LIFECORE BIOMEDICAL, INC. \DE\LFCR決算レポート

Lifecore has become a leading U.S. manufacturer of pharmaceutical-grade, non-animal-sourced hyaluronic acid (“HA”) using our proprietary, fermentation-based HA process that we developed in 1981.

We have leveraged this expertise in HA fermentation, manufacturing and aseptic formulation and filling to also develop highly viscous non-HA-based sterile injectable products with our customers for multiple applications. Lifecore’s product development service capabilities include analytical method development and validation, formulation development, sterile filtration, process scale-up, pilot studies, stability studies, process validation and production of materials for clinical studies.

We also operate semi-automated Restricted Access Barrier Systems (“RABS”) and fully automated aseptic filling lines with isolators. These systems support efficient and safe aseptic processing of both synthetic and biologic drug products. Manufacturing takes place across our three cGMP facilities, where we produce FDA-approved (as defined below) commercial drug and device products.

We have earned multiple certifications from regulatory agencies in Europe, Japan, Brazil and the International Organization for Standardization (“ISO”). Lifecore’s predecessor business commenced in the mid-1960’s with a primary focus on microbial diagnostic devices, but Lifecore developed its HA capabilities in the early 1980’s.

From 2010, when it was acquired by Landec Corporation, until 2023, our CDMO business was operated through the Lifecore subsidiary of lower-margin food businesses. In 2022, we changed our corporate name from Landec Corporation to Lifecore Biomedical, Inc. to reflect the growing focus on the CDMO business.

In May 2023, Lifecore completed the divestiture of these food businesses, and beginning with fiscal year 2024, we operate as a stand-alone integrated CDMO. During fiscal year 2025, Lifecore continued to execute on the previously announced strategic initiatives to support higher performance as a CDMO.

We have made significant improvements to our revenue generating capacity, financial position, management team, governance, financial reporting and stock exchange compliance, and business development efforts, including: • In September 2024, we doubled our revenue-generating capacity (to support up to approximately $300 million in annual revenue-generating capacity) through the installation of a new fully automated high-speed, multi-purpose 5-head aseptic isolator filler; • We strengthened our financial position through, among other actions, (i) raising $24.3 million in a private placement of Lifecore common stock in October 2024, (ii) a three-year term extension of our existing asset-based lending revolving credit facility with BMO Harris Bank N.A.

(“BMO”) in November 2024, (iii) the sale of certain excess capital equipment for $17 million in January 2025, and (iv) the implementation of operational cost reductions, including overhead costs and professional fees associated with legal, accounting and consulting spend; • We made key executive officer appointments, including a new CEO in May 2024 and a new CFO in September 2024, as well as other senior leadership appointments thereafter, to join the existing, talented Lifecore team; 1 Table of Contents • In June 2024, we reached a cooperation agreement with 22NW, LP pursuant to which we agreed to the appointment of certain Board members who we believe will reinforce alignment between the full Board and our stockholders; • In August 2024, we completed required filings of our periodic reports with the SEC, held our 2023 annual meeting of stockholders and regained compliance with the listing requirements of the Nasdaq Stock Exchange (“Nasdaq”), resulting in Nasdaq ceasing potential action to delist the Company’s common stock; and • We enhanced our business development strategy, increased our investment in sales and marketing to support brand visibility, and expanded our business development team with new sales talent who will focus on key drug development geographies in the United States and internationally.

In addition, we also implemented various process improvements to ensure improved productivity and discipline in key areas of our business. Based on all of these improvements, together with our competitive advantages and our strategic plan described below, we believe that we are well-positioned for future growth.

Competitive advantages Lifecore believes that we have developed and are maintaining certain advantages that we expect to enable us to succeed in a competitive CDMO marketplace, including: Strong relationships with market leaders Through our history of successfully developing and manufacturing highly viscous HA and HA-based products, Lifecore has established long-term relationships with global and emerging biopharmaceutical and biotechnology companies who have marketing, sales and distribution capabilities to end-user markets across multiple therapeutic categories.

Lifecore has multiple customer relationships ranging from 20 years to nearly 40 years. We intend to continue leveraging these relationships to attract new, long-term relationships and expand into additional pharmaceutical modalities and medical device applications.

Further applications may involve expanding process development activity.

Most recently, in September 2024, Lifecore installed a new fully automated high-speed, multi-purpose 5-head aseptic isolator filler, which has significantly expanded our available capacity and the range of project opportunities we can support. 2 Table of Contents Vertically integrated CDMO capabilities Lifecore’s vertically integrated development and manufacturing capabilities allow us to establish a variety of contractual relationships with customers globally.

In March 2025, the FDA completed a general drug product good manufacturing practices inspection of Lifecore, and in May 2025 it closed its inspection without further required action. Our strategy As a trusted partner to our customers and the patients they serve, we are dedicated to supporting them in improving healthcare outcomes through the highest standards of quality and service.

We provide innovative, value-added solutions for sterile development and manufacturing, driven by our talented team. Our mission drives our commitment to excellence, quality, performance and culture. To accomplish our mission, we have implemented the following growth strategies and sustaining objectives.

