PresentationGood afternoon. Thanks for joining us for another session at the 44th JPMorgan Healthcare Conference. I'm Brian Cheng. I'm the senior biotech analyst here at the firm. On stage, we have Zymeworks. I will now pass the mic to their CEO, Kenneth Galbraith, for a short presentation, followed by a live audience Q&A. Ken, welcome back. The stage is yours.Kenneth GalbraithChairman of the Board, CEO & President Great. Thanks very much, Brian. Good afternoon, everyone. I'm really pleased to be back here ...

Summary of Zymeworks Conference Call Company Overview - **Company**: Zymeworks - **Event**: 44th JPMorgan Healthcare Conference - **CEO**: Ken Galbraith Key Points Company Transformation and Strategy - Zymeworks experienced a transformative year, highlighted by the readout of the Horizon-GEA-01 study for zanidatamab, which is expected to become the new standard of care in HER2-overexpressing gastric and esophageal adenocarcinoma (GEA) [2][4] - The company is evolving its strategy to leverage the success of zanidatamab and create shareholder value through innovative approaches beyond traditional R&D [4][6] - Leadership changes have been made to align the team with the new strategic direction [5] Financial Position and Future Outlook - Zymeworks has a strong financial foundation, with expectations of excess cash flow rather than cash flow issues, allowing for a long-term focus on shareholder value [12][22] - The company anticipates significant appreciation in stock value as zanidatamab continues to succeed and other agents progress [12][14] - The partnership with Jazz Pharmaceuticals and B1 is crucial for capital and development capabilities, enhancing the potential for zanidatamab's success [11][22] Product Development and Competitive Landscape - Zanidatamab is positioned as a superior HER2-targeted agent compared to trastuzumab, with promising clinical data supporting its efficacy [32][34] - The competitive landscape has shifted favorably for zanidatamab, as competitors have faced challenges in their clinical trials [33][36] - Zymeworks is exploring additional indications for zanidatamab and other products, including JNJ-64264681, which is expected to be a significant revenue generator [15][36] Royalty and Partnership Strategy - The company is focused on holding onto royalty streams from zanidatamab and other products, believing this approach will maximize long-term value for shareholders [29][50] - Zymeworks is open to monetizing royalties but seeks fair value, indicating a strategic approach to partnerships and asset management [49][51] - The company aims to build a portfolio of high-quality royalty streams, enhancing its financial stability and growth potential [50][53] Research and Development Focus - Zymeworks continues to invest in R&D, with a focus on innovative biologics and antibody-drug conjugates [23][24] - The company is exploring new product opportunities, including bispecific antibodies and ADCs, while maintaining a unique position in the market [65] Future Expectations - Zymeworks plans to present further data and updates on its pipeline in the coming year, aiming to exceed current expectations [25][26] - The company is committed to innovation and leveraging its scientific expertise to drive future successes [23][24] Additional Insights - The CEO emphasized the importance of adapting strategies to ensure continued success in a competitive biotech landscape, highlighting the need for flexibility in product development and partnerships [18][20] - Zymeworks is positioned to capitalize on its unique offerings in the HER2 space, with a differentiated approach that sets it apart from competitors [24][25]

Financial Highlights - The company anticipates near-term milestones of up to $440 million for global GEA approvals[12] - The company has received $400 million in upfront and milestone payments to date[12] - Future potential regulatory and commercial milestones are valued at $13 billion[12] - Ziihera has a peak sales potential of over $20 billion[12] - The company reported revenues of $103 million for 2025[27] Pipeline and Partnerships - The company has potential future milestone payments of up to $434 million with Phase 3 partners[16] - The company has potential future milestone payments of up to $11 billion with Phase 1 partners[16] - The company has potential future milestone payments of up to $313 million with Phase 1 partners[16] - The company has potential future milestone payments of up to $230 million with Preclinical partners[16] Strategic Outlook - The company's cash resources of over $270 million provide a runway beyond 2028[27]

January 2026 44th Annual J.P. Morgan Healthcare Conference Redefining Possibilities in Rare Disease Renee Gala, President & CEO Transforming Lives. Redefining Possibilities. Caution Concerning Forward-Looking Statements This presentation contains forward-looking statements and financial targets, including, but not limited to, statements related to: the Company's growth prospects and future financial and operating results, including the ability of the Company's portfolio to drive long-term shareholder value; ...

Needham analyst Ami Fadia raised the firm’s price target on Jazz Pharmaceuticals (JAZZ) to $235 from $210 and keeps a Buy rating on the shares. The firm cites the company having presented the HERIZON-GEA-01 study with additional color on the subgroup analysis, noting that the overall data favored zani treatment arms across all subgroups with a longer tail on PFS for tislelizumab arm and slightly higher efficacy in TAP under 1% over TAPat 1% or higher. A key opinion leader on the call also noted that the be ...

