Core Insights - Lifecore Biomedical, Inc. has signed a new 10-year commercial manufacturing and supply agreement with an existing customer to support the advancement of a novel ophthalmic therapeutic towards commercialization [1][2] - The agreement is part of Lifecore's growth strategy, emphasizing the importance of late-stage customer projects that are nearing potential commercialization [2] - A multi-million-dollar statement of work has also been signed, detailing various fill and finish CDMO services to advance the drug candidate towards regulatory approval [2] 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 [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]

April 2025 Important Information Regarding Forward-Looking Statements This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, among other things, relate to the Company's growth drivers and expected levels of our organic growth; the impact of our investment in development and commercial initiatives; financial guidance, including timing of revenues and EBITDA; our ability to ...

Core Insights - Lifecore Biomedical has received the remaining $10 million from the sale of its excess high-speed, multi-purpose 10-head isolator filler, completing a $17 million transaction ahead of schedule [1][2] - The company emphasizes its disciplined capital management approach and the positive momentum from recent operational enhancements, including the installation of a high-speed 5-head filler with a capacity of up to $300 million in annual revenue [2] Financial Developments - The total proceeds from the sale of the 10-head isolator filler amounted to $17 million, with $7 million received at the close of the transaction in early 2025 [1][2] - The accelerated payment from the buyer was made as a lump sum rather than the originally planned 18-month installment plan [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 [3] - The company has over 40 years of expertise in manufacturing premium, injectable-grade hyaluronic acid and serves global and emerging biopharmaceutical and biotechnology companies [3]

Core Insights - Lifecore Biomedical has appointed Mark DaFonseca as chief commercial officer, bringing nearly 30 years of pharmaceutical industry experience, particularly in contract development and manufacturing organizations (CDMOs) [1][2] - DaFonseca will focus on executing a three-pronged growth strategy aimed at enhancing Lifecore's brand, expanding customer partnerships, and growing the business portfolio through new collaborations [1][3] Company Background - Lifecore Biomedical is a fully integrated CDMO specializing in the development, fill, and finish of sterile injectable pharmaceutical products, including complex formulations [7] - The company has over 40 years of expertise in manufacturing premium, injectable-grade hyaluronic acid and serves global biopharmaceutical and biotechnology companies [7] Leadership Experience - Prior to joining Lifecore, DaFonseca held significant roles at CordenPharma, AmbioPharma, and CoreRx, where he led sales, marketing, and project management efforts [2] - His track record includes consistently exceeding key performance indicators in various sales leadership positions within the CDMO sector [2] Strategic Goals - DaFonseca expressed eagerness to leverage Lifecore's assets to strategically grow the business by expanding current customer relationships and increasing the overall customer base [4] - The company aims to enhance its market presence and address the industry's capacity needs through investments in state-of-the-art facilities and equipment [4] Compensation Details - As part of his appointment, Lifecore will grant DaFonseca a restricted stock unit (RSU) award for 20,000 shares and an option for 30,000 shares of common stock [4][5] - The RSU will vest on the third anniversary of the grant date, while the stock option will have a vesting schedule based on continued employment [6]

Core Insights - Lifecore Biomedical, Inc. will participate in the CDMO Live 2025 conference, a key event for the biopharma outsourcing industry, scheduled for May 7-8, 2025, in Rotterdam, Netherlands [1] - Jackie Klecker, Lifecore's executive vice president, will lead a discussion on transforming quality management into a strategic driver for CDMO partnerships, leveraging her 30 years of industry experience [2] 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 serves global and emerging biopharmaceutical and biotechnology companies across various therapeutic categories [3]

Core Insights - Lifecore Biomedical has appointed Thomas Salus as chief legal and administration officer and corporate secretary, bringing over 30 years of legal and management expertise, particularly in the life sciences industry [1][2][3] - Mr. Salus will oversee all legal activities and human resources, contributing to strategy development and corporate development focused on strategic alliances and partnerships [1][3] - The appointment is part of Lifecore's strategy to enhance corporate governance and SEC/Nasdaq reporting and compliance, aiming to streamline processes that impact performance [3] 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 [4] - 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 [4]

