Summary of Amylyx Pharmaceuticals FY Conference Call Company Overview - **Company**: Amylyx Pharmaceuticals (NasdaqGS:AMLX) - **Focus**: Clinical-stage biotech developing therapies for neurodegenerative and endocrine diseases [1][2] Key Programs and Developments - **Avexitide**: - Late-stage asset focused on post-bariatric hypoglycemia (PBH) - Phase 3 LUCIDITY study ongoing, with expected enrollment completion by the end of 2025 and data release in the first half of 2026 [3][20] - First-in-class GLP-1 receptor antagonist with FDA Breakthrough Therapy Designation for PBH [5][6] - Mechanism: Blocks GLP-1 to reduce insulin production, addressing hypoglycemia caused by hyperinsulinemia [6][8] - Phase 2 studies showed a 64% reduction in level 3 hypoglycemic events and a 53% reduction in level 2 events [13][14] - Safety profile: Generally well tolerated with mild to moderate side effects [15] - **Wolfram Syndrome**: - Rare, progressive disease with no current treatment - Using AMX0035, showing positive outcomes in C-peptide and HbA1c levels [21][24] - Estimated 3,000 to 3,500 patients in the U.S. [25] - **ALS Program**: - Targeting axonal degeneration with AMX0114, an antisense oligonucleotide aimed at Calpain 2 - First patient data expected by the end of 2025 [26] Financial Position - Recently completed financing of $175 million, extending runway into 2027 - Cash balance of $180 million as of June 30, 2025 [27] Market Opportunity - Over 160,000 individuals in the U.S. suffer from persistent hypoglycemia post-bariatric surgery, a significant unmet medical need [18][20] - Over 2 million bariatric surgeries performed in the U.S. over the last decade, with 8% developing PBH [18] Regulatory and Patent Status - Patent rights for avexitide extend through 2037, with orphan designation granted for PBH [20][21] Conclusion - Amylyx Pharmaceuticals is actively advancing multiple programs in rare diseases with significant unmet needs, backed by a strong financial position and promising clinical data [27]

Summary of BioAge Labs FY Conference Call Company Overview - **Company**: BioAge Labs (NasdaqGS:BIOA) - **Focus**: Development of therapeutics targeting metabolic aging and obesity Key Points Platform and Data - BioAge Labs has developed a unique platform with approximately **50 million molecular data points** collected over decades, making it one of the largest human aging data sets globally [5][6] - The platform focuses on identifying targets for metabolic aging, particularly in the context of obesity and related comorbidities [5][6] - Recently expanded its discovery capabilities by incorporating data from the **HUNT Biobank** in Norway, which includes over **30 years of health records** and a significant portion of individuals developing cardiometabolic diseases [12] Therapeutic Focus - The company is concentrating on the next generation of obesity therapies that address not only weight loss but also muscle loss and inflammation [6] - BioAge Labs is advancing its lead program, **BGE-102**, a brain-penetrant NLRP3 inhibitor, which has shown promising preclinical results in weight loss comparable to semaglutide [25][26] - The mechanism of BGE-102 targets neuroinflammation, which is linked to appetite dysregulation and obesity [25] Collaborations - BioAge Labs has established collaborations with major pharmaceutical companies, including **Novartis** and **Eli Lilly**. The Novartis partnership focuses on novel target discovery related to aging biology and exercise [18][21] - The collaboration with Eli Lilly involves developing molecules based on BioAge's human data, allowing for expanded capabilities in drug development [21] Clinical Development - BGE-102 has initiated a **Phase 1 study** with results expected by the end of the year, focusing on pharmacodynamics (PD) and safety [30][35] - The company plans to advance into a monotherapy obesity trial following the Phase 1 results, with a robust design aimed at weight loss [47] Financial Position - As of June, BioAge Labs reported over **$310 million** in cash, sufficient to fund operations for over three years, covering ongoing studies and development milestones [71] Future Catalysts - Upcoming catalysts include the **SAD data** by the end of the year, **MAD data** in the first half of 2026, and IND filings for APJ agonist programs by the end of 2026 [73] - External catalysts include data readouts from competitors, which may provide insights into the market landscape [74] Market Position and Strategy - BioAge Labs aims to leverage its unique platform to explore novel targets, differentiating itself from competitors who focus on validated targets [75] - The company is also exploring the integration of **artificial intelligence** in its operations, particularly in target discovery and molecule identification [77][81] Conclusion - BioAge Labs is positioned to capitalize on its extensive data platform and strategic collaborations to develop innovative therapies for metabolic aging and obesity, with a strong financial foundation to support its clinical and operational goals.

