Jazz Pharmaceuticals Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 6, 2025
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Operator

Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the Jazz Pharmaceuticals First Quarter twenty twenty five Webcast Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks,

Operator

there

Operator

will be a question and answer session. Thank you. I would now like to turn the call over to Executive Director of Investor Relations, Jeff McDonald. Please go ahead.

Jeff Macdonald
Jeff Macdonald
Executive director & IR at Jazz Pharmaceuticals

Thank you, operator, and good afternoon, everyone. Today Jazz Pharmaceuticals reported its first quarter twenty twenty five financial results. The slide presentation accompanying this webcast is available on the Investors section of our website. Investors should also refer to the press release we issued earlier today that is available on our website. On the call today are Bruce Kozad, Chairman and Chief Executive Officer Renee Gala, President and Chief Operating Officer Rob Yunone, Executive Vice President, Global Head of R and D and Chief Medical Officer and Phil Johnson, Chief Financial Officer.

Jeff Macdonald
Jeff Macdonald
Executive director & IR at Jazz Pharmaceuticals

On slide two, I'd like to remind you that today's webcast includes forward looking statements such as those related to our future financial and operating results, growth potential and anticipated development, regulatory and commercial milestones and goals, which involve risks and uncertainties that could cause actual events, performance and results to differ materially from those contained in these forward looking statements. We encourage you to review the statements contained in today's press release, in our slide deck and the risks and uncertainties described under the caption Risk Factors in our annual report on Form 10 ks for the fiscal year ended 12/31/2024 and our subsequent filings with the SEC, including our quarterly report on Form 10 Q for the financial quarter ended 03/31/2025, which identifies certain factors that may cause the company's actual events, performance and results to differ materially from those contained in the forward looking statements made on today's webcast. We undertake no duty or obligation to update our forward looking statements. As noted on Slide three, we will discuss non GAAP financial measures on this webcast. Descriptions of these non GAAP financial measures and reconciliations of GAAP to non GAAP financial measures are included in today's press release and the slide presentation available on the Investors section of our website.

Jeff Macdonald
Jeff Macdonald
Executive director & IR at Jazz Pharmaceuticals

I'll now turn the call over to Bruce.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Thanks, Jeff. Good afternoon, everyone. Thank you for joining us today to discuss Jazz's first quarter twenty twenty five results. I'll start on Slide five. Jazz started the year with strong momentum following a productive 2024, and we're pleased with the meaningful progress we've made across the business in the first quarter of twenty twenty five.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Our focus on execution and operational excellence resulted in solid commercial performance led by Epidiolex and Xywav and significant progress across our R and D pipeline. We submitted a supplemental new drug application or sNDA to expand Zepzelca into first line maintenance in extensive stage small cell lung cancer and received a positive CHMP opinion recommending the marketing authorization for zanidatumab in advanced HER2 positive biliary tract cancer, or BTC, in the European Union. In addition, the acquisition of Chimerix has further strengthened our presence in rare oncology. On the commercial front, we generated $898,000,000 in total revenues across our portfolio. Our neuroscience portfolio had a strong start to the year with Xywav growing 9% year over year, remaining the number one branded treatment for narcolepsy as measured by revenue and the only therapy approved to treat idiopathic hypersomnia or IH.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

We saw strong Epidiolex demand as revenues increased 10% year over year, and we remain confident in its blockbuster potential. While we experienced near term headwinds with certain oncology products, our oncology portfolio is poised for growth with three potential regulatory approvals in the coming months, including dardavaprone, Zepzelca expansion in the first line maintenance therapy in The U. S. And zanidatumab advanced DTC in Europe. Moving to R and D, we're advancing promising opportunities in our pipeline.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

The Horizon GEA-one Phase III trial evaluating zanidatumab in first line gastroesophageal adenocarcinoma or GEA remains on track to read out in the second half of this year. We continue to progress other key zanidatumab clinical trials, including the Phase III EMPOWUR BC-three zero three trial in breast cancer. We're looking forward to sharing important data on Zepzelca, zanidatumab and doravaprone at ASCO in June. We added doravaprone to our pipeline through the Chimerix acquisition, which closed in April, enhancing our presence in rare oncology and bringing a near term commercial opportunity to help patients with limited treatment options. Given its patent protection into 02/1937 with possible extensions and the potential for expanded use in the frontline setting, we view dorvapron as a meaningful and durable revenue opportunity for Jazz.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

We are well positioned with respect to the impact of potential tariffs and have maintained financial flexibility supported by our strong balance sheet and cash flow. We remain confident in our top line revenue guidance and have updated our financial guidance to include the recent Chimerix acquisition and litigation settlement charges. I'll now turn the call over to Renee to discuss our commercial performance, after which Rob will cover our R and D pipeline. Bill will then provide a financial overview and discuss our updated guidance. And after that, we will open the call to Q and A.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Renee?

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Thanks, Bruce. I'll begin on Slide seven to discuss the continued progress of our commercial portfolio, starting with our sleep therapeutic area. I'm pleased to report total revenue for sleep, which includes Xywav and Xyrem net product sales plus royalties from high sodium oxybate authorized generics or AGs was approximately $431,000,000 in the first quarter of twenty twenty five. Xywav net product sales were approximately $345,000,000 in the first quarter, an increase of 9% year over year. As a reminder, we typically see seasonality in our sleep revenue due to reauthorizations at the beginning of each year.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Despite the expected seasonality, Xywav had a robust quarter of patient adds driven by strong execution from the field teams and we continue to be excited about the direction of our sleep portfolio. There were approximately 14,600 active Xywav patients exiting the first quarter, representing an increase of approximately four fifty net patient adds compared to the fourth quarter of twenty twenty four, comprised of one hundred and 20 five narcolepsy patients and three twenty five IH patients. Narcolepsy patient adds consisted predominantly of oxybate naive patients along with patients transitioning from high sodium oxybates. Our efforts to educate on the importance of reducing sodium intake and the increased risk of cardiovascular comorbidities among narcolepsy patients continue to resonate with HCPs and with patients. We see the most opportunity for patient growth from the IH market, where Xywav is the first and only FDA approved therapy.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

