Summary of the Conference Call Company Overview - **Company**: Orchestra Lab - **Industry**: Medical Devices Key Points and Arguments Business Model - Orchestra Lab operates a partnership-driven business model aimed at advancing and commercializing high-impact medical device therapies, inspired by successful biotech partnerships [3][4] - The company aims to address the lack of partnership activity in the medical device sector, which contrasts with the pharmaceutical industry where partnerships are common for drug development [4] - The average R&D spending for the medical technology industry is around 7% of revenue, compared to 20% for pharmaceuticals, indicating a significant R&D constraint for med tech companies [5] Revenue Generation - Orchestra Lab plans to generate revenue through significant long-term royalty interests, which can yield high gross margins [6] - The company is focused on driving top-line growth without compromising EBITDA and EPS through collaborations with larger companies like Medtronic and Terumo [5][6] Core Capabilities - The founding team has extensive experience in innovation, clinical execution, regulatory expertise, and financial management [9] - Orchestra's lead program, ABIM therapy, aims to enhance existing pacemaker technology to reduce blood pressure in high-risk patients [12][13] Clinical Programs - **BackBeat Program**: Focuses on a therapy that upgrades existing pacemakers to reduce blood pressure, targeting older patients with hypertension [12][13] - The pivotal study is expected to provide data that could establish this therapy as a standard of care for managing hypertension in pacemaker patients [15] - Previous studies showed significant reductions in systolic blood pressure, with an 11 mmHg reduction in the treatment group [16][17] - The study has been adjusted to widen eligibility criteria, with completion expected in 2026 [24] - **Virtue Program**: A novel sirolimus drug-eluting balloon aimed at treating coronary artery disease [39][42] - Terumo is the strategic partner responsible for regulatory and commercial operations, with Orchestra receiving royalties and payments for the drug [42] - The program has faced delays due to changes in Terumo's management but remains a priority for both companies [43][45] Market Potential - The partnership with Medtronic allows Orchestra to tap into a significant market, with a potential revenue share of $500 to $1,600 per device sold, targeting approximately 750,000 patients annually who have hypertension and require pacemakers [32][33] - The Virtue program is positioned to address unmet needs in both coronary and peripheral artery disease, with breakthrough designations in various indications [63][64] Future Opportunities - There is potential for expanding the partnership with Medtronic to include broader patient populations beyond those needing pacemakers [35][36] - The Virtue program is exploring applications in below-the-knee treatments and other areas where inflammation and post-procedural healing are critical [64][65] Additional Important Content - The company ended the last quarter with over $50 million in cash, sufficient to fund operations for nearly a year, with options for equity financing if needed [25][26] - The business model is designed to minimize capital needs while maximizing growth potential through strategic partnerships [27] This summary encapsulates the key insights from the conference call, highlighting Orchestra Lab's innovative approach to the medical device industry, its strategic partnerships, and the promising clinical programs underway.

Summary of Foghorn Therapeutics (FHTX) Conference Call Company Overview - **Company**: Foghorn Therapeutics (FHTX) - **Event**: Jefferies Global Healthcare Conference - **Date**: June 05, 2025 Industry Focus - **Industry**: Biotechnology, specifically targeting chromatin regulatory systems and cancer therapies Key Points and Arguments Chromatin Regulatory System and BAF Complex - Foghorn Therapeutics focuses on the chromatin regulatory system, which is crucial for gene expression, likening it to an architect (regulatory system) and blueprints (genes) [3][4] - Approximately **20% of all cancers** have mutations in the BAF complex, and about **50% of cancers** relate to chromatin biology [4] Clinical Pipeline - The company is currently in clinical stages with a **Phase 1 trial** for a selective SMARCA2 inhibitor (FHD-909) in collaboration with Eli Lilly [6] - The next **12 to 18 months** are expected to be significant for the company with potential data releases [6][7] Challenges in Drug Development - Developing drugs targeting the chromatin system is challenging due to the complexity of proteins and their paralogs, which often share high sequence similarity [10][11] - Issues include purification difficulties and the intrinsic disorder of some proteins, making it hard to find selective chemical matter [12] Patient Enrollment and Selection Criteria - The Phase 1 trial includes patients with various tumor types, specifically those with **SMARCA4 mutations** [15] - Approximately **10% of non-small cell lung cancer (NSCLC)** patients have SMARCA4 mutations, with **60-70%** of those being loss-of-function mutations [19][20] Efficacy Expectations - The company aims for a response rate of **10-20%** in refractory