Summary of Foghorn Therapeutics FY Conference Call Company Overview - **Company**: Foghorn Therapeutics (NasdaqGM:FHTX) - **Focus**: Targeting the chromatin regulatory system and the BAF complex, primarily in oncology [2][3] Industry Insights - **Oncology Relevance**: Approximately 50% of cancers have dependencies or mutations related to chromatin regulation, highlighting the importance of this area in cancer biology [2] - **Targeting Challenges**: The similarity between proteins in the BAF complex (e.g., SMARCA2 and SMARCA4) complicates selective targeting due to their 90%-95% similarity [3][4] Key Programs and Developments SMARCA2 Program - **Scientific Rationale**: SMARCA2 is targeted due to its synthetic-lethal relationship with SMARCA4, where loss of SMARCA4 increases dependency on SMARCA2 in cancer cells [6][7] - **Clinical Data**: Patients with SMARCA4 mutations show significantly worse prognosis in non-small cell lung cancer, with response rates dropping from approximately 40% to 20% [7] - **Market Opportunity**: In the U.S., about 22,000 non-small cell lung cancer patients have SMARCA4 mutations, with an estimated 11,000-17,000 potentially having loss of function [8] Clinical Trials - **Current Status**: The SMARCA2 inhibitor FHD-909 is in phase one trials, with ongoing dose escalation and no maximum tolerated dose reached yet [16][17] - **Study Design**: The trial includes various cancer histologies with a focus on non-small cell lung cancer patients with SMARCA4 mutations [15] - **Expected Outcomes**: Anticipation of a go/no-go decision for dose expansion in the first half of 2026 [16] CBP and EP300 Programs - **Mechanism**: CBP and EP300 are sister proteins involved in histone acetylation, with challenges in dual inhibition leading to myelosuppressive effects [21][22] - **Commercial Opportunity**: Targeting CBP could address approximately 20,000-25,000 patients with specific mutations, while EP300 shows potential in hematological malignancies [23][24] ARID1B Program - **Target Validation**: ARID1B is a highly mutated target in cancer, with Foghorn being the only company to develop selective binders for this target [27][28] - **Development Status**: The program is in hit-to-lead stage, with in vivo proof of concept expected in 2026 [29] Additional Insights - **Combination Studies**: The company recognizes the importance of combination therapies in oncology and plans to explore both monotherapy and combination regimens in future studies [18][19] - **Clinical Risks**: Acknowledgment of the risks associated with being first to market, particularly in the context of the SMARCA2 program [9][10] Conclusion Foghorn Therapeutics is positioned in a promising niche within oncology, focusing on challenging targets related to chromatin regulation. The company is advancing several innovative programs, particularly in SMARCA2, CBP, and EP300, with significant market opportunities and ongoing clinical trials that could lead to impactful treatments for cancer patients.

Summary of Relay Therapeutics FY Conference Call Company Overview - **Company**: Relay Therapeutics (NasdaqGM: RLAY) - **Focus**: Development of targeted therapies, particularly in oncology and vascular malformations Key Points on Portfolio and Development Priorities - **RLY-2608**: First PI3K mutant selective inhibitor in clinical trials with three ongoing trials - Pivotal trial for hormone receptor positive, HER2 negative breast cancer initiated in summer 2025 - Trials include combinations with RIBO, PALBO, and abemaciclib [5][6] - **Financial Position**: Company has sufficient cash to operate until 2029 with multiple upcoming catalysts [5] Clinical Profile and Competitive Positioning - **Efficacy vs. Safety**: RLY-2608 shows improved safety and tolerability compared to capivasertib, leading to longer treatment durations and better progression-free survival (PFS) rates [6][7] - PFS for RLY-2608 in second line setting is in double digits, significantly higher than capivasertib's 5.5 months [7] - **Market Dynamics**: Capivasertib has captured significant market share despite lower PFS due to its safety profile, generating $800 million annually [9] - **Comparative Data**: RLY-2608 has a confirmed objective response rate of 39%, outperforming competitors like the Scorpion Lilly molecule, which reported a 20% response rate [11][12] Strategic Considerations - **Post-CDK4/6 Market**: The company emphasizes the importance of the post-CDK4/6 market, which is expected to grow as CDK4/6 inhibitors gain traction in earlier treatment settings [15][16] - **Triplet Combinations**: Ongoing research into triplet combinations with fulvestrant and CDK inhibitors, focusing on dose optimization and patient selection [19][20] Expansion into Vascular Malformations - **Rationale for Development**: Similar to oncology, targeting PI3K mutations in vascular malformations is expected to yield significant benefits [28] - **Market Opportunity**: Estimated 170,000 patients in the U.S. with PI3K mutant vascular malformations, with potential for a multi-billion dollar market [39][41] - **Regulatory Path**: Following alpelisib's unusual regulatory approval, Relay plans to use similar endpoints for their trials [44][45] Enrollment and Market Research - **Patient Enrollment**: Positive feedback on enrollment pace in clinical trials for vascular malformations, despite the nascent nature of the disease setting [36][37] - **Current Treatment Landscape**: Limited use of existing therapies like alpelisib and sirolimus, with many patients unable to tolerate long-term treatment [42][43] Conclusion - Relay Therapeutics is positioned to leverage its innovative RLY-2608 in both oncology and vascular malformations, with a strong focus on safety, efficacy, and market potential. The company is optimistic about its clinical trials and the commercial opportunities that lie ahead.

Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Event**: FY Conference held on November 10, 2025 Key Points Industry and Market Performance - Axsome Therapeutics operates in the biotechnology sector, focusing on treatments for mental health and neurological disorders [1] - The company reported a strong Q3 performance with total net sales of **$171 million**, driven by their leading product for Major Depressive Disorder (MDD) which generated **$136 million**, reflecting a **69% year-over-year growth** and **14% quarter-over-quarter growth** [4][5] Product Pipeline and Development - Axsome has several products in various stages of development: - **AXS-05** for MDD - **AXS-12** for narcolepsy - Ongoing Phase III programs for other indications [3] - The company is expanding its earlier stage pipeline and has launched a direct-to-consumer (DTC) campaign to enhance product visibility [3][5] Direct-to-Consumer Campaign - The DTC campaign launched in early September has already shown positive early metrics, including increased Google searches and new prescriptions (NBRxs) [8][10] - NBRxs increased from **2,000 per week** to **2,800**, attributed largely to the DTC efforts [9][10] - The company is taking a disciplined approach to DTC spending, ensuring that sales in Q4 will meet or exceed the additional DTC expenditures [11][12] Market Access and Sales Force Expansion - Axsome has improved its gross-to-net dynamics, achieving a discount in the high **40s%** and covering **85% of total lives** [18][19] - The sales force currently consists of **300 representatives**, with plans for expansion upon receiving approval for additional indications [20][21] Regulatory and Approval Process - Axsome is preparing for an NDA submission for Alzheimer's Disease Agitation (ADA), with a robust package that includes three positive controlled trials and a standalone safety database [24][25] - The company has received breakthrough therapy designation and is eligible for priority review, although they are modeling a standard review timeline [32][33] Competitive Landscape - The market for Alzheimer's Disease treatments is evolving, with competitors like Rexulti showing growth rates of **20% to 25%** [39][40] - Despite the presence of approved products, a significant portion of patients are still treated off-label, indicating room for growth in formalized treatment protocols [42][43] Financial Outlook - Axsome achieved cash flow positivity for the first time, with approximately **$1 million** positive cash flow from operations in Q3 [60] - The company anticipates operating leverage moving into Q4 and next year, with revenue growth of **14%** and operating expenses growing at **5.5%** [61] Future Projections - Axsome projects peak sales for its products, including **$500 million to $1 billion** for Cymbravo and **$300 million to $500 million** for Sunosi [51][57] - The company is focused on maintaining a disciplined approach to its investments while preparing for potential growth in the ADA market [58][61] Conclusion - Axsome Therapeutics is positioned for significant growth with a strong product pipeline, effective marketing strategies, and a disciplined financial approach. The upcoming regulatory submissions and market expansions are critical to the company's future success.

Stan Kovler SVP, Finance and Corporate Development Investor Day Welcome to 1 Disclaimer Non - GAAP Financial Measures Forward - Looking Statements This presentation contains forward - looking statements including statements regarding our business outlook; future operating and financial metrics and results; market conditions and global demand; customer adoption of our technologies, products and solutions; our product roadmap and innovation priorities; our go - to - market execution; and our ability to compet ...

