market share.

Daniel N. Swisher: Notably, we are seeing continued strong growth in second-line market share. In the first quarter of VIXIOS, net product sales were $33 million, an increase of 1% compared to the same period in 2020. We continue to support the growth of XPS with ongoing development and commercial activities as well as expansion into new international markets. For Defitilio, we saw net product sales of $50 million, an increase of 5% over the same period last year.

In the first quarter of this year net product sales were $33 million, an increase of 1% compared to the same period in 2020.

We continue to support the growth of the FCS with ongoing development and commercial activities as well as expansion into new international markets.

For deathbed failure, we saw net product sales of $50 million, an increase of 5% over the same period last year.

First quarter <unk> net product sales were $41 million, 9% above the same period in 2020.

Daniel N. Swisher: First quarter Erwin H. Neck product sales were $41 million, 9% above the same period in 2020. For our agreement with PBL, which terminated at the end of 2020, we expect to have supply of Irwin Ace in the U.S. and other select markets through the first half of this year. Given the urgent need for a reliable and high-quality recombinant asparaginase, we remain focused on bringing JCP458 to market as quickly as possible. Our commercial team is currently preparing for the U.S. launch upon FDA approval, which we are anticipating for mid-year.

For our agreement with PVA, which terminated at the end of 2020, we expect to have supply of her when ace in the U S and other select markets through the first half of this year.

Given the urgent need for reliable and high quality, we're confident asparaginase, we remain focused on bringing Jay Z P for a five day to market as quickly as possible. Our commercial team is currently preparing for the U S launch upon FDA approval, which we are anticipating for mid year.

In summary, our continued performance has led to a strong start to 2021, we remain focused on execution across our operating teams, including the continued progress of our recent product launches and the successful execution of our upcoming planned launches for <unk>.

Daniel N. Swisher: In summary, our continued performance has led to a strong start to 2021. We remain focused on execution across our operating teams, including the continued progress of our recent product launches and the successful execution of our upcoming planned launches for JCP458 and Zywave NIH. I'm now going to turn the call over to Rob for an update on our...

<unk> 458, and XI with NIH I'm now going to turn the call over to Rob for an update of our development programs Rob.

Robert Iannone: For an update on our development programs. Rob? Thank you, Dan. I'll start on slide 11.

Thank you Dan I'll start on slide on women and.

Robert Iannone: In the first quarter, we continued to make significant progress across our R&D efforts. Our two near-term areas of focus are Zywave for idiopathic hypersomnia and JCB458. In April, we announced that the FDA granted priority review and set a PDUFA action date of August 12th of this year for Zywave and i8. As Dan mentioned, at the American Academy of Neurology Annual Meeting, we presented compelling Phase 3 clinical trial results, which were foundational to our supplemental NDA submission.

The first quarter, we continued to make significant progress across our R&D efforts are two near term areas of focus on XI wave Pathic hypersomnia.

JCB 458.

In April we announced that the FDA granted priority review and set up to do for action date August 12 of this year for XI wave two high H.

As Dan mentioned at the American Academy of Neurology annual meeting, we presented compelling phase III clinical trial results.

Which are foundational to our supplemental NDA submission.

The overall results of the trial was striking highly statistically significant and clinically meaningful for all pre specified endpoints.

Robert Iannone: The overall results of the trial were striking, highly statistically significant, and clinically meaningful for all pre-specified, both clinical measures and patient-reported outcomes. I also want to take a moment to stress that IH is a debilitating disorder with no FDA-approved therapy. Patients are often consumed by sleep and exhibit sleep inertia, brain fog, poor memory, and episodes of microsleep.

Clinical measures and patient reported outcomes.

I also wanted to take a moment to stress that IH is a debilitating disorder with no FDA approved therapies.

Patients are often consumed by sleep and exhibit sleep inertia brainfag poor memory and episodes of Microsleep.

Robert Iannone: The impact of the condition has severe consequences professionally, socially, and in patients' daily lives. We are excited about the potential of XyWave to provide a much needed therapeutic option to people living with IA. Now turning to our oncology development programs on slide 12, I'll start with Densel. We continue to work on the development program in collaboration with our partner pharmacy. Robust Data Generation in Combination with Other Therapies in Small Cell Lung Cancer as Well as in Other Tumor Tumors. This includes a phase three trial evaluating first-line use in combination with immunotherapy as maintenance therapy compared to immunotherapy alone in patients with extensive stage small cell lung cancer after induction chemotherapy. Moving to JZP 458

The impact of the condition is severe consequences professionally socially and patients' daily lives we.

We are excited about the potential of <unk> to provide a much needed therapeutic option to people living with IH.

Now turning to our oncology development programs on slide 12, I'll start with net okay.

We continue to work on the development program in collaboration with our partner farming.

To support robust data generation in combination with other therapies in small cell lung cancer as well as in other tumor types.

This includes a phase III trial evaluating first line use in combination with immunotherapy as maintenance therapy comparing to immunotherapy alone.

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

Moving to GGP for a five day in December we initiated a BLA submission to the FDA under real time oncology review.

Robert Iannone: In December, we initiated a BLA submission to the FDA under real-time oncology review. We are working closely with the FDA to complete the BLA submission and remain on track for a mid-2020 wind launch in the U.S. As a reminder, there are two parts to this trial. The first part, which has completed enrollment, evaluated the intramuscular administration of JZP 458. The second part, which opened in February and is currently enrolling participants, is evaluating the intravenous administration of JVP456.

We're working closely with the FDA to complete the BLA submission and remain on track for mid 2021 launch in the U S.

As a reminder, there are two parts to this trial the first part which has completed enrollment.

<unk> Intramuscular administration of JCB 458.

The second part, which.

Which opened in February and is currently enrolling participants is evaluating intravenous administration of GBP four five day.

We're also working on our regulatory strategy in Europe, and Canada as well as our approach in Japan.

Robert Iannone: We are also working on our regulatory strategy in Europe and Canada, as well as our approach in Japan. We anticipate that the data from our current development program for JCP 458 will support our efforts to seek approval in Europe and Canada, and we will be confirming these plans with regulators later in the year.

We anticipate that the data from our current development program for <unk> for a five day will support our efforts to seek approval in Europe, and Canada, and we will be confirming these plans with regulators later in the year.

As we've previously noted the results of the Atlantis trial.

Robert Iannone: As we previously noted, the results of the ATLANTIS trial,

We inform them are met with FDA to share topline results.

Robert Iannone: We inform them that we met with the FDA to share top-line results. We anticipate meeting with the FDA again later this quarter to determine the appropriate confirmatory trial. For Vixios, the FDA recently approved a revised label for AML to include pediatric patients aged one year and above. We have also submitted an application to European regulatory authorities, and the potential for approval in Europe later this year. While pediatric patients represent a relatively small proportion of AML cases, there is a critical need for more effective therapies in this setting, and the approval demonstrates our commitment to the often overlooked groups with high unmet needs. With that, I'll turn the call over to Rob. Thanks, Rob.

Anticipate meeting with the FDA again later this quarter to determine the appropriate confirmatory trial package.

On <unk> the FDA recently approved the revised label for AML to include pediatric patients aged one year on a boat.

We also submitted an application to European regulatory authorities and with potential for approval in Europe later this year.

On pediatric patients represent a relatively small portion of the AML cases.

