Neurocrine Biosciences (NasdaqGS:NBIX) 2025 R&D Day December 16, 2025 12:00 PM ET Speaker0Good morning and good afternoon. My name is Todd Tushla. I'm the Vice President of Investor Relations at Neurocrine Biosciences, and on behalf of our entire company, welcome to our 2025 R&D Day. Whether you're here in person, on the webcast, or reading the transcript, we're grateful for your time. We will be making forward-looking statements today to refer you to our latest SEC disclosures. Our speakers for today from ...

Sanofi (NasdaqGS:SNY) Update / Briefing December 16, 2025 11:15 AM ET Company ParticipantsLouisa Hector - Head of Global Pharma Equity ResearchThomas Kudsk Larsen - Head of Investor RelationsSachin Jain - VPSarita Kapila - Co-Head European Pharmaceuticals Equity ResearchSimon Baker - Head of Global Biopharma ResearchNone - Company RepresentativeJames Quigley - Executive DirectorGraham Parry - Managing Director and Head of European Pharmaceuticals Biotechnology Equity ResearchJean-François Toussaint - Global ...

Vivos Therapeutics (NasdaqCM:VVOS) Fireside Chat December 16, 2025 11:00 AM ET Company ParticipantsR. Kirk Huntsman - CEOBrad Amman - CFOModeratorLet me start. As the year draws to a close, 2025 stands out as one of the most pivotal in the company's history. It marked the launch of a potentially transformative shift in Vivos' business model, highlighted by the June acquisition of the Sleep Center of Nevada, or SCN. Before we get into the operational progress of the transition, Kirk, could you start by shari ...

Artemis Gold (OTCPK:ARGT.F) Update / Briefing December 16, 2025 11:00 AM ET Company ParticipantsJeremy Langford - PresidentSteven Dean - Executive ChairMeghan Brown - VP of Investor RelationsDale Andres - CEOConference Call ParticipantsHarrison Reynolds - AnalystAndrew Mikitchook - AnalystPierre Vaillancourt - AnalystJeremy Hoy - AnalystMeghan BrownThank you, Operator, and good morning, everyone. Thank you for joining our conference call and webcast following yesterday's announcement of our expanded Phase 2 ...

Summary of ReNew Energy Global Conference Call Company Overview - **Company**: ReNew Energy Global (NasdaqGS:RNW) - **Date of Call**: December 16, 2025 Key Points Industry Context - The call addressed the recent developments regarding a consortium involving ReNew Energy and its potential acquisition discussions, particularly focusing on the withdrawal of Masdar from the consortium [4][5]. Core Insights - **Masdar's Withdrawal**: Masdar has officially withdrawn from the consortium, leading to the termination of discussions regarding the proposed transaction. This decision was unexpected and disappointing for ReNew, especially after a year of negotiations and due diligence [4][5][12]. - **Shareholder Confidence**: Despite Masdar's exit, major shareholders CPPIB and ADIA have reaffirmed their confidence in ReNew's business and growth prospects. The company remains committed to delivering value for all shareholders [5][6]. - **Financial Position**: ReNew maintains a robust liquidity position with over $1 billion in cash. The company’s portfolio is fully funded through internal cash flows and capital recycling [6][7]. - **Growth Guidance**: ReNew has reaffirmed its megawatt and EBITDA guidance for the year, indicating continued business growth and a decline in leverage [7][8]. Strategic Considerations - **Future Plans**: The board is evaluating options for realizing value from various parts of the business and will develop a plan moving forward. The leadership team is prepared for alternative strategies following the consortium's dissolution [15][16]. - **Capital Allocation**: The management is considering various strategic options, including potential share repurchases, although no immediate discussions are underway regarding new offers from other shareholders [14][22]. - **Funding and Growth Strategy**: ReNew plans to continue its growth trajectory, targeting an annual capacity of 2 to 3 GW. Funding will come from internal growth and capital recycling, with no reliance on external capital infusion from the failed transaction [32][41]. Market Reaction - Following the announcement of Masdar's withdrawal, there was a notable decline in ReNew's share price. Management expressed confidence that the market will eventually recognize the company's true value [18][52]. Additional Insights - **Operational Performance**: The company is meeting all operational deliverables for the year and does not foresee issues in raising external funding for its current pipeline [16][46]. - **Long-term Strategy**: The board emphasizes the importance of execution in a rapidly growing market and maintains confidence in the management team to deliver long-term shareholder value [51][52]. Conclusion ReNew Energy Global is navigating a challenging situation following the withdrawal of a key consortium member. However, the company remains financially strong and committed to its growth strategy, with plans to communicate further updates to shareholders in the coming months.