As we continue to build this market, disease education on the benefits of using a nighttime therapy to address sleep inertia and symptoms like brain fog and excessive daytime sleepiness for IH remains important to drive prescribing. We've launched consumer targeted digital and media campaigns to increase disease awareness coupled with promotion and medical education to HCPs. These campaigns are performing well, contributing to the growth of the IH market, and we continue to enhance our field effectiveness to optimize our impact for patients. Turning to Slide eight and Epidiolex. Epidiolex had net product sales of approximately $218,000,000 in the first quarter, a 10% increase year over year.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Growth was primarily driven by underlying demand and to a lesser extent favorable U. S. Payer mix, partially offset by U. S. Inventory burn.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Exiting the first quarter, inventory was lower than we would typically see at this time of the year. Our Epidiolex commercial and medical teams have been executing well with key drivers of demand growth in The U. S. Including continued data generation on the benefits of Epidiolex beyond seizure control, expanded reach to adult patients and long term care facilities, along with broad quality access and the nurse navigator program. We're pleased with the growth of Epidiolex and expect it to reach blockbuster status in 2025.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Moving to oncology on Slide nine. Net product sales were approximately $94,000,000 in the first quarter of twenty twenty five, a decrease of 8% year over year. As we previously noted, Rylee sales have been impacted by the update to Children's Oncology Group or COG pediatric treatment protocols for acute lymphoblastic leukemia made in mid twenty twenty four. Based on feedback from KOLs about their expected use of asparaginase, we continue to see the impact to Rylase as temporary with revenue normalizing during the second quarter of twenty twenty five. We are making steady progress in the adolescent and young adult market and place Subselka back on a growth trajectory.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Moving to Slide 11 and our ongoing ZYHERA launch. In December of last year FDA approved ZYHERA, the first and only dual HER2 targeted bispecific antibody approved for positive second line DTC in The U. S. We recognized approximately $2,000,000 of net product sales in the first quarter of twenty twenty five. While certainly launch, recession from HEP has been positive.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

We are hearing initial customer experiences are aligned with the clinical profile we observed in clinical trials. As a reminder, DTC is a rare disease with a limited number of patients and we expect revenue contribution to be modest from this rare cancer. We expect this initial launch in second line HER2 positive BTC will help us for two targeted therapy that are a significant benefit for patients. In addition, the BTC approval helps healthcare professionals gain meaningful experience with Cyhera prior to its potential indication in GEA. I will now turn it over to Rob for an update on our pipeline and upcoming milestones.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Rob?

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

Thanks, Renee. I'll begin on

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

Slide 13. I'm excited about our pipeline and the significant progress we have made on key programs with additional milestones expected this year. Looking first at oncology, we completed the submission of an sNDA to FDA to expand the Zipselka label to include maintenance therapy in first line extensive stage small cell lung cancer for patients who have not progressed during induction chemotherapy. The submission is based on statistically significant and clinically meaningful progression free survival or PFS and overall survival or OS data from the phase three AMFORT trial of Zipselka in combination with atezolizumab compared to atezolizumab alone. The results have the potential to be practice changing, and we look forward to showcasing the data in an oral presentation at ASCO on Monday, June 2.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

Presentation in a peer reviewed form also enables us to submit the data for potential inclusion in NCCN guidelines and compendia listing. We also remain on track for top line readout of PFS data from the Horizon GEA o one trial in the second half of this year. The first interim analysis of OS will also occur at this time. We are encouraged by the positive results from two independent phase two trials of zanadatumab in first line GEA that demonstrated increased median PFS, duration of response, and confirmed objective response rates. If the phase three trial findings are positive, we expect the data will support registration based on potentially clinically meaningful PFS and supportive OS data.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

Three Thanadatumab presentations have been accepted at ASCO, including updated overall survival data from the Phase two first line GEA trial. In addition, there will be an oral presentation on the safety and efficacy of dirdavapril. Turning to neuroscience, we recently initiated our planned Phase 1b trial to evaluate the efficacy, safety, tolerability, and pharmacokinetics of JZP-four forty one in participants with type one narcolepsy. And with respect to our Epidiolex trial in Japan, we are continuing to collect long term safety data, which was included in the trial design for twenty six and fifty two week analyses. We observed numeric improvements in both the primary and several secondary endpoints, And we remain on track to meet with the Japanese health authorities in mid twenty twenty five.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

As outlined on slide 14, Sanadatumab has proven to be a unique, differentiated, and highly effective tool targeted HER two therapy. Zanadatumab provides opportunities across multiple HER two positive solid tumors and represents a global opportunity for Jazz in multiple markets. Following the FDA approval of Zanadatumab in second line BTC last year, the CHMP recently adopted a positive opinion recommending the marketing authorization of zanadatumab for the treatment of adults with previously treated unresectable locally advanced or metastatic HER2 positive BTC. We look forward to the European Commission's decision and for the opportunity to bring a new treatment option to patients in Europe if approved. We have also completed recruitment for our Phase three trial evaluating semidatumab in first line GEA and expect top line PFS data later this year.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

The overall development program for zanadatumab includes multiple registration enabling trials, including pivotal trials in first line BTC, first line GEA, advanced breast cancer, and in a pan tumor basket trial focused on areas where we believe Xanny has the potential to emerge as the preferred HER two targeted therapy. This comprehensive development program underscores our confidence in zanzatumab's potential. Turning to slide 15. We are also very excited that the Chimerix transaction has been completed. I'm thrilled to welcome our new colleagues to Jazz.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

Our team is now engaged and working toward the shared goal of delivering dirzavapril to patients. Dirzavapril is a groundbreaking first in class small molecule in development for h three k twenty seven m mutant diffuse glioma, a rare high grade brain tumor that most commonly affects children and young adults. There are currently no approved drug therapies for these patients, and the median overall survival from diagnosis is approximately only one year. Multiple clinical studies have demonstrated dirdavaprone's benefit in patients with recurrent h three k twenty seven m mutant diffuse glioma, both as monotherapy and in combination with other treatment approaches, including radiation, with a consistently favorable safety profile. The FDA has accepted an NDA for doradaviprone, seeking accelerated approval for treatment of h three k twenty seven m mutant fusculioma in adult and pediatric patients with progressive disease following prior therapy.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