A critical need for more effective therapies in the setting and the approval demonstrates our commitment.

To the often overlooked groups with high unmet need.

With that I'll turn the call over to Rene.

Thanks Ross.

I'm very pleased to share our financial results for the first quarter of 'twenty, 'twenty, one, which demonstrate continued topline revenue growth.

Rene D. Gal: I'm very pleased to share our financial results for the first quarter of 2021, which demonstrate continued top-line revenue growth, including a meaningful contribution from our recently launched product. In particular, our strong Q1 performance was driven by Zywave adoption and Zepselka growth. On today's call, I'll highlight several key items from the quarter.

<unk> a meaningful contribution from our recently launched products.

In particular, our strong Q1 performance was driven by XI wave adoption and <unk> growth.

On today's call I'll highlight several key items from the quarter.

Rene D. Gal: Full financial results are available in our press release and our 10-Q. As shown on slide 14, total revenues of $608 million represented an increase of 14% in the first quarter of 2021 compared to the same period in 2020. In the first quarter, we were pleased to see significant adoption of ZyWave and substantial growth in our oncology portfolio. A key point to note.

Full financial results are available in our press release and our 10-Q.

As shown on slide 14 total revenues at $608 million represented an increase of 14% in the first quarter of 2021 compared to the same period in 2020.

In the first quarter, we were pleased to see significant adoption on sideways and substantial growth in our oncology portfolio.

A key point to note our efforts to diversify revenue are being realized with 23 per cent of net product sales in the quarter coming from newly launched products.

Rene D. Gal: Our efforts to diversify revenue are being realized, with 23% of net product sales in the quarter coming from newly launched products. Cash from operations also increased compared to the first quarter of 2020, with $285 million generated by the business. We remain focused on maintaining strong cash generation while continuing to invest in the commercial launches of ZyWave, Zepselka, and Synosy and the upcoming planned launches of ZyWave and IH and JZP458. We ended the quarter with $2.4 billion in cash, further strengthening our financial position as we prepare to close the GW transaction.

Cash from operations also increased compared to the first quarter of 'twenty 'twenty with $285 million generated by the business.

We remain focused on maintaining strong cash generation, while continuing to invest in the commercial launches on sideways that soccer in San Jose and the upcoming planned launches of Sideway, then I H and J C. P $4 58.

We ended the quarter with $2.4 billion in cash.

Further strengthening our financial position as we prepare to close the GW transaction.

Rene D. Gal: Turning to slide 15, I'd like to expand on the impact and current status of the GW transaction, and also provide some commentary around guidance. GW adds a high-growth commercial product to our portfolio, multiple clinical stage programs, and importantly, the cannabinoid research, development, commercialization, and manufacturing expertise of the GW team.

Turning to slide 15, I'd like to expand on the impact on current status of the GW transaction.

And also provide some commentary around guidance.

GW as a high growth commercial product to our portfolio.

Multiple clinical stage programs and importantly, the cannabinoid research development commercialization and manufacturing expertise of the GW team.

This transaction is consistent with our overall business and capital allocation strategy to expand our neuroscience portfolio ex.

Rene D. Gal: This transaction is consistent with our overall business and capital allocation strategy to expand our neuroscience portfolio, accelerate and diversify our revenue growth, and drive substantial value for our shareholders. We are pleased that GW shareholders voted to approve the acquisition on April 23rd. The scheduled date for the hearing of the High Court of Justice of England and Wales to sanction the acquisition is tomorrow, May 5th, and pending a positive decision, we expect to close the transaction in early May.

Celebrate and diversify our revenue growth and drive substantial value for our shareholders.

We are pleased that GW shareholders voted to approve the acquisition on April 23rd.

The scheduled date for the hearing at the high Court of Justice of England and Wales.

Thanks, and the acquisition is tomorrow May 10.

And pending a positive decision we expect to close the transaction in early may.

Rene D. Gal: To support the acquisition, we successfully secured financing of $1.5 billion in senior secured notes and a $3.85 billion term loan for a total of $5.35 billion. We were pleased with the strong demand in the market and favorable terms of this non-dilutive financing.

To support the acquisition, we successfully secured financing of $1.5 billion in senior secured notes.

A $3.85 billion term loan for a total of $5.35 billion.

We were pleased with the strong demand on the market and favorable turns on this non dilutive financing.

Inclusive of this new debt, we're on track to meet our post acquisition target of total weighted average cost of debt of less than 4%.

Rene D. Gal: Inclusive of this new debt, we're on track to meet our post-acquisition target of total weighted average cost of debt of less than 4%. We now expect Net Leverage at Close to be approximately five times, with a rapid de-de-de-de-levering plan to meet our target of less than three and a half times by the end of 2022. While we will be aggressive in deleveraging.

We now expect net leverage at close to be approximately five times.

With rapid deleveraging plan to meet our target of less than three and a half times.

At the end of 'twenty 'twenty two.

While we will be aggressive on deleveraging.

We will also continue to make investments to grow the business.

Rene D. Gal: We will also continue to make investments to grow the business. The GW transaction is expected to accelerate our double-digit top-line revenue growth, be EPS accretive in 2022, the first full calendar year of combined operations, and substantially accretive thereafter. As we've progressed our integration work with our new colleagues at GW, our excitement about this transaction has only increased. Leveraging the combined talents and expertise of the Jazz and GW Global teams, we have the opportunity to develop and launch differentiated therapies that deliver real value to patients. Turning to Guidance.

The GW transaction is expected to accelerate our double digit topline revenue growth.

Be EPS accretive in 'twenty 'twenty two the first full calendar year of combined operations and substantially accretive thereafter.

As we've progressed our integration work with our new colleagues at GW, our excitement about this transaction has only increased.

Leveraging the combined talents and expertise at the jazz and GW of global teams, we have the opportunity to develop and launch differentiated therapies that deliver real value to patients.

Turning to guidance the on.

Rene D. Gal: The underlying jazz business remains on track and is performing in line with our expectations, and we are reiterating our previously communicated jazz standalone financial guidance for 2021. As a reminder, total revenue guidance is in the range of $2.5 to $2. Non-gap adjusted net income and EPS are in the ranges of $915 to $985 million and $15.65 to $15.65, respectively.

Underlying jazz business remains on track and is performing in line with our expectations and we are reiterating our previously communicated jazz Standalone financial guidance for 2021.

As a reminder, total revenue guidance is in the range of 2.55 to $2 $7 billion and non-GAAP adjusted net income and EPS are in the ranges of $915 million to $985 million and $15 six.

<unk> five cents to $16.85 respectively.

We plan to provide 2021 financial guidance for the combined jazz GW organization.

Rene D. Gal: We plan to provide 2021 financial guidance for the combined JazzGW organization following the close of the transaction. This guidance will include the addition of GW from the date of close through year end, which we expect to be approximately eight months. I'll close on slide 16.

Knowing the close of the transaction.

This guidance will include the addition of G. W. From the date of close through year end, which we expect to be approximately eight months.

I'll close on slide 16.

We are on track to deliver our 2021 goals.

Rene D. Gal: We are on track to deliver our 2021 goals. Our commercial team has done an outstanding job with the recent launches of Zywave and Zepselka. We are seeing strong momentum for Synosy growth globally and are preparing for two additional launches this year. The R&D organization continues to advance novel therapies with two programs under review by the FDA and three mid and late stage clinical trials slated to begin later this year. The GW acquisition will contribute to both our commercial portfolio and our clinical stage pipeline.

