ProPhase Labs, Inc.
Climate Impact & Sustainability Data (2018-06-30, 2022)
Reporting Period: 2018-06-30
Environmental Metrics
Climate Goals & Targets
Environmental Challenges
- Income tax accounting errors requiring restatement of consolidated financial statements for fiscal year ended December 31, 2017, fiscal quarters within that year, and the fiscal quarter ended March 31, 2018.
Mitigation Strategies
- Restatement of financial statements.
Supply Chain Management
Climate-Related Risks & Opportunities
Reporting Period: 2022
Environmental Metrics
Social Achievements
- Developed a comprehensive, cohesive and positive company culture and employee experience.
- Provided employees and their families with access to a variety of flexible and convenient health and wellness programs, health reimbursement accounts and retirement savings plan
Climate Goals & Targets
Medium-term Goals:
- Pursue initial commercialization of the BE-Smart test as an LDT (Laboratory Developed Test) and RUO (Research Use Only) for the third quarter of 2023 with full commercialization backed by insurance expected by mid-2024.
- Aim to submit IND application for LB-1 in mid-2024.
Short-term Goals:
- Anticipate trial completion for Equivir in the third quarter of 2023 and anticipate launching Equivir (dietary supplement) in the United States toward the end of 2023.
Environmental Challenges
- Disruptions to our supply chain or increases in the price of testing supplies, equipment and raw materials needed for our businesses.
- Adulteration of key testing materials and raw materials needed for our businesses.
- Product liability claims.
- Need for additional capital to support our businesses.
- System failures, security breaches or cyberattacks.
- Dependence on key personnel.
- Fluctuations in COVID-19 testing demand.
- Seasonal fluctuations in personal genomics kit sales and contract manufacturing revenues.
- Disruptions at our PMI manufacturing facilities or any loss of manufacturing certifications.
- Extensive governmental regulation of contract manufacturing and dietary supplement businesses.
- Potential for unsuccessful product development and commercialization efforts.
- Potential for undesirable side effects from products.
- Challenges in commercializing product candidates.
- Delays or difficulties enrolling patients in clinical trials.
- High cost and uncertainty of clinical trials.
- Potential for inadequate demonstration of safety and efficacy of product candidates.
- Potential for serious adverse events or undesirable side effects from product candidates.
- Potential for failure to obtain regulatory approvals.
- Potential for failure to establish marketing and sales capabilities.
- Potential for lack of market acceptance of products.
- Potential for unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives.
- Failure to protect intellectual property.
- Potential for licensors' inability to maintain effective patents or for inability to maintain license rights.
- Potential for third-party claims of intellectual property infringement.
- Risks associated with sharing trade secrets or confidential proprietary information.
- Complex and overlapping laws protecting the privacy and security of health information and personal data.
- Potential for data security breaches or cyberattacks.
- Dependence on third parties for critical services.
- Laws and regulations regarding direct selling.
- Potential for material weaknesses in internal accounting procedures.
- Potential for future sales of shares of common stock to adversely affect the trading price of shares of common stock.
- Potential for adverse opinions from securities or industry analysts.
- Potential for barriers to a takeover.
- Potential for limitations on stockholders' ability to obtain a favorable judicial forum for disputes.
- Indemnification of officers and directors.
- Inflationary trends.
Mitigation Strategies
- Maintaining relationships with suppliers.
- Maintaining product liability insurance.
- Exploring alternative approaches such as licensing, joint venture, or partnership arrangements to provide long-term capital.
- Implementing and improving operational, financial and management information systems.
- Expanding, training and managing employee base.
- Developing internal systems and procedures to handle billing and collections functions.
- Entering into confidentiality agreements and material transfer agreements with third parties.
- Implementing processes to manage compliance with the CCPA and assessing the impact of the CPRA.
- Vigorously defending litigation or entering into reasonable settlements.