Core Points - Lifecore Biomedical, Inc. plans to hold a special meeting on April 10, 2025, to seek stockholder approval for a proposal to remove the Convertible Preferred Stock Exchange Cap, allowing for potential conversion of Series A Preferred Stock beyond the current limit of 19.99% of outstanding Common Stock [1][2] - The current maximum number of shares of Common Stock that can be converted from the Convertible Preferred Stock is 6,056,284 shares, and no holders have yet elected to convert their shares [2] - The board of directors has set February 18, 2025, as the record date for stockholders entitled to vote at the special meeting [3] Proposal Details - The proposal aims to eliminate the limitation on the conversion of Convertible Preferred Stock, which is currently capped at 19.99% of the outstanding Common Stock prior to issuance [2] - The meeting is specifically to accommodate the terms of the Convertible Preferred Stock Securities Purchase Agreement dated January 9, 2023, and Lifecore has no current plans to raise additional equity capital [2] Proxy Statement and Participation - Lifecore intends to file a preliminary proxy statement with the SEC regarding the special meeting, followed by a definitive proxy statement after SEC clearance [4] - Stockholders will receive further details on how to participate and vote at the special meeting through the definitive proxy statement [4] Company Overview - Lifecore Biomedical is a fully integrated contract development and manufacturing organization (CDMO) specializing in the development and manufacturing of sterile injectable pharmaceutical products, including injectable-grade hyaluronic acid [5]

Core Viewpoint - Lifecore Biomedical is strategically positioned for mid-term and long-term growth, supported by its current capacity to generate up to $300 million in annual revenue through the recent installation of a high-speed 5-head filler and the sale of excess equipment [1][2]. Group 1: Financial Transactions - Lifecore has entered into a sales agreement for a high-speed, multi-purpose 10-head isolator filler, receiving an aggregate purchase price of $17 million, with $7 million received at closing and the remainder to be paid in three tranches over the next 18 months [1][2]. - The sale of the 10-head filler is viewed as a compelling opportunity to monetize unused equipment and enhance the company's financial position [2]. Group 2: Operational Capacity - The installation of the new high-speed, multi-purpose 5-head isolator filler has doubled Lifecore's available capacity, allowing the company to better serve existing and future customers [2]. - The 5-head filler is GMP-ready, and the company is currently engaging in discussions with customers to leverage its speed and aseptic isolation capabilities [2]. Group 3: Company Overview - Lifecore Biomedical is a fully integrated contract development and manufacturing organization (CDMO) specializing in the development, fill, and finish of sterile injectable pharmaceutical products, including complex formulations [3]. - The company has over 40 years of expertise in manufacturing premium, injectable-grade hyaluronic acid and partners with global and emerging biopharmaceutical and biotechnology companies [3].

Company Participation - Lifecore Biomedical, Inc. will participate in the 43rd Annual J.P. Morgan Healthcare Conference from January 13-16, 2025, in San Francisco, California [1] - The company's management, including CEO Paul Josephs and CFO Ryan Lake, will engage in one-on-one meetings during the conference [1] Company Overview - Lifecore Biomedical is a fully integrated contract development and manufacturing organization (CDMO) specializing in the development, fill, and finish of sterile injectable pharmaceutical products [2] - The company has over 40 years of expertise in manufacturing premium, injectable-grade hyaluronic acid and serves global and emerging biopharmaceutical and biotechnology companies across various therapeutic categories [2]