Our commercial team has done an outstanding job on the recent launches of Sideway then that's alka.

We are seeing strong momentum for Sanofi growth globally and are preparing for two additional launches this year.

The R&D organization continues to advance novel therapies with two programs under review by the FDA and three mid and late stage clinical trials slated to begin later this year.

The GW acquisition will contribute to both our commercial portfolio and clinical stage pipeline.

Following the acquisition, we will be well positioned to reach our goal of generating 65% of our 'twenty 'twenty two revenues from products that had been launched or acquired since 2019.

Rene D. Gal: Following the acquisition, we will be well positioned to reach our goal of generating 65% of our 2022 revenues from products that have been launched or acquired since 2019. We are continuing our transformation to an innovative, high-growth biopharmaceutical company and achieved a number of significant milestones in the first quarter that contribute to that goal. We are excited about the direction of the company and our potential to deliver important new therapies to patients and meaningful value to shareholders.

We are continuing our transformation to an innovative high growth Biopharma company and achieved a number of significant milestones in the first quarter that contribute to that goal.

We are excited about the direction of the company and our potential to deliver important new therapies to patients and meaningful value to shareholders.

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

Rene D. Gal: That concludes our prepared remarks. I'd now like to turn the call over to the operator to open up the line for Q&A. Thank you, ma'am. At this time, if you would like to ask a question, please...

Thank you ma'am pharmaceuticals.

Operator: Thank you, ma'am. At this time, if you would like to ask a question, please press star, then the number one on your telephone keypad. Please limit yourself to one question. Again, participants are allowed to ask one question each. We will pause for just a moment to compile the Q&A roster. Our first question comes from the line of Ken Kashiotori from Coen and Company. Your line is open.

Like to ask a question please.

Then the number one on the telephone keypad.

Please limit yourself to one question I get on participants are allowed to ask one question.

Well pause for just a moment to compile the Q&A roster.

Our first question comes from the line of Ken Cacciatore from Cowen and company. Your line is open.

Ken Kashiotori: Hey team, congratulations on all the results. A really fantastic performance.

Hey team congratulations on all the results are really fantastic performance on all respect your one question and just go Big picture kind of looking at the cash generation of the combined company and you're talking about the the ability to delever fairly quickly. It just by my math it looks like you could be in 24 months in a position to do another five to 7 billion.

Ken Kashiotori: I'll respect your one question and just go big picture. Kind of looking at the cash generation of the combined company, and you're talking about the ability to deliver fairly quickly. It's just by my math, it looks like you could be in a position in 24 months to do another $5 to $7 billion type of transaction without really going into any equity. Can you just talk about the combined business in terms of your appetite for BD, either in the near term or around the timelines that I just laid out? Thanks so much.

Any type of transaction with without really going into any equity can you just talk about the combined business in terms of your appetite for BD either in the near term or around the timelines that I just laid out thanks so much.

Hey, Ken let me have Renee take that one.

Rene D. Gal: Hey Ken, let me have Rene tell you something. Great. Yeah, I'm happy to jump in, Ken. Great question.

Great I'm happy to jump in on Ken Great question. So, yes, clearly this business generates a lot of cash currently on on a combined basis, we see acceleration of our growth of the cash profile and that's what gives us the confidence to execute that the finish.

Rene D. Gal: So, yes, clearly, this business generates a lot of cash currently, and on a combined basis, we see an acceleration of our growth in the cash profile, and that gives us the confidence to execute the financing that we did, as well as confidence in that target of getting below three and a half times by the end of next year and then continuing to rapidly deleverage thereafter. So, I would say, certainly, with that cash profile and that rapid deleveraging, we do have the ability to think about additional transactions at that time.

One thing that we did as well as confidence in that target of getting below three and a half times by the end of next year and then continuing to rapidly deleverage thereafter, so I would say certainly with that cash profile and that rapid deleveraging. We do have the ability to think about additional transactions at that time.

<unk>. It certainly gives us optionality I also just want to emphasize how transformative. This particular transaction is for us.

Rene D. Gal: It certainly gives us options. I also want to emphasize how transformative this particular transaction is for us and how excited we are to be able to continue the momentum with Epidiolex, to integrate the company, integrate the pipeline, and ensure that we're able to realize the full value of what this acquisition is providing us from just a full transformation perspective.

And how excited we are to be able to continue the momentum with other dialects to integrate the company integrate the pipeline and ensure that we're able to to realize the full value of some of what of what this acquisition is providing us from just a full transformation perspective.

Jason Matthew Gerberry: Your next question comes from the line of Jason Gerberry from Bank of America. Your line is open. Hey guys, thanks for taking my question.

Thank you.

Your next question comes from the line of Xyrem Barry from Bank of America on your line is open.

Hey, guys. Thanks for taking my question. So my question is about the XI wave IH opportunity and I'm. Just curious how you guys think about potential treatment rates for XI wave in this population versus the roughly 25% oxalate share and the more moderate to severe narcolepsy patients.

Jason Matthew Gerberry: Hey guys, thanks for taking my question. So my question is about the Zywave IH opportunity, and I'm just curious how you guys think about potential treatment rates for Zywave in this population versus the roughly 25% oxidate share in the more moderate to severe narcolepsy patients. Should we look at these penetration rates as similar? Do you think that they could be meaningfully different one way or another?

Should we look at these penetration rates as similar or do you think that they could be meaningfully different one way or another I know you guys have talked about a potentially larger tam, which will be something that'll be elucidated over time, but.

Daniel N. Swisher: I know you guys have talked about a potentially larger TAM, which will be something that'll be elucidated over time, but just kind of curious if you could level set as it pertains to penetration rates. And when you launch Zywave for IH, from a reimbursement perspective, are you going through another potential six to nine month process to get that access, or do you step pretty much into the access that Zywave has through the narcolepsy contracting? Thanks.

I'm just kind of curious if you could level set as it pertains to two penetration rates and when you launch a day away for IH from a reimbursement perspective are you going through another potential six to nine month process to get that access or your step pretty much into the access the day, we passed through the narcolepsy contracting. Thanks.

Daniel N. Swisher: Hey, Jason, let me ask Dan to jump in on this one. Yeah, and Kim, feel free to add as well in the launch planning. But yeah, we have been looking at this market; we did a chart review, in terms of diagnosis, and we came across 37,000 diagnosed patients. But given that there are no approved treatments, we believe that's probably an understatement of exactly how much of an underrepresentation we'll get a better chance to see once we can really start promotion.

Hey, Jason Let me ask Dan to jump in on this one.

Yeah, and Kevin feel free.

To add as well on the launch planning, but.

Yes, we have been looking at this market. We did a chart review in terms of diagnosis and we came across 37000 diagnosed patients.

Given that there is no approved treatments, we believe thats, probably an under understatement exactly how much of an underrepresentation, we will get a better chance to see once we can really start promotion once we can start promotion.

Daniel N. Swisher: We have heard in certain offices, some of the bigger sleep centers, there could be an equal number of IH patients to, you know, narcolepsy. I think there's going to be similar patterns that it's going to be the more moderate and severe patients that are going to, you know, adopt and integrate oxidative therapy adopts the I wave into their lifestyle. But we know from the clinical results we presented at the AAN meeting that there was a very meaningful benefit across all endpoints, clinically meaningful, as well as statistically meaningful. So we're on track and excited for the launch. Kim, do you want to say anything further about the launch preparation? Yeah, sure.