Summary of Aldeyra Therapeutics Regulatory Update Conference Call Company Overview - **Company**: Aldeyra Therapeutics (NasdaqCM:ALDX) - **Focus**: Development of reproxalap for the treatment of dry eye disease Key Points Regulatory Update - **PDUFA Extension**: The FDA has extended the PDUFA target action date for the new drug application (NDA) of reproxalap, originally set for December 16, 2025, due to the request for additional clinical study reports (CSR) [2][8][10] - **NDA Resubmission**: The NDA for reproxalap was resubmitted on June 16, 2025, and accepted by the FDA as a complete Class II response on July 16, 2025 [6] - **Field Trial Results**: A field trial supportive of reproxalap did not meet its primary endpoint of reducing symptoms compared to the vehicle, which led to the FDA's request for the CSR to be included in the NDA [7][9] FDA Interactions - **Communication with FDA**: Aldeyra has had limited direct communication with the FDA's Office of Specialty Medicine, focusing primarily on the Division of Ophthalmology [5] - **Labeling Discussions**: A draft label was sent by the FDA to Aldeyra in early December, and Aldeyra has provided comments on it [9][32] - **Next Steps**: If no major deficiencies are identified during the extended review, labeling requests and potential post-marketing requirements will be communicated by February 16, 2026 [10] Commercialization and Agreements - **AbbVie Option Agreement**: AbbVie has 10 business days to exercise its option following the approval of the NDA, with no changes to the terms due to the extension [18][27] - **Commercialization Timeline**: The launch date for reproxalap will depend on FDA approval, with expectations that it could occur within one to two quarters post-approval [21] Additional Insights - **FDA Guidance**: There was a discussion regarding the standard practice of submitting all CSRs with an NDA, which was initially agreed upon to be limited to the chamber trial only [14][15] - **Safety Data Requests**: The request for safety data from the field trial is considered standard during NDA reviews [25] - **Director Changes**: The director of the Office of Specialty Medicine retired, which may have influenced the recent request for the CSR submission [13] Conclusion The call provided detailed insights into the regulatory status of reproxalap, the implications of the FDA's extension of the PDUFA date, and the company's ongoing interactions with the FDA. The potential for commercialization remains contingent on the outcome of the extended review process.

Summary of Pfizer's 2026 Financial Guidance Call Company Overview - **Company**: Pfizer - **Event**: Analyst and investor call to review full year 2026 financial guidance Key Points Financial Performance and Guidance - Pfizer reaffirmed its full year 2025 adjusted diluted EPS guidance and revised revenue guidance to approximately **$62 billion** for 2025, which is within the previous range [5][16] - For 2026, total revenues are expected to be in the range of **$59.5 billion to $62.5 billion** [17] - COVID-19 product revenues are projected to decline to approximately **$5 billion** in 2026, down from **$6.5 billion** in 2025, reflecting a **40% decline** year-over-year [16][18] - Adjusted diluted EPS for 2026 is anticipated to be in the range of **$2.80 to $3.00** [19] Strategic Initiatives - Pfizer has entered a landmark voluntary agreement with the U.S. Government to lower prescription drug costs, providing clarity on pricing and tariffs [6][35] - The company is focusing on expanding its obesity portfolio, with plans to advance about **15 programs** in 2026, many of which will be in phase 3 studies [7][51] - Pfizer's oncology pipeline remains strong, with recent FDA approvals and ongoing studies expected to enhance its market position [9][10] Cost Management and Efficiency - Pfizer is on track to achieve approximately **$7.2 billion** in total combined net cost savings by the end of 2026, one year ahead of schedule [11][23] - Adjusted SI&A and R&D expenses for 2026 are expected to be in the range of **$23 billion to $25 billion**, with a focus on maintaining productivity and efficiency [20][21] Market Dynamics and Challenges - The company anticipates facing significant headwinds from loss of exclusivity (LOE) for several major brands, with approximately **$17 billion** in revenues impacted by patent expirations expected between 2026 and 2028 [26] - Pfizer is committed to maintaining its dividend while prioritizing investments in business development to ensure long-term growth [85] Future Outlook - Pfizer expects to return to growth by the end of the decade, driven by the maturation of its R&D pipeline and the performance of recently launched products [26][68] - The company is optimistic about the potential for growth in 2029 and 2030, with a focus on maximizing the potential of its pipeline and acquisitions [48][69] Additional Insights - The new organization for global hospital and biosimilars products aims to enhance productivity and streamline operations [25][80] - Pfizer's commitment to vaccines remains strong, despite current market challenges, as they are viewed as essential for public health [59] Conclusion Pfizer's 2026 financial guidance reflects a strategic focus on managing costs, expanding its product portfolio, and navigating the challenges posed by LOEs and market dynamics. The company is positioning itself for future growth while maintaining a commitment to shareholder value through dividends and strategic investments.

