ESG at Mirum

At Mirum, we are committed to putting the needs of the patient first. This commitment guides our efforts to develop and deliver safe, effective and impactful therapies for patients living with rare diseases. Strong governance structures are crucial to fulfill this mission and deliver value for our stakeholders and we have integrated environmental, social, and governance (ESG) principles and practices across our business to ensure continued transparency and accountability.

In formalizing our approach to ESG at Mirum, we identified and prioritized the ESG topics most relevant to our business and engaged a cross-functional group of experts to guide our efforts. We were also guided by peer benchmarking, stakeholder feedback, and industry best-practices, including the Sustainability Accounting Standards Board (SASB) standard for the Biotechnology and Pharmaceuticals industry.

Our Board of Directors is deeply engaged and involved in overseeing our long-term strategy, including our ESG initiatives. In 2024, we assigned oversight responsibility for ESG matters to our Nominating and Corporate Governance Committee.

For more information on our governance practices, please refer to our proxy statement as well as our Board committee charters:

AUDIT COMMITTEE CHARTER

COMPENSATION COMMITTEE CHARTER

NOMINATING AND CORPORATE GOVERNANCE COMMITTEE CHARTER

Addressing Rare Diseases

Mirum is committed to transforming the treatment of rare diseases by putting the needs of patients first. We are an established leader in the development and commercialization of life changing medicines for rare and orphan diseases where the unmet medical need is high. Our desire to fill a therapeutic void for people with rare diseases drives our passion for science and continued clinical evaluation of investigational therapies.

LIVMARLI

Our first commercial product, LIVMARLI (maralixibat) is an orally administered, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for two pediatric cholestatic liver diseases. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) in the U.S. three months of age and older and in Europe for patients two months of age and older. It is also approved in the U.S. for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) 12 months of age and older and in Europe for the treatment of PFIC in patients three months of age and older.

ALGS is a rare genetic disorder of severe cholestasis where bile ducts abnormally narrow and malform, leading to bile accumulation in the liver and ultimately progressive liver disease. In patients with ALGS, multiple organ systems may be affected by the mutation, including the liver, heart, kidneys and central nervous system. The high levels of bile acid buildup in patients with ALGS is an underlying cause of cholestatic pruritus (itch), which affects 88% of people with the syndrome and is considered the most burdensome symptom. In children with cholestasis due to ALGS, it is estimated that six in ten children progress to transplant or death by adulthood. We believe the prevalent patient population for ALGS in the United States and Europe is approximately 4,000 - 5,500 pediatric patients. ALGS is estimated to impact one out of every 30,000 births globally.

Cholestatic pruritus also occurs in patients with PFIC, a rare genetic disorder caused by defects in genes that produce proteins needed to form bile and transport it out of the liver. In children, PFIC represents 10% to 15% of indications for liver transplant, either due to intractable pruritus or end-stage liver disease. The prevalent patient population for PFIC is approximately 1,000.

CHOLBAM

The FDA approved CHOLBAM (cholic acid) capsules in March 2015, as the first FDA-approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects and for adjunctive treatment of patients with peroxisomal disorders, including PBD-ZSD and SLOS. Bile acid synthesis disorders (BASD) due to single enzyme defects are a rare group of inherited genetic disorders caused by defects in the enzymes that make bile acids. These defects interfere with normal production of bile acids. As a result, bile cannot flow from the liver to the small intestine, a condition called cholestasis that presents as prolonged jaundice in newborns. The effectiveness of CHOLBAM has been demonstrated in clinical trials for bile acid synthesis disorders and the adjunctive treatment of peroxisomal disorders.

CHENODAL

CHENODAL (chenodiol) is a naturally occurring bile acid that is approved for the treatment of people with radiolucent stones in the gallbladder. While indicated for radiolucent stones in the gallbladder, CHENODAL has received medical necessity recognition by the FDA for the treatment of cerebrotendinous xanthomatosis (CTX), and is the standard of care for CTX, although it is not currently labeled or promoted for this indication. CTX is a rare, progressive and underdiagnosed bile acid synthesis disorder affecting many parts of the body. We estimate there are 1,000 - 2,000 prevalent CTX patients in the United States, however only 10% are currently diagnosed. We submitted an NDA for the treatment of CTX to the FDA in the first half of 2024.