We have heard in certain offices some of the bigger sleep centers, there could be an equal number of IH patients too.

Two narcolepsy I think theres going to be similar patterns that it's going to be the more moderate and severe patients that are going to.

Adopt <unk> therapy adopt sideways into their lifestyle, but we know from the clinical results. We presented at the AAN meeting there was very meaningful benefit across all endpoints clinically meaningful as well as statistically meaningful.

So we're on track and excited for the launch Kim you want to say anything further about launch preparation.

Yeah, sure and I'll address the specific question about the payer space you know what I can say is the very strong position that we've achieved in terms of commercial coverage and die wave in narcolepsy is setting us up really well to go into discussions with payers around idiopathic hypersomnia.

Kim Sablich: And I'll address the specific question about the payer space. You know, what I can say is that the very strong position that we've achieved in terms of commercial coverage and by way of narcolepsy is setting us up really well to go into discussions with payers around idiopathic hypersomnia. You know, given this coverage, we expect to achieve very similar coverage rates in IH and probably more rapidly than we did in narcolepsy, given that we have those contracts in place. You know, really, what it's going to come down to is discussions with payers around what type of utilization management is going to be put in place for these patients.

Given this coverage, we expect to achieve very similar coverage rate.

I I H and probably more rapidly than we did in narcolepsy given that we have those contracts in place you know really what is going to come down to his discussions with payors.

Around what type of utilization management is going to be put in place for the patients. So that's really what we're focused on in terms of access for the IH indication.

Kim Sablich: So that's really what we're focused on in terms of, you know, access to the IH indication. I'll mention a little bit more about Launch Prep. We've already gotten started on the medical side with, you know, educating healthcare providers on this condition and reinforcing that, you know, how it's different from other conditions such as narcolepsy and depression is going to be really critical to helping our healthcare providers and our patients as well better understand the condition.

Yes. Thank you I'm not sure I tell a little bit more about launch prep is really around we've already gotten started on the medical side with educating H C piece on.

On this condition and reinforcing that you know how it's different from other condition such as narcolepsy in depression is going to be really critical to helping our health care providers and their patients as well better understand the conditions. So we've gotten started on that with our MSL. We're doing the same with patients through disease education.

Kim Sablich: So we've gotten started on that with our MSLs, and we're doing the same with patients through a disease education campaign we've recently launched. So that's going to be a really important aspect of the launch in advance of, you know, doing the actual branded product launch.

Campaign, we've reached recently launched them. So that's going to be a really important aspect of the launch in advance.

The actual branded product launch.

Yes.

Great. Thanks.

Yeah.

Our next question comes from the line of Jessica Fye from JP Morgan Your line is open.

Jessica Fye: Our next question comes from the line of Jessica Fye from J.P. Morgan. Your line is open. Hey guys, good afternoon. Question on the XiWave switch. Is there any reason to think that initial adopters of XiWave

Hey, guys. Good afternoon. Thanks for taking my question a question on <unk>.

By way of switch is there any reason to think that initial adopters of sideways represent low hanging fruit and that you could see a slowing from here or can we take this as a sign of momentum that should continue adding about 2000 patients per quarter.

Jessica Fye: Adopters of Zywave represent low-hanging fruit and that you could see a slowing from here, or can we take this as a sign of momentum that should continue adding about 2,000 patients per quarter? So Jess, this is Bruce.

So just this is Bruce I'll just start by reminding you that we're getting patients on the XI wave both.

Bruce C. Cozadd: You know, I'll just start by reminding you that we're getting patients on ZyWave, both who were on Xyrem immediately before or at some point in the past, and we're also getting new doxabate patients, whether they're newly diagnosed with narcolepsy, or they've been diagnosed before but hadn't tried the higher sodium Xyrem in the past. So it's You know, for your question about sustainability of momentum and whether it's low-hanging fruit, maybe I'll ask Kim to comment. Yeah, no, we really believe it's not a matter of low-hanging fruit.

Who were on Xyrem Amit.

<unk> before or at some point in the past and we're also getting new docs of eight patients whether they're newly diagnosed with narcolepsy or they've been diagnosed before but hadn't tried.

The higher sodium xyrem in the past so it's not just a switch its adoption by all sorts of patients.

For your question about sustainability of momentum and was it low hanging fruit, maybe I'll ask him to comment.

Yeah, now, we really believe it's not a matter of low hanging fruit with 3900 patients already transitioned in the first five months you know, we don't really see any slowdown.

Kim Sablich: With 3,900 patients already transitioned in the first five months, you know, we don't really see any slowdown in that. So just quantitatively, the number is strong. Qualitatively, when we talk to customers, you know, we don't hear them. It's not just a subset of customers that are adopting the product, and it's not just a subset of patients that they're thinking about using Xiwaven. So we really do believe that the momentum is in a very healthy place to continue.

And that so just quantitatively the numbers strong qualitatively when we talk to customers.

We don't hear them.

It's not just a subset of customers that are adopting the product and it's not just a subset of patients that they are thinking about using <unk>. So we really do believe that this man momentum isn't a very healthy place to continue.

Thank you.

Yeah.

Our next question comes from the line of value Index, one from BMO capital. Your line is open.

Gary Nachman: Our next question comes from the line of Gary Nachman from BMO Capital. Your line is open.

Gary Nachman: Thanks. Good afternoon.

Thanks, Good afternoon regarding the payer access for <unk> in narcolepsy, we've heard from a few physicians that in some cases it could be challenging to get sideways as a patient doesn't have a documented history of hypertension, rather than as a preventative measure to prevent the C V issues from happening.

Bruce C. Cozadd: Regarding payer access for Zywave in narcolepsy, we've heard from a few physicians that in some cases, it could be challenging to get Zywave if a patient doesn't have a documented history of hypertension, rather than as a preventative measure to prevent CV issues from happening. So how are you getting around that potential hurdle, if it is a hurdle for you? I mean, it sounds like you feel very good about where access is at this point, but is that something that physicians sort of have to get around in order to get patients on it? Thanks. Gary, this is Bruce.

<unk>.

So how are you getting around that potential hurdle. If it is a hurdle for you I mean, it sounds like you feel very good about where access is at this point, but is that something that the physicians sort of have to get around in order to get the patients on it.

Yes.

Yeah. Gary This is Bruce we have not heard that that is a general isolable trend, we're finding that for most.

Bruce C. Cozadd: We have not heard that this is a generalizable trend. We're finding that for most, the vast majority of patients, access to XyWave tracks access to XyREM. This is a product that delivers the same active moiety that provides efficacy to patients but without that additional gram to a gram and a half of sodium every night in a condition that is treated chronically and known to occur in a patient population at high cardiovascular risk.

The vast majority of patients.

Access to XI wave tracks access to Xyrem.

This is a product that delivers the same active moiety.

That provides the efficacy to patients, but without that additional graham to agree on a half of sodium every night and a condition that is treated chronically and known to occur on a patient population at high cardiovascular risk. So.