The application has been granted priority review and assigned a PDUFA target action date of August eighteenth of this year. Based on communication with the FDA to date, we do not expect the agency to hold an oncology drug advisory committee meeting in connection with the review of the NDA. Beyond the recurrent disease setting, soradavaprone is being studied in the ongoing phase three action trial, evaluating its use in newly diagnosed h three k twenty seven m mutant diffuse glioma patients following radiation treatment. This trial has the potential to confirm the clinical benefit of doradavaprone in recurrent h three k twenty seven m mutant diffuse glioma and potentially extend this treatment option into the frontline setting. We believe that tirzanepirone has the potential to transform the standard of care for this underserved patient population with very limited treatment options.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

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

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

Thanks, Rob. I'll start with our top line results on slide 17. As a reminder, our full financial results are available in our press release, which is available today, and in our 10 Q, which will be filed tomorrow morning. In the first quarter of twenty twenty five, we recorded $898,000,000 in total revenues. I'll note our first quarter revenues have historically been affected by several factors, including reauthorizations and inventory build in the latter part of the prior year, which typically burns off in the first half of the following year.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

As Renee mentioned, for Epidiolex, we saw more of this burn in the first quarter of this year. Despite these factors, Xywav and Epidiolex revenues grew 910% year over year, respectively. Our oncology product experienced a decline relative to the first quarter of twenty twenty four. In part, this was driven by having one fewer shipping week in the first quarter of twenty twenty five compared to the first quarter of twenty twenty four. In addition, the decline was primarily driven by our two largest oncology products, Zepzelca and Rylase.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

As Renee noted earlier, we believe we have line of sight into a resumption of growth for these products in the coming quarters. As I'll highlight on the next slide, we are affirming our total revenue guidance for 2025 based on our conviction in the strength of our overall commercial portfolio. Adjusted net income and earnings per share in the first quarter of this year were impacted by a charge related to certain Xyrem antitrust litigation settlements. This 172,000,000 charge to SG and A in the first quarter reduced our adjusted net income by $146,000,000 and our GAAP and non GAAP EPS by $2.38 per share and $2.34 per share, respectively. Before discussing our updated 2025 financial guidance, I'd like to comment on tariffs.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

Now I'm sure we'll have several questions on this topic during the Q and A session to limit my commentary to the most essential items. I'll start with the tariffs already enacted on China, Mexico and Canada as well as the general 10% tariff levied more broadly. For 2025, we anticipate no direct financial impact from these tariffs and currently expect any indirect impact resulting in inflation on goods we purchased can be managed within our existing internal budgets and external guidance. We won't speculate on the potential impact of future tariffs on pharmaceutical products imported into The U. S.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

At some hypothetical rate. As you can expect, we've evaluated various scenarios and are positioned to comment in a timely manner if and when such tariffs are enacted. I can say we have sufficient inventory in The U. S. To serve all or nearly all of our 2025 needs for each of our products.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

Consequently, we expect that any impact to our 2025 financials would be de minimis, if any, and unlikely to affect our guidance. With that context, let's move to our updated 2025 financial guidance. Now at first glance, the updates may seem complex. In reality, there are three drivers for the updates, and I think you'll find they're pretty straightforward. Those three drivers are the Chimerix acquisition, certain Xyrem antitrust litigation settlements and slightly revised expectations for full year R and D expense.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

The Chimerix acquisition affects guidance in three ways. First, it will be accounted for as an asset acquisition. Consequently, we'll recognize a nontax deductible acquired IPR and D charge that we estimate will be between $870,000,000 and $900,000,000 Second, we'll recognize Chimerix's results from operations from the date of close to the end of the year. At a high level, this includes a nonmaterial amount of revenue and cost of sales as well as roughly $50,000,000 in SG and A expenses and roughly $60,000,000 in R and D expenses. Third, our interest expense and interest income expectations have been adjusted to reflect the timing of the net outlay for Chimera, which was approximately $890,000,000 as well as the continued investment in Chimerix's operations over the remainder of the year.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

Moving to Xyrem antitrust litigation settlements. Our 2025 guidance has been updated to reflect the tax deductible charge of $172,000,000 we recognized in our SG and A expenses in the first quarter. Finally, excluding Chimerix, our guidance has been adjusted to reflect slightly lower R and D expense, roughly $20,000,000 in aggregate, in our existing Jazz portfolio, driven primarily by the successful early conclusion of two Phase IV Xywav studies. Moving on to the slides that illustrate the specific revisions to our guidance, you'll see on Slide 18 that we are affirming our full year 2025 revenue guidance. Our guidance range remains 4,150,000,000.00 to $4,400,000,000 which represents 5% year over year growth at the midpoint.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

This is driven by our confidence in both the neuroscience and oncology portfolios. Xywav continues to grow with impressive new patient adds and expansion of the IH market. We continue to expect that the DIALEX will reach blockbuster status in 2025 and anticipate RILEY's revenues will normalize during the second quarter of twenty twenty five. We also believe Zepzelca's potential expansion into first line maintenance therapy will provide more patients the ability to receive treatment for a longer duration. Turning to Slide 19.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

Our non GAAP adjusted SG and A guidance range for $1,250,000,000 to $1,310,000,000 has been updated to $1,470,000,000 to $1,530,000,000 The revised range reflects the $172,000,000 pretax charge both this quarter associated with certain Xyrem antitrust litigation settlements and the addition of Chimerix. Our non GAAP adjusted R and D guidance range of $720,000,000 to $770,000,000 has also been updated to $760,000,000 to $810,000,000 This change is driven primarily by additional investment in ongoing clinical programs for dordeviprone, partially offset by the slight reduction in spend on the Jazz portfolio I mentioned earlier. On the bottom line, we expect adjusted net income to be $250,000,000 to $350,000,000 for the full year of 2025. The updated ANI guidance reflects the cumulative effect of all the items I described earlier. We're in a sound financial position with healthy cash flow generation, worth $400,000,000 in the first quarter, and we have several near term commercial opportunities and a particularly important upcoming data readout.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

We continue to believe that a disciplined approach to capital allocation, including prioritized spend on our ongoing R and D programs and lead commercial products as well as corporate development, will drive long term shareholder value. I'll now turn the call back to Bruce for closing remarks.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

