Madrigal Pharmaceuticals : ESG Fact Sheet 200.3 KB

Published: 2025-05-14 16:53:13 ET MDGL

Published on 05/14/2025 at 16:53

Last Updated: May 14, 2025

Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease with high unmet medical need that can lead to cirrhosis, liver failure and premature mortality. Madrigal's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by the FDA for the treatment of MASH with moderate to advanced fibrosis (consistent with stages F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (consistent with stage F4c). For more information, please visit https://www.madrigalpharma.com. The purpose of this document is to help our stakeholders better understand our commitment to key ESG areas. We will continue to be transparent in our commitment to corporate responsibility.

Our Core Values define the behaviors we expect from each other as team members and set the standard for how we engage with our external partners and stakeholders. These values emerged

from feedback we have heard from employees of our organization, as well as extensive discussion with our leadership team. We want our Core Values to uphold principles that are already a strong part of our culture, while defining new aspirational values to help us continue to grow and evolve as the leader in MASH. Madrigal employees' professional growth is aligned with our corporate goals to ensure a culture of compliance and integrity.

Madrigal is committed to the essential principles of good corporate conduct and integrity in all our activities as we focus on delivering novel therapeutics for patients. As part of our ongoing commitment to ethics and compliance, Madrigal conducts regular compliance risk assessments to ensure that our Compliance Program addresses appropriate risks. We designed and

implemented a Compliance Program based on the guidance set forth by the Pharmaceutical Research and Manufacturers of America (PhRMA Code), Office of Inspector General, U.S.

Department of Health and Human Services (OIG), which outlines the seven key elements of an

effective compliance program. Madrigal has developed and implemented an effective Compliance Program, and we will continually work to evolve our Compliance Program and all compliance-related activities to adapt to the dynamic regulatory landscape and our Company's continued growth.

Our Code of Conductserves as the foundation for the expected ethical behaviors and compliance standards to guide our daily operations. The Code applies to all employees, full-time and part-time, including temporary workers, and officers and directors of Madrigal. Key topics of our Code of Conduct include anti-discrimination and anti-harassment, employee health and safety, scientific integrity, fraud prevention, anti-bribery and anti-corruption, confidentiality and privacy, marketing promotion, distribution, and sales of our products, public disclosure, conflicts of interest, insider trading, grants and other third-party support, and government interaction.

Madrigal personnel must certify that they have read and agree to abide by the Code of Conduct, including the key ethical principles and standards to help ensure compliance with applicable industry laws and Madrigal policies. In addition to our Code of Conduct, Madrigal has developed and implemented policies, standard operating procedures and other guidance to address potential risk areas, including those identified by the OIG. Madrigal personnel must regularly certify that they have read and agree to abide by compliance-related policies, procedures, and other guidance, as applicable to their role.

Madrigal's Compliance Program includes compliance-related monitoring and auditing functions to help evaluate ongoing compliance with applicable policies and procedures. The Compliance Team handles assessing, evaluating, monitoring and auditing identified risk areas on an ongoing basis to ensure the Compliance Program is operating effectively. New legal requirements, business developments and similar considerations may require new or revised compliance-related monitoring and auditing activities.

Our Compliance Committee, led by our Chief Legal Officer, presents any relevant findings to our executive leadership team on a quarterly basis. Our Chief Legal Officer also provides compliance updates to our Audit Committee at regularly scheduled committee meetings.

Madrigal takes risk oversight very seriously; our Board committees support key oversight of various risks and provide oversight to our management team. Set forth below are the charters for the

standing committees of our Board:

Nominating and Governance Committee

Audit Committee

Compensation Committee

Science and Technology Committee

Madrigal implements a framework that embeds quality management as an end-to-end organizational priority. The framework is based on industry recognized quality management principles and is regularly monitored. Our policies are clear and effectively communicate

pathways that can be activated should there be any concerns about quality and safety. We adhere to GxP (Good Practice Quality Guidelines and Regulations) and only use vendors that are qualified against the same respective standards. The link to our quality policy can be found here.

Our clinical trials are designed and executed with patient safety at the forefront. We continuously monitor and evaluate all relevant safety and quality information pertinent to clinical trial participants and the sites. To ensure robust clinical trial safety, our focus spans many areas including (but not limited to) ethical trial design, comprehensive review by Institutional Review Boards (IRBs), appropriate documentation of informed consent, regular data monitoring committee (DMC) meetings and transparent reporting.

Ethical Trial Design: Madrigal conducts clinical studies in accordance with applicable laws, regulations and international standards. This ensures that trials are ethically sound and prioritizes participant well-being.

Comprehensive Protocols: Madrigal develops detailed clinical trial protocols that are rigorously reviewed and approved by IRBs (Institutional Review Boards). Study design, methodology and statistical analyses are thoroughly analyzed.

Informed Consent: Madrigal provides clinical trial participants with comprehensive information about its studies, including the potential risks and benefits. This educates participants and enables them to make informed decisions about their involvement.

Data Monitoring Committee (DMC): Our DMC meets quarterly and oversees patient safety which is of paramount importance to us. They ensure the ongoing evaluation of trial participants and have the authority to recommend modifications or termination of studies based on their assessments.