Core Insights - Lifecore Biomedical reported a quarterly loss of $0.19 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.14, and compared to a loss of $0.05 per share a year ago, indicating a significant decline in performance [1] - The company posted revenues of $35.15 million for the quarter ended February 2025, missing the Zacks Consensus Estimate by 3.95% and showing a slight decrease from year-ago revenues of $35.7 million [2] - Lifecore Biomedical shares have declined approximately 3.1% since the beginning of the year, which is slightly better than the S&P 500's decline of 3.6% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.07 on revenues of $35.99 million, and for the current fiscal year, it is -$0.91 on revenues of $129.86 million [7] - The estimate revisions trend for Lifecore Biomedical is mixed, resulting in a Zacks Rank 3 (Hold), suggesting that the shares are expected to perform in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Lifecore Biomedical belongs, is currently ranked in the top 31% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]

Lifecore Biomedical, Inc. (LFCR) Q3 2025 Earnings Conference Call April 03, 2025 04:30 PM ET Company Participants Stephanie Diaz - Manager, Investor RelationsPaul Josephs - President & Chief Executive OfficerRyan Lake - Chief Financial OfficerUnknown - Conference Call ModeratorUnknown - Conference Call Operator Conference Call Participants Matthew Hewitt - Analyst, Craig Callum Capital GroupMichael Petusky - Analyst, Barrington Research Unknown we'll be in a listen-only mode. Unknown Now, I would like to tu ...

Financial Data and Key Metrics Changes - Revenues for Q3 2025 were $35.2 million, a decrease of 2% compared to $35.7 million for the same period last year [9] - Gross profit for Q3 2025 was $9.8 million, down from $11.9 million in the prior year, primarily due to a decrease in CDMO gross profit [10] - The company recorded a net loss of $14.8 million or $0.47 per diluted share, compared to net income of $15.6 million or $0.42 per diluted share for the same period last year [12] - Adjusted EBITDA for Q3 2025 was $5.7 million, a decrease of $0.7 million compared to $6.4 million in the prior year [12] - For the first nine months of fiscal 2025, revenues were $92.4 million, an increase of 2% compared to $90.4 million for the same period last year [13] Business Line Data and Key Metrics Changes - CDMO revenues decreased by $1.5 million due to the completion of discrete development revenue project life cycles [10] - Hyaluronic acid (HA) manufacturing revenues increased by $1 million due to increased demand from a customer [10] - For the nine months ended February 23, 2025, gross profit improved to $26.3 million from $24.6 million, driven by increased volumes in HA manufacturing [14] Market Data and Key Metrics Changes - The company signed multiple new agreements with both new and existing customers during the quarter, indicating strong market engagement [6] - LifeCorps added six new customers in the first nine months of fiscal 2025, including a significant agreement with Nersim Laboratories [25][26] Company Strategy and Development Direction - The company aims to drive a 12% revenue growth and increase EBITDA margins to over 25% in the coming years [19] - Key growth strategies include maximizing existing customer business, advancing late-stage development programs towards commercialization, and winning new impactful business [20] - The company is focused on reducing operational expenses and enhancing productivity through various initiatives [29][30] Management's Comments on Operating Environment and Future Outlook - Management noted that discussions around domestic drug manufacturing have increased among prospective customers, indicating a potential shift in the industry [44] - The company expects to be cash flow positive from operations in the second half of the fiscal year, with a focus on improving free cash flow [63] - Management reiterated financial guidance for the fiscal year, expecting revenue to be approximately $126.5 million to $130 million [17] Other Important Information - The company has made significant improvements in operational efficiencies and productivity without compromising quality [32][38] - LifeCorps is implementing live production monitoring to enhance operational performance [35] Q&A Session Summary Question: Insights on the desire to bring back drug manufacturing in the US - Management noted increased discussions about domestic manufacturing among large pharmaceutical companies, driven by administrative uncertainty [44] Question: Details on the Humanetics contract signed post-quarter - The contract involves a tech transfer for a promising project, indicating a phase two development stage [46] Question: Progress on identified opportunities with multinational companies - Management reported positive progress and increased engagement with large multinationals, indicating a successful strategy [54] Question: Cash flow from operations and capital expenditures in the quarter - Positive cash flow from operations was approximately $2 million, with capital expenditures around $2 million as well [56][58] Question: Expectations for cash flow generation in the remainder of the fiscal year - Management expects to be cash flow positive in the second half of the year, with potential improvements in free cash flow [63] Question: Outlook on SG&A expenses - SG&A expenses are expected to decrease further in the second half of the year, with ongoing improvements in operational efficiency [66]