Summary of Monte Rosa Therapeutics Conference Call Company Overview - **Company**: Monte Rosa Therapeutics (NasdaqGS:GLUE) - **Focus**: Development of MRT-2359, a GSPT-1-directed molecular glue degrader for treating metastatic castration-resistant prostate cancer (CRPC) Key Industry Insights - **Target Market**: Heavily pretreated metastatic castration-resistant prostate cancer patients, particularly those with androgen receptor (AR) mutations - **Market Opportunity**: Up to 30% of metastatic CRPC patients in later lines of therapy carry AR mutations, indicating a substantial market potential for MRT-2359 [6][25] Core Findings from Clinical Trials - **Clinical Activity**: In a small phase II expansion arm, MRT-2359 combined with enzalutamide showed a 100% PSA response rate in four patients with AR mutations, with two patients achieving PSA 90 responses and two achieving PSA 50 responses [5][17] - **Disease Control Rate**: The overall disease control rate was 64% across 14 patients, with two RECIST partial responses and several patients showing stable disease [6][18] - **Safety Profile**: The combination was well tolerated, with mild to moderate gastrointestinal adverse events being the most common, suggesting a favorable safety profile compared to other therapies [6][17] Mechanism of Action - **MRT-2359 Mechanism**: Acts as a molecular glue degrader of GSPT-1, leading to the degradation of MYC and other oncoproteins, which is critical for the growth of prostate cancer cells [7][9] - **Preclinical Evidence**: Prostate cancer cell lines with high MYC expression showed greater sensitivity to MRT-2359, supporting its therapeutic rationale [10][11] Future Directions - **Next Steps**: Plans to initiate a signal-confirming phase II study in 2026, focusing on AR mutant patients and potentially expanding to earlier line settings [24][25] - **Study Design**: The upcoming study will utilize a Simon's two-stage design, enrolling up to 25 patients with metastatic CRPC and AR mutations, with endpoints including PSA response and safety [24] Pipeline Updates - **Other Programs**: Progress on MRT-6160, a VAV1-directed MGD program licensed to Novartis, and MRT-8102, a NEK7-directed MGD, with plans for multiple phase II studies in immune-mediated diseases and cardiovascular conditions, respectively [26][27] Additional Insights - **Comparative Analysis**: The PSA response rate of 29% in the overall population is comparable to other combination therapies, indicating competitive positioning in the market [17][25] - **Patient Demographics**: The study population was heavily pretreated, with 75% having prior treatment with second-generation AR inhibitors and 80% with chemotherapy, highlighting the challenging nature of the patient cohort [16][18] Conclusion - **Encouraging Data**: The results from the phase I-II study of MRT-2359 demonstrate compelling clinical activity in a high unmet need population, with plans for further studies to confirm its efficacy and safety in treating metastatic CRPC [25][26]