patients, which would be considered promising compared to existing treatments [25][26] - Patients with SMARCA4 mutations have a worse prognosis and lower response rates to existing therapies [20][21][22] Combination Therapy Potential - There is interest in exploring combination therapies with KRAS inhibitors and immune checkpoint inhibitors, pending monotherapy efficacy results [39][40] - The timeline for potential combination studies is expected around **2026**, depending on the results of the ongoing trials [41] CBP and EP300 Programs - Foghorn is developing selective degraders for CBP and EP300, with potential applications in various cancers, including gastric and bladder cancers [44][48] - The CBP program is set to begin IND-enabling studies in the second half of 2025, with EP300 following closely behind [47][48] Upcoming Milestones - Key milestones include updates on the FHD-909 program, CBP, and EP300, with potential IND submissions in the next year [54][58] - The company anticipates significant data releases in the **October timeframe** related to ongoing studies [57] Additional Important Information - The company emphasizes the importance of a homogeneous patient population for clinical trials to avoid confusion in data interpretation [31] - Foghorn aims to avoid interim data releases to provide clearer insights into trial outcomes [32] - The therapeutic window for their compounds appears promising based on preclinical data, suggesting better tolerability compared to previous dual inhibitors [35][36] This summary encapsulates the critical insights from the conference call, highlighting the company's strategic focus, clinical developments, and future expectations in the biotechnology sector.

Summary of PMV Pharma Conference Call Company Overview - PMV Pharma was founded approximately eleven years ago by David Mack, Arne Levine, and Thomas Shank, focusing on harnessing the power of the p53 protein [3][4] - The company is currently advancing its Phase two registrational study for rizatapupt, targeting the TP53Y220C mutation in solid tumors [3][4] Current Programs and Clinical Trials - The Phase one program evaluated rizatapupt, leading to a successful transition into Phase two, with enrollment expected to complete by the end of this year [4][36] - An interim analysis is planned for mid-year, sharing data from around 50 patients, including 20 with ovarian cancer [4][36] - The Y220C mutation occurs in approximately 1% of all solid tumors and 3% in ovarian cancer, driving the design of a basket study across multiple tumor types [9][10] Efficacy and Safety Data - Preliminary Phase one data showed a 38% confirmed overall response rate across six tumor types, with a median duration of response (DOR) of seven months [11][35] - Safety profile was favorable, primarily grade one and two treatment-related adverse events, mainly gastrointestinal toxicities, which were mitigated by food [12][35] Study Design and Regulatory Alignment - The FDA provided alignment on the Phase two study design and recommended dose in July 2023, facilitating a potential registration path [22][23] - The Phase two study aims for a 30% response rate in ovarian cancer patients, with a confidence interval lower bound excluding 12% [24][31] Enrollment and Future Plans - Enrollment is on track, with 114 patients expected by year-end, including 42 in the ovarian cancer cohort [36][43] - NDA submission is anticipated by the end of next year, contingent on follow-up data from the ovarian cancer cohort [42][54] Financial Position - PMV Pharma has approximately $165 million in cash, supporting operations until the end of next year, covering the NDA submission timeline [54][56] Future Development - The company is working on an undisclosed target in lead optimization, with hopes for an IND submission in 2026 [51][52] - There are considerations for combination studies with KRAS inhibitors, although no formal announcements have been made yet [46][47] Key Takeaways - PMV Pharma is addressing a significant unmet medical need in cancer treatment through innovative approaches targeting p53 mutations [58] - The excitement around the interim analysis and ongoing enrollment reflects strong interest from clinical centers [59]

Summary of Septerna (SEPN) 2025 Conference Call Company Overview - **Company**: Septerna (SEPN) - **Focus**: Development of drugs targeting G protein-coupled receptors (GPCRs) using a proprietary platform called the native complex platform [1][2] Portfolio Strategy - **Target Selection**: Focus on biologically and clinically validated targets with significant unmet needs and market opportunities [2] - **Current Programs**: Discussion of four main programs, including a parathyroid hormone receptor agonist, MRGPRX2, thyroid stimulating hormone receptor negative allosteric modulator, and an incretin receptor agonist [3][4] Financial Position - **Capitalization**: Well-capitalized following an IPO in October and a recent collaboration with Novo Nordisk, providing a strong financial position for ongoing research and development [3][54] Key Programs 1. **Parathyroid Hormone Receptor Agonist Program** - **Target**: Oral small molecules for hypoparathyroidism [16] - **Challenges**: Discontinued trial of first compound (SEP-786) due to unanticipated bilirubin levels, but ongoing investigation