Financial Performance & Guidance - BRINSUPRI achieved preliminary unaudited U S net revenues of approximately $144 6 million in Q4 2025 and $172 7 million for the full year 2025[23] - ARIKAYCE generated worldwide revenue of approximately $433 8 million in FY 2025, representing a 19 3% increase year-over-year[27] - The company anticipates ARIKAYCE revenue to be between $450 million and $470 million for the full year 2026[28] Clinical Development Programs - The company expects topline data readout from the Phase 3 ENCORE trial for ARIKAYCE in March/April 2026, potentially leading to label expansion[30, 31] - Phase 3 trials for TPIP in PAH, PPF, and IPF are expected to initiate in early and the second half of 2026 respectively[13, 38] - Topline data readout from the Phase 2 CEDAR trial for brensocatib in Hidradenitis Suppurativa is expected in Q2 2026[46, 50] Pipeline Expansion - The company plans to file Investigational New Drug (IND) applications for RA and IBD in the second half of 2026[13, 50] - IND filing for Stargardt is anticipated in 2026[13, 59] - Phase 2 programs in ILD and moderate to severe asthma are planned for INS1148[13, 40] Commercial Expansion - BRINSUPRI is expected to launch in the EU and UK, pending regulatory approval[13, 44] - BRINSUPRI is also anticipated to launch in Japan, pending regulatory approval[13, 44] Cash Position - The company reported a cash position of $1 7 billion as of September 30, 2025[62]

Summary of Soho House & Co. Special Meeting Company Overview - **Company**: Soho House & Co. (NYSE: SHCO) - **Event**: 2026 Extraordinary General Meeting - **Date**: January 09, 2026 Key Points Meeting Structure and Participants - The meeting was chaired by Andrew Carnie, the CEO of Soho House & Co., who acknowledged the board of directors and the executive management team for their support [2] - The special committee, including Eric Deardorff and Yusef Jackson, was recognized for their efforts in evaluating and negotiating the proposed transaction [2] - Legal and election representatives were present, including Ben Varkoly (Chief Legal Officer) and Christopher Woods (inspector of elections) [3] Voting Procedures - Stockholders were required to use a 16-digit control number to vote or submit questions [4] - A total of 54,149,151 shares of Class A Common Stock and 141,500,385 shares of Class B Common Stock were outstanding as of the record date [5] - A quorum was confirmed, allowing the meeting to proceed [6] Proposals Presented 1. **Merger Proposal**: - The first proposal involved adopting the Agreement and Plan of Merger dated August 15, 2025, which requires majority approval from both common stockholders and unaffiliated stockholders [9] 2. **Adjournment Proposal**: - The second proposal was to approve the adjournment of the meeting if necessary to solicit additional proxies. However, this proposal was deemed moot as sufficient votes were expected for the merger proposal [10] Voting Results - Preliminary results indicated that stockholders voted to adopt and approve the merger proposal, pending final verification [11] - The company plans to announce official voting results on May 4, following the completion of verification [12] Conclusion of Meeting - The business portion of the meeting concluded with a transition to a question-and-answer session, allowing stockholders to submit questions [12][13] - The meeting was adjourned without further business to discuss [13] Additional Notes - The meeting was conducted virtually, and all proceedings were recorded [5] - Stockholders were encouraged to respect the rules and procedures outlined for the meeting [4]

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.