Curis FY Conference Summary Company Overview - **Company**: Curis (NasdaqCM:CRIS) - **Focus**: Development of novel cancer treatments, particularly emiflucertib, an IRAK4 inhibitor with applications in lymphoma, leukemia, and solid tumors [2][3] Key Points on Emiflucertib - **Proof of Concept**: - Data from 34 patients with Primary CNS Lymphoma (PCNSL) and 21 patients with Acute Myeloid Leukemia (AML) show significant improvement over standard care [2] - Confidence in efficacy extends to other Non-Hodgkin Lymphoma (NHL) subtypes, including Chronic Lymphocytic Leukemia (CLL) [2][3] - **Mechanism of Action**: - Emiflucertib targets IRAK4, which downregulates NF-kappa B, a key driver in CLL and NHL [5] - Combination therapy with BTK inhibitors enhances treatment efficacy [4][5] - **Market Opportunity**: - BTK inhibitors represent an $11 billion industry, growing at 20% annually, but have limitations such as incomplete responses and side effects [7][8] - Emiflucertib aims to provide a better safety profile and the potential for complete responses [8][14] Clinical Development - **Clinical Trials**: - Designed for accelerated filing, focusing on dose escalation and combination therapy [9][10] - Early data shows promising activity in PCNSL, with plans to expand into other NHL subtypes [10][13] - **Safety Profile**: - Treatment well tolerated with no dose-limiting myelosuppression observed [13][25] - **Regulatory Perspective**: - Increasing receptiveness from FDA and EMA towards Minimal Residual Disease (MRD) as a clinical endpoint [15] AML Insights - **Targeting FLT3 and IRAK4**: - Both are critical in AML, with emiflucertib showing potential to outperform current standards like gilteritinib [17][25] - Data indicates better outcomes in patients who have failed FLT3 inhibitors [25][27] - **Future Studies**: - Plans for a head-to-head registrational study against gilteritinib to establish emiflucertib as a best-in-class treatment for FLT3 AML [26][27] Solid Tumor Potential - **Research Expansion**: - Emiflucertib is being evaluated in five investigator-sponsored trials for solid tumors, with preliminary data expected soon [28] Financial Overview - **Funding**: - As of Q2, Curis has approximately $17 million in funding and a strong intellectual property position extending to 2035 [28] Conclusion - Curis is positioned to leverage its novel IRAK4 inhibitor, emiflucertib, to address significant unmet needs in the oncology market, particularly in NHL and AML, while also exploring opportunities in solid tumors [29][30]

Summary of Coya Therapeutics FY Conference Call Company Overview - **Company**: Coya Therapeutics (NasdaqCM: COYA) - **Focus**: Development of transformative therapies for patients suffering from neurodegenerative diseases such as ALS, frontotemporal dementia, Alzheimer's, and Parkinson's [2][3] Core Points and Arguments - **Vision and Mission**: Coya aims to make neurodegenerative diseases manageable, shifting the narrative from the disease to the patients' lives [3] - **Scientific Approach**: The company believes that neurodegenerative diseases are primarily neuroinflammatory and that addressing neuroinflammation can halt disease progression [5][6] - **Lead Program**: COIA-302, a combination of low-dose interleukin-2 and CTLA-4, is set to enter a pivotal Phase 2b study involving 120 ALS patients, with the first patient expected to be dosed in Q4 2025 [8][24] - **Clinical Trial Support**: Coya has partnered with the NILS Foundation, the largest ALS consortium, to facilitate faster recruitment for the trial [9] Clinical Data and Outcomes - **Current ALS Treatment Landscape**: Existing therapies show minimal efficacy, with patients declining by approximately 6 points in 6 months on the ALSFRS scale [14] - **Initial Study Results**: In a small investigator-initiated study, Coya observed stabilization or improvement in ALSFRS scores, contrasting with expected declines [16][17] - **Mechanistic Insights**: The combination therapy has shown to maintain Treg function and numbers, which are crucial for managing neuroinflammation [12][18] Future Plans and Partnerships - **Regulatory Pathway**: The primary endpoint for the Phase 2b trial is set for 6 months, with plans to approach the FDA for a BLA filing based on the data [23] - **Commercialization Partnership**: Coya has partnered with Dr. Reddy's Laboratories for the commercialization of COIA-302, which will alleviate some financial burdens associated with bringing the product to market [24][26] - **Funding and Cash Flow**: A $700 million partnership with Dr. Reddy's provides non-dilutive cash flow, enhancing Coya's financial position [26] Additional Indications - **Frontotemporal Dementia (FTD)**: Coya plans to file an IND for FTD this year, with a small randomized study expected to start in 2026, supported by a $5 million investment from the Alzheimer's Drug Discovery Foundation [29] - **COIA-303 Development**: A new product combining COIA-301 with GLP-1 weight loss drugs shows promise in reducing neuroinflammatory markers, with potential applications in Alzheimer's disease [30][31] Key Metrics and Milestones - **Upcoming Milestones**: - Dosing of the first ALS patient in 2025, triggering a $4.2 million payment from Dr. Reddy's [33] - Filing for FTD IND and additional data from ongoing trials expected by the end of 2025 [33] Conclusion - Coya Therapeutics is positioned to make significant advancements in the treatment of neurodegenerative diseases, with a strong scientific foundation, promising early clinical data, and strategic partnerships that enhance its operational and financial capabilities [34]

Summary of M&T Bank Corporation Conference Call Company Overview - **Company**: M&T Bank Corporation - **Industry**: Banking and Financial Services - **Geographic Presence**: Operates in 13 states plus the District of Columbia Key Points and Arguments Economic Outlook and Customer Sentiment - Customer sentiment has improved over the past six months, with increased comfort regarding tariffs and investments, although growth is still modest [2][4] - The new tax bill is expected to provide more security and contribute to economic growth, leading to increased loan growth [2] Strategic Direction - M&T Bank Corporation focuses on deepening its presence in existing markets rather than pursuing high-growth markets [3][4] - The strategy emphasizes serving customers and communities, aiming for density in the markets served [4][5] Financial Performance - The bank is on track for record earnings per share (EPS) this year despite softer net interest income [7][9] - Fee income has outperformed expectations, contributing significantly to overall revenue growth [9][26] Loan Growth Insights - Commercial and Industrial (C&I) loan growth is primarily driven by specialty businesses such as large corporate and fund banking [11] - The bank is optimistic about growth in middle markets as the year progresses [11][12] - Commercial Real Estate (CRE) lending is expected to grow, particularly in industrial, multifamily, and retail sectors, with a projected growth starting in Q4 2025 [13][14] Consumer Banking - Strong production in indirect auto, marine, and RV portfolios was noted, with a focus on home equity lending due to favorable mortgage rates [16] Deposit Strategy - The deposit beta has remained low at around 50%, with proactive rate cuts in anticipation of Federal Reserve actions [17][18] - The bank aims to maintain competitive rates to attract deposits without leading the market [17] Credit Quality - Charge-off guidance is set at less than 40 basis points, with a significant reduction in criticized loans from 12.5% to 7.5% [42][43] - Continued improvement in credit trends is expected, with a target of reducing criticized loans to under 6% [43] Capital Deployment - The bank increased its dividend by 11% to $1.50 per quarter, maintaining a payout ratio of around 33% [46] - Share repurchases have been significant, with over $1 billion in stock repurchased recently [45] Acquisition Strategy - M&T Bank Corporation is open to acquisitions, focusing on partnerships that enhance service to customers and communities [50][51] - The regulatory environment is seen as more favorable for acquisitions, with quicker approvals expected [56] Operational Efficiency - The bank is investing in technology and infrastructure to improve operational efficiency, including a new general ledger system and cloud-based applications [37][39] Market Positioning - M&T Bank Corporation differentiates itself by focusing on community engagement and local decision-making, contrasting with larger banks that prioritize digital-first strategies [58][59] Future Outlook - The bank anticipates continued growth in fee income and a positive trajectory in loan growth, with expectations for margins to improve in the coming year [21][26] Additional Important Insights - The bank's wealth management business is performing well, with a focus on cross-selling to business banking customers [30] - The management emphasizes a disciplined approach to acquisitions and operations, ensuring alignment with customer and shareholder interests [63][65]

