Jazz Pharmaceuticals, Inc. 2026 Q2 Earnings Call

Please go ahead. Thank you, and good afternoon, everyone.

Today, Jazz Pharmaceuticals reported its second quarter 2026 financial results. The slide presentation accompanying this webcast is available on the Investors section of our website, along with the press release and quarterly report on Form 10-Q for the second quarter ended June 30, 2026. On the call today are Renee Gala, President and Chief Executive Officer; Sam Pearce, Chief Commercial Officer; Robert Iannone, Global Head of R&D and Chief Medical Officer; and Phil Johnson, Chief Financial Officer. On slide two, I'd like to remind you that today's webcast includes forward-looking statements such as those related to our future financial and operating results, growth, potential, and anticipated development, regulatory and commercial milestones, 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 these risks and uncertainties described in today's press release and under the caption Risk Factors in our annual report on Form 10-K for the fiscal year ended December 31st, 2025. 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. I'd like to turn the call over to Renee.

Thanks, John. Good afternoon, everyone, and thank you for joining today's conference call. We delivered another outstanding quarter, generating record revenue of $1.2 billion, representing 16% year-over-year growth. The momentum we've built in the first half of the year provides us with confidence to raise our full-year revenue guidance. Our results reflect an intense focus on aligned execution across our diversified portfolio, sustained demand of our commercial products, and progress in advancing our long-term priorities for value creation. As we approach a significant milestone with the August 25th PDUFA date for zanidatamab in first-line HER2-positive metastatic GEA, our commercial, medical, and market access teams are fully prepared to successfully launch zanidatamab. We're entering a new phase of growth created by the opportunity to deliver clinically meaningful outcomes for patients facing this highly aggressive, difficult to treat disease.

Our consistent execution reflects the focus strategy we outlined at the beginning of the year. Expand our leadership in key therapeutic areas, advance differentiated innovation, and create durable long-term value. Across the business, our teams are delivering key therapies to patients, advancing zanidatamab, and leveraging our financial strength to invest in both internal R&D and external innovation. An example of this approach is our preclinical research collaboration with AbCellera, which leverages their T-cell engager platform to discover novel multi-specific antibodies. This agreement directly complements our oncology expertise and supports our refined rare disease strategy. These exceptional results from the quarter position us to sustain our momentum while delivering meaningful benefits for patients and driving robust returns for our shareholders. With that, I'll turn the call over to Sam to share more details on our commercial performance.

Thank you, Renee. Our commercial teams delivered another impressive quarter of revenue, with 16% growth across the portfolio and double-digit growth from each of our key promoted brands. This performance is a result of focused investment and targeted, impactful execution, which is driving sustained momentum across our increasingly diversified portfolio. I'll begin on slide seven with rare sleep. XYWAV's profile as the only low-sodium oxybate on the market continues to resonate with physicians and patients. XYWAV net product sales increased 13% to $471 million in the second quarter of 2026 compared to the second quarter of 2025. Supported by targeted healthcare provider and patient-focused digital campaigns, our field execution continues to expand the narcolepsy and idiopathic hypersomnia markets and deliver sustained new patient adds.

These efforts emphasize XYWAV's differentiated low-sodium profile and the efficacy it provides by treating underlying disrupted nighttime sleep and addressing daytime symptoms for patients living with narcolepsy and idiopathic hypersomnia. Demand for XYWAV remains robust, with approximately 525 net patient additions in the quarter. This brings our total active patients to approximately 17,125, representing more than 12% year-over-year growth. This momentum is supported by our targeted investments in high-touch patient support services such as our field nurse educator program, which deliver differentiated support to help patients achieve optimal dosing and sustained treatment. This first-half performance underscores the durability of our sleep franchise, with limited impact from high-sodium generics. Whilst we will closely monitor second-half market dynamics, including generic availability and potential new product launches, our confidence in XYWAV's foundational role is unwavering. Its clinical profile remains differentiated as the only low-sodium oxybate and the only FDA-approved option for IH patients.