Bruce C. Cozadd: We have not, in general, heard what you're describing. Kim, anything you want to add to that? Yeah, no, I think, you know, there are exceptions out there to the rule, and certainly it can differ by geography, so perhaps you've talked to somebody that we're in that geography is where we've got, you know, the exceptions. But for the most part, this has not been coming up with the barriers. We've heard the opposite, that customers are very pleased with how easy it's been to transition patients to Zyweigh. Okay, good to hear. Thank you.

We have not in general heard what Youre describing.

Kim anything you want to add to that.

Yeah, No I think you know that.

There are exceptions out there to that rule.

And certainly it can differ by geography. So perhaps you can talk to somebody that were in that geography is where we thought the exceptions, but the most part this has not been coming up on the barriers. We've heard the opposite the customers are very pleased with how easy it's been to transition patients to xilinx.

Okay. Good to hear thank you.

Our next question comes from the line of David on Columbus.

David A. Amsellem: Our next question comes from the line of David Amsellem from Piper Sandler.

From Piper Sandler.

David A. Amsellem: Thanks. I wanted to ask you about idiopathic hypersomnia and specifically how you're thinking about the payer landscape. The question, I guess, is, is it your expectation that these patients are going to have to have, or will be on, provisional or stimulants and have to have that exposure? And is it your view that you're going to contract in such a way where that's the only utilization management, and you won't have to worry about, say, a Xyrem step through? How do you think about that? Thanks. Yeah, well, let's take this in two pieces.

Thanks, So I wanted to ask about idiopathic hypersomnia, and specifically, how youre thinking about the payer landscape.

The question I guess is it your expectation that these patients are going to have to have or will be on.

Provigil.

Or or stimulants and have to have that exposure.

And is it your view that you're going to.

Contract in such a way, where that's the only utilization management and you won't have to.

Worry about say a ziram step through how do you think about that thanks.

Yeah, well, let's take this in two pieces and maybe Phil I could ask you to comment before we go to the payer side just on what our expectations are for patients who are currently dealing with IH without an approved therapy and how.

Bruce C. Cozadd: And maybe Phil, I could ask you to comment before we go to the payer side, just on what our expectations are for patients who are currently dealing with IH without an approved therapy and how Xiwave might be added to that.

Z wave might be added into that.

Bruce C. Cozadd: Okay, thank you, Bruce. So first, I would say that...

Great. Thank you Bruce So first I would say that.

Many of these patients a day.

Philip Jochelson: Many of these patients with telepathic hypersomnia are on a weight-promoting agent already and still need further improvement in not only the benefit that they may be getting from their weight-promoting agent, but the weight-promoting agents are not actually providing any benefit for the other symptoms. And I think we showed that in the clinical trial, where despite many of these patients coming in already on a weight-promoting agent, the equity sleepiness score was actually filling the range of pathological sleepiness with a baseline of about, if I remember correctly, 15 or 16, very similar to the narcolepsy population on effort scores. So from my perspective, I think

Patti Hart to 70 on a wake promoting agent already.

And still needs the improvement and not on.

The benefit that they may be getting from the wake promoting agents that day wake promoting agents are not actually providing benefit on the other symptoms and I think we showed that in the clinical trial.

Despite many of these patients coming in already on a wake promoting agent the APRA sneaking a school was actually still in the range of pathological sleepiness with the.

Based on of about say, if I meant that <unk> 16, very similar to the narcolepsy population of.

It put scores.

On my perspective, I think minions people will still be on away commodity agents on lost any good satisfactory.

Philip Jochelson: Many people will still be on the way promoting agents are not going to get satisfactory benefits in the most part for all the symptomatology of IH. And we showed, as I said, benefits for multiple symptoms in the data that we had presented, including the IHSS.

The benefits in the most part or all of the symptomatology of IH and we show it as I said.

Benefits on multiple symptoms.

In the day to day, we had presented including the IHA says.

Philip Jochelson: This is a scale that measures both daytime symptoms and nighttime symptoms and sleep inertia. So, Bruce, I don't know if that's enough. Thanks, Phil. And, Kim, maybe you could take the second part of David's question. Sure.

Scale, which measures.

On a daytime symptoms and niton symptoms and Sneakiness share.

So that Bruce.

Thanks, and thanks, Phil and Kim maybe you could take on.

The second part of David's question.

Sure Yeah, as I mentioned, a moment ago that will be the main thing we're negotiating with payers is how much utilization management, such as step edits and prior authorizations will be required.

Kim Sablich: As I mentioned a moment ago, that will be the main thing we're negotiating with payers, how much utilization management, such as step edits and prior authorizations, will be required. And really, as Phil said, we see that the majority of patients are already going to have tried provisional or new vigil. So that will not be, even if it's in there, a burdensome step to go through. On the other hand, Xyrem will not be indicated, nor will any other Oxivate product.

And you know really as Phil said, we will see that the majority of patients are already going to have tried provigil or new vigil, so that will not be even if it's in there.

Burdens on them.

You know step to go through and on.

On the other hand, xyrem will not be indicated.

Nor any other activate product so it's not impossible, but probably unlikely that a step through that is going to be required and we are already hearing.

Kim Sablich: So, not impossible, but probably unlikely that a step through that is going to be required. And we are already hearing, and believe that payers are recognizing the value and the clinical significance of low-sodium Oxivate. So, again, I think that's probably unlikely, but we'll see in terms of where our negotiations ultimately end up. But we feel quite positive about where we're headed.

We believe the payers are recognizing the value and the clinical significance of low sodium.

So again I think that's probably unlikely, but we will see in terms of you know where our negotiations ultimately end up but we feel quite positive about where we're headed.

Okay. Thank you.

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

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

Yes, thank you very much could.

David Reisinger: Yes, thank you very much. Could you discuss Zepselka in some detail, please?

Could you discuss Zip soca in some detail please.

So the sales were I think up very marginally sequentially versus the fourth quarter. Despite the product only being in its effectively in its third full quarter of launch and so if you could just talk about that performance sequentially.

Bruce C. Cozadd: So the sales were, I think, up very marginally sequentially versus the fourth quarter, despite the product only being in its effectively third full quarter of launch. And so if we could just talk about that performance sequentially and then the outlook, looking forward to sequential growth. Thank you.

And then the outlook looking forward for sequential growth. Thank you.

Kim Sablich: Yeah, David, I'll ask him to comment on what we're seeing in the first quarter that forms the basis of our confidence for continued growth. You know, we haven't provided product-specific revenue guidance for the year. But I think we've said, we do expect significant growth of Zep Zelka as we move through 2021. Kim, do you want to comment on the first quarter? Yeah, sure.

Yeah, David I'll ask him to comment on what we're seeing in the first quarter that forms the basis of our confidence for continued growth.

We haven't provided.

<unk> specific revenue guidance for the year, but I think we said we do expect significant growth observed soccer as we move through 2021, Jim you want to comment on the first quarter.

Yeah sure we're actually very pleased with the performance in the first quarter and maintain our optimism on the full year projections that we have and that really is based on the underlying demand patterns that we see we saw very strong demand increase quarter over quarter. So I feel very confident that he.

Kim Sablich: We're actually very pleased with the performance in the first quarter and maintain our optimism on the full year projections that we have. And that really is based on the underlying demand patterns that we see. We saw a very strong demand increase quarter over quarter, so I feel very confident that the underlying demand is strong and particularly encouraged when we look at patient types. We continue to see really nice growth in second-line market share among new patients, and we see that both in platinum resistant and platinum sensitive patients. So I feel very good and have no reason to believe that demand is flattening.