Financial Data and Key Metrics Changes - Total company revenue increased by 13.4% compared to last year's third quarter, reaching a quarterly record [4][18] - Adjusted EBITDA increased by 15.2%, resulting in a 26 basis point improvement in adjusted EBITDA margins [4][21] - Cash balance as of September 30, 2025, was $804.7 million, with a net debt to adjusted EBITDA ratio of approximately 1.0 [14][22] Business Line Data and Key Metrics Changes - Advanced imaging procedures increased by 13.0% on an aggregate basis and 9.9% on a same-center basis compared to last year's third quarter [6][18] - MRI volume increased by 14.8%, CT volume by 9.4%, and PET/CT volume by 21.1% from last year's third quarter [18] - Digital health revenue increased by 51.6% from last year's third quarter, with AI revenue within digital health increasing by 112% [19][20] Market Data and Key Metrics Changes - 28.2% of procedures were from advanced imaging compared to 26.7% in the third quarter of last year [7] - The blended adoption rate for the EBCD DeepHealth AI-powered breast cancer screening program is above 45% nationally [9] Company Strategy and Development Direction - The company is focusing on expanding its digital health segment and integrating AI technologies to enhance operational efficiency and patient outcomes [10][80] - There is an ongoing initiative to pursue acquisitions that align with the company's strategic objectives in both imaging services and digital health [14][82] - The company plans to enhance its EBCD program to improve risk prediction models and early cancer detection capabilities [44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the positive trends in reimbursement rates and the shift towards more cost-effective imaging solutions [8][26] - The company anticipates a $4-$5 million uplift in Medicare revenue for 2026, breaking a trend of annual cuts [25][26] - Management acknowledged challenges in the labor market but noted stabilization and efforts to improve hiring and retention of radiology technologists [55][59] Other Important Information - The company completed the acquisition of iCAD, enhancing its capabilities in AI-powered breast health solutions [10] - The integration of CMODE's thyroid ultrasound technology has been completed across more than 240 RadNet centers, improving diagnostic accuracy [11] Q&A Session Summary Question: Update on TechLive rollout and dynamic scheduling - The TechLive rollout is expected to be substantially complete by the end of the year, significantly reducing exam room closures and increasing capacity [33][34] - Dynamic scheduling utilizes AI to predict patient no-shows, allowing for overbooking and better utilization of exam slots [36] Question: Progress on EBCD coverage and capitated contracts - Discussions with commercial payers regarding EBCD coverage are ongoing, with positive feedback expected to lead to adoption [40] - Capitated contracts are seeing increased rates, with some larger groups beginning to offer EBCD as a covered benefit [42] Question: Outlook for joint ventures and partnerships - The company is receiving more inquiries from health systems regarding radiology strategies, indicating robust interest in partnerships [50] Question: Exposure to Medicaid programs and labor costs - Medicaid fee-for-service business constitutes about 2.5% of total business, with minimal impact expected from changes in Medicaid programs [52] - Labor costs remain a challenge, but stabilization efforts are underway, including training programs and partnerships with tech schools [55] Question: Future of DeepHealth and sales personnel - The company recognizes the need for more sales personnel to effectively market DeepHealth solutions, leveraging cross-selling opportunities [90] Question: EBITDA margins and cost management - Margins improved, but the company is focused on further enhancements through digital health initiatives and AI integration [96]

Financial Data and Key Metrics Changes - Total company revenue increased by 13.4% compared to last year's third quarter, reaching a quarterly record [4][18] - Adjusted EBITDA increased by 15.2% year-over-year, resulting in a 26 basis point improvement in adjusted EBITDA margins [4][21] - Cash balance as of September 30, 2025, was $804.7 million, with a net debt to adjusted EBITDA ratio of approximately 1.0 [14][22] Business Line Data and Key Metrics Changes - Advanced Imaging revenue increased by 13.0% on an aggregate basis and 9.9% on a same-center basis compared to last year's third quarter [6][18] - MRI volume increased by 14.8%, CT volume by 9.4%, and PET/CT volume by 21.1% year-over-year [18] - Digital Health revenue increased by 51.6% from last year's third quarter, driven by contributions from iCAD [19] Market Data and Key Metrics Changes - The blended adoption rate for the EBCD DeepHealth AI-powered breast cancer screening program is above 45% nationally [9] - Medicare reimbursement is expected to increase by approximately $4 million to $5 million in 2026, breaking a trend of annual cuts [25][26] Company Strategy and Development Direction - The company plans to continue expanding its Digital Health segment and has successfully integrated iCAD's operations, achieving cost synergies ahead of schedule [10][23] - There is a focus on enhancing operational