Patient Assistance

The Mirum Access Plus (MAP) program helps patients and families navigate the treatment journey for all three of our medicines – LIVMARLI, CHOLBAM, and CHENODAL. Through this program, MAP experts support patients by explaining the process of getting medication, working with dedicated healthcare teams to figure out insurance coverage and eligibility for financial support programs, and providing education and resources to help patients start and stay on therapy. Mirum is committed to finding access solutions to support appropriate patients in need of our products. CHOLBAM, CHENODAL and LIVMARLI all have reimbursable pathways with most payers.

In addition, Mirum has an expanded access program open across multiple countries for eligible patients with ALGS and PFIC.

Development Pipeline

Our late-stage pipeline includes three investigational treatments for debilitating liver diseases. LIVMARLI is currently being evaluated in the Phase 3 EXPAND study in additional settings of cholestatic pruritus. Volixibat, an IBAT inhibitor, is being evaluated in two potentially registrational studies including the Phase 2b VISTAS study for primary sclerosing cholangitis and Phase 2b VANTAGE study for primary biliary cholangitis. Lastly, chenodiol, has been evaluated in a Phase 3 clinical study, RESTORE, to treat patients with CTX, with positive topline results reported in 2023. Mirum has submitted a new drug application with the FDA for the approval of chenodiol to treat CTX in the U.S.

People

At Mirum, we provide our employees with the opportunity to develop and deliver medicines that can potentially change and save lives for our patient communities. This mission transforms our work into more than just a job. We strive to nurture a work environment where our purpose and values can be shared and where people have a voice, create and collaborate, and have meaningful personal and professional experiences. Our employees are inspired every day to go to incredible lengths to make a positive difference for people living with rare diseases.

Talent Attraction and Retention

From early-stage research and clinical trial management to commercialization, our employees’ expertise covers a wide range of disciplines within rare disease and pharmaceutical drug development. Our approach to hiring talent at Mirum is one that is strategic, inclusive, and tailored to the needs of our organization. To secure, keep and develop talent, we have implemented practices that promote a diverse work culture.

We simplified the recruiting process to minimize barriers and developed a screening process to assess candidates’ skills and cultural fit. During the interview process, we showcase initiatives and programs that emphasize a diverse and inclusive environment, and we highlight opportunities for career growth and professional development. We utilize multiple sources to recruit talent globally, including online job boards, social media, and websites, and have established a large employee referral network as well as professional networking platforms.

Mirum has consistently experienced lower turnover rates compared to the industry average across all levels, including executives and senior managers, mid-level managers, and professionals.

Compensation and Benefits

We care about our employees’ physical and financial wellness and value work-life blend. We offer a competitive salary and benefits package and consider flexible work arrangements.

Our general benefits package includes:

  • Paid Parental Leave
  • Medical, Dental, and Vision Insurance with 100% Company Paid Premium
  • Basic Life Insurance & AD&D
  • Short-Term & Long-Term Disability Insurance
  • 401(k) Retirement Plan with 4% employer match
  • Pre-Tax Commuter Benefits
  • Employee Assistance Program (EAP)
  • Supplemental Health Insurance
  • 11 Paid Company Holidays, as well as a 5-Day shutdown during December
  • 4 Weeks of Accrued Vacation Time per Year

We also provide additional offerings focused on career development and financial wellness, including:

  • Mirum Employee Stock Purchase Plan (ESPP): Employees are eligible to purchase Mirum stock at a discount
  • Tuition Reimbursement for certain continuing education, programs, and/or in an area related to their current position and/or career development
  • Mobile Phone and Internet Reimbursement

Employee Engagement

We seek to make all of our employees feel welcomed and valued. Our most recent employee engagement survey revealed three strengths that showcase the positive sentiment among our workforce:

  • Purposeful Work: A significant number of employees emphasized the meaningfulness of their work, noting that they strongly believe in our organization's purpose and its impact on improving the lives of patients. This underscores a shared commitment to our mission, contributing to a sense of fulfillment among our team.
  • Warm Onboarding Experience: Employees consistently reported feeling welcomed when they joined our organization. This positive onboarding experience sets the tone for their tenure, fostering a sense of belonging and laying the groundwork for long-term engagement.
  • Impactful Contributions: A notable portion of respondents expressed satisfaction with the perceived impact of their work on improving lives. This indicates a strong connection between individual roles and the broader mission of our organization, reinforcing a sense of purpose and accomplishment among our employees.