Financial Data and Key Metrics Changes - Product sales for Q4 2025 were $7.6 million, a decrease of 1.6% compared to Q4 2024, with domestic sales growing 8.7% to $7 million [12][13] - Full-year product sales for 2025 totaled $27.6 million, reflecting a growth of 4.3% compared to 2024 [14] - A non-cash impairment write-down of approximately $2.9 million is expected due to the shift in strategy regarding Re-Tain [15] Business Line Data and Key Metrics Changes - The First Defense product line saw a significant growth of 41.3% in Q4 2025 compared to Q4 2024, indicating strong demand [5] - There is a noted shift towards the Tri-Shield product within the First Defense suite, reflecting a migration from Dual-Force products [14] Market Data and Key Metrics Changes - Domestic sales showed an increase of 8.7%, while international sales declined by 52.6% in Q4 2025, primarily due to order timing in Canada [13][14] - The total addressable market for First Defense is estimated to be approximately $900 million worldwide, driven by increased calf values and the need for early-life calf health solutions [8] Company Strategy and Development Direction - The company is shifting its strategic focus to prioritize First Defense, pausing investments in Re-Tain due to regulatory challenges and a high confidence in First Defense's growth potential [6][7] - Plans include expanding the sales team by 50% and creating two new U.S. sales territories to drive growth in First Defense [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the future sales and profit growth potential of First Defense, emphasizing the importance of operational excellence and capacity expansion [17][18] - The company is optimistic about the ongoing investigational studies for Re-Tain, which are expected to provide valuable data for future partnerships [41] Other Important Information - The company is repurposing manufacturing assets from Re-Tain to support First Defense, which is expected to enhance production capacity without significant additional capital [6][11] - A write-down of approximately $600,000 is planned for inventory deemed unsuitable for requirements [16] Q&A Session Summary Question: Impact of regional pathogens on foreign sales development - Management acknowledged the complexity of international sales and the need for experienced personnel to navigate product requirements and market strategies [22] Question: Explanation for contract manufacturer's failure to comply with FDA requirements - Management declined to provide details but confirmed that the Incomplete Letter from the FDA was solely due to issues with the contract manufacturer [24][25] Question: Timeline for securing a strategic partner for Re-Tain - Management expressed confidence in the product's capabilities and indicated that they would seek partnerships after completing investigational studies in 2026 [28][41] Question: Clarity on the self-imposed milk discard period for Re-Tain - Management clarified that the discard period is necessary to avoid impacting cheese production, but it is still less than competitors' requirements [47][48] Question: Explanation for exceeding sales expectations - Management attributed the sales exceeding expectations to effective management practices and a strong commercial team, despite complexities from previous backorder situations [54][55]

Financial Data and Key Metrics Changes - The company reported product sales for Q4 2025 at $7.6 million, a decrease of 1.6% compared to Q4 2024, primarily due to a previous backorder situation that inflated sales in the prior year [12][13] - Domestic sales grew by 8.7% year-over-year to $7 million, while international sales declined by 52.6% due to order timing in Canada [13][14] - Full-year product sales for 2025 totaled $27.6 million, reflecting a 4.3% increase compared to 2024 [14] Business Line Data and Key Metrics Changes - The First Defense product line saw significant growth, with Tri-Shield experiencing a 41.3% increase in Q4 2025 compared to Q4 2024, indicating a shift from Dual-Force products [5][14] - The company is focusing on increasing manufacturing output for First Defense, achieving over a 15% increase in lyophilization output in 2025, with expectations for similar growth in 2026 [9][18] Market Data and Key Metrics Changes - The newborn calf market has evolved, with calf values increasing significantly, leading to a greater economic emphasis on early-life calf health and survival [8] - The total addressable market for scour protection is estimated at approximately $900 million worldwide, indicating substantial growth potential for First Defense products [8] Company Strategy and Development Direction - The company is shifting its strategic focus to First Defense, pausing investments in Re-Tain due to an Incomplete Letter from the FDA, which has delayed the product's approval process [6][7] - The strategy includes expanding the sales team by 50% and creating two new U.S. sales territories to drive growth in First Defense [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of First Defense, citing the need for increased focus and execution to capitalize on market opportunities [6][9] - The company plans to complete investigational studies for Re-Tain to prepare for potential partnerships, emphasizing that manufacturing in-house is not the best use of resources [11][41] Other Important Information - A non-cash impairment write-down of approximately $2.9 million is expected due to the shift in strategy regarding Re-Tain [15] - An estimated write-down of $600,000 for inventory deemed unsuitable for requirements has been planned [16] Q&A Session Summary Question: Impact of regional pathogens on foreign sales development - Management acknowledged the complexity of international sales and the need for experienced personnel to navigate product requirements and market strategies [21][22] Question: Explanation for contract manufacturer's failure to comply with FDA requirements - Management declined to provide details but confirmed that the Incomplete Letter was solely due to issues with the contract manufacturer [24][25] Question: Timeline for securing a strategic partner for Re-Tain - Management expressed confidence in the product's capabilities and indicated that they would seek partners after completing investigational studies in 2026 [28][41] Question: Clarity on the self-imposed milk discard period for Re-Tain - Management clarified that the discard period is necessary to prevent impact on cheese manufacturing processes, although it is less than competitors [46][48] Question: Explanation for exceeding sales expectations - Management attributed the sales exceeding expectations to effective management practices and a strong commercial team, despite complexities from previous backorder situations [52][55]