Growth strategies 1) Maximizing Existing Customer Business : Maximize and expand our scope of work for each customer by driving more robust relationships while ensuring our customers understand our capabilities and prioritize us for additional opportunities. 2) Advancing Programs Towards Commercialization : Continue to seek out opportunities to advance customers’ early-to-mid stage and late-stage product development activities by supporting their clinical programs and commercial process scale-up activities. 3) Driving New Business : Implement a new sales strategy to strategically expand our target market to increase our focus on large multinational pharmaceutical companies, capitalizing on investments we have made in technology and creating a more agile organization to support our expanding pipeline.

Sustaining objectives 1) Reduced Operational Expenses : Focus on value creation initiatives by eliminating low-return activities, optimizing key processes, and having a culture of continuous improvement in order to drive sustainable savings across the Company. 2) Performance-Driven Culture : Commitment to a high-performance culture driven by exceptional talent, one where we are data-driven, have top talent in all strategic roles, and where incentives are aligned with our stockholders. 3) Commitment to Quality : Maintain the highest level of quality in every aspect of our work and in our relationships with customers and regulatory agencies alike.

Reportable segments The Company’s chief operating decision maker, as defined by U.S. generally accepted accounting principles (“U.S.

GAAP”), manages CDMO and HA manufacturing operations on the basis of a single integrated segment. 3 Table of Contents Sales and marketing Historically, Lifecore has leveraged its deep technical expertise, long-standing customer relationships, strong brand recognition and word-of-mouth referrals to support its leadership in HA, development and manufacturing experience and expertise.

We are focused on better aligning our internal resources to lead and manage existing and new clinical and commercial customer relationships in order to free up our business development team.

We believe our business development team is well-positioned to strategically expand our target market by increasing focus on: large multinational pharmaceutical companies; later-stage clinical development programs; technology transfers of existing commercial programs; and a broader range of modalities. These efforts are aimed at driving new development programs into our organization.

To support this strategy, we have increased our investment in sales and marketing to enhance brand visibility. Additionally, we have expanded our business development team by adding experienced sales talent focused on key drug development geographies in the United States and internationally.

Manufacturing and processing Lifecore has three state-of-the-art facilities with a combined 250,000 square feet in Chaska, Minnesota that are all located within two miles of one another and regulated under one FDA establishment identifier number.

In September 2024, Lifecore installed a new fully automated high-speed, multi-purpose 5-head aseptic isolator filler, which has significantly expanded our available capacity and the range of project opportunities we can support. The Company believes that its current manufacturing capacity plan will be sufficient to allow it to meet the needs of its current customers for the foreseeable future.

Most of our customers’ products are regulated by the FDA and similar agencies in other countries. These products are often classified as medical devices or drugs and usually require FDA approval or clearance before they can be sold in the United States. Beyond approval, there are strict rules for how these products are designed, made, packaged, labeled, and distributed.

Our customers must keep detailed records, follow quality control standards, and are considered the product’s “Sponsor”. During commercialization of the product, the Sponsor must submit annual reports and get approval for major changes to the product or its labeling. The FDA also requires reporting of any adverse events and imposes other post-market responsibilities.

Lifecore provides support to the Sponsor as requested. In addition, Lifecore is subject to extensive and continuing regulation by the FDA, including compliance with current Good Manufacturing Practices, or cGMP, which impose procedural and documentation requirements.

The FDA or other regulatory agencies can delay approval of a drug if our manufacturing facilities are not able to demonstrate compliance with cGMPs, pass other aspects of pre-approval inspections (i.e., compliance with filed submissions) or properly scale-up to produce commercial supplies.

Drug manufacturers and their subcontractors, and those supplying products, ingredients and components of them, are required to register their establishments with the FDA and state agencies and are subject to periodic announced and unannounced inspections by the FDA and state agencies for compliance with cGMP and other regulations.

In addition, changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements.

Accordingly, manufacturers like Lifecore must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance.

Failure to comply with applicable requirements may result in restrictions on a product, manufacturer or holder of an approved NDA, including withdrawal of product approval, recall or seizure of the product or other voluntary, FDA‑initiated or judicial action that could delay or prohibit further operations.

Human capital Our employees In the first quarter of fiscal year 2025, we completed an initiative to strategically optimize our cost structure, which included optimizing our workforce. We also recast our executive leadership team, which we believe has the requisite background and experience to support Lifecore’s transformation into a standalone CDMO with enhanced technical and regulatory strengths.

Our human capital focus We believe that the strength of our team and our workplace culture is essential to our ability to achieve our strategic and operational goals. Lifecore maintains an active strategy of recruitment, development and retention aligned to our growth strategies described under “Strategy” above.

We closely monitor employee turnover rates, as our success depends upon retaining and investing in our team, particularly our highly trained manufacturing and technical staff.

Lifecore aims to decrease employee-initiated voluntary turnover and increase employee retention through a combination of an engaging culture and opportunities for individual developmental and personal career growth. 5 Table of Contents Our culture and employee development Lifecore invests in creating a differentiated culture for our team that enables continuous innovation at scale.