Lifecore Biomedical, Inc
Lifecore Biomedical is a U.S.-based contract development and manufacturing organization focused on complex sterile injectable products and pharmaceutical-grade hyaluronic acid (HA). It develops, scales, and aseptically fills viscous formulations in syringes, vials, and cartridges for biopharma and medtech customers, while also supplying HA bulk material and HA-based finished products.
Tilikausi 2025 · muutos edellisvuodesta
Kehitys 2020–2025
Liiketoiminta
Osuus liikevaihdostaAnalytical, formulation, scale-up, validation, and clinical development work for injectable products.
Commercial and clinical aseptic filling of sterile injectables in syringes, vials, and cartridges.
Production and sale of pharmaceutical-grade, non-animal-sourced HA as an API or input.
Highly viscous non-HA injectable programs and related manufacturing services.
Tuotteet
Raportoitu · osuus liikevaihdosta- Contract Development and Manufacturing Organization69,9 %
- HA Manufacturing30,1 %
Lähde: 10-K FY2025, yhtiön tuotelinjoittain raportoima liikevaihto (SEC XBRL). Osuudet on laskettu näytetyistä riveistä ja ne summautuvat 100 %:iin.
Asiakkaat
Lifecore sells primarily to global and emerging biopharmaceutical and biotechnology companies that need a partner for complex injectable programs. It also serves customers in medical device and other medical applications that use HA, including ophthalmic, orthopedic, wound care, aesthetic surgery, and drug delivery uses. Academic and corporate research customers are a smaller but relevant segment for early-stage HA applications.
Buy development and commercial manufacturing for sterile injectable drug products and need regulatory, scale-up, and fill-finish support.
Use Lifecore for clinical-to-commercial manufacturing of complex formulations where technical execution and speed matter.
Buy HA bulk material and HA-based finished products for ophthalmic and device-related applications.
Use HA and viscous injectable capabilities for orthopedic and other specialty medical applications.
Purchase HA-related materials and development support for exploratory and early-stage applications.
Strategia
Lifecore is focused on expanding its CDMO footprint by adding aseptic filling capacity, broadening the range of complex injectable programs it can support, and winning new customers outside traditional HA markets. It is also pushing operational efficiency through productivity gains, procurement discipline, and a new ERP system expected to improve inventory control and cost management.
More development and commercial programs increase utilization and diversify revenue beyond HA.
Additional capacity supports larger and more complex injectable programs and removes a growth bottleneck.
Lower cost structure and better productivity are needed to scale profitably in a competitive CDMO market.
Maantiede
Lifecore is headquartered in Chaska, Minnesota and operates three cGMP facilities in the United States. Its customer base is global, with long-term relationships across the U.S. and international biopharma markets, and it holds certifications from regulators in Europe, Japan, Brazil, and ISO bodies. Geography matters because the business depends on cross-border customer programs, regulatory approvals, and supply chain execution for sterile injectable manufacturing.
Riskit
Lifecore’s results depend on successful execution in a technically demanding CDMO market, where quality failures, regulatory findings, or project delays can quickly affect customer trust and utilization. The company also faces supply chain, tariff, and financing risks because it relies on specialized inputs, capital equipment, and ongoing investment to support growth and compliance.
Sterile injectable manufacturing depends on cGMP performance and customer trust; adverse findings can delay production or new awards.
Kohdistuu: FDA GMP inspections and global regulatory oversight
Development revenue is recognized based on estimated hours and project progress, so underestimation can overstate revenue.
Kohdistuu: Clinical and process development contracts
Long-duration CDMO relationships can be lumpy; delays or cancellations can leave capacity underutilized.
Kohdistuu: Biopharma and biotech sponsor programs
Debt service and refinancing needs can restrict investment and increase sensitivity to operating setbacks.
Kohdistuu: Revolving credit and term debt
Imported raw materials, components, or equipment could become more expensive and reduce margins.
Kohdistuu: U.S. trade policy and supplier footprint
Kirjanpito
Harkinnanvaraiset erätManagement estimates total hours and progress; errors can overstate or understate revenue and margin.
Vaikutus: Development revenue and gross profit
Embedded derivative features are marked to market using management assumptions, creating earnings volatility.
Vaikutus: Other income/expense and net income
Valuation depends on market capitalization, forecasts, and qualitative assessments; impairment would reduce earnings and equity.
Vaikutus: Balance sheet carrying values and operating results
Complex injectable manufacturing can create excess or obsolete inventory risk and margin swings.
Vaikutus: Cost of goods sold and gross margin
Samankaltaisia listattuja yhtiöitä
Julkisesti listattuja yhtiöitä, joilla on samankaltainen liiketoiminta.
Xencor Inc
XNCR · Pharmaceutical Preparations
Harvard Bioscience, Inc
HBIO · Laboratory Analytical Instruments
Harvard Bioscience designs, manufactures, and sells life-science research tools used in drug discovery, translational medicine, and preclinical testing.
International Stem Cell CORP
ISCO · Pharmaceutical Preparations
Zymeworks Inc.
ZYME · Pharmaceutical Preparations
Biomerica, Inc
BMRA · In Vitro & In Vivo Diagnostic Substances
Impact BioMedical, Inc
IBO · Pharmaceutical Preparations
Päivitetty: 28.4.2026