Financial Data and Key Metrics Changes - Revenues for Q2 2025 were $32.6 million, an increase of 8% compared to $30.2 million in the prior year [11] - Gross profit for Q2 2025 was $11.1 million, up from $10 million in the same period last year, primarily due to a $1.6 million increase in CDMO gross profit [12] - The company recorded a net loss of $6.6 million for Q2 2025, compared to a net income of $14.2 million in the prior year, which included a favorable $20.7 million non-cash fair market value adjustment [13][16] - Adjusted EBITDA for Q2 2025 was $6.5 million, an increase of $1.1 million compared to $5.4 million in the prior year [13] Business Line Data and Key Metrics Changes - CDMO revenues increased by $1.9 million, driven by a $3.8 million increase in sales volume from the largest customer, partially offset by a $1.9 million decrease from other customers [11] - Manufacturing revenues increased primarily due to timing, resulting in higher shipments in Q2 2025 [11] Market Data and Key Metrics Changes - Revenues for the first six months of fiscal 2025 were $57.3 million, a 5% increase from $54.7 million in the prior year [14] - The company reported a significant increase in its pipeline related to large multinational pharmaceutical companies, which now represents over 30% of the overall pipeline, up from less than 10% previously [50][81] Company Strategy and Development Direction - Lifecore has implemented a three-pronged growth strategy aiming for a 12% revenue CAGR and EBITDA margins over 25% in the coming years [22] - The strategy focuses on maximizing existing customer business, advancing development pipeline programs towards commercialization, and driving new business through expanded efforts [22][27] - The company is expanding its focus beyond complex highly viscous formulations to include other products and formulations across multiple modalities [26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about ongoing momentum in development programs and late-stage site transfers, indicating a positive outlook for fiscal 2025 [49] - The company is confident that its growth strategy and leadership priorities are aligned to achieve success in the near, mid, and long term [36] Other Important Information - Lifecore successfully closed a $24.3 million PIPE offering, significantly improving its liquidity position [18] - The company amended and extended its revolving credit facility with BMO, resulting in a three-year extension and reduced interest rates [19] Q&A Session Summary Question: Details on the Nersum opportunity - Management indicated that the Nersum opportunity arose from the business development team's efforts and that ongoing development agreements are anticipated as the project progresses [44] Question: Feedback from pharma customers regarding fiscal 2025 - Management noted continued momentum in development programs and an increase in the pipeline related to large multinational pharmaceutical companies, indicating optimism for future success [49] Question: Opportunities for late-stage or commercial tech transfer projects - Management confirmed that pursuing late-stage or commercial site transfers is part of their strategy, with significant opportunities already in the pipeline [55] Question: Trends in gross margins for the rest of the year - Management expects overall margins to remain in the low thirty percent range, with improvements anticipated as revenues grow [60] Question: Clarification on revenue outlook - Management confirmed that there are no changes to the top-line revenue guidance for the year, maintaining the range of $126.5 million to $130 million [67] Question: Insights on early learnings and customer perceptions - Management acknowledged a lack of awareness about Lifecore's capabilities beyond fermentation but noted positive reception regarding their sterile fill-finish capabilities [81]

Revenue Growth - Revenues increased by $2.0 million in HA manufacturing primarily due to higher sales volume from the largest customer[184] - CDMO revenues increased by $0.6 million, driven by $3.3 million higher sales volume from the largest customer, partially offset by $2.6 million reduction due to a customer working down inventory levels[184] Expenses and Costs - R&D expenses for the three months ended November 24, 2024 were $1.924 million, a decrease of $0.174 million (8%) compared to the prior period[177] - SG&A expenses increased by $1.777 million (19%) primarily due to $1.8 million increase in non-cash stock-based compensation expense[178] - Interest expense, net increased by $1.392 million (34%) to $5.465 million for the three months ended November 24, 2024[179] - Other expense, net decreased by $0.663 million (69%) primarily due to the end of accumulation of monetary penalties to preferred stockholders[181] Financial Liabilities and Derivatives - Change in fair value of debt derivative liability, related party decreased by $19.5 million (94%) to $1.2 million[179] Legal and Compliance - The company intends to vigorously defend against claims filed by 22NW Fund, L.P. regarding alleged material misrepresentations and breaches of the Securities Purchase Agreement[191] - The company is committed to remediating control deficiencies by adding qualified personnel, enhancing controls, and implementing a SOX Steering Committee[295][296][300] Business Relationships - The company has established long-term relationships with global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories[169]

Financial Performance - Revenues for the three months ended November 24, 2024, were $32.6 million, an increase of 8% compared to $30.2 million for the same period last year[4] - The company recorded a net loss of $22.8 million for the six months ended November 24, 2024, compared to a net income of $3.5 million for the same period last year[7] - Revenues for the six months ended November 24, 2024, were $57.3 million, an increase of 5% compared to $54.7 million for the same period last year[6] - Net loss for the three months ended November 24, 2024, was $6.6 million, compared to net income of $14.2 million for the same period last year[42] - Adjusted EBITDA for the six months ended November 24, 2024, was $4.7 million, a $1.3 million increase from $3.4 million in the prior year period[7] - Adjusted EBITDA for the three months ended November 24, 2024, was $6.5 million, an increase of $1.1 million compared to $5.4 million in the prior year period[42] - Gross profit for the three months ended November 24, 2024, was $11.1 million, compared to $10.0 million for the same period last year[41] - The company recorded a gross profit increase of $3.8 million for the six months ended November 24, 2024, compared to the same period last year[43] Expenses and Costs - Selling, general and administrative expenses for the three months ended November 24, 2024, were $11.1 million, an increase from $9.3 million for the same period last year[19] - Interest expense for the six months ended November 24, 2024, was $10.8 million, an increase from $8.0 million for the same period last year[29] - The company incurred restructuring, reorganization, and stockholder activist settlement costs of $2.9 million for the three months ended November 24, 2024[50] Strategic Developments - The company signed two new project agreements during the second quarter, enhancing its early-stage development pipeline[2] - The company successfully completed the installation of a high-speed, multi-purpose 5-head isolator filler, doubling its capacity with a potential revenue generation of up to $300 million annually[16] - The company appointed new leadership, including a new chief financial officer and senior vice president of human resources, to support its growth strategy[40] - The company is focusing on new business opportunities[52] Financing and Compliance - The company closed a $24.3 million private placement of 5,928,775 shares of its common stock with new and existing shareholders[17] - The company strengthened its balance sheet by raising approximately $24.3 million through equity financing and restructuring its credit facility[38] - The company expects a net loss for the fiscal year to be between $28.6 million and $26.6 million, an increase from previous estimates due to higher expenses[14] - The company regained compliance with Nasdaq listing requirements, ceasing any action to delist its common stock[39] Related Party Transactions - Revenues from related parties for the three months ended November 24, 2024, were $13.0 million, compared to $9.6 million in the same period last year[49] Miscellaneous - Lifecore Biomedical is a fully integrated contract development and manufacturing organization (CDMO)[51] - The financial results were announced on January 2, 2025[51] - Recorded revenues of $32.6 million for Q2 fiscal 2025[51]