into next-generation compounds [23][24][26] - **Animal Model Results**: Promising results in normalizing calcium levels in hypoparathyroid rat models with new compounds showing lower dosing requirements compared to SEP-786 [29][31][34] 2. **MRGPRX2 Program** - **Target**: Mast cell diseases, including chronic spontaneous urticaria and allergic asthma [35][37] - **Compound**: SEP-631, a negative allosteric modulator showing potent inhibition of receptor activation and promising preclinical results [38][42] - **Clinical Timeline**: Expected to enter Phase 1 trials in Q3 [43] 3. **Thyroid Stimulating Hormone Receptor Program** - **Focus**: Treating Graves' disease and thyroid eye disease with a negative allosteric modulator [44] - **Mechanism**: Aiming for a universal approach to target multiple autoantibodies in patients [45][46] 4. **Incretin Receptor Agonist Program** - **Innovation**: Discovery of a novel binding pocket allowing for the development of multi-incretin receptor agonists [50] - **Preclinical Results**: Early-stage molecules showing weight loss effects comparable to existing treatments [52] Collaboration with Novo Nordisk - **Details**: Collaboration includes three known targets and two undisclosed targets, with an upfront payment of $195 million and Novo responsible for all R&D costs [53][54] Leadership and Future Outlook - **Team**: Experienced leadership with decades of industry experience and a strong advisory board [55] - **Market Potential**: Each program represents a significant market opportunity, with ongoing efforts to extend financial runway into early 2028 and beyond [56] Conclusion - **Overall Position**: Septerna is well-positioned in the GPCR drug discovery space with a robust pipeline and strategic collaborations, aiming to address significant unmet medical needs across various therapeutic areas [56]

Summary of NN Inc. Conference Call Company Overview - **Company Name**: NN Inc. (NNBR) - **Industry**: Precision component manufacturing, focusing on automotive, industrial, and medical applications - **Key Products**: Machined and stamped parts, custom metal parts for automotive and industrial applications, medical components Core Points and Arguments 1. **Transformation and Growth**: NN Inc. is undergoing a significant repositioning and transformation program, with an experienced management team that has successfully executed transformations in the past. The company has delivered seven consecutive quarters of results and is launching new programs worth over $50 million at peak annual sales, with $30 million expected this year [5][4][6]. 2. **Market Conditions**: The core markets are primarily in North America, with about 70% of volume coming from the U.S. The company initially planned for a 3% growth in the base business but is currently experiencing a 3% decline due to external factors, including changes in the presidential administration and supply chain issues. However, a rebound is anticipated [6][7][8]. 3. **Automotive Sector Focus**: Approximately 48% of NN's business is tied to the automotive sector, which is undergoing significant innovation. The company is well-positioned to benefit from this trend, with a large existing pipeline of opportunities valued at around $750 million [8][9]. 4. **Global Manufacturing Footprint**: NN operates 24 facilities across six countries, with a significant presence in North America (65% of revenue) and a joint venture in China. The company is strategically positioned to service customers regionally [10][14][15]. 5. **Financial Performance**: For the year, NN expects net sales in the range of $430 million to $460 million, with adjusted EBITDA projected between $53 million and $63 million. The company is also focused on rationalizing costs and improving EBITDA margins [28][29][30]. 6. **New Business Development**: NN has secured $160 million in new business wins over the past two years, with a strong pipeline of approximately 700 programs. The company is launching 20 new programs this year and has already won an additional 57 programs [12][22][20]. 7. **Medical Segment Growth**: The medical segment has seen growth from sub-$15 million to over $15 million, with new wins expected to launch this year. The company is focusing on orthopedics and robotic surgery equipment [45][47][50]. 8. **Tariff Impact**: NN's business model is not directly impacted by tariffs, as materials are sourced and sold within the same region. However, the uncertainty caused by tariffs has led to a slight decline in revenue, which is expected to rebound [33][34][35]. Additional Important Insights 1. **Capacity Utilization**: The company is currently operating at around 50% capacity utilization, with significant room for growth in various regions [41][43]. 2. **Cash Flow and Debt Management**: NN is on track to improve free cash flow and reduce net debt throughout the year, with expectations of receiving approximately $12.5 million from the CARES Act [30][51][52]. 3. **Strategic Focus**: The management emphasizes a strategic approach to new business development, focusing on complex and high-value products that align with the company's capabilities [22][24][36]. This summary encapsulates the key points discussed during the conference call, highlighting NN Inc.'s current position, market dynamics, and future outlook.