Moving to slide eight and Epidiolex. Epidiolex delivered another outstanding quarter, with net product sales growing 16% year-over-year to $292 million, driven primarily by robust underlying demand. This momentum is fueled by our field team's ongoing success in educating HCPs and caregivers on Epidiolex's broad-spectrum efficacy and its meaningful beyond-seizure benefits for new and existing patients. Concurrently, we are actively expanding the Epidiolex franchise. While Rob will cover our clinical expansion into new treatment-resistant seizures, I want to highlight a critical lifecycle initiative, our novel capsule formulation. Designed to unlock additional utilization within our approved indications, the capsule targets deeper penetration in certain segments of the adult patient population. By offering this convenient alternative alongside our oral solution formulation, we aim to improve accessibility and compliance for adult patients while firmly reinforcing our long-term leadership in the anti-seizure market. Turning to our oncology portfolio.

We are extremely pleased with the ongoing launch of Ziihera in BTC, as shown on slide nine. In the second quarter of 2026, Ziihera generated $15 million in net product sales. Since launching in second-line BTC, we have rapidly established clinical leadership, achieving more than 50% of the addressable market share in the U.S. This clinical momentum is driven by deepening utilization in academic centers and expanding adoption across community settings, supported by highly consistent, positive real-world prescriber experiences. Critically, our success in BTC serves as a powerful commercial foundation for our next major growth phase in GEA. Because there is significant direct overlap between existing BTC and GEA treating accounts, our commercial infrastructure is fully primed. On slide 10, you can see how our launch readiness framework is designed to drive rapid uptake.

Our commercial footprint is highly optimized, with over 90% target physician overlap, allowing our team to rapidly generate clinician excitement and demand. This enthusiasm is rooted in zanidatamab's exceptional clinical data, specifically an unprecedented median overall survival exceeding two years, establishing it as the potential preferred backbone in HER2+ GEA. To support immediate clinical adoption at launch, we've submitted this data to key oncology pathways and will leverage our already established permanent J-code to minimize reimbursement barriers. Backed by our robust JazzCares patient support program, we are fully prepared to deliver seamless access to patients upon approval. Turning to slide 11 and Modeyso. Modeyso generated $48 million in net product sales in the second quarter of 2026, representing remarkable progress since our launch in August of last year.

Driven by highly coordinated, disciplined execution, more than 600 patients have now been treated with Modeyso through the end of the second quarter. To sustain this upward trajectory, we initiated additional non-personal promotion and peer-to-peer speaker programs in the second quarter. These initiatives are designed to educate community-based physicians and expand our reach to ensure timely referral of patients to academic centers of excellence. On the diagnostic front, while biomarker testing is already high in high-grade gliomas, we are actively working to establish reflexive testing across all gliomas. This systematic approach is critical to ensure every H3K27M patient is identified early and referred to targeted care. To support this, updated NCCN guidelines now endorse liquid biopsy for the H3K27M biomarker. This represents a major milestone that broadens diagnostic pathways, reduces patient risk, and accelerates time to treatment. Finally, Modeyso continues to benefit from robust, highly favorable payer coverage.

Combined with our dedicated patient support services, we are exceptionally well-positioned to maintain this strong commercial momentum. Moving to slide 12 and Zepzelca. We are very pleased with Zepzelca's performance this quarter, achieving $106 million in net product sales, a 42% year-over-year increase. This robust growth was driven by highly positive prescriber feedback and rapid adoption in the first-line maintenance setting, which more than offset the anticipated tapering of our historical second-line business. The strength of our IMforte trial data clearly demonstrates that Zepzelca's greatest clinical value is in early intervention in combination with a PD-L1 inhibitor in the first-line maintenance setting, a consensus recently reinforced by its elevation to a Category 1 listing in the NCCN guidelines. Because metastatic small cell lung cancer progresses so rapidly, reaching patients earlier in their journey is critical. Later, Rob will provide an update on the second-line indication.

Overall, we are very pleased with the commercial performance across our portfolio in the second quarter, and we remain focused on sustaining this momentum throughout the remainder of the year. With that, I'll now turn the call over to Rob to provide an update on our pipeline.