Summary of Conference Call Company Overview - The conference call features First Advantage, with CEO Scott Staples and CFO Steven Marks discussing the company's performance and outlook in the employment services industry [1][2]. Industry Insights - The current job market is described as flat, with no significant peaks or valleys in hiring or layoffs. Clients are engaging in just-in-time hiring rather than growth hiring [3][4][5]. - Earnings for companies remain strong, leading to continued demand for products and services, which supports the flat job market outlook [5][6]. - International demand has shown growth, particularly in the healthcare sector, although some segments like hospital networks are sluggish due to funding uncertainties [9][10]. Financial Performance and Projections - Base growth is expected to be negative for the year, with a slight improvement anticipated in the second half, influenced by external factors such as tariffs and policy changes [13][14]. - Long-term targets for base growth are projected at 2-3%, with expectations of a neutral state in the next 18 months due to ongoing policy noise [17][18]. - International growth was reported at over 7% last quarter, indicating optimism for future performance [18]. AI and Technology Impact - AI is expected to create jobs in the short term as industries adapt, but certain sectors like BPO and IT services may face long-term impacts [21][22]. - First Advantage has implemented AI in customer care, resulting in a 30% reduction in headcount, with plans for further optimization [25][29]. - The company is focused on using AI to enhance quality and customer experience rather than immediate cost savings [30]. Growth Strategies - First Advantage aims for 4-5% growth from new logos, leveraging its strong brand and complementary verticals from the Sterling acquisition [38][39]. - Upsell and cross-sell opportunities are driven by increased demand for risk management and security in employment background checks, particularly in response to rising fraud concerns [54][56]. - The integration of digital identity solutions with I-9 processes is highlighted as a unique offering that addresses current market needs [62][63]. Capital Allocation and Future Plans - The company is focused on completing the integration of Sterling, achieving synergy targets, and deleveraging its balance sheet [64][65]. - First Advantage plans to maintain a conservative approach to M&A, prioritizing debt reduction over new acquisitions in the near term [69][70]. Key Metrics - Retention rate is a key performance indicator, with a target of over 96% [64]. - The company is currently free cash flow positive and has already prepaid $45 million of its debt [65]. This summary encapsulates the key points discussed during the conference call, providing insights into First Advantage's current position, industry dynamics, and strategic direction.

Summary of I-Mab Biopharma FY Conference Call Company Overview - **Company**: I-Mab Biopharma (NasdaqGM:IMAB) - **Industry**: Clinical-stage biotechnology focused on precision immuno-oncology therapies - **Key Assets**: Jeva Stomach, Raja Stomach, Uli Ledla Mab - **Financial Position**: $227 million in cash, providing runway through Q4 2028 [3] Core Points and Arguments - **Strategic Focus**: I-Mab has divested its China operations to concentrate solely on the U.S. market [2] - **Lead Asset - Jeva Stomach**: - Positioned as a best-in-class Claudin 18.2 therapeutic for front-line metastatic gastric cancer [4] - Ongoing phase one study combining Jeva with standard care (I/O plus chemotherapy) [5] - Plans to initiate a randomized phase two study in Q1 2026 [2][5] - **Market Opportunity**: Gastric cancer represents a $12 billion market opportunity, with high unmet medical need due to low five-year survival rates [9] - **Clinical Data**: - Objective Response Rate (ORR) of 18% in monotherapy with no dose-limiting toxicity [9] - Recruitment for gastric cancer trials is significantly higher than historical norms, indicating strong investigator interest [21] - ORR of 71% across the cohort in the phase one study, exceeding benchmarks from other treatments [22] - **Comparison with Competitors**: - Jeva Stomach has a lower eligibility threshold for Claudin 18.2 expression (1%) compared to Zolbetuximab (75%), potentially doubling the patient pool [11] - Jeva shows a better safety profile with lower rates of nausea and vomiting compared to Zolbetuximab [19][25] - **Future Development**: - Expansion into other tumor types such as biliary tract cancer and pancreatic cancer, with market opportunities of $6 billion and $3 billion respectively [26] - Plans for a large randomized phase two study with 180 patients [26] Important but Overlooked Content - **Toxicity Profile**: Jeva Stomach has a favorable toxicity profile compared to competitors, with only 33% of patients experiencing grade three or above treatment-related adverse events [19] - **Durability of Response**: Responses to Jeva Stomach are rapid, deepen over time, and show durability, with some patients remaining progression-free beyond a year [23] - **Intellectual Property**: Strong intellectual property protection is in place for Jeva Stomach, enhancing its competitive position [27] - **Competitive Landscape**: The competitive landscape includes several Claudin 18.2 assets, with Zolbetuximab being the leading competitor, but I-Mab's unique positioning may provide an advantage in front-line settings [30]