Karyopharm Therapeutics (KPTI) Conference Summary Company Overview - Karyopharm Therapeutics is an innovation-driven commercial stage oncology company focusing on myelofibrosis and endometrial cancer treatments [3][4] Key Points on Myelofibrosis - The company is conducting two transformative Phase 3 studies: one for myelofibrosis and another for endometrial cancer, with top-line data expected by the end of 2025 or early 2026 [2][4] - The potential peak opportunity for myelofibrosis treatment is projected to exceed $1 billion [5] - The ongoing Phase 3 program targets JAK naive patients, with a focus on the efficacy of selinexor in combination with ruxolitinib [5][6] - Selinexor has shown promising results in heavily pretreated patients, demonstrating significant spleen volume reduction and symptom improvement [6][16] - The combination therapy has achieved a 79% SVR 35 rate compared to the 30-35% rate seen with ruxolitinib alone [16][28] - The durability of response is notable, with a 100% probability of maintaining spleen volume reduction among patients achieving SVR 35 [18] - The company emphasizes the importance of modifying the underlying disease and improving patient outcomes through innovative treatment approaches [34] Key Points on Endometrial Cancer - Karyopharm is leveraging the p53 wild type biomarker in endometrial cancer, which is present in approximately 50% of patients [38][39] - Selinexor has demonstrated a median progression-free survival (PFS) of 28.4 months in p53 wild type patients, significantly outperforming placebo [40] - The ongoing Phase 3 trial for endometrial cancer will evaluate selinexor as a monotherapy in a maintenance setting, with a planned enrollment of 276 patients [41] Additional Insights - The company has established commercialization capabilities to rapidly launch treatments upon receiving positive data [9][10] - The focus on innovative therapies aims to transform treatment standards in both myelofibrosis and endometrial cancer, enhancing patient outcomes [44] - The management team expresses confidence in the potential of selinexor to address unmet needs in oncology, particularly in challenging patient populations [11][12] Conclusion - Karyopharm Therapeutics is positioned for significant advancements in oncology with its innovative treatments for myelofibrosis and endometrial cancer, backed by promising clinical data and a strong commercialization strategy [44]

Summary of Prelude Therapeutics Conference Call Company Overview - Prelude Therapeutics is a precision oncology company focused on discovering and developing novel small molecules and degrader antibody conjugates for aggressive cancers that lack effective therapies [5][6] Key Updates and Core Points - **Lead Clinical Program**: The lead program targets the chromatin remodeling complex SMARCA2, with the first clinical candidate being a selective degrader molecule named 3,789, currently in clinical trials [5][6] - **Clinical Data**: Recent data presented showed a 23% response rate in patients with upper GI and lung tumors having SMARCA4 mutations at doses greater than 283 mg [11] - **Dose Selection**: The recommended phase 2 dose (RP2D) for the IV molecule has been set at 500 mg based on safety and efficacy data [11][13] - **Oral Molecule Development**: An oral molecule, 7,732, began clinical trials late last year, with rapid progress noted in patient enrollment and dose escalation [7][22] - **Research and Development**: Prelude is also advancing a new program called Cat6 Degrader, which is a selective degrader targeting Cat6a, with potential advantages over existing inhibitors [8][45] Upcoming Catalysts - **Data Updates**: The company plans to provide updates on both the IV and oral programs later this year, with a focus on the totality of phase one data and ongoing patient enrollment [16][23] - **IND Submission**: For the Cat6a program, the company aims to select a development candidate soon and hopes to submit an IND in early 2026 [48] Financial Position - As of the end of the last quarter, Prelude had $103 million in cash, which is expected to support operations into the second quarter of the following year [58] Competitive Landscape - Prelude acknowledges competition in the SMARCA space but emphasizes the unique aspects of their degrader approach, which may offer better safety profiles and efficacy compared to existing therapies [37][39] Additional Insights - **Partnerships**: Prelude is collaborating with Absella on developing dual degraders conjugated to antibodies, which have shown promising preclinical results [53][54] - **Patient Selection**: The company has established a biomarker for patient selection, enhancing the potential for successful clinical outcomes [21][39] Conclusion - Prelude Therapeutics is positioned well within the oncology space, with a strong pipeline of innovative therapies and a solid financial foundation to support its clinical and preclinical endeavors. The focus on selective degraders and the rapid advancement of both IV and oral programs highlight the company's commitment to addressing unmet medical needs in aggressive cancers [5][58]