Underlying demand is.

It is strong and particularly very encouraged when we look at patient types. We continue to see really nice growth in second line market share among new patients.

And we see that both in the platinum resistant and platinum sensitive patient. So feeling very good and have no reason to believe that demand is flattening.

Balaji V. Prasad: Our next question comes from the line of Balaji Brahas from Barclays. Your line is open. Thank you.

Thank you.

Our next question comes from the line of allergy Baja from Barclays. Your line is cell phone.

Thank you hi, those balance of year.

Balaji V. Prasad: Hi, this is Balaji here. Speaking to one question, Bruce, since we seem to be quite close to the deal closure, I wanted your insights on the legal landscape for GW and any potential restrictions on raw materials based on a cannabis extraction patent infringement lawsuit filed by canopy growth as against GW Pharma. I think it was filed last December.

So.

Taking the one question Bruce since it seem to be quite close to the.

Deal flow here I want to do your insights on the legal landscape for GW and any potential restrictions on raw material.

On a cannabis extraction patent infringement lawsuit that canopy growth as games GW pharma I think it was filed last December thank you.

Yeah, Bob as you know I'm not going to make any.

Bruce C. Cozadd: Yeah, Balaji, I'm not going to make any additional disclosure on that legal action. You know, we continue to feel confident in our ability to continue to grow Epidiolex and really build on the excellent momentum coming out of the first couple full years on the market under GW's leadership. And more recently, the European launch, which is in its early phases, you know. We're really excited about where this product can go and don't see any barriers from what you're describing.

Additional disclosure on that legal action, we continue to feel confident in our ability to continue to grow.

At the dial ex to really continue on the excellent momentum coming out of the first couple of full years on the market under Gw's leadership and more recently the European launch, which is in its early phases. We're really excited about where this product can go and don't see any.

Barriers.

Marc Goodman: Our next question comes from the line of Mark Goodman from SVB Learing. Your line is open. Hi, could you give us

From what Youre describing.

Thank you.

Okay.

Our next question comes from the line of Marc Goodman from <unk> Leerink. Your line is open.

Marc Goodman: Hi, could you give us a little more color on the 3% decline in bottle growth year-on-year and talk about it in the context of the higher patients, quarter-to-quarter, and then maybe give us a sense of how you're thinking about bottle growth for the year, for the whole Oxabate franchise? Thanks.

Yeah, Hi, could you give us a little more color on the 3% decline in bottle growth year on year and talk about in the context of the higher patients a quarter to quarter and then maybe give us a sense of how youre thinking about profit growth for the year for the whole oxalate franchise. Thanks.

Bruce C. Cozadd: Yeah, so it's important to see the continued growth in patients on Oxybate across Xyrem and XyWave and, increasingly, you know, the share moving towards XyWave. You know, we have said there'll be some impact. Uh, you know, the temporal impact on revenue bottles as that transition occurs for some patients, but we don't think it's an underlying trend. We, you know, continue to see patients new to oxybate therapy who, you know, are more often going directly to ZyWave than to ZyRam. So this is not patients taking fewer bottles. This is not that dynamic.

Yeah. So it's important to see the continued growth in <unk>.

Patients on auction bait across Xyrem in July wave and increasingly.

The share moving towards high wave, we have said there'll be some impact.

Temporal impact on revenue bottles as that transition occurs for some patients.

But we don't think it's on underlying trend we continue to see.

Patients new to <unk> therapy.

Who are more often going directly to XI wave and to Xyrem.

So this is not patients taking less bottles. This.

It's not that dynamic the dynamic is basically for raid bottles is what you're talking about.

Bruce C. Cozadd: The dynamic is basically paid bottles, is what you're talking about. Correct. Revenue bottles.

Correct revenue bottles correct revenue bottles, yeah got it thanks.

Yeah.

Okay.

Our next question comes from the line of Gregg Gilbert from Theresa Chen Your line is open.

Greg Gilbert: Our next question comes from the line of Greg Gilbert from Curious Security. Your line is open.

Greg Gilbert: Thank you. On 458: Are FDA actions and interactions providing you with more confidence in an approval versus a typical situation given the unique circumstances of the supply situation, and do you have any updated thoughts on your former partner's ability to compete with, let's call it, the older product in the U.S. or around the world? Thank you. For the first part of that question on the regulatory side, I'll let Rob answer that. Sure, happy to, Bruce. I would just say that throughout this development, the collaboration with Children's Oncology Group and the FDA has been really great. And as you can see from...

Thank you on four or five eight.

Our FDA actions and interactions, providing you with more confidence on AR and approval versus a typical situation given the unique circumstances of the supply situation and do you have any updated thoughts on your former partners ability to compete.

With let's call it the older product in the U S or around the world. Thank you.

Yes for the first part of that question on the regulatory side, let me have Rob answer that.

Sure happy to Bruce.

I'd, just say that throughout this development the collaboration with children's oncology group and the FDA has been really great.

Great and as you can see from.

Robert Iannone: The process so far, granting a real-time oncology review; all parties are invested in having this review go as quickly as possible, and I would just say that everything is really on track based on guidance we've given in the past. And then just to weigh in, Greg, on your question about, you know, a former partner and what their plans are. I think internationally it's a little bit easier for them to reference their UK filing and get into international markets.

The process, so far granting of real time oncology review.

All parties are invested in.

Having this review going on as quickly as possible and I would just say that everything is really on track based on.

Guidance, we've given in the balance.

And then just to when Gregg on your question about.

Our former partner on what their plans are I think internationally, it's a little bit easier for them to reference their U K filing and get into the international markets. It's a little lesser than what their path forward is going to be in the U S are they likely need to file and get approval with a BLA.

Robert Iannone: It's a little less clear what their path forward is going to be in the US; they likely need to file and get approval with the BLA. And again, I think if the FDA and the COG are very supportive of a recombinant product with high quality supply, that's going to make a difference in the marketplace as well. So I think a little less about exactly where their strategy and timing is going to be in the US market.

And again I think it's the FDA and the <unk> are very supportive of a recombinant product with high quality supply.

That's going to make a difference in the marketplace as well so I think a little lesser on exactly where their strategy in time, and it's going to be in the U S market.

Robert Iannone: Thanks. And Greg, I'll just tag on to Dan's answer by saying, you know, we're really excited to be able to get back to, you know, promoting this effective treatment for those patients who have a hypersensitivity reaction or silent inactivation. You know, we've had to curtail our promotional activities for a number of years, given the supply constraints, and now we need not only to continue that effective penetration into the pediatric ALL market but really expand the adolescent and young adult marketplace where we think more patients could benefit from an asparaginase-containing regimen and then continue our international expansion, where again we've been limited by supply for a number of years.

Thanks.

And then Greg I'll, just tag I'll, just tag on to Dan's answer by saying you know, we're really excited to be able to get back to you.

Promoting this effective treatment for those patients who have hypersensitivity.

The action or silent in activation.

Had to curtail our promotional activities for a number of of years given the supply constraints and you know not only be able to continue that effective penetration into the pediatric alo market, but really.

Expand in adolescent and young adult.

Marketplace, where we think more patients could benefit from an asparaginase containing regimen and then continue our international expansion, where again, we've been limited by supply for a number of years.

Thanks.

Gregory Daniel Fraser: Your next question comes from the line of Greg Svanavich from Goldman Sachs. Your line is open.