Summary of Avadel Pharmaceuticals FY Conference Call Company Overview - **Company**: Avadel Pharmaceuticals (NasdaqGM: AVDL) - **Product**: LUMRYZ, an extended-release oxybate for narcolepsy treatment Key Points Industry and Product Insights - LUMRYZ utilizes an innovative extended-release delivery technology allowing for once-at-bedtime dosing, aligning with patients' natural sleep cycles, which enhances therapeutic efficacy and promotes uninterrupted sleep [1] - The product has gained traction with a concentrated writer base, with 1,600 healthcare providers (HCPs) accounting for approximately 80% of overall oxybate volume [1] - The adoption of LUMRYZ has shown a persistent pattern of growth, particularly among new writer cohorts who are transitioning patients from older treatments to LUMRYZ [2][3] Growth Drivers - The company is expanding its sales force to maintain focus on high-volume writers while also onboarding new writers, which is crucial for driving growth momentum [4] - A strong emphasis is placed on the fulfillment process, ensuring that healthcare providers can efficiently initiate therapy and manage patient compliance [5] - There is a notable increase in patient requests for LUMRYZ, indicating a highly engaged patient community and effective direct-to-patient marketing efforts [6] Market Potential - The demand for LUMRYZ is expected to be driven by both patients previously on oxybate therapy and treatment-naive patients, reflecting a broad growth potential [8] - Physicians are increasingly recognizing the benefits of LUMRYZ, leading to a shift in prescribing patterns towards this product as the preferred oxybate option [9] Financial Performance - In the first half of 2025, Avadel Pharmaceuticals added 600 patients on therapy, achieving profitability with positive cash flow, operating income, and net income [15] - The company has provided revenue guidance of $265 to $275 million for the year, with confidence in achieving this target [17] Future Developments - LUMRYZ is currently in pivotal development for idiopathic hypersomnia, with an estimated market opportunity of around 40,000 patients [20] - The company anticipates completing enrollment for the REVITALYZ study by the end of 2025, with top-line data expected by mid-2026 and a potential NDA filing in the second half of 2026 [23] - Avadel has licensed VeloLoxibate, an extended-release oxybate, which is expected to complement LUMRYZ and expand treatment options for patients [24][25] Strategic Focus - The company is committed to maximizing the potential of LUMRYZ and VeloLoxibate while exploring additional business development opportunities in the sleep disorder space and beyond [36][40] - Future indications for oxybate use are being evaluated, including potential applications in Parkinson's disease [31] Conclusion - Avadel Pharmaceuticals is positioned for significant growth with a strong product pipeline, ongoing clinical trials, and a focus on expanding its market presence in the oxybate space [41]

Summary of the Conference Call Company and Industry Overview - The conference is part of the 23rd annual Morgan Stanley Healthcare Conference, focusing on the healthcare industry and innovations in home-based care [2][3] - The company discussed is DocGo, a medical transportation and mobile health provider, which has been innovating in the medical transportation space for over 10 years [4][5] Key Points and Arguments Mobile Health Growth - DocGo has seen significant growth in the mobile health segment, particularly in coordinating care for high-utilizing members through partnerships with insurance companies [4][5] - The company has expanded its reach from serving 2,000 patients to nearly a million patients across the New York tri-state area and California [6][8] - On average, DocGo closes almost two care gaps per home visit, with some visits closing up to six gaps [6][8] Technology Integration - The tech stack developed by DocGo is crucial for efficient home-based medical care, allowing licensed practical nurses (LPNs) and medical assistants to provide care under the direction of primary care providers [10][11] - Integration with electronic health record (EHR) systems like Epic enhances coordination and efficiency in patient care [11] Revenue and Contract Stability - DocGo's contracts in the transportation segment typically last three to five years and are described as "sticky," indicating high customer retention [13][14] - The company is transitioning from episodic contracts with municipal governments to more sustainable, population health-focused contracts with payers [15] Labor and Inflation Management - Staffing is a significant challenge, with 800 open roles to fill, but the company maintains a strong reputation as a desirable workplace [16][18] - Inflationary pressures are minimal, with fuel costs decreasing and existing vehicles owned or procured under favorable terms [17] Payer Opportunities - DocGo works