Core Insights - Lifecore Biomedical, Inc. reported revenues of $32.6 million for Q2 Fiscal 2025, reflecting an 8% increase compared to $30.2 million in the same period last year [8][12] - The company signed multiple development agreements with new customers, enhancing its early-stage development pipeline [3][2] - Lifecore strengthened its balance sheet by raising approximately $24.3 million through equity financing and restructuring its credit facility with BMO [5][6] Financial Performance - Revenues for the six months ended November 24, 2024, were $57.3 million, a 5% increase from $54.7 million in the prior year [13] - Gross profit for Q2 was $11.1 million, up from $10.0 million year-over-year, driven by increased CDMO gross profit [9] - The company recorded a net loss of $6.6 million for Q2, compared to a net income of $14.2 million in the same period last year [12] Operational Developments - Lifecore successfully installed and qualified a high-speed, multi-purpose 5-head isolator filler, doubling its capacity and creating a potential revenue-generating capacity of up to $300 million annually [4] - The company appointed several key executives to support its growth strategy, including a new CFO and senior vice president of human resources [7] Business Development - Lifecore signed two new project agreements with Nirsum Laboratories, focusing on CDMO services for clinical development [3] - The business development team achieved significant milestones during the quarter, contributing to the overall growth strategy [2] Balance Sheet and Financing - The company completed a $24.3 million private placement of shares, enhancing its financial position [5] - Lifecore amended its revolving credit facility with BMO, resulting in a three-year extension and reduced interest rates [6]

Core Insights - Lifecore Biomedical, Inc. will report its financial results for the second quarter of fiscal year 2025 on January 2, 2025, after market close [1] - A webcast will be hosted by Lifecore's senior management team at 4:30 p.m. Eastern Time on the same day to discuss the financial results and recent corporate developments [1] Company Overview - Lifecore Biomedical is a fully integrated contract development and manufacturing organization (CDMO) specializing in the development, fill, and finish of sterile injectable pharmaceutical products, including complex formulations [3] - The company has over 40 years of expertise in manufacturing premium, injectable-grade hyaluronic acid and partners with global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories [3]

Core Insights - Lifecore Biomedical has been selected by Nirsum Laboratories to provide contract development and manufacturing organization (CDMO) services for the clinical development of NRS-033, a treatment for opioid use disorder (OUD) and alcohol use disorder (AUD) [1][2][5] - The agreement includes technology transfer and assessment of the fill and finish process for NRS-033, leveraging Lifecore's expertise in sterile injectable pharmaceutical products [1][3] - NRS-033 aims to address the high relapse rates associated with current therapies for OUD and AUD, with the potential to improve therapeutic retention for patients [3][5] Company Overview - Lifecore Biomedical is a fully integrated CDMO specializing in the development, fill, and finish of sterile injectable pharmaceutical products, including complex formulations [4] - The company has over 40 years of experience and serves global and emerging biopharmaceutical and biotechnology companies [4] - Nirsum Laboratories is a development-stage biotechnology company focused on creating curable treatments for addiction, with NRS-033 being funded in part by the NIH [5]

Company Overview - Lifecore Biomedical, Inc. is a fully integrated contract development and manufacturing organization (CDMO) specializing in the development, fill, and finish of sterile injectable pharmaceutical products [2] - The company has over 40 years of expertise in manufacturing premium, injectable-grade hyaluronic acid, serving global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories [2] Recent Developments - Lifecore hosted a virtual investor day where senior management discussed the company's business and future growth strategy [1] - The event was made accessible via a webcast, allowing investors to engage with the company's strategic direction [1]