I'll conclude our prepared remarks on Slide 21. We had a strong start to 2025 with continued focus on commercial execution led by growth of Xywav and Epidiolex and the ongoing launch of ZYHERA. In addition, we were pleased to close the Chimerix transaction and welcome our new colleagues as we work together to prepare for the potential launch of dorbavaprone. Corporate development remains key to our strategy and the Chimerix transaction is representative of our ability to identify and execute transactions that are strong strategic fits. Dorbaprone is a potential near term commercial opportunity with an efficient commercial call point and durable revenue stream.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Our R and D pipeline continues to advance with the top line PFS readout from our Phase III GEA trial of zanidatumab expected in the second half of twenty twenty five, the near term PDUFA date of dorvapron in August and the recent submission of the Zepzelca sNDA. Our financial position, balance sheet and cash flow generation remain strong, supported by our focus on operational excellence and strategic capital allocation. We remain well positioned to continue delivering innovative therapies that transform the lives of patients and their families. That concludes our prepared remarks. I would now like to turn the call over to the operator to open the line for Q and A.

Operator

Your first question comes from the line of Jason Gerberry of Bank of America. Please go ahead.

Jason Gerberry
Jason Gerberry
MD & Equity Research at Bank of America Merrill Lynch

Hey guys, thanks for taking my question. And so I'm going to respect Phil's comment about not asking to speculate on tariffs, but what I'm gonna ask is about your supply chain and specifically Xywav. So you have a US CDMO.

Jason Gerberry
Jason Gerberry
MD & Equity Research at Bank of America Merrill Lynch

And so I'm just curious, you

Jason Gerberry
Jason Gerberry
MD & Equity Research at Bank of America Merrill Lynch

know, if you can speak to Xywav is not a very high volume product. So just curious to to the extent that, you know, if need be in 2026, you could, you know, fully supply the product from your US CDMO. And if you can comment if your API can be sourced in The US such that you've got a fully US supplied product for The US market. Thanks.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

Yeah. Jason, thanks for the question, and I appreciate your being respectful of the prior comments as long as we can comment on what we can. So you're correct. We do have a US supplier for oxybate, including Xywav. That supplier does have enough capacity that we can access to fully meet our US needs.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

And, certainly, if, tariffs are coming into play, would be a very effective option for us to mitigate, that exposure. And there's no particular issues that I would note with regard to API and having that subject to to tariff. Operator, next caller, please.

Operator

Your next question comes from Jessica Fye with JPMorgan. Please go ahead.

Jessica Fye
Jessica Fye
Managing Director & Equity Research Analyst - Biotechnology at JP Morgan

Hey, guys. Good afternoon. Thanks for taking my question. So following up on the first question, maybe thinking beyond oxybate, can you talk about Jazz's manufacturing footprint, including sources of API and any other possible mitigation strategies or contingency plans to neutralize any potential impact of biopharma tariffs if they're implemented?

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Maybe I'll ask Renee to take the first part of that, which is just factually where we do our manufacturing. Then, Phil, if you want to add anything more on tariffs, jump in.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Sure, Bruce. And thanks for the question, Jeff. So with respect to where we manufacture Xywav and Xyrem, Phil mentioned we do have a CMO in The US. We also have a facility in Athlone, Ireland, and so we do have a a level of flexibility there. With respect to Epidiolex, we have a facility in The UK, where we produce that product, and we have the capability to to also develop other products at that plant.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

And then some of our other smaller products on the oncology side are manufactured in different locations, and Depitilio is in Villa Guardia, Italy. Vyxeos is manufactured by Cintra, and then Rylase is manufactured in Denmark. So we do have quite, a lot of manufacturing in Europe. In terms of our capabilities and what options we have going forward, obviously, making changes to our manufacturing sources is something that we don't take lightly. It does take a period of time, but we do have a level of flexibility as we've mentioned today with our oxybate products, and we'll continue to evaluate both backup options and other sources of manufacturing.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Phil?

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

Yeah. No. It's great summary. And as you'd expect, Jess, this has been subject of quite a bit of work across across functional team since sort of late last year, early this year. And there certainly are opportunities for us to work with CMOs here in The US to further reduce the exposure to jazz beyond those that we're currently working with.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

To date, sort of the primary way that we've buffered impact would be through having sufficient inventory in market here in The US to cover all or nearly all of our US needs at this point for 2025 for each of our products. We'll continue with that strategy. Then, obviously, depending upon if and when tariffs come into effect, what geographies they would impact and what rate, we may have some protection from inventory for 2026 as well. Turn it back to the operator for the next question, please.

Operator

Your next question comes from David Amsellem with Piper Sandler. Please go ahead.

David Amsellem
David Amsellem
Sr. Research Analyst at Piper Sandler Companies

Actually wanted to ask a question about Zepzelca and competition from Indaltra. I know it's having an impact, and the label expansion is certainly not lost on me. But I guess my question here is how should we think about Zepzelca over time in terms of its trajectory? Do you anticipate that first line contribution will overwhelm the pressure in the second line setting? And then also, how are you thinking about the expansion of IMDELTRA itself, bearing in mind that Amgen has a pretty comprehensive development program in small cell lung, in terms of, earlier lines of therapy.

David Amsellem
David Amsellem
Sr. Research Analyst at Piper Sandler Companies

So how are you thinking about the ZELKA overall as a growth product going forward? Thanks.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Yeah. I'm happy to jump in and take that one. So as we think about Zepzelca, we did have some dynamics impacting the first quarter. As we look forward though to your point on Zepzelca returning to growth, even with competition and some, delayed progression of first line limited stage patients coming into the second line, Zepzelca in the second line still remains the leading treatment as measured by market share. Importantly, we do look forward to both sharing our data at ASCO on the first line and FORTE trial where we showed stat say, again, clinically meaningful PFS and OS in our study of first line extensive stage maintenance patients.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

And so this is something we look forward to presenting at ASCO and then rapidly submitting that data for potential inclusion in NCCN treatment guidelines. We do expect this data to be practice changing, and therefore, going into the first line, we look to a larger patient population to treat in the extensive stage, patients, but also longer treatment duration. So we do expect this to contribute to future growth of the brand, and we would also expect, patients that didn't receive Zepzelca in first line to have the opportunity to receive it in the second line. And then, Rob, do you wanna take, the question with respect to, the views of tirlatumab going forward from a clinical perspective?