Summary of Citius Pharmaceuticals (CTXR) Conference Call Company Overview - Citius Pharmaceuticals operates two companies: Sidious Pharmaceuticals and Sidious Oncology, with Sidious Oncology being a subsidiary focused on cancer treatment [3][4] - Sidious Oncology has an approved drug, LENFIR, for cutaneous T cell lymphoma (CTCL) and plans to launch it within the year [4][9] Key Products and Developments - **LENFIR**: - Approved for CTCL, with a market size of approximately $400 million [9] - Offers 12 years of BLA exclusivity as the first new systemic treatment since 2018 [9][36] - Clinical trial results show a 36% objective response rate and an 84.4% reduction in skin burden [24][25] - Expected to add to the market rather than take market share due to the nature of oncological treatments [10] - **Miniloc**: - An antibiotic lock solution for infected central venous catheters, completing a Phase III trial [5][37] - Unique in its ability to clear biofilm from catheters, with a significant market opportunity [39][42] - Results showed a p-value of 0.0006, indicating a superior outcome compared to standard care [45] - **Hemorrhoid Drug**: - A cream formulation combining halobetasol and lidocaine, currently in Phase 2b trials [48] - Aims to monetize through partnerships after demonstrating efficacy [48] Management and Investment - The management team has significant personal investments totaling $26.5 million, indicating strong commitment [7][51] - Experienced professionals lead the company, including former executives from major pharmaceutical firms [18][19] Market Strategy and Sales - A small prescriber base for CTCL, with only 25 representatives needed to cover the market [32][33] - The pricing for LENFIR is projected between $325,000 and $350,000 for a course of therapy [30] - Plans to establish a patient services hub and a sales force to support the launch of LENFIR [15][16] Regulatory and Competitive Landscape - Miniloc has received QIDP designation, reducing NDA review time and providing extended market exclusivity [46] - Competitive advantages include a unique mechanism of action for LENFIR and a lack of existing treatments for peripheral T cell lymphoma [26][30] Conclusion - Citius Pharmaceuticals is positioned to launch LENFIR, with a strong management team and significant investment backing. The company is exploring additional market opportunities and preparing for regulatory interactions to advance its product pipeline [50][51]

Summary of Autolus Therapeutics (AUTL) 2025 Conference Call Company Overview - **Company**: Autolus Therapeutics - **Product**: Ocatsil (formerly ObiCell) - **Approval Date**: November 8, 2024 - **Indication**: Approved for patients with relapsed/refractory Acute Lymphoblastic Leukemia (ALL) in the adult population - **Unique Selling Point**: First CAR T therapy approved without a Risk Evaluation and Mitigation Strategy (REMS) obligation, indicating a strong safety profile [4][5] Key Achievements and Launch Strategy - **Launch Progress**: Initiated launch at the end of 2024, currently has 40 active centers, expecting to reach 60 by year-end, providing approximately 90% patient access across the US [5][6] - **Market Access**: Achieved about 90% of lives covered, ensuring reimbursement for patients interested in therapy [6] - **Support Services**: Emphasized the importance of qualifying centers and providing comprehensive support, including training, product management, and patient support [7][8] Manufacturing and Quality Control - **Manufacturing Facility**: Located in the UK, underwent rigorous inspections by MHRA and FDA, allowing for high control over manufacturing processes [8] - **Quality Metrics**: Approximately 5-6% of manufactured products were out of specification during pivotal studies, indicating a low failure rate [29] Product Safety and Efficacy - **Adverse Events**: Reported low rates of high-grade cytokine release syndrome (2%) and neurological toxicities (7%), significantly lower than other T cell-mediated therapies [15][16] - **Dosing Strategy**: Tailored dosing based on tumor burden, allowing for better management of adverse events and improved patient tolerability [12][14] Financial Performance and Revenue Guidance - **Q1 Sales**: Reported $9 million in sales for Q1 2025, with cautious optimism about future revenue growth due to increasing center