Your next question comes from the line that's good because I know that's from Goldman Sachs. Your line is open.

Yeah. Thanks for taking my question and congrats on the quarter, maybe my question.

Gregory Daniel Fraser: Yeah, thanks for taking my question and congrats on the quarter. Maybe my question would be about kind of the real world experience of patients who are now on Zywave. Could you give any color?

On would be about kind of the real world experience on.

On patients.

So we're not ones that wave could you give any color I know, it's still early but any color around compliance.

Bruce C. Cozadd: I know it's still early, but any color around compliance or discontinuation rates? I'm just trying to get a sense of how, how sticky you think this business will be relative to Zyro. Well, maybe we'll take that in two parts.

Compliance or discontinuation rates I'm, just trying to get a sense of how how sticky you think this business will be relative to xyrem.

<unk>.

Well, maybe we'll take that in two parts.

Bruce C. Cozadd: You know, Phil, I'd love just your perspective on what we saw in our clinical trials with patients moving over onto ZyWave in terms of tolerability. And then, Kim, we can talk about what you're seeing in the patients who've started on ZyWave. Phil? Thank you, Bruce.

You know Phil I'd Love just your perspective on what we saw on our clinical trials with patients moving over on to XI wave in terms of Tolerability.

And then Kim we could talk about what youre seeing on.

The patients who are.

Started on sideways Phil.

Thank you Bruce.

So as you know in our clinical trial with a sideways the $15 six study in patients with narcolepsy, we brought in a broad range of subjects.

Philip Jochelson: 150630 in patients with narcolepsy. We brought in a broad range of subjects, including those who were treatment-known.

Including those who are treatment naive versus those who were previously on xyrem.

Philip Jochelson: those who were treatment naive versus those who were previously on Xyrem with or without a weight-promoting agent. And in the patient population that were previously on Xyrim, which was a substantial portion of the clinical trial participants, we had a gram-for-gram switch as part of the protocol, and it turned out to be a very seamless transition, with the vast majority of patients having that transition and sticking with the same dose of Xyrim that they were previously on with minimal discontinuation rates.

With or without a.

On a wake promoting agent.

And as we say in the patient population that were previously on Xyrem, which was a substantial portion of the clinical trial participants we had a gram per gram switch as part of the protocol and turned out to be a very seamless transition with the vast majority of patients having that transition.

Sticking with the same dose sub fab upside was as always.

They were previously on but the book Xyrem, but with minimal discontinuation rates. So the patients who zone xyrem and instead really stayed with Xyrem really seem.

Philip Jochelson: So the patients who have already stayed with Xyrim really seem to persist and continue with Xyrim and seem to do very well with that gram-for-gram switch. And obviously, with coming into a clinical trial, there may be a little bit more dose optimization as part of the clinical trial, but overall, I think, you know, a very good experience for that patient population. Kim, do you want to jump in with what we're seeing with the launch thus far?

Seem to persist and continue with Xyrem and seem to do so well with that Gram per gram switch and obviously, both coming into a clinical trial that may be a little bit more dose optimization.

As part of the clinical trial and overall I think a day.

Good experience for that patient population.

Kim do you want to jump in with what we're seeing with the launch thus far.

Sure.

Kim Sablich: Sure, you know, I don't have hard quantitative data, but I can say that the large majority of patients that are starting Zywave or are experienced patients with Zyrum. And in terms of the feedback we're getting from customers, it's been largely positive. There's no reason to believe that persistence will really differ with Zywave from Zyrum at this point, and we actually do see some patients who previously took Zyrum and discontinued coming back on to Oxabate therapy with the launch of Zywave.

I don't have hard quantitative data, but what I can say that the large majority of patients.

That are starting to die labor, our experienced patients with xyrem and in terms of the feedback we're getting from customers. It's been it's been largely positive. There's no reason to believe that persistence really differ with <unk>.

On Xyrem at this point and we actually do see some patients who previously to Xyrem in discontinued I'm coming back on the asset based therapy with the launch a sideways.

Esther Lojavelu: Your next question comes from the line of Esther Lojavelu from UBS. Your line is open. Hey, thanks.

Yes.

Thank you.

Okay.

Your next question comes from the line of Oscar.

Book value from UBS. Your line is open.

Hey, Thank you for taking my question I'm on.

Esther Lojavelu: Hey, thank you for taking my question. On 458, can you remind us of the considerations for the two different administrations and whether that might have any implications for the OUS markets versus the U.S. market? Rob or Ann, do you want to start on just how we're thinking about the route of administration for 458? You can go ahead, Ann. Yes, thank you.

On 458 can you remind us on the considerations for the two different administrations and weather.

Whether that might have any implications for the O U S markets versus the U S market.

Okay.

Robber Anne do you want to start on.

Just how we're thinking about route of administration of $4 58.

Please go ahead.

Yes. Thank you.

The current study is focusing on the intramuscular or I am.

Robert Iannone: The current study is focusing on the intramuscular (IM) route of administration for JCP 458. However, the trial has progressed so swiftly and nicely that we have initiated the intravenous (IV) portion of the study. This will follow on very shortly after our efforts focus on pursuing an IM approval through the RTOR process. United States. And Dan, you just want to talk a little bit about how we're thinking about the opportunity globally, not just in the U.S.? Sure. Yeah, so I mean, it's important for us to get the full data pack.

Route of administration per J D. P for a five day that being said the trial. The trial has progressed, so swiftly and nicely that we have initiated the intravenous or IV portion of the study.

Todd This will follow on very shortly after.

Our efforts focused on pursuing.

Pursuing and I am approval through the <unk> process and United States.

And Dan you just do you want to talk a little bit about how we're thinking about the opportunity globally not just in the U S.

Sure, Yes, so I mean, it's important for us to get the.

Full data packet, which will include both the IV and I am in the U S. I am will likely be the first approval that will pivot very quickly given the rate of accrual to the current study on.

Robert Iannone: which will include both IV and IM. In the U.S., IM will likely be the first approval, but we'll pivot very quickly given the rate of accrual to the current study and the close working relationship with the FDA.

Robert Iannone: Yeah, a close working relationship with the FDA. In Europe, we may be able to file for the IV IM together. And that's just something we're exploring in terms of how to do so. But importantly, we've been optimizing the clinical profile and the dosing to really get the best results. And that will be part of the label as well.

The close working relationship with the FDA.

In Europe, we may be able to file for the I V. I N together and that's just something we're exploring in terms of how to do so.

But importantly, we've been optimizing the clinical profile and the dosing to really get to a best results and that will be part of the label as well.

Got it thank you.

Annabel Eva Samimy: Our next question comes from the line of Annabel Samimy from Stifel. Your line is open.

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

Annabel Eva Samimy: Hi, thanks for taking my question. Just back on Zipfelka, I know that you had touched on this before, the sales level seems to have been slightly down this quarter. And can you just maybe help us understand if this is a factor of ordering patterns, if it's a factor of earlier deductibles, patient assistance, because that doesn't really jive with the strong underlying demand patterns that you're talking about. And then maybe you can just touch on the change in the NCCN classification of immuno-oncology in the second line setting, if you think that should have a big impact on uptake Thanks.

Hi, Thanks for taking my question just back on to talk a.

I know that you had touched on this before.

On the sales level it seems to have.

Then slightly down this quarter and can you just maybe help us understand.