Financial Data and Key Metrics Changes - The company reported product sales for Q4 2025 at $7.6 million, a decrease of 1.6% compared to Q4 2024, with domestic sales growing 8.7% to $7 million [11][12] - Full-year product sales for 2025 totaled $27.6 million, reflecting a 4.3% increase compared to 2024 [12] - The company experienced a significant decline in international sales, particularly in Canada, which dropped 52.6% year-over-year in Q4 [12] Business Line Data and Key Metrics Changes - The First Defense product line saw a notable shift towards Tri-Shield, indicating a migration from Dual-Force products and attracting new dairy and beef customers [12] - Manufacturing output for the key bottleneck process, lyophilization, increased by more than 15% in 2025, with expectations for similar growth in 2026 [8][17] Market Data and Key Metrics Changes - The newborn calf market has evolved, with calf values increasing significantly, now worth approximately $1,300 on day one of life compared to roughly $200 in 2003, raising the economic stakes for early-life calf health [7] - The total addressable market for scour protection is estimated to be around $900 million worldwide [7] Company Strategy and Development Direction - The company is shifting its strategic focus to First Defense, pausing investment in Re-Tain due to an Incomplete Letter from the FDA regarding its new animal drug application [4][6] - The strategy includes expanding the sales team by 50% and creating two new U.S. sales territories to drive growth [16] - The company aims to repurpose manufacturing assets from Re-Tain to support First Defense, enhancing operational efficiency [10][14] Management's Comments on Operating Environment and Future Outlook - Management expressed high confidence in the future sales and profit growth potential of the First Defense business, justifying the strategic shift [5][6] - The company is focused on operational excellence to ensure consistent supply and quality of products, with plans to optimize manufacturing processes [16][17] Other Important Information - A non-cash impairment write-down of approximately $2.9 million is expected due to the shift in strategy regarding Re-Tain [14] - An estimated write-down of $600,000 was taken for inventory deemed unsuitable for requirements [15] Q&A Session Summary Question: Impact of regional pathogens on foreign sales development - Management acknowledged the complexity of international sales and the need for expertise in launching products in different markets, highlighting the importance of hiring experienced personnel [20] Question: Explanation for contract manufacturer's failure to comply with FDA requirements - Management declined to provide details but confirmed that the Incomplete Letter was solely due to issues with the contract manufacturer [22][23] Question: Realism of securing a strategic partner for Re-Tain - Management expressed confidence in the product's capabilities and the need to find the best go-to-market strategy post-investigational studies [27] Question: Timeline for hiring new sales team members - Management confirmed that hiring processes for new sales team members are underway, with expectations to complete them within the current quarter [31] Question: Future cash needs and potential share dilution - Management indicated that various funding options are available, including operating cash flow, loans, and capital raises, but declined to comment on specific plans [33] Question: Clarity on self-imposed milk discard period for Re-Tain - Management explained that the discard period is necessary to avoid impacting cheese manufacturing processes, but it remains less than competitors' requirements [44][45] Question: Explanation for exceeding sales expectations - Management attributed the sales exceeding expectations to effective management practices and a strong commercial team, despite complexities from previous backorder situations [49][50]

January 9, 2026 Zanidatamab: Pivotal Phase 3 HERIZON-GEA-01 Trial Results in Gastroesophageal Adenocarcinoma (GEA) Innovating to Transform the Lives of Patients and Their Families Intended for U.S. investor audiences only. Intended for U.S. investor audiences only. 2 January 9, 2026 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 C ...