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

Yeah. Again, Jess, I think you covered it very well, Renee. With our new data and ultimately adoption into NCCN and and in the label as first line, you know, that that affords us a larger population for a longer duration of therapy. Tirilatumab is not approved in that in that setting, and it would be quite a while before a new trial would read out there. So I think that's the you know, that as a new standard of care, I think that's the key that extensive stage patients who don't progress after induction, as you said, should become the standard of care to get Subzelca.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

And then for patients who don't receive it in frontline Subzelca, you know, has data to show that it's an effective second line therapy.

Operator

Your next question comes from Mark Goodman with Leerink Partners. Please go ahead.

Marc Goodman
Senior MD - Neuroscience at Leerink Partners

Bill, your comments about tariffs not impacting 2025, I assume have to do with the fact that you have inventory that you've just built up in The U. S. And so you don't have to worry about it. But is it a fair question to ask what would be the impact for a full year just on an annual basis if you did have all that inventory built up? Like what would we be talking about here as far as the numbers?

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

Yeah. Mark, appreciate the question. Sort of in this theoretical realm of what might happen in the future, it depends, obviously, in what kind of rates being put in, what kind of geographies are affected. So we're not commenting at this point in time on those hypotheticals. I would say, again, depending on when tariffs would go into effect, if they are, we could get some coverage from inventory as we're getting effectively this year.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

And then we also have the ability for our oxybate products to use US source to effectively mitigate that exposure. Beyond that, the main tools available to us would be things like looking to work with other third party manufacturers here in The US to further reduce the impact. But feel very good about the position that we're in currently, obviously closely monitoring the situation. We'll take actions as needed.

Operator

Your next question comes from Andrea Newkirk of Goldman Sachs. Please go ahead.

Analyst

Hi, This is Telani on for Andrea. Thanks for taking our questions today. You want to understand a little bit better, why does the ChimeraX acquisition make sense for Jazz? And what do you find most compelling about the dorvapril and commercial opportunity? And related to that, how are you thinking about additional BD activities going forward?

Analyst

Thank you.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

So maybe I'll jump in, at the total company acquisition level, and then, Renee or Rob, if you wanna add anything on dorvaprone in particular, you can. We've been, I think, pretty clear about our corporate development strategy for some time now as a major pillar of how we invest capital to create value for shareholders in addition to what we do in our investments in our commercial portfolio and in our R and D efforts. And we've been clear that our priorities include finding products that would represent you know, a real advance where there's unmet medical need in a serious condition that aligns with our capabilities, that has an efficient commercial call point so that we don't need to do, you know, a massive buildup of commercial expense that have long durability. And we really feel that Chimerix on all fronts was a perfect fit for us. It matches well with what we do well, particularly in oncology, near term launch, again, efficient and we're confident fills a serious unmet need.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Rob, you wanna jump in?

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

Yeah. I'd love to. You know, the the treatment for diffuse glioma hasn't changed since I trained as a pediatric oncologist twenty five years ago. Patients get debulking surgery, which is never curative, and then radiation therapy. And that's that's essentially it prior to diradaviprone and prior to the discovery that h three k twenty seven ten mutations occurred and were a driver for oncogenesis in this setting.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

It's been shown now with diradaviprone that for patients with this mutation, the therapy is effective. We're really impressed with not only the efficacy, but also the safety profile in a disease setting, as they indicated, has a ongoing very high unmet need and and without many other prospects, unfortunately.

Operator

Your next question comes from Annabel Samimy of Stifel. Please go ahead.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Hi. Thanks for taking my question. For Rylase, I understand obviously that the protocols have changed for the pediatric indication that delays treatment. But what quick do you expect for pickup in AYA? It's been, I guess, quite a little bit of time that you've been trying to drive growth in that area.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

And when do you think we can get some critical mass there and some momentum to return Riley's back to growth?

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Renee?

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Yeah. Thanks for the question there. With respect to the AYA segment, it really does take time to drive education with adult treaters to use asparaginase and rylase. These are, treaters that often have a different protocol that they're following. And so we were certainly pleased last year with the updated results from the protocol that created the gap in asparaginase treatment because although it created, a delay in when asparaginase is dosed, and it has led to some of the challenges that we've had with revenues, we feel very confident that it is, demonstrating the importance of asparaginase to treatment, and it's also resulted in much higher overall survival, which is good news for patients.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

So we are having, some momentum and success with respect to segment. It does take a little bit more time than than, what we see in pediatrics where we've had pretty much universal adoption, but there has been some delay in getting back to that, continued use. Importantly, as we've said before, there is no change to the total doses of asparaginase with the new protocol that is in place, and so we expect we will be getting back to normalization in the second quarter and can continue to focus on the growth in AYA.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

Maybe before we go to the next caller, can just add something real quick. Annabel, if you think about our oncology performance, particularly year over year here in the first quarter, I think it's important to keep in mind what I mentioned about there being one fewer shipping week effectively in the first quarter of this year. Obviously, it's hard to know, you know, when you have an additional week, are you getting that at an average rate higher or lower? But just on pure math, missing one out of 13 is 7.7% or roughly 8% of the opportunity. So certainly, there was an impact on the year over year growth just given the fact that we had one fewer shipping day.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

So keep that in mind as you think about the trends and what you're seeing.

Jeff Macdonald
Jeff Macdonald
Executive director & IR at Jazz Pharmaceuticals

Go to the next caller, please.

Operator

Your next question comes from Akash Tewari with Jefferies. Please go ahead.

Amy Li
Amy Li
SVP Equity Research at Jefferies

Hey, this is Amy on for Akash. Thanks so much for taking our question. Just one for Horizon GEA, would love to get your expectations on the control arm performance and what gives you confidence that TRASM chemo isn't outperforming what was shown with keynote eight eleven? Thanks so much.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Rob?