Summary of Conference Call Industry Overview - The global macroeconomic environment remains fragile, with limited signs of improvement noted in recent data [1] - Consumer confidence in the euro area is unchanged at -14.2, indicating subdued household sentiment [1] - In the U.S., the University of Michigan's consumer sentiment index is at 51.0, significantly lower than the previous year, reflecting cautious household behavior due to cost-of-living concerns [2] - China's economic recovery is uneven, with subdued consumer confidence and increasing discount-driven order demand [2] - Chinese exports of electric vehicles are growing, intensifying competition in Europe [2] - S&P Global has revised its automotive sales volume forecast upwards, but the U.S. premium segment is expected to contract by 2.4% in 2025, Europe by 4.9%, and China by approximately 10% [3] Company-Specific Insights (Volvo Cars) - Retail sales for October and November showed a 6% volume decline, with October down 2% and November down 10% [3] - Revenue from contract manufacturing was SEK 2 billion in Q1 2025, SEK 3 billion in Q2, and SEK 3.2 billion in Q3 [4] - The stronger Swedish krona continues to pose a headwind for revenue [4] - The U.S. Section 45W ending will negatively impact PHEVs sold in the U.S. by $7,500 per car [4] - Gross margins are expected to be negatively affected by weaker volume development and U.S. tariffs introduced in Q2 [5] - Retail sales have dropped by 6% quarter-to-date, negatively impacting gross margins [5] - The EBIT margin will also be affected by negative volume and discount developments [6] - Free cash flow typically shows stronger generation in Q4, but inventory reduction seen in Q4 2024 will not repeat this year [6] Market Dynamics - Discounts for battery electric vehicles (BEVs) in the U.S. have reached around $11,000, significantly higher than normal levels [9] - Order trends for BEVs are positive year-over-year, indicating a potential recovery despite current sales declines [17] Financial Guidance and Outlook - The company does not provide specific guidance for Q4 or 2026, but aims for transparency in reporting [14][15] - The restructuring program will impact costs, with a headcount reduction expected to affect fixed employee costs from Q4 onwards [14] - Inventory dynamics are returning to normal seasonality, with some inventory build-up for specific models [17] Risks and Concerns - There are concerns regarding the balance sheet exposure towards Polestar, particularly in the event of financial difficulties [18] - The company is cautious about commenting on specific financial figures for Q4, indicating a level of uncertainty in performance [22][23] Conclusion - The overall sentiment is cautious, with a focus on managing costs and navigating a challenging macroeconomic environment while looking for signs of recovery in BEV orders and sales. The company is preparing for potential impacts from tariffs and market competition, particularly in the U.S. and European markets.

Summary of Radiopharm Theranostics (NasdaqCM:RADX) Update / Briefing December 15, 2025 Company Overview - **Company**: Radiopharm Theranostics - **Ticker**: RADX - **Focus**: Development of imaging agents for brain metastases, specifically RAD-101 targeting fatty acid synthase Key Industry Insights - **Target Market**: Brain metastases primarily from lung cancer, breast cancer, and melanoma, which account for approximately 90% of cases [3][4] - **Current Treatment Challenges**: Difficulty in differentiating between tumor recurrence and treatment-related effects post-stereotactic radiosurgery (SRS) [4][11] - **Unmet Medical Need**: High demand for effective imaging solutions to accurately assess brain metastases and guide treatment decisions [11][19] Core Findings and Data - **RAD-101 Performance**: Preclinical data shows RAD-101 has superior uptake and tumor-to-brain ratios compared to traditional imaging agents like 18F FTG in various cancer models [2] - **Phase IIB Study**: Currently recruiting 30 patients in the U.S. to evaluate RAD-101's effectiveness in patients with suspected brain metastases post-SRS [4][5] - **Survival Correlation**: Patients with a standardized uptake value (SUV) greater than 2 showed significantly shorter overall survival, indicating the potential prognostic value of RAD-101 [6][8] - **Market Potential**: Estimated market size of $500 million in the U.S. for RAD-101, with a projected price of $4,800-$5,000 per dose [46][56] Competitive Landscape - **Lack of Competition**: Currently, no other imaging agents specifically targeting brain metastases are in clinical development, providing RAD-101 a unique market position [49][50] - **Differentiation from Other Agents**: RAD-101 targets fatty acid metabolism, while competitors focus on amino acid metabolism, addressing different patient populations [48][50] Future Plans - **Phase III Study**: Anticipated to include around 150 patients, focusing on sensitivity and specificity as primary endpoints [40][41] - **Longitudinal Studies**: Plans to conduct longitudinal scans to establish a truth standard for imaging efficacy [77] - **Potential for Therapeutic Version**: Exploration of developing a therapeutic isotope version of RAD-101 is underway [64] Additional Considerations - **Combination with MRI**: Initial strategy involves using RAD-101 in conjunction with MRI to enhance diagnostic accuracy [45][68] - **Patient Management Improvement**: Aim to enable earlier diagnosis and treatment of tumor recurrence, potentially improving patient outcomes [54][56] - **Safety Concerns**: Emphasis on the importance of accurate imaging to avoid unnecessary SRS procedures, which carry risks of side effects [65][67] Conclusion Radiopharm Theranostics is positioned to address a significant unmet need in the imaging of brain metastases with RAD-101, showing promising preclinical results and a clear path towards clinical development. The company is focused on establishing its market presence while ensuring patient safety and improving treatment outcomes through innovative imaging solutions.