PresentationGood morning and welcome to the zanidatamab HERIZON-GEA-01 Investor Call and Webcast. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the call over to Renee Gala, President and Chief Executive Officer of Jazz Pharmaceuticals. Thank you. Please go ahead.Renée GaláPresident, CEO & Director Good morning, everyone. My name is Renee Gala, President and CEO of Jazz Pharmaceuticals. Thank you for joining us. Before I begin, please note that today' ...

Summary of Jazz Pharmaceuticals Investor Call on Zanidatamab Horizon-GEA-01 Company and Industry - **Company**: Jazz Pharmaceuticals (NasdaqGS:JAZZ) - **Industry**: Oncology, specifically focusing on HER2-positive gastroesophageal adenocarcinoma (GEA) Core Points and Arguments 1. **Clinical Trial Presentation**: Jazz Pharmaceuticals presented data from the phase III Horizon-GEA-01 Clinical Trial at the American Society of Clinical Oncology Gastrointestinal Cancer Symposium, focusing on zanidatamab in combination with chemotherapy for HER2-positive GEA patients [2][4] 2. **Efficacy of Zanidatamab**: The trial demonstrated a 35% reduction in the risk of disease progression or death, translating to over four months of improvement in median progression-free survival (PFS) compared to trastuzumab plus chemotherapy [7][24] 3. **Overall Survival Benefits**: There was a statistically significant 28% reduction in the risk of death for zanidatamab plus tislelizumab plus chemotherapy versus trastuzumab, leading to a more than seven-month improvement in median overall survival (OS) [8][24] 4. **Mechanism of Action**: Zanidatamab is a bispecific antibody targeting two extracellular domains of HER2, which differentiates it from traditional therapies and enhances its efficacy [22][23] 5. **Safety Profile**: The safety profile of zanidatamab was consistent with known profiles of the individual treatments, although there was an increase in grade three or more toxicities in zanidatamab-containing arms [18][19] 6. **Regulatory Plans**: Jazz Pharmaceuticals plans to submit a supplemental biologics license application in the first half of the year and seeks inclusion in NCCN guidelines based on the trial results [21][33] Additional Important Content 1. **Patient Demographics**: The trial included 914 patients, with approximately 50% enrolled from Asia and 80%-85% of tumors being HER2 IHC3+ [12][13] 2. **Adverse Events**: Infusion-related reactions occurred in 25% of patients receiving zanidatamab, compared to 13.2% for trastuzumab, indicating a need for careful monitoring [18] 3. **Market Opportunity**: GEA is the fifth most common cancer globally, with a significant unmet need for effective HER2-targeted therapies, as the last new option was introduced in 2010 [30][31] 4. **Commercial Strategy**: Jazz Pharmaceuticals is positioned to leverage existing infrastructure for a rapid launch of zanidatamab if approved, with a focus on the strong data supporting its efficacy [31][32] 5. **Future Development**: The company is exploring zanidatamab in various HER2-positive solid tumors, indicating a robust pipeline and potential for broader applications [29][28] This summary encapsulates the key points discussed during the investor call, highlighting the promising data for zanidatamab and its potential impact on the treatment landscape for HER2-positive GEA.

DUBLIN, Dec. 17, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company will participate in the following investor events: Zanidatamab HERIZON-GEA-01 Investor Webcast on Friday, January 9, 2026 About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious disease ...

Financial Data and Key Metrics Changes - The company reported record revenues of $1.13 billion for the third quarter, representing a 7% increase year-over-year [3] - The guidance for revenue was narrowed, reflecting strong performance and disciplined expense management, with an increase in ANI and EPS guidance [4] - A deferred tax asset of $206 million was recognized in the third quarter related to the Chimerix acquisition, which will reduce future tax liabilities [5] - The company ended the quarter with approximately $2 billion in cash and investments, and generated about $1 billion in cash flow for the first nine months of the year [5] Business Line Data and Key Metrics Changes - Epidiolex and Xywav, the two largest brands, showed strong growth, contributing significantly to the overall revenue increase [3] - Xywav has been particularly successful in the idiopathic hypersomnia (IH) market, with 325 new patient ads in IH compared to 125 in narcolepsy during the most recent quarter [18] - Epidiolex is on track to achieve blockbuster status, with an 11% growth year-to-date, needing only 3% growth to reach that milestone [24] Market Data and Key Metrics Changes - The company is experiencing growth in the idiopathic hypersomnia market, which is expected to be about half the size of the narcolepsy market [19] - The competitive landscape in small cell lung cancer is evolving, with new entrants and significant advancements in treatment options [39] - The company anticipates potential headwinds for Xywav in 2026 due to the expected entry of generic versions of Xyrem [20][21] Company Strategy and Development Direction - The company is focused on business development opportunities in oncology and epilepsy, with a strategic fit seen in the Chimerix acquisition [10][15] - There is an emphasis on expanding the presence in brain cancer and glioma, leveraging the capabilities gained from the Chimerix acquisition [11] - The company is open to various transaction types, including licensing deals, to enhance its portfolio [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong momentum heading into 2026, particularly with the performance of Epidiolex and Xywav [3][4] - The company is aware of potential challenges from generic competition but believes it is well-positioned due to the unique attributes of its products [20][21] - Management highlighted the importance of educating physicians about the benefits of using Xywav for IH patients to drive market penetration [23] Other Important Information - The company has made significant investments in patient identification tools and nurse navigator programs to enhance the patient experience with Epidiolex [26][27] - The initial launch of Midaso has exceeded expectations, with strong uptake and positive feedback from physicians [43][45] - The company is actively working on expanding awareness and testing for patients eligible for Midaso treatment [47] Q&A Session Summary Question: What is the rationale behind the Chimerix deal? - The acquisition addresses a significant unmet need in a rare form of glioma and aligns with the company's capabilities and expertise [10] Question: How is the company approaching the SAN2355 licensing agreement? - The licensing agreement aims to build on the company's presence in epilepsy, leveraging the attributes of the Saniona molecule [14] Question: What are the growth drivers for Epidiolex? - Key drivers include patient identification initiatives, nurse navigator programs, and increasing awareness of both seizure and non-seizure benefits [24][26] Question: How is the company positioned in the small cell lung cancer market? - The company is optimistic about Zepzelca's potential in first-line maintenance settings, despite increased competition [39] Question: What is the company's strategy regarding business development? - The company is focused on later-stage assets and is open to various transaction types, including acquisitions and licensing deals [16][62]