Financial Performance - Total revenues for the three months ended February 23, 2025, were $35,154,000, a slight decrease of 1.5% compared to $35,704,000 for the same period in 2024[11] - Gross profit for the nine months ended February 23, 2025, was $26,316,000, representing an increase of 7.1% from $24,578,000 in the prior year[11] - Operating loss for the three months ended February 23, 2025, was $(9,029,000), compared to a loss of $(895,000) for the same period in 2024[11] - Net loss for the nine months ended February 23, 2025, was $(37,570,000), compared to a net income of $19,096,000 for the same period in 2024[12] - The company reported a basic loss per share of $(0.47) for the three months ended February 23, 2025, compared to earnings of $0.48 per share for the same period in 2024[12] - For the nine months ended February 23, 2025, Lifecore Biomedical reported a net loss of $37,570,000 compared to a net income of $19,096,000 for the same period in 2024[16] Cash and Liquidity - Cash and cash equivalents decreased to $5,417,000 as of February 23, 2025, down from $8,462,000 as of May 26, 2024[9] - The company reported cash and cash equivalents of $5,417,000 at the end of the period, down from $19,091,000 at the beginning of the period[16] - Cash flows from operating activities resulted in a net cash used of $5,553,000 for the nine months ended February 23, 2025, an improvement from $8,459,000 in the prior year[16] - The company believes its cash from operations and available credit will be sufficient to finance operational and capital requirements for at least the next twelve months[173] Assets and Liabilities - Total assets decreased to $237,693,000 as of February 23, 2025, from $253,960,000 as of May 26, 2024[9] - Total liabilities decreased to $190,267,000 as of February 23, 2025, compared to $200,058,000 as of May 26, 2024[9] - The company’s accumulated deficit increased to $(204,093,000) as of February 23, 2025, from $(166,523,000) as of May 26, 2024[9] - The balance of redeemable convertible preferred stock increased to $45,197,000 as of February 23, 2025, from $44,312,000 at the end of the previous reporting period[16] Expenses - Research and development expenses for the three months ended February 23, 2025, were $2,045,000, a decrease of 5.8% from $2,170,000 in the same period last year[11] - Stock-based compensation increased to $8,343,000 in the nine months ended February 23, 2025, compared to $4,603,000 in the same period of 2024[16] - Total operating expenses for the nine months increased by 37% to $48,888 million, driven by a significant rise in selling, general, and administrative expenses[157] - Operating expenses increased by 48% to $18.874 million for the three months ended February 23, 2025, compared to $12.789 million for the same period in 2024[141] Debt and Financing - As of February 23, 2025, total debt net of discounts was $124,939 million, slightly up from $124,668 million on May 26, 2024[64] - The Company’s term loan principal is $184,361 million, with a significant portion due in 2029 amounting to $170,325 million[64] - The Term Loan Credit Facility has an effective annual interest rate of 20.9% as of February 23, 2025[69] - The Company incurred total expenses of $18,490 million under the restructuring plan, with expected remaining costs of $1,971 million, leading to total expected costs of $16,519 million[48] Revenue Concentration - The Company had significant revenue concentrations during the three months ended February 23, 2025, with two customers accounting for 54% and 18% of total revenues, compared to 52% and 14% in the same period of 2024[89] - Alcon accounted for 43% of the Company's revenues for the nine months ended February 23, 2025, highlighting its significance as a major customer[117] Stock and Equity - Lifecore Biomedical issued common stock, net of fees, amounting to $23,858,000 during the nine months ended February 23, 2025[16] - The Company issued 5,928,775 shares of common stock on October 3, 2024, for gross proceeds of approximately $24,300, with an issuance cost of $467[78] - As of February 23, 2025, the aggregate liquidation preference of the Redeemable Convertible Preferred Stock was $45,455, with $561 of dividends in arrears[80] Operational Highlights - Lifecore's vertically integrated capabilities allow for rapid movement from product development to commercial production, enhancing supply chain efficiency[132] - The FDA completed a GMP inspection of Lifecore in May 2025, with an initial response to observations provided within the expected timeframe[128] - The company has made strategic capital investments to extend its formulation and filling capacity to meet increasing partner demand[131] Compliance and Governance - Certifications of the Principal Executive Officer and Principal Financial Officer were filed pursuant to the Sarbanes-Oxley Act of 2002, ensuring compliance with regulatory requirements[192] - Management is committed to remediating material weaknesses in internal control over financial reporting, including engaging a third-party consultant and enhancing the internal audit function[180]