Transparent Reporting: Madrigal is committed to transparent reporting of clinical trial results, including adverse events to both regulatory authorities and the public.

Madrigal is committed to designing studies and investigative sites that appropriately reflect the diverse populations we serve. We have implemented measures to improve clinical trial diversity for our ongoing studies, and our enrollment processes are geared to help drive inclusion and access across our clinical trial sites. Our principal investigators represent a diverse group of physician scientists who are experts in the field and committed to medical innovation. Since we know MASH is more prevalent in the Hispanic population, many of our trial participants and sites are in parts of the country that appropriately reflect this. Our trial sites are diverse and include both community centers, as well as large academic centers across the country.

Due to the strategic importance of CMOs (Contract Manufacturing Organizations) and CROs (Contract Research Organizations), Madrigal has dedicated policies in place to effectively identify and mitigate risk. Madrigal Quality Assurance qualifies our CMOs and CROs and ensures the respective product safety and quality standards are met. Re-qualification occurs on a biannual basis, or earlier if needed.

Customers depend on us for accurate and balanced information about the efficacy and safety of our product(s). Madrigal has designed and implemented a Compliance Program based on the guidance set forth by the Pharmaceutical Research and Manufacturers of America (PhRMA) Code, Office of Inspector General and the U.S. Department of Health and Human Services. Our code (Ethics and Compliance) reflects our commitment to comply with applicable laws, rules and regulations reiterating the following:

Familiarity with biopharmaceutical industry laws and regulations as well as Company policies applicable to one's role.

Expectations of integrity and accountability in business dealings and obligations.

Avenues for reporting noncompliant or unethical conduct.

Prohibition of the use of favors, gifts or other inducements to generate or reward business.

Commitment to building and fostering an inclusive culture and environment.

Additionally, all new hires are required to complete a series of compliance modules. One of these modules is a U.S. Healthcare Compliance Overview which includes an overview of the regulatory environment, including the PhRMA Code. The other module, Interactions with Healthcare Professionals, also focuses on the PhRMA Code.

Madrigal practices responsible marketing related to how we promote, market, and educate patients and health-care providers with accurate and well-balanced scientific information. We ensure that promotional communications about our products are consistent with the approved labels, and we do not promote our products for unapproved uses.

Our promotional materials must meet the requirements of all applicable local laws, regulations and industry codes including the PhRMA Code on Interactions with Healthcare Professionals. Our Promotional and Non-Promotional Medical Interactions policies guide our responses to questions on products prior to approval. To ensure activities are conducted appropriately, field employees who engage in promotional interactions with customers receive training covering applicable laws, regulations and industry codes. Certain contractors are also provided with training to the extent that their role requires it. Training is done at the time of hire.

Madrigal is an Equal Opportunity Employer; all employment decisions are based on qualifications, merit and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status or other characteristics protected by applicable federal, state or local law.

Madrigal is focused on creating a collaborative and supportive environment for its employees by paying special attention to health and wellness in the workplace. The culture at Madrigal is built on our core values. These values were developed with input from employees across every level of our organization. They drive our behaviors and keep us grounded in our focus with the intent of rewarding integrity, hard work and innovation while supporting professional growth.

We focus on ensuring that each of our employees feels connected to our purpose and most importantly supported by their colleagues.

In 2025, we plan to conduct regular employee engagement surveys that will help us gauge

the following areas:

Ensure managers provide clear goals, consistent regular feedback and recognition for achievements using our model of continuous feedback and goal setting aligned by function to the corporate goals.

Encourage open dialogue and feedback to foster a sense of belonging and inclusion.

Regularly monitor workload to prevent burnout and ensure a healthy work environment.

Madrigal encourages employees to work with their managers on an individual development plan aimed at building their strengths to support long-term career aspirations and goals. The development program focuses on empowering employees in their roles, while promoting a greater sense of purpose. Employees are also expected to set objectives aligned with Madrigal's corporate goals, which are entered into a development plan in Workday. Finalized development plans, including key goals, are reviewed and approved by the employee's manager.

Our performance management process ensures managers provide regular feedback to assist in the success and development of their employees; managers give continuous feedback throughout the year to drive peak performance.

As the Company's infrastructure evolves to support growth, employees will naturally have the opportunity to develop new skills through various internal projects and peer mentoring. Employees are encouraged to participate in these opportunities aimed at building their individual strengths in support of their long-term career aspirations and goals. In 2025 we will formulate our Talent Development / Talent Management Strategy to build capabilities based on skills that are aligned with our job architecture framework.

Madrigal total rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands.

Full-time employees are eligible for bonus, equity and comprehensive benefits including flexible paid time off (PTO), medical, dental, vision and life/disability insurance. We also offer Voluntary benefits like life insurance, pre-paid legal and supplemental insurance. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family.

Reinforcing personal wellness, flexibility and work-life balance has been central to our philosophy of human capital management. As a result, our employee turnover is trending below industry average.

Disclaimer

Madrigal Pharmaceuticals Inc. published this content on May 14, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 14, 2025 at 20:52 UTC.