openings and physician adoption [19][24] - **Revenue Guidance**: Company refrained from providing specific revenue guidance, citing the complexity of launch dynamics and the need for more data over the next three quarters [19][24] Future Opportunities and Trials - **Expansion of Indications**: Plans to expand indications to pediatric ALL and autoimmune diseases, with ongoing trials and discussions with regulatory agencies [34][38] - **Lupus Nephritis Trials**: Focus on patients with advanced lupus nephritis, planning a pivotal study in the second half of 2025 [41][46] - **Multiple Sclerosis Exploratory Study**: Investigating the potential of CAR T cells to cross the blood-brain barrier for treating progressive multiple sclerosis [46][48] Regulatory Considerations - **Single Arm Trials**: Regulatory agencies may consider single-arm trials for high medical need settings, provided there is a high treatment effect and sufficient safety data [51][55] Upcoming Milestones - **Key Data Releases**: Anticipated updates from ongoing studies at upcoming conferences, including EHA and ASH, with a focus on leukemia and lupus nephritis [57] Conclusion - **Overall Sentiment**: The company expressed confidence in its product's safety and efficacy, with a strong focus on execution and market penetration as it navigates the complexities of launching a new CAR T therapy [10][24]

Summary of LivaNova (LIVN) 2025 Conference Call Company Overview - **Company**: LivaNova (LIVN) - **Industry**: Medical Supplies and Devices - **Key Focus Areas**: Cardiopulmonary and Neuromodulation markets, specifically in epilepsy and obstructive sleep apnea (OSA) [5][6] Core Business Insights - **Market Position**: LivaNova operates in large, growing markets driven by cardiovascular and neurological diseases, which are significant global health burdens [5] - **Leadership**: The company is a leader in the cardiopulmonary and epilepsy markets, with a strategic focus on expanding into high-growth areas with unmet needs [6] - **Growth Performance**: Achieved double-digit growth in eight out of the last nine quarters, primarily driven by the cardiopulmonary portfolio [8] Financial Performance - **Cardiopulmonary Growth Drivers**: - Strong market growth - Pricing capabilities and momentum - Market share gains in disposable products, particularly oxygenators - Successful launch of the new heart-lung machine, Essence, which has a significant pricing upgrade and customer benefits [8][9] New Business Developments - **Obstructive Sleep Apnea (OSA)**: - Strong clinical data from the OSEPRY trial, with ongoing market access approvals in the U.S. and a PMA submission to the FDA [10][11] - **Difficult to Treat Depression**: - Positive 24-month data showing significant improvements, with reimbursement requests submitted to CMS [12][19] Clinical Data Highlights - **Difficult to Treat Depression (DTD)**: - Over 80% of patients maintained treatment effects at 24 months, with a 10% increase in efficacy and a 40% reduction in suicidality compared to sham [17][18] - **Epilepsy Treatment**: - Significant reductions in seizures observed in various patient populations, with an 80% reduction in focal seizures with impaired awareness [35][36] Market Strategy and Future Outlook - **Commercialization Strategy**: - Confidence in the ability to commercialize independently while exploring partnerships to enhance market reach [27][28] - **Market Size**: - The addressable market for OSA is over $1 billion, growing at double digits, with potential for expansion due to the complexity of patients treated [32] Competitive Landscape - **Cardiopulmonary Market**: - LivaNova holds approximately 70% market share globally for heart-lung machines, with a target of 60% placement penetration for the Essence machine this year [41][42] - **Oxygenator Market**: - Increased market share from 30% to nearly 40% due to expanded manufacturing capacity and upcoming product innovations [46][47] Challenges and Risks - **Regulatory and Safety Issues**: - Anticipated deferred procedures due to a voluntary field safety notice affecting a small percentage of generators, with expected impacts on Q2 financials [50][51] - **Tariff Impacts**: - A $5 million tariff headwind factored into guidance, with minimal impact expected due to the company's manufacturing footprint [52][53] Capital Allocation Strategy - **Focus Areas**: - Continued investment in the epilepsy business, OSA, and difficult to treat depression markets, leveraging neuromodulation capabilities for growth [58][59] Conclusion - LivaNova is positioned for growth in attractive markets with a strong focus on innovation and addressing unmet medical needs, while navigating regulatory challenges and competitive dynamics [5][6][12]