efficiency through AI and digital solutions, which are expected to improve margins and capacity [56][60] - The company is evaluating an attractive pipeline of acquisition opportunities in both core imaging services and digital health [14][82] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to grow through patient referrals and contracts with radiology practices, despite challenges in the labor market [4][55] - The company anticipates that the labor market challenges may be at an inflection point, with potential stabilization in staffing issues [58][60] - Management highlighted the importance of AI in transforming healthcare delivery and improving patient outcomes [80] Other Important Information - The company will host its inaugural Investor Day, showcasing its digital health solutions and future growth strategies [27][30] - The implementation of See-Mode's thyroid ultrasound technology has shown a 30% reduction in scan time, enhancing operational efficiency [11] Q&A Session Summary Question: Update on TechLive rollout and dynamic scheduling - The TechLive rollout is expected to be substantially complete by the end of the year, significantly reducing exam room closures and increasing MRI volume [34][35] - Dynamic scheduling utilizes AI to predict patient no-shows, allowing for overbooking and better utilization of exam slots [36] Question: Progress on EBCD coverage and capitated contracts - Discussions with commercial payers regarding EBCD coverage are ongoing, with positive momentum expected [40] - Capitated payers are recognizing the value of early detection and are increasing rates for the EBCD program [42] Question: Outlook for joint ventures and partnerships - The company is receiving more inquiries from health systems regarding radiology strategies, indicating robust interest in partnerships [50][51] Question: Exposure to Medicaid programs and labor costs - Medicaid fee-for-service business constitutes about 2.5% of total revenue, with minimal impact expected from changes in Medicaid programs [52] - Labor costs remain a challenge, but the company is implementing various strategies to stabilize staffing [55] Question: Future of DeepHealth and sales personnel - The company recognizes the need for more sales personnel to effectively market DeepHealth solutions, leveraging cross-selling opportunities [90] Question: EBITDA margins and cost side considerations - The company is focused on margin improvement, with expectations that digital health initiatives will drive future margin expansion [96]

Summary of EyePoint Pharmaceuticals FY Conference Call Company Overview - **Company**: EyePoint Pharmaceuticals (NasdaqGM:EYPT) - **Mission**: To improve patients' lives through enhanced treatment of retinal diseases, focusing on drug delivery systems [6][5][4] Key Trials and Developments - **Pivotal Trials**: - Two pivotal trials for wet age-related macular degeneration (AMD): Lugano Trial and Lugia Trial, both fully enrolled with over 400 patients each [6][7] - Expected readout for Lugano Trial in mid-2026 and Lugia Trial shortly thereafter [6] - Phase three trials for diabetic macular edema (DME) named COMO and COPRI, with patient dosing starting in Q1 2026 [7] - **Drug Mechanism**: Vorolanib, the drug in focus, exhibits both anti-VEGF and anti-inflammatory effects by blocking the JAK1 receptor, which is significant for conditions like diabetic macular edema and wet AMD [9] Enrollment and Study Design - **Rapid Enrollment**: The rapid enrollment in the wet AMD trials was attributed to strong phase two data and the patient-centric design of the studies [11][10] - **Patient Population**: The phase three study includes both previously treated and naive patients, with expectations of better outcomes in naive patients [14][13] Safety and Efficacy Expectations - **Safety Profile**: The safety results so far are consistent with prior trials, with no vision loss reported due to the drug insert [21][23] - **Efficacy Goals**: The aim is to be statistically non-inferior to Eylea, with hopes of achieving statistical superiority [20][19] Competitive Landscape - **Market Position**: EyePoint aims to differentiate itself from competitors like Vabysmo and Eylea by offering a different mechanism of action and a six-month dosing schedule [36][37] - **First-to-Market Advantage**: If approved, EyePoint will be the first to market with its sustained-release product, which is expected to be advantageous [38] Market Potential - **DME Market Size**: The DME market is approximately $3 billion in the U.S., representing about 35-40% of the overall market for retinal diseases [49][50] Regulatory and Global Strategy - **Regulatory Readiness**: EyePoint is preparing for a pre-approval inspection by the FDA and has a clear plan for NDA submission based on the results of the ongoing trials [33][31] - **Ex-U.S. Strategy**: The company plans to include European sites in its studies and is preparing for potential launch outside the U.S., with a focus on finding a global partner at the right time [50][51] Conclusion EyePoint Pharmaceuticals is positioned at a pivotal moment with multiple ongoing trials and a strong focus on innovative drug delivery for retinal diseases. The company is optimistic about its upcoming trial results and the potential market impact of its products.