Financial Data and Key Metrics Changes - The company reported record revenues of $1.13 billion for the third quarter, representing a 7% increase year-over-year [3] - The guidance for revenue was narrowed, reflecting strong performance and disciplined expense management, with an increase in ANI and EPS guidance [4] - A deferred tax asset of $206 million was recognized in the third quarter related to the Chimerix acquisition, which will reduce future tax liabilities [5] - The company ended the quarter with approximately $2 billion in cash and investments, and generated about $1 billion in cash flow for the first nine months of the year [5] Business Line Data and Key Metrics Changes - Epidiolex and Xywav, the two largest brands, showed strong growth driven by demand, contributing significantly to overall revenue [3] - Xywav has been particularly successful in the idiopathic hypersomnia (IH) market, with 325 new patient ads in IH compared to 125 in narcolepsy [18] - Epidiolex is on track to achieve blockbuster status, with an 11% growth year-to-date and a focus on patient titration and nurse navigator programs to enhance persistence [24][26] Market Data and Key Metrics Changes - The market for idiopathic hypersomnia is estimated to be about half the size of narcolepsy, indicating potential for growth as awareness increases [19] - The company anticipates the entry of generic versions of Xyrem in 2026, which could impact Xywav depending on the number and pricing of generics [20][21] - In the small cell lung cancer market, Zepzelca is positioned to become a standard of care, with significant advancements noted in recent medical meetings [39] Company Strategy and Development Direction - The company is focused on business development opportunities in oncology and epilepsy, with a strategic fit seen in the Chimerix acquisition [10][15] - Jazz Pharmaceuticals aims to build on its presence in brain cancer and glioma, leveraging the expertise gained from the Chimerix team [12] - The company is open to various transaction types, including licensing deals, to enhance its portfolio and address unmet medical needs [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong momentum heading into 2026, particularly with the performance of Epidiolex and Xywav [3][4] - The company is aware of potential headwinds from generic competition and payer actions but feels well-positioned to mitigate these risks [20][21] - There is a strong focus on increasing awareness and understanding of the benefits of products like Xywav and Epidiolex among healthcare providers [23][24] Other Important Information - The company has made significant investments in patient identification tools and commercial initiatives to support the growth of Epidiolex and Xywav [26][27] - Jazz Pharmaceuticals is exploring opportunities in rare and orphan diseases, aiming to leverage its existing capabilities in new therapeutic areas [59] Q&A Session Summary Question: What was the rationale behind the Chimerix acquisition? - The acquisition addressed a significant unmet need in a rare form of glioma and provided strong patent protection, aligning with the company's capabilities and expertise [10][11] Question: How is the company addressing the growth in the epilepsy market? - The company is leveraging its leadership position with Epidiolex and exploring new opportunities to enhance its presence in epilepsy treatments [14][15] Question: What are the growth drivers for Xywav in the sleep franchise? - The majority of new patient ads are coming from the IH indication, with a strong opportunity for continued growth as awareness increases [18][19] Question: How does the company view the competitive landscape in oncology? - The company acknowledges the competitive nature of the oncology market but is optimistic about the potential for Zepzelca and other products to capture market share [39][40] Question: What is the company's approach to managing potential tariff impacts? - The company has built inventory in the U.S. to buffer against tariff impacts and is actively working to mitigate exposure [35][36]