Avid Bioservices, Inc. operates as a contract development and manufacturing organization (CDMO) that provides a comprehensive range of services from process development to Current Good Manufacturing Practices (CGMP) clinical and commercial manufacturing of biologics for the biotechnology and biopharmaceutical industries.
The company’s services include clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. The compa...
Avid Bioservices, Inc. operates as a contract development and manufacturing organization (CDMO) that provides a comprehensive range of services from process development to Current Good Manufacturing Practices (CGMP) clinical and commercial manufacturing of biologics for the biotechnology and biopharmaceutical industries.
The company’s services include clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. The company also provides a variety of process development services, including cell line development, upstream and downstream development and optimization, analytical method development, testing and characterization. The company has completed 10 pre-approval inspections with each of its last five U.S. Food and Drug Administration (FDA) inspections resulting in zero Form 483 observations. The company has produced more than 500 CGMP batches of product, of which more than 220 have been commercial batches. Commercial biologics produced by the company is distributed to over 90 countries world-wide and it routinely inspected by global regulatory authorities and large pharmaceutical companies alike, as part of their on-going quality assurance audit programs. The company’s business is organized into one operating segment, its contract manufacturing and development services segment.
Business Strategy
The company continues to execute on a growth strategy that seeks to align with the growth of the biopharmaceutical drug substance contract services market. The key elements of the company’s strategy are to invest in additional capacity, capabilities and resources required for it to achieve its long-term growth strategy and meet the growth-demand of its customers’ programs, moving from development through to commercial manufacturing; broaden its market awareness through a diversified yet flexible marketing strategy; expand its customer base and programs with existing customers for both process development and manufacturing service offerings; and explore and invest in strategic opportunities both within its core business as well as in adjacent and/or synergistic service offerings in order to enhance and/or broaden its capabilities.
The company has a significant opportunity to continue to drive organic growth by leveraging its strengths, broadening its capabilities, increasing its capacity and improving its market visibility through various strategies, such as diversify customer base; expand service offerings; expand process development capabilities; expand manufacturing footprint and enhance efficiencies; reinvest in equipment and facilities; and explore & invest in strategic opportunities.
Regulatory Matters
The company has been audited by several regulatory agencies, including the FDA, the European Medicines Agency (‘EMA’), the Brazilian Health Surveillance Agency (‘ANVISA’), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the Canadian Health Authority (Health Canada), the California Department of Health and the Australian Department of Health.
The company is required to comply with the regulatory requirements of various local, state, national and international regulatory bodies having jurisdiction in the countries or localities where it manufactures products or where its customers’ products are distributed. In particular, the company is subject to laws and regulations concerning research and development, testing, manufacturing processes, equipment and facilities, including compliance with CGMPs, labeling and distribution, import and export, and product registration and listing. As a result, the company’s facilities are subject to regulation by the FDA, as well as regulatory bodies of other jurisdictions where its customers have marketing approval for their products including, but not limited to, the EMA, ANVISA, PMDA, Health Canada, and the Australian Department of Health.
In addition, various aspects of the company’s business may be subject to other U.S. healthcare laws, including U.S. federal Anti-Kickback Statute, the civil False Claims Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), HIPAA, as amended by Health Information Technology for Economic and Clinical Health Act of 2009, and similar state and local laws and regulations. Penalties for violating these laws can be significant.
Customers
The company continues to expand its customer base, it remains dependent on a limited number of customers for a substantial majority of its revenues. For the fiscal years ended April 30, 2024, the company derived approximately 55% of its revenues from its top three customers.
History
The company was founded in 1981. It was incorporated in California in 1981 and reincorporated in the state of Delaware in 1996. The company was formerly known as Peregrine Pharmaceuticals, Inc. and changed its name to Avid Bioservices, Inc. in 2018.
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