Financial Data and Key Metrics Changes - The company reported a cash position of $562 million, with $72 million restricted, ensuring coverage for covenants and capital needs [11] - Earnings and cash flow increased compared to the first nine months of 2024, with a significant increase in contracted revenues of $778 million added through the first nine months of 2025 [6][11] - The annualized dividend was increased to $2.50 per share, representing a 19% increase from the previous dividend and a total increase of 67% from $1.50 over the past 18 months [6][25] Business Line Data and Key Metrics Changes - The company added 38 charters through the first nine months of 2025, with $380 million added in the third quarter alone [8] - The charter portfolio now has over $1.9 billion in forward contracted revenues, with 2.5 years of remaining contract coverage [8][23] Market Data and Key Metrics Changes - The company noted that charter rates remain steady at historically high levels despite volatility in freight markets [28] - The ongoing disruption in the Red Sea has absorbed about 10% of effective capacity, driving up charter rates [15] Company Strategy and Development Direction - The company focuses on maintaining optionality in a volatile geopolitical and trade environment, emphasizing the need for flexible mid-size and smaller container ships [4][7] - The strategy includes locking in long-term charters while ensuring financial flexibility to respond to market changes [7][9] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of flexibility in the current environment, where supply chains are becoming less efficient and more fragmented [4][24] - The deferral of the IMO net-zero framework is expected to extend the economic life of older conventionally fueled vessels, benefiting the company's fleet [19] Other Important Information - The company has reduced its outstanding debt from $950 million at the end of 2022 to a projected under $700 million by the end of 2025 [12] - The blended cost of debt has been lowered to 4.34%, down from over 6% in 2020 [13] Q&A Session Summary Question: Are freight rates and charter rates showing a healthy gap? - Management confirmed that charter rates are steady at high levels despite freight market volatility [28] Question: How is the company balancing rates versus duration for renewals or forward charters? - The company is focused on risk-averse mid-term and longer charters, preferring to secure attractive economic rates for extended durations [29] Question: What contributed to the significant backlog added in the third quarter? - Management indicated that the backlog addition reflects broader market dynamics rather than being unique to the company, with a resurgence in chartering activity following a disrupted second quarter [34] Question: Can older vessels continue to trade as they age? - Management stated that container ships can trade beyond 28 or 29 years if the market conditions remain favorable, citing the strong safety record of container ships [38][40] Question: What is the outlook for transits through the Red Sea? - Management noted that discussions regarding Red Sea transits are not currently underway, emphasizing the complexity of decisions involving insurers and charterers [42]

Financial Data and Key Metrics Changes - Total company revenue increased by 13.4% compared to last year's third quarter, reaching a quarterly record [4][17] - Adjusted EBITDA increased by 15.2%, resulting in a 26 basis point improvement in adjusted EBITDA margins [4][19] - Cash balance as of September 30, 2025, was $804.7 million, with a net debt to adjusted EBITDA ratio of approximately 1.0 [13][19] Business Line Data and Key Metrics Changes - Advanced imaging procedures accounted for 28.2% of total procedures, up from 26.7% in the same quarter last year [6] - Aggregate MRI volume increased by 14.8%, CT volume by 9.4%, and PET/CT volume by 21.1% compared to last year's third quarter [17] - Digital health revenue increased by 51.6% year-over-year, with AI revenue within digital health rising by 112% [18] Market Data and Key Metrics Changes - Same-center procedural volume showed robust growth, particularly in advanced imaging, with same-center advanced imaging increasing by 9.9% [5] - The company experienced a blended adoption rate of over 45% for its AI-powered breast cancer screening program [9] Company Strategy and Development Direction - The company plans to continue expanding its digital health segment and has successfully integrated iCAD's operations, achieving cost synergies ahead of schedule [10][21] - There is a focus on enhancing operational efficiency through AI and digital health solutions, which are expected to drive future growth [48][56] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, noting that the company will benefit from an anticipated $4-$5 million Medicare revenue uplift in 2026, breaking a trend of annual cuts [23][24] - The company is actively pursuing acquisition opportunities to further its strategic objectives in both core imaging services and digital health [14][19] Other Important Information - The company has opened five new facilities in 2025, with plans for more in the fourth quarter [17] - The integration of CMODE's thyroid ultrasound technology has improved diagnostic accuracy and enhanced clinical workflows [10] Q&A Session Summary Question: Update on TechLive rollout and dynamic scheduling - Management indicated that the TechLive rollout should be substantially complete by the end of the year, significantly reducing exam room closures and increasing MRI volume [29][30] Question: Progress on EBCD coverage and capitated contracts - Management reported positive discussions with commercial payers regarding EBCD coverage and noted that capitated contracts are beginning to offer the EBCD program as a benefit [33][36] Question: Outlook for joint ventures and partnerships - Management stated that there is robust interest from health systems in RadNet's radiology strategy, with potential partnerships expected to be announced soon [40] Question: Labor market challenges and hiring strategies - Management acknowledged ongoing challenges in hiring radiology technologists but noted stabilization and efforts to improve recruitment and retention [45][47] Question: Future of virtual radiology capabilities - Management confirmed that developing virtual radiology capabilities is an inevitability, aimed at assisting radiologists rather than replacing them [50] Question: Digital health revenue expectations for Q4 - Management clarified that digital health revenue is expected to remain strong, with an increase in guidance reflecting the contribution from iCAD [65]

Exelixis FY Conference Summary Company Overview - Exelixis is a midsized commercial-stage biotech company focused exclusively on oncology, navigating the discovery, clinical, regulatory, and commercial landscape for 25 years [3][4][6] Financial Performance - Q3 2025 net product revenue reached $543 million, primarily driven by success in kidney cancer treatments [4] - Total revenues for the quarter were slightly below $600 million, with global revenues for the brand at $760 million, indicating blockbuster status [5] Product Highlights Cabometyx (Cabo) - Cabo has achieved over 40% market share in new patient starts for kidney cancer, with a 50% quarter-over-quarter growth [4][9] - The company anticipates exceeding $100 million in sales for Cabo in neuroendocrine tumors (NET) for the full year [7] - 80% of the NET prescriber population has previously used Cabo, indicating strong familiarity and confidence in the product [12] Zanzalintinib (Zanza) - Zanza is positioned as a key pipeline product, with positive data recently presented at ESMO for colorectal cancer [14][17] - The potential market opportunity for Zanza in the U.S. is estimated at $1 billion, with expectations for growth as therapies improve [18] - The company plans to initiate a post-chemo adjuvant study (STELLAR-316) early next year, targeting high-risk patients post-surgery [18][24] Strategic Initiatives - Exelixis aims to build a pipeline of franchise molecules, leveraging the success of Cabo to develop additional products [5][19] - The company is expanding its salesforce to enhance its presence in the gastrointestinal (GI) space, anticipating the launch of two drugs in successive years [9][11] - The focus is on creating value for patients and shareholders through disciplined expense management and strategic investments in marketing and sales [6][11] Market Dynamics - The competitive landscape for colorectal cancer treatments is evolving, with physicians showing interest in non-chemotherapy regimens [16][17] - Exelixis is exploring partnerships, such as with Merck for a Zanza-Belzutifan combination, to enhance its competitive positioning in renal cell carcinoma (RCC) [31][34] Future Outlook - The company is optimistic about its growth trajectory, aiming to increase its market share and expand its product offerings across various oncology indications [19][30] - Upcoming R&D day is expected to provide further insights into the company's pipeline and strategic direction [35]