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

Yeah. So as you know, there's been quite a bit of experience in this first line HER two positive GEA setting from the original TOGA trial that was the basis for the approval of Herceptin through the Jacob trial and then more recently, KEYNOTE eight eleven. And across those studies, the control arm of trastuzumab chemotherapy has performed pretty consistently with a median PFS between, I think, about 6.9 months up to high of about 8.1 months in the more modern era. So through these three phase three trials, I think it gives us a pretty good idea of what to expect from the call control arm, and we planned accordingly. We continue to have confidence in zanidatumab's ability here.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

As you know, there have been two phase twos published showing very promising results. Sani chemo with a median PFS of 15.2. That's the last publication in Sani chemo tocilizumab with a median PFS of 16.7. And at ASCO this year, we will update for the first time the overall survival data with anti chemo. Prior to this, the the median wasn't estimatable based on the maturity level.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

We look forward to presenting those data as well.

Operator

Your next question comes from Joseph Thome with TD Cowen. Please go ahead.

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

Good afternoon. Thank you for taking my question. On gordemaprone, think Chemerics paused enrollment in the Phase III study ahead of the acquisition. So kind of just curious if that has restarted and if you anticipate making any changes to the Phase III trial in the first line patients? And maybe relatedly, obviously a lot of shakeups at the FDA.

Joseph Thome
Managing Director, Senior Biotechnology Analyst at TD Cowen

I guess what kind of data points can you provide to make sure that everything is on track with the upcoming PDUFA date, especially given Kymriahx did do a little bit of a 180 on the submission? Thank you.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Rob?

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

Yeah. Happy to take those. So with regard to the with regard to the FDA, so far, the review is going exactly as we expect. No surprises there and no indication that we would be off of our PDUFA date of August 18. The first part of your question was related to pausing enrollment in the ongoing confirmatory frontline trial.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

And just to clarify, that was paused only in The US. And, you know, there, we were anticipating an approval and availability of drug, and, therefore, we want to avoid the problem of patients enrolling and then crossing over from the control arm to get through dabaproem by prescription, which could confound the overall survival results. As you mentioned, while the trial isn't rolling very well, we would have time potentially to make changes to the analysis plan. We haven't announced any of those changes, but certainly, we'll look at that carefully to be sure that that trial is well powered to deliver the results not only in a timely fashion, but that would be most informative.

Operator

Your next question comes from Gregory Renza with RBC Capital Markets. Please go ahead.

Gregory Renza
Gregory Renza
Senior Biotechnology Analyst at RBC Capital Markets

Hey, good evening guys. Thanks for taking my question. My question is just on the oxybates. And as Renee, you were articulating just some effectiveness on the campaigns and how those are performing well. I just wanted to give an opportunity to elaborate a little bit about what you're seeing and what the direct impacts are from the campaigns that have led to your reassurance about the contribution and the growth of the IH market.

Gregory Renza
Gregory Renza
Senior Biotechnology Analyst at RBC Capital Markets

Thanks so much.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Yeah. Thanks for the question. So we are seeing beneficial response, to the campaigns. We're seeing as we are building, in particular, the idiopathic hypersomnia market, we are seeing our disease education and continued interactions, with physicians helping them to better identify idiopathic hypersomnia. It also helps patients to better understand this condition for which there has not been a lot of disease awareness in the past because without an approved medication, there's not a lot of incentive to actually diagnose someone with idiopathic hypersomnia.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

So not only have we had good success with the digital and media campaigns that I mentioned, but we've continued to sharpen our execution in the field. We have, continued to grow new prescribers. We've had great success with our field nurse educator program, and we've had another, sorry, a number of other initiatives that are proving effective and really give us confidence in the growth. If you look at where we ended this quarter, this first quarter of twenty twenty five, and compare that to where we were a year ago, stepping out of the first quarter of twenty twenty four, Looking at the patient adds, we've seen an increase of five percent, and that is in a mature market with competition, which, is really a great progress. Then with idiopathic hypersomnia, we've had an increase of thirty nine percent looking at the progress over the last twelve months.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

So we're really excited about the continued momentum that we have. Certainly, we have seasonality each year in the first quarter, but still executing really well in this area.

Operator

Your next question comes from Joel Beatty with Baird. Please go ahead.

Joel Beatty
Senior Research Analyst at Baird

Hi. Thanks for taking the question. And, doctor Pravone, could you discuss a little bit more about where it could fit in the treatment algorithm initially upon approval? And then also when could the first results come from the action trial that might affect how it's used?

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Rob?

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

Yes. So we expect, based on the submission that we, that we've made, we expect the initial, accelerated approval to be in the recurrent setting. The action trial, as you know, is treating in the frontline setting after patients received the bulking surgery and radiation therapy, and that will give us an opportunity to expand to the frontline. We haven't given specific dates on when that would read out, but we have said it's enrolling enrolling to plan.

Operator

Your next question comes from Amy Fadia with Needham. Please go ahead.

Ami Fadia
Senior Analyst at Needham & Company

Thanks for taking my question. Can you provide us with an update on JZP-four 41, where you are with the NT1 study and when we might get an update on that? And then just more broadly touching upon the, comments previously around business development. Have your priorities changed or evolved, in the last couple of months as, you know, we've seen the market change and, if you could sort of comment on, what types of assets, whether it's by the therapeutic area, or the stage of development you'd be focused on, as you think about adding something inorganically? Thank you.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

I'm just gonna remind people, try to limit it to one question. But on this one, maybe, Rob, you could talk about four four one. And then, Phil, if you wanna jump in on corporate development priorities.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

Yeah. We we have initiated the four four one trial, which I'll remind you is intended to be in a small number, approximately 10 patients with n t one. And we expect to look at those data as they come in, but we haven't given any specific guidance on, you know, when we would share information on those data just as yet.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

Yeah. And, Tommy, on I'm sorry.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

I missed the second part of the question.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

So for corporate development, priorities are unchanged. We continue to look at corporate development as a very important way for us to go ahead and reach more patients over time, create value for shareholders. We finished the first quarter in a really strong financial position with $2,600,000,000 in cash investments, $430,000,000 in operating cash flow in the quarter. So even after the payment of roughly $890,000,000 net to acquire Chimerix, we're in a really strong position to continue to invest in our future. We do look across the various therapeutic areas that we're currently in as well as selectively at other rare orphan diseases where we can deploy our capabilities to create value.

