Lifecore Biomedical, Inc. \De\ (NASDAQ: LFCR)

Lifecore Biomedical, Inc. is a fully integrated contract development and manufacturing organization that provides clinical and commercial capabilities in the development, cGMP manufacturing and aseptic filling of complex formulations and highly viscous sterile injectable pharmaceutical drug or medical device products in syringes, vials and cartridges across a wide variety of modalities. The company is a leading United States manufacturer of pharmaceutical grade non animal sourced hyaluronic acid using its proprietary fermentation based HA process developed in 1981. Lifecore produces HA in bulk form and for use in formulated and filled syringes and vials for customers treating ophthalmic, orthopedic, wound care, aesthetic surgery, drug delivery and other medical applications. The company operates 3 state of the art facilities in Chaska Minnesota with a combined 250,000 square feet that support HA manufacturing, sterile manufacturing, analytical testing, secondary packaging, warehousing and distribution. All 3 facilities are located within 2 miles of each other and operate under a single FDA establishment identifier number.

Lifecore generates revenue by offering contract development and manufacturing services including analytical method development, formulation development, sterile filtration, process scale up, pilot studies, stability studies, process validation and production of materials for clinical studies. The company also earns income from the sale of hyaluronic acid raw material and from the aseptic filling of finished sterile injectable products for biopharmaceutical and biotechnology customers. Revenue is derived from fees charged for development work, technology transfer and manufacturing services as well as from product sales of HA based and non HA based formulations. The company also generates income from licensing its HA technology and from providing analytical testing services to external clients.

The company operates through a single integrated segment that combines CDMO and HA manufacturing operations.

• Single Integrated Segment: Provides contract development and manufacturing services including analytical method development, formulation development, sterile filtration, process scale up, pilot studies, stability studies, process validation, production of clinical materials and aseptic filling of complex and viscous sterile injectable products in syringes, vials and cartridges as well as manufacturing of pharmaceutical grade hyaluronic acid.

Lifecore holds a strong position in the contract development and manufacturing market due to its long standing customer relationships, some exceeding 20 years, and its expertise in non animal sourced hyaluronic acid and highly viscous injectable formulations. The company’s competitive advantages include vertically integrated capabilities, regulatory and quality expertise, and recent capacity expansion through the installation of a new high speed 5 head aseptic isolator filler in September 2024, which increased annual revenue generating capacity to approximately $300 million. While the CDMO industry is highly competitive with larger full service contract manufacturers and pharmaceutical companies, Lifecore differentiates itself through its niche HA technology and deep technical knowhow.

Lifecore serves global and emerging biopharmaceutical and biotechnology companies that have marketing sales and distribution capabilities across multiple therapeutic categories. The customer base includes long term partners with relationships ranging from 20 to nearly 40 years and encompasses firms seeking development and manufacturing support for ophthalmic, orthopedic, wound care, aesthetic surgery, drug delivery and other medical device applications.