Summary of BridgeBio Pharma's Achondroplasia Investor Webinar Company and Industry Overview - **Company**: BridgeBio Pharma (NasdaqGS:BBIO) - **Industry**: Biotechnology, specifically focusing on treatments for genetic disorders, with a current emphasis on achondroplasia Key Points and Arguments Achondroplasia Overview - Achondroplasia is the most common form of disproportionate short stature, affecting approximately 15,000 individuals in North America, with a prevalence of about 1 in 25,000 births [4][5] - The condition is caused by a gain-of-function mutation in the FGFR3 gene, which negatively regulates bone growth [15][16] - Diagnosis typically occurs within the first few days of life, with prenatal diagnosis possible through genetic testing [5][6] Clinical Development of Infigratinib - **Infigratinib**: An oral first-in-class FGFR123 tyrosine kinase inhibitor being developed for achondroplasia [15] - The drug aims to inhibit the overactive FGFR3 receptor, which is responsible for decreased bone growth [16][15] - The clinical development program includes five studies involving approximately 300 children aged 0 to 18 [18] Phase 2 Study Results - The phase 2 study (ProPEL 2) demonstrated a statistically significant increase in annualized height velocity of 2.5 cm per year at months 12 and 18, with a p-value of 0.0015 [21] - Safety data indicated that Infigratinib was well tolerated, with no serious adverse events leading to treatment discontinuation [20] Phase 3 Study (PROPEL 3) - The PROPEL 3 study is a double-blind placebo-controlled trial designed to evaluate the efficacy and safety of Infigratinib in children aged 3 to 18 [25] - The primary endpoint is the change in annualized height velocity compared to placebo, with secondary endpoints including height Z-score and body proportions [25] Market Opportunity - There are over 55,000 individuals globally with achondroplasia and open growth plates, representing a market opportunity exceeding $5 billion [30] - Currently, only about 10% of these individuals are receiving treatment, primarily due to the burden of injection therapies [31] Physician Insights and Market Research - A survey of nearly 100 healthcare providers indicated a strong preference for an oral treatment option, with 94% citing avoidance of injections as a compelling reason to switch therapies [30] - The value proposition for Infigratinib is seen as compelling, with projected market share exceeding 50% in a three-way market scenario [29] Safety and Efficacy Expectations - The expectation for safety includes maintaining low-grade hyperphosphatemia rates below 10%, which is significantly lower than rates seen with other growth-promoting agents [38][57] - Clinically meaningful improvements in annualized height velocity are expected to be at least 1.5 cm per year compared to placebo [34] Future Directions - BridgeBio is committed to exploring the impact of Infigratinib beyond height, including quality of life and skeletal changes in long-term studies [36] - The company is also investigating potential applications of Infigratinib for other conditions related to FGFR3 mutations, such as Turner syndrome [37] Other Important Content - The webinar included a Q&A session addressing concerns about hyperphosphatemia, treatment adherence, and the potential for combination therapies with other growth treatments [38][47] - Dr. Lagarde emphasized the importance of early treatment and the potential for oral therapies to improve patient compliance and outcomes [41][44]

Summary of Conference Call Company Overview - The conference call pertains to Pandora, a jewelry brand, discussing its Q4 trading performance and future outlook [1] Key Points and Arguments Performance Metrics - Q4 organic growth was reported at 4%, leading to a full-year organic growth of 6%, which was below the guidance of 7%-8% [2] - The EBIT margin for Q4 is expected to be around 33.5%, with a full-year EBIT margin landing at approximately 24%, consistent with previous guidance [3][6] - North America experienced a 2% like-for-like growth in Q4, while organic growth was at 8% [3] - Europe showed a stable performance with a like-for-like growth of -1% and organic growth of +2% [4] Market Challenges - The macro environment is described as challenging, impacting consumer behavior and traffic, particularly in North America [2][4] - Consumer confidence in the U.S. reached its lowest since 1960, contributing to a decline in traffic during the holiday period [15] - The accessible market segment faced significant challenges, with overall category performance declining [3][17] Strategic Focus - The company aims to strengthen brand desirability and address high silver prices through new products and materials [9] - There is a focus on re-energizing collections, particularly in mature markets like Italy, where initial efforts have shown promise [18] - The Silverstone cost program is progressing well, helping maintain profitability despite external headwinds [5] Pricing Strategy - Average pricing in the U.S. for Q4 saw a year-over-year increase of around 10%, with a high single-digit average increase throughout the quarter [25] - Future pricing strategies will likely return to a standard model of 1%-2% annual increases, but higher commodity prices may necessitate adjustments [43][44] Future Outlook - The company plans to provide more detailed insights into its commodity exposure and metal strategy in February [50] - There is an emphasis on maintaining marketing investments to support brand strength, with marketing as a percentage of revenue remaining consistent with the prior year [52] Additional Important Information - The EBIT margin in Q4 was lower than the previous year by approximately 100 basis points, attributed to external headwinds from foreign exchange, commodities, and tariffs [6] - The company is currently 75% hedged for 2026 regarding silver prices, which may mitigate some impacts of rising costs [47] - The performance of the Talisman collection has been strong, contributing positively to the brand's growth [78] This summary encapsulates the key points discussed during the conference call, highlighting Pandora's current performance, market challenges, strategic initiatives, and future outlook.

KalVista Pharmaceuticals Corporate Overview January 2026 1 Forward-looking statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management's beliefs and assumptions and on information currently available to our management. For this purpose, any statements that are not statements of historical fact may be deemed forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be ...