Philip Johnson
Philip Johnson
Executive VP & CFO at Jazz Pharmaceuticals

We do look at both licensing, like we did very successfully with the licensing deal with Zymworks that's brought us, obviously, Zhihira. And then, obviously, for acquisitions like we've done, we think very successfully looking forward to the upcoming PDUFA and then hopefully launch shortly thereafter of dordavaprone. So we continue to be active in looking at opportunities, see a number of them we think that would make sense for us across our various therapeutic areas, and I would expect to see us continue to be active in this area. I would say on the margin, the uncertainty that's created by some of the tariff and other policy discussions does not change fundamentally what we're looking to do, but probably the margin means that we wanna take a slightly more conservative capital structure stance, maybe keeping a bit more cash than we might otherwise, and maybe not fully using all of the potential debt capacity that we have, but still able to use a significant portion of that to advance our corporate development efforts. So hope that gives you some some context.

Jeff Macdonald
Jeff Macdonald
Executive director & IR at Jazz Pharmaceuticals

If we can

Jeff Macdonald
Jeff Macdonald
Executive director & IR at Jazz Pharmaceuticals

go to next caller, please.

Operator

Your next question comes from Ashwani Burma of UBS. Please go ahead.

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Hi. Yeah. Thanks for taking my question. I just wanted to clarify, like, so when you I think you mentioned that one less week of ordering, is that for a handful of products? Or which product is it for?

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Or is it across the business?

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Yes. That would have been across our US Oncology business and common for the various products there. Renee, anything you want to add?

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

No. That's correct.

Operator

Your next question comes from Mohit Bansal with Wells Fargo. Please go ahead.

Mohit Bansal
Mohit Bansal
Managing Director at Wells Fargo Securities

Great. Thank you for taking my question. I have a question for you, Rob. So in our conversation with some breast cancer doctors, the interesting takeaway was that it is not a hormone confusion that that and HER two would become frontline agent for all the HER two positive patients. Likely, part of it is safety and comfort with the Cleopatra regimen.

Mohit Bansal
Mohit Bansal
Managing Director at Wells Fargo Securities

So the question is, do you see a potential for Zany to be the first line as well? And what kind of trials you may have to do there? Because Cleopatra is

Mohit Bansal
Mohit Bansal
Managing Director at Wells Fargo Securities

a really long regimen here. Thank you.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

Sure. Well, I I mean, I would just reinforce our primary strategy, which is to position after in HER two because of the data we've generated showing activity of Xan, you know, very promising activity after just about any prior and even multiple different HER two agents, you know, including standard frontline therapy, which is Herceptin, Perjeta, and chemo, and HER two TDM one, tucatinib, etcetera. So positioning it after in HER two, which is currently second line and likely to move to frontline for, I would say, great majority of patients And this d disease setting is really very meaningful, and there won't be any other HER two therapies that will have been evaluated in that particular setting. Remember, these patients tend to go on to get multiple lines of of therapy. You're right that there would be a few there would be some patients who may not tolerate an HER two or would have some preexisting condition that would prevent them from and I think in those cases, patient who's either progressed on or intolerant to Enhertu could move on to zanadatumab based on the three zero three trial.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

You know, if if Enhertu, you know, is is ultimately approved in the frontline setting, I

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

do think it will be

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

the great majority of patients who get it, you know, based on the strong efficacy.

Operator

Your next question comes from Sean Lalman of Morgan Stanley. Please go ahead.

Michael Riad
Michael Riad
Analyst at Morgan Stanley

Hi. This is Mike Riad on for Sean Lalman. Thank you for taking our question. For Xywav, in narcolepsy, are you able to provide a more granular breakout for patients who need oxybate versus high sodium switches? And then in IH, how are you thinking about Xywav's value proposition with potential for a competitive threat there from Lumrise?

Michael Riad
Michael Riad
Analyst at Morgan Stanley

Thank you.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Renee?

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Yeah. So with respect to the narcolepsy ads, we have seen primarily ads in the quarter coming from new to oxybate patients. And I think that does speak to what we're now starting to see, which is an a bit of an expansion to the market given that this is a more, mature product. We've been really pleased, with what we're seeing in terms of both field execution, the, appreciation of low sodium, to physicians and also to patients, and that's really resonating. It's clear that HCPs and patients are prioritizing long term health benefits of low sodium as well as the dosing flexibility that Xywav offers.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

So we do see switching to or shifting over to IH. We do see IH as the area where there's the most opportunity to drive growth. With respect to any future potential competition in IH from Lumerize, I would say, again, Xywav is the only low sodium option, and we do know from the data that we have been able to generate, we know that narcolepsy and IH patients are at increased risk for cardiovascular comorbidities relative to the general population, and so we do continue to see all high sodium oxybate patients as potential Xywav patients. And keep in mind that within our label for Xywav for idiopathic hypersomnia, there is flexible dosing. That indication is twice nightly or once nightly depending on what the physician and the patients choose to pursue in terms of their therapy.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

So we feel we're quite well positioned with respect to narcolepsy and idiopathic hypersomnia. Hypersomnia.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

I will also just jump in and and point out that, you know, for those of you that saw the court decision today, you know, that our IP has been found to be valid that Avadel has admitted to infringing it, we still don't see even after today's ruling a viable path for Avadel to commercialize Bloomrise and IH before the expiration of the relevant patent in 02/1936. So I totally agree with everything Renee said in terms of potential competitive positioning and differences between the product. But there's some room to go before we actually do have competition in IH.

Operator

Your next question comes from Gary Nachman with Raymond James. Please go ahead.

Gary Nachman
Gary Nachman
Managing Director - Equity Research at Raymond James Financial

Thanks, and good afternoon. So for ZYHURA and DTC, understanding it's a small indication, how is the ramp going? How rapid is the penetration? And what's the anecdotal feedback on how the drug is performing? And have there been any challenges with access and and how you're helping facilitate that?

