Sodium Hyaluronate

-- Recorded Revenues of $32.6 Million for Q2 Fiscal 2025 -- -- Signed Multiple Development Agreements with New Customers -- -- Strengthened Balance Sheet with Financing Raising Approximately $24.3 Million, and Favorable Restructuring of Credit Facility with BMO -- Conference Call Today at 4:30pm ET CHASKA, Minn., Jan. 02, 2025 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and manufacturing organization (“CDMO”), today announced its financial results for the second quarter of fiscal 2025. Highlights from Second Quarter of Fiscal 2025: “The second quarter was a very productive time at Lifecore. Our achievements during the period spanned finance, operations and business development, all of which supported our overall growth strategy. Revenues in the period were strong and in line with our fiscal year guidance. Gross margins improved during the period as compared to our first quarter margins, reflecting greater leverage of our overhead costs across increased revenues and favorable sales mix. Our business development team was successful in signing multiple new projects. And importantly, our balance sheet was materially strengthened during the period with the combination of the successful completion of our previously announced equity financing, and the restructuring of our revolving credit facility with BMO on significantly improved terms to Lifecore,” stated Paul Josephs, president and chief executive officer of Lifecore. Second Quarter Developments New Business The company signed two new project agreements during the second quarter with new customers, adding to its early stage development pipeline. This included Nirsum Laboratories selecting Lifecore to provide CDMO services focused on supporting Nirsum’s clinical development of its lead development candidate, NRS-033. Capabilities and Capacity During the quarter, the company successfully completed the installation and qualification of its high-speed, multi-purpose 5-head isolator filler, which is now GMP-ready. With the addition of the 5-head isolator filler, which is designed for fill/finish activities for vials, cartridges, and pre-filled syringes, the company has more than doubled its capacity, creating maximum revenue-generating potential of up to $300 million annually, based on historical fiscal year 2024 revenues, projected development pipeline, and new business pricing, volume and other assumptions. Financial and Corporate In September, Lifecore announced that the company received written notice from the Nasdaq Listing Qualifications Department stating that it had regained compliance with the filing and annual meeting requirements in the Nasdaq Listing Rules, and Nasdaq had ceased any action to delist the company’s common stock. In October, the company announced the successful closing of a $24.3 million private placement of 5,928,775 shares of its common stock with new and existing shareholders. In November, the company announced the successful amendment and extension of its revolving credit facility with its existing lender, BMO. The terms of the amendment provide for, among other things, a three-year extension, as well as a reduction in interest rates that the company believes has further strengthened its balance sheet and overall financial position. During the second quarter, the company executed multiple key leadership changes, appointing exceptional talent across the organization to execute its ambitious growth strategy. Appointments included Ryan Lake as chief financial officer, Brikkelle Thompson as senior vice president of human resources, Thomas Guldager as vice president, operations, and Jackie Klecker as executive vice president, quality and development services. Consolidated Second Quarter Fiscal 2025 Financial Results Revenues for the three months ended November 24, 2024, were $32.6 million, an increase of 8% compared to $30.2 million for the comparable prior year period. The increase in revenues was primarily due to a $1.9 million increase in CDMO revenues, which increase comprised $3.8 million of higher sales volume from the company’s largest customer, partially offset by $1.9 million of lower sales volume from other CDMO customers. In addition, hyaluronic acid (“HA”) manufacturing revenues increased $0.5 million primarily from increased revenue from a customer due to timing, with increased shipments in the second quarter of 2025. 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. The $1.1 million increase in gross profit is primarily due to a $1.6 million increase in CDMO gross profit as a result of price increases to certain customers partially offset by a $0.5 million decrease in HA manufacturing gross profit due to manufacturing variances. Selling, general and administrative expenses for the three months ended November 24, 2024, were $11.1 million, compared to $9.3 million for the same period last year. The increase was primarily due to increases in non-cash stock-based compensation expense of $1.8 million, the majority of which was related to new hire performance stock unit grants to principal executive officers. Interest expense was $5.5 million for the three months ended November 24, 2024, an increase compared to $4.1 million for