This is a factor of ordering patterns, but it's a factor of earlier deductibles on patient assistance.

Because that doesn't really drive with strong underlying demand patterns that you're talking about and then maybe you can just touch also on the change in that as you see on classification of immuno oncology in the second line setting if you think that should have.

A big impact for uptake on some soccer thanks.

Yes, so again Annabel I think I think you're focused on the the right main point was up Selco, which is the demand growth other things can impact reported sales in the short term, but the trends we're seeing.

Bruce C. Cozadd: Yeah, so again, Annabel, I think you're focused on the right main point with Zepselka, which is demand growth. Other things can impact reported sales in the short term, but the trends we're seeing, you know, underlie our confidence that we are seeing and we'll see continued growth with Zepselka. Rob, do you want to comment a little bit on what some of the changes of IO moving out of the later lines of therapy mean for Zepselka? Yeah, I was going to ask for that clarification.

Underlie our confidence that where we are seeing and will see continued growth with <unk> silica, Rob do you want to comment a little bit on you.

You know what some of the changes of Io moving out of the later lines of therapy.

<unk> force up Selco.

It was kind of asked for that clarification. So if that's the question.

Robert Iannone: So if that's the question, I think it has little impact. I mean, what's happened in the IO space is that there have been approvals for extensive stage small cell therapy on the first line, and that's the great majority of patients. And so effectively, patients are getting IO up front, and that's by a later line, like second or third line IO. It's not really relevant to clinical practice. Zip Zelka Second Line Plus or after failure of upfront chemotherapy is becoming a standard of care based on the data relative to other therapies like topotecam, which are not particularly

I think it has little impact what's happened in the Io space is that there have been approvals share extensive stage small cell on the finish line and Thats. The great majority of patients and so effectively patients are getting Io upfront.

And that's why a later line like Secretary Duane Hi, Allison.

The relevant clinical practice.

<unk> second line plus thereafter failure upfront.

On the therapy.

As.

On becoming a standard of care based on the data relative to other therapies like too, particularly on which are not particularly good.

David Steinberg: The next question comes from the line of David Steinberg from Jeffries. Your line is open.

Thank you.

Okay.

The next question comes from the line of Gleevec Feinberg from Jefferies. Your line is open.

David Steinberg: Thanks. I wanted to ask an additional question about 458 and the asparagus market, particularly how you see it evolving competitively down the road. So, as I understand it, a third competitor, Aeritech, recently had some good phase two data, and they're seeking FDA guidance and approval pathway. They're obviously behind you.

Thanks.

Wanted to ask an additional question about 458 and the disparages market.

Particularly how you see it evolving competitively down the road so.

As I understand on a third a third competitor Aerotech recently had some some good phase two data and they're seeking.

FDA guidance on on approval pathway, there obviously behind behind you.

How do you see that market three way market evolving over time.

David Steinberg: How do you see that market, the three-way market, evolving over time? You know, the negatives are there are more players, the positives are you're supply constrained. Do you see them as a meaningful competitor, and sort of how do you see your share roughly breaking out over time? Thanks.

The negatives are there more players the positives on you were supply constrained do you see them as a meaningful competitor and sort of.

How do you see your share roughly breaking out over time. Thanks.

Yes, I can.

Bruce C. Cozadd: Yeah, I could comment. Maybe Rob could just start on the sort of scientific medical side. And then Dan, you can jump back in on the market side. But Rob, do you want to give a little perspective? Sure, you know, I would say a very different therapy that's based on using red cell transfusions to deliver asparaginase. However, the data I'm aware of, at least are relatively limited and so far, in adults only. So I think, you know, the positioning of 4-5A is pretty strong at this point.

Comment maybe Rob could just start on the sort of scientific medical side, and then Dan you can jump back in on the on.

On the market side, but Rob do you want to give a little perspective.

Sure.

I would say very different therapy, that's based on using red cell transfusions to deliver risperidone as the data I'm aware of at least.

Relatively limited.

And so far in adults only so I think the positioning of core five areas.

Strong at this point.

Robert Iannone: Yeah, and just to add in, I think we're going to have some time as the recombinant high.

Yeah, and just to just add and I think we're going to have some time as Rick commented on high quality product with a good supply to reestablish this market and re grow it with promotion and awareness of looking for hypersensitivity looking for.

Daniel N. Swisher: Yeah, and just to add in, I think we're going to have some time as the recombinant high quality product with good supply to reestablish this market and regrow it with promotion and awareness of looking for hypersensitivity, looking for silent inactivation, and really broadening the use of asparaginase broadly into the AYA market, in addition to moving into geography. So there's plenty of growth. I think, oh, what we can control in the near term is really our product offering, the label, and promotional efforts. We'll wait to see how the rest of the market evolves over time. Operator, any more questions, or shall we wrap?

Silent in activation and really broadening the use of asparaginase broadly into the a Y a market. In addition to moving into geographies. So there is plenty of growth.

While we can control in the near term is really our product offering label and promotional efforts.

Wait to see how the rest of the market evolves over time.

Operator, any more questions or should we wrap up.

Operator: There are no questions at this time. I'll turn the call back to Mr. Bruce Cozadd for a closing remark.

Yeah.

There are no questions at this time.

I'll turn the call back to Mr. Bruce Goldfarb for closing remarks.

Bruce C. Cozadd: Okay, thank you so much. And thank everyone for joining us today. We're really excited about another great year in 2021. You know, as we talk about the launches you asked questions about today, you know, couldn't be more pleased with the way the Zywave launch is going. You know, great progress with Zepselka. We're seeing growth with Cynosi.

Okay. Thank you so much.

And thanks, everyone for joining us today, we're really excited about another great year in 2021.

As we talk about the launches you asked questions about today.

Couldn't be more pleased with the way the skywave launches going on.

Great progress with <unk>, we're seeing growth with Sanofi and as we talked about on this call we've got upcoming launches of 458.

Bruce C. Cozadd: And as we talked about on this call, we've got upcoming launches of 458 and idiopathic hypersomnia ahead of us, and we're excited about the transformative GW transaction. And remember that Xywave and IH and JCB458 are really great examples of our ability to advance programs from concept all the way through to commercial readiness, which I think speaks well to how people should look at our portfolio and development capabilities. We will look forward to speaking with many of you at the Bank of America, RBC, and UBS conferences later this month.

Any day Pathic Hypersomnia ahead of us and we're excited about the transformative GW transaction.

And remember the July wave and IH and JCB for 58 are really great. Examples of our ability to do advanced programs from concept all the way through to commercial readiness, which I think speaks well to how people should look at our portfolio on development capabilities. We will look forward to speaking with many of you at the bank of America.

RBC and UBS conferences later this month and I'd, just like to close by thanking our colleagues here at jazz for their creativity and strong sense of urgency that continues to fuel our success.

Bruce C. Cozadd: And I'd just like to close by thanking our colleagues here at Jazz for their creativity, commitment, and strong sense of urgency that continues to fuel our success. We look forward to welcoming our new GW colleagues, and we thank our patients, partners, and shareholders for their continued confidence and support. And with that, we'll close the call.

We look forward to welcoming our new GW colleagues and we thank our patients partners and shareholders for their continued confidence and support and with that we'll close the call.

Operator: This concludes today's conference call. Thank you all for participating. You may now disconnect.

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

Okay.

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