Gary Nachman
Gary Nachman
Managing Director - Equity Research at Raymond James Financial

And then if GEA ends up being positive, in first line as a as a bigger market, would you consider changes to pricing at all? And also how your promotional efforts, would change for that indication versus BTC? Thanks.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Yeah. Thanks for the question. So we had our first patients treated in December shortly after launch for BTC, and the reception has been quite positive. HCPs are are glad to have ZiHera available to treat patients. Just as a reminder, BTC is a very small patient population, three thousand patients in The US in first line and second line.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

And therefore, we do expect revenues from this first indication as as we've stated to be quite modest. In terms of access, we haven't really had any issues. What we're in, in the process of doing is ensuring we've spent quite a lot of time in these first few months ensuring that we have agreements of the necessary, logistics in place for community and academic centers to be able to get access to the product rapidly And, certainly, the the efficacy supporting this approval is something that they're excited to be able to bring to patients. When we look at GEA, we're, excited to be able to read out that study in the second half. With that data and with, publication of that data, we would, intend to go rapidly towards, again, trying to get NCCN guidelines in place similar to what we intend to do relative to Zepzelca.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Of course, we would not promote without having an approval, but having the product on NCCN guidelines will enable use for that indication should physicians choose to do so. I think with respect to pricing, we're in a good position. We typically will comment on pricing when we have a launch slash approval. So stay tuned, but we think given the benefit that we are seeing in efficacy, we'll be in a good position where we are today.

Operator

Your next question comes from Charles Duncan with Cantor Fitzgerald. Please go ahead.

Analyst

On for Charles. Thank you for taking our questions. So you reiterated confidence in Epidiolex reaching blockbuster status in 2025. Can you speak about any catalysts? Or what market dynamics underpin that expectation?

Analyst

And also can you talk about any meaningful impact of The U. S. Or in off label usage that could contribute to this trajectory? Thank you.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Yeah. Renee?

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Yeah. I didn't hear the full question, but what I understood was

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

I can I can jump I can jump in on I can jump in on the first part, Renee, and just say, you know, our confidence that it remains on track for blockbuster status is in part driven by

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Yes?

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

It's it's already, you know, it's already at that run rate and has been continuing to grow as you saw with the 10% first quarter over first quarter growth. Renee, you can comment on where where growth can be coming from, but, you know, we're very solidly on track.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

Yeah. Thanks, Bruce. The call had cut out for me. So we are quite, quite confident in where we're going with respect to the future. Epidiolex is a highly differentiated product within the ASM landscape.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

We have a robust body of evidence supporting that both on the seizure side as well as the non seizure benefits. And that data continues to resonate with physicians and caregivers, in particular on the non seizure benefits side, cognition, behavior, emotional, and social function. And also, the broad spectrum efficacy and well characterized safety profile enables physicians to have Epidiolex combined well with other agents, which is particularly important in this area, given polypharmacy. While we do not promote off label, we do see the product used across a number of different epilepsy subtypes across the, underlying seizures, for which we've shown efficacy. And then in terms of additional growth, we're having great momentum in the adult and long term care setting.

Renée Galá
Renée Galá
President & COO at Jazz Pharmaceuticals

We have a a new screening tool that we've put into, that we've launched and additional initiatives to help identify LGS, for example, in previously undiagnosed patients in the adult setting, our access has been high quality and continues to improve. And then also with respect to our nurse navigator program, we're seeing strong persistency and seeing that even, become stronger with respect to the nurse navigator program helping to guide patients through starting therapy. So all of those, elements give us, confidence in the overall growth. And, of course, the durability we've talked about having settled with our ANDA filers, we think we're in an excellent position there as well.

Operator

Your final question comes from Julie with Truist Securities. Please go ahead.

Joon Lee
Joon Lee
Director & Senior Biotech Analyst at Truist Securities

Hey. Thanks for squeezing me in. For the Horizon GEA, are you able to comment on the ratio of patients who are p d one positives? I mean, is the ratio closer to what we saw in keynote eight one one or closer to your phase one two XANE plus chemo plus tislide study? Thank you.

Robert Iannone
Robert Iannone
Executive VP, Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals

I don't have that information, and I just would remind you that, you know, how you characterize positive depends a little bit on which assay you're using, etcetera. So we are measuring it, and we'll have the ability to look at that, you know, post hoc as needed to support regulatory approval.

Operator

That will conclude our question and answer session. I will now turn the call back over to Chairman and Chief Executive Officer, Bruce Cozad, for closing remarks.

Bruce Cozadd
Bruce Cozadd
Chairman and Chief Executive Officer at Jazz Pharmaceuticals

Thank you, operator. Let me just say with Epidiolex and Xywav growth, some upcoming exciting approvals on the oncology side of our business across three different products and GEA data upcoming, there's a lot to look forward to. I'd just like to close today's call by recognizing our Jazz colleagues for their efforts and thanking our partners and shareholders for their continued confidence and support. Thank you all for joining us today.

Operator

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

Executives
    • Jeff Macdonald
      Jeff Macdonald
      Executive director & IR
    • Bruce Cozadd
      Bruce Cozadd
      Chairman and Chief Executive Officer
    • Renée Galá
      Renée Galá
      President & COO
    • Robert Iannone
      Robert Iannone
      Executive VP, Chief Medical Officer and Global Head of Research & Development
    • Philip Johnson
      Philip Johnson
      Executive VP & CFO
Analysts
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Key Takeaways

  • Jazz reported Q1 2025 total revenues of $898 million, driven by Xywav (+9% YoY) and Epidiolex (+10% YoY), while oncology sales declined 8% due to protocol changes and shipping timing.
  • The company submitted an sNDA to expand Zepzelca into first-line maintenance for extensive-stage small cell lung cancer and received a positive CHMP recommendation for zanidatumab in advanced HER2-positive biliary tract cancer in the EU.
  • Jazz closed its acquisition of Chimerix in April, adding the first-in-class rare oncology asset doravaprone, which has a PDUFA date of August 18, 2025, and strong patent protection into 2037.
  • Key pipeline milestones include a topline readout from the Phase III Horizon GEA-101 trial of zanidatumab in first-line gastroesophageal adenocarcinoma in H2 2025 and multiple ASCO presentations on Zepzelca, zanidatumab, and doravaprone.
  • The company reaffirmed its 2025 revenue guidance of $4.15–4.40 billion, updated non-GAAP SG&A to $1.47–1.53 billion and R&D to $0.76–0.81 billion to reflect the Chimerix deal and litigation charges, and expects minimal tariff impact.
AI Generated. May Contain Errors.
Earnings Conference Call
Jazz Pharmaceuticals Q1 2025
00:00 / 00:00

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