primarily with managed care, Medicaid, and Medicare Advantage plans, focusing on the dual special needs population, which shows higher engagement rates [20][21] - The company aims to keep patients out of hospitals, aligning with value-based care models that incentivize health plans to manage costs effectively [23][24] M&A Strategy - DocGo is looking for M&A opportunities that add capabilities or expand geographic reach, particularly in underserved areas [26][27] - The medical transportation market is estimated at $10 billion, with DocGo currently capturing around $225 million, indicating significant growth potential [49] Capital Allocation - The company prioritizes organic growth, staff training, and M&A opportunities while maintaining a strong balance sheet with over $100 million in cash [30][32][33] Market Expansion - DocGo expands into new markets based on demand from existing customers, ensuring they have anchor clients before entering new regions [37][38] Go-to-Market Strategy - The sales cycle for new customers can range from 6 to 18 months, with existing customers typically resulting in faster expansions [42][43] Telehealth Perspective - While telehealth is recognized as a valuable service, DocGo emphasizes the necessity of in-person care for certain medical needs, positioning itself uniquely in the market [54][56] Other Important Insights - The company has a high Net Promoter Score of over 90, indicating strong patient satisfaction [47][48] - The medical transportation segment is increasingly recognized as vital for patient flow management within hospital systems [51][52]

Tandem Diabetes Care Conference Call Summary Company Overview - **Company**: Tandem Diabetes Care (NasdaqGM:TNDM) - **Date**: September 10, 2025 - **Speakers**: CEO John Sheridan, CFO Leigh Vosseller Key Points Industry and Market Dynamics - Tandem Diabetes Care is undergoing a transformation aimed at driving double-digit growth and profitability starting next year and beyond [2][5] - The company is focusing on a multi-channel access strategy, particularly expanding into the pharmacy channel, which offers lower out-of-pocket costs for patients and easier prescription processes for physicians [2][3] - The type 2 diabetes market presents a significant opportunity, potentially doubling the available market in the U.S. with approximately 2.3 million people requiring insulin-intensive treatment [12][13] Financial Performance and Strategy - Approximately 30% of U.S. lives are currently covered under pharmacy contracts, with expectations to increase coverage significantly in the next two to three years [7][11] - The company aims for a gross margin of 60% by the end of 2026, with a focus on improving profitability through increased supply sales and reduced manufacturing costs [28][22][25] - Recurring revenue from supply sales and renewals is becoming a larger part of the revenue base, providing predictability and driving growth [22][23] Product Pipeline and Innovations - Tandem has an exciting product pipeline, including the Tandem Mobi system and upcoming Tubeless Mobi system, which are designed to meet diverse patient needs [5][42][44] - The SteadySet infusion set, which allows for extended wear of up to seven days, has received FDA approval and is expected to enhance the customer experience [46] - Control-IQ technology continues to be a competitive advantage, with recent improvements aimed at simplifying user interaction and enhancing diabetes management [49][50] Competitive Landscape - The diabetes management market is becoming increasingly competitive, with new entrants expected to create turbulence. However, Tandem believes that competition drives innovation and benefits patients [17][20] - The company is prepared to leverage its superior algorithm and product offerings to capture market share, particularly in the underpenetrated type 2 diabetes segment [15][48] International Expansion - Tandem plans to expand its direct sales operations in certain international markets starting January 1, 2026, aiming to improve sales effectiveness and capture more market share [3][34][36] - The company operates in about 25 countries outside the U.S., with significant growth potential due to low penetration rates [39][41] Operational Improvements - The company is focused on enhancing operational efficiency through automation and improved sales processes, which are expected to contribute to margin improvements [26][30] - Recent expansions in the commercial team are aimed at increasing productivity and effectiveness in the sales organization [3][32] Conclusion - Tandem Diabetes Care is positioned for significant growth through strategic expansion into the pharmacy channel, innovative product offerings, and operational efficiencies. The company is optimistic about its future prospects in both the U.S. and international markets, particularly in the type 2 diabetes segment.