We are proud of these strengths and remain committed to further enhancements through continuously listening to and addressing the needs and feedback of our valued employees.

2023 Global Engagement Survey

>90%
would recommend Mirum as a great place to work, are proud to work here, and felt welcome when they joined

Career Development and Training

At Mirum, we are dedicated to enabling continuous professional development and supporting career advancement for our employees.

Our offerings include:

  • Tailored Manager Workshops: In-person and virtual sessions covering leadership skills, effective communication, and team management.
  • HR Coaching: The HR department offers individual coaching sessions on a case-by-case basis. This personalized approach ensures that employees receive guidance and support tailored to their unique career goals and challenges.
  • Internal Hiring and Lateral Transfers: We actively focus on internal hiring and facilitate lateral transfers to enable employees to explore new roles and learn additional skills. This approach not only supports career advancement but also contributes to the overall growth and diversification of our workforce.
  • Competency Ladders for People Managers: We launched career advancement frameworks that outline clear paths to progression for aspiring people managers, defining the skills and competencies required at each level.
  • LinkedIn Learning: Our employees have access to a wide range of online courses and resources through LinkedIn Learning, allowing them to enhance their skills and knowledge at their own pace.

These offerings are part of our commitment to creating a dynamic and supportive work environment, where employees can continuously develop their skills, pursue career growth opportunities, and achieve their professional aspirations.

Diversity and Inclusion

We strive toward having a diverse team of employees and are committed to diversity, equity, and inclusion (DEI) in the workplace. As part of this commitment, we have established a Culture Team that includes employees across a representative cross-section of departments in both the U.S. and our international offices. Our Culture Team engages in continual discussions across the various business functions to identify potential actions to address areas of improvement and is focused on building accountability across the organization to ensure we meet our diversity objectives.

In our most recent engagement survey, employees expressed satisfaction with our commitment to DEI, reflecting the success of our ongoing dedication to creating an environment where everyone feels valued and included. Moreover, we regularly evaluate our compensation practices with an external firm to promote pay equity across our workforce as part of this commitment. We aim to continually enhance our initiatives to meet the evolving needs and interests of our diverse workforce.

Mirum’s 2023 EEO-1 Employee Diversity Statistics

262
full time employees as of December 31, 2023

Gender

2023 Executives/ Senior Managers Midlevel Managers Professionals Grand Total
Female 51% 66% 58% 62%
Male 49% 34% 42% 38%
Grand Total 100% 100% 100% 100%

Ethnicity

2023 Executives/ Senior Managers Mid-level Managers Professionals Grand Total
All other ethnicities 0% 7% 0% 4%
Asian 27% 46% 3% 35%
Black or African American 2% 8% 3% 6%
Hispanic or Latino 0% 3% 13% 4%
White 71% 36% 81% 51%
Grand Total 100% 100% 100% 100%

Community Engagement

We actively engage with the communities in which we operate. Our employees participate in hands-on volunteering events, such as Earth Day beach-clean ups and Little Free Library build events. These initiatives not only contribute to a positive company culture but also emphasize our commitment to social responsibility and community involvement.

Anti-Harassment Policy

We strictly prohibit unlawful discrimination and harassment in all its forms and strive to maintain a safe, respectful work environment for all our employees. We conduct comprehensive sexual harassment prevention training for all our U.S. employees, ensuring full compliance with local legislation.

Product Quality and Safety

The quality of our medicinal products is our highest priority. We are committed to meeting all relevant quality standards as we pursue the development of novel therapeutic strategies. It is the responsibility of all Mirum employees and relevant third parties to comply with our quality requirements while maintaining the highest ethical standards in an atmosphere of continuous improvement and innovation.

We do not own or operate manufacturing facilities to produce our approved medicines or any product candidates. We currently depend on third-party contract organizations to manage the manufacturing, testing, packaging, and distribution of our products. We also outsource clinical trial management activities to clinical research organizations (CROs). Utilizing third party vendors allows us to source high quality expert providers for the unique need each product and study has.

Nevertheless, we are responsible for ensuring that all our manufacturing and clinical trial activities are conducted in accordance with applicable legal, regulatory, and scientific standards. Our reliance on third parties does not relieve us of our regulatory responsibilities and we are ultimately responsible for ensuring compliance with requirements such as current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and Good Pharmacovigilance Practices (GVP).

As part of our Quality Management System (QMS), we have implemented a robust vendor qualification and management program to assess and qualify contracted organizations. This program includes the following processes and activities:

  • Quality oversight to ensure vendors comply with applicable regulatory requirements, including QMS evaluations through audits and other assessment tools
  • Competency assessments to verify that vendors can carry out the activity or provide purchased materials
  • Change management procedures to review and approve vendor changes before they are enacted
  • Continuous monitoring of the performance of vendors, contract organizations, and the quality of purchased materials
  • Batch record reviews for product disposition

To date, we have not experienced any product recalls or enforcement actions in violation of cGMP. We also have not had any inspections that have resulted in entity voluntary remediation or regulatory or administrative actions taken against Mirum or its CROs.

Supply Chain Management

We are committed to ensuring that our supply chain reflects Mirum’s values and respect for human rights and the environment. Our relationships with suppliers are based on lawful, efficient, and fair practices and we require suppliers by contract to comply with all applicable laws and regulations. We have also implemented a Supplier Code of Conduct to communicate our expectations regarding ethics, labor, and quality to suppliers. For more information, please refer to our California Transparency in Supply Chains Act Disclosure statement.

We maintain traceability of all products in our supply chain and have instituted technologies to our container closure systems to prevent counterfeiting. We also apply serial numbers to enable product traceability at the carton level.

Critical Materials

As our approved medicines are intended to treat rare diseases, we only require a low-volume of raw materials and APIs from suppliers and manufacturers, who in some cases are single-sources for these materials. To ensure security of supply, we select our suppliers based on criteria such as country risk, material risk, supplier risk, and their strategic importance to the business. We maintain long-term supply agreements with our commercial manufacturers, and we maintain sufficient stocks of our drug substances and drug products to ensure business continuity in the event of a production disruption.

Data Security and Privacy

As part of our overall risk management processes, we have implemented various information technology (IT) safeguards to protect and secure our networks and data. The Audit Committee of our Board of Directors is responsible for overseeing cybersecurity-related risks, while the Senior Director of IT and Information Security is responsible for managing our cybersecurity program and providing reports to the committee about significant cybersecurity threats.

The IT team has put in place incident management protocols to mitigate any potential security breaches, such as multi-factor authentication and disaster recovery software. Moreover, we conduct quarterly cybersecurity training for all our employees, including ongoing, random phishing simulation tests and interactive training sessions. We also maintain a cybersecurity risk insurance policy to protect against potential losses from cybersecurity incidents. To date and to our knowledge, we have not identified any cybersecurity incidents or data breaches.

We take a number of organizational, technical, and physical measures to protect protected health information (PHI) and personally identifiable information (PII). We have established policies and procedures to manage PHI as required by the HIPAA and HITECH Acts. For example, our data governance policy is designed to train relevant employees how to properly manage PHI and PII, and use the principle of least privilege to determine whether employees are allowed access to personal information. For more information, please refer to our Privacy Policy.

Environmental Sustainability

Mirum is committed to ensuring that we operate responsibly with respect to the environment. We comply with all applicable laws and regulations related to the environment and are actively taking steps to quantify and address our environmental impact.

We conduct our corporate operations out of our headquarters in Foster City, which is a LEED Gold certified leased facility. Our facilities have several energy efficiency features, including LED and motion activated lights as well as EV charging stations. We also aim to minimize our water usage by using low-running faucets, leak detectors, and auto shut-off valves.

Waste

We are committed to responsible waste management and strive to recycle a majority of the waste generated at our facilities. We do not produce any hazardous or medical waste on site.

Percentage of Waste 2023
i) incinerated 0%
ii) recycled or treated, and 70%
iii) landfilled 30%

Product Takeback

We participate in a drug take-back program that provides us with DEA-compliant prescription drug take-back receptacles that patients use to simply and safely dispose of surplus and expired medications. Our patients are currently covered in Washington, Maine, New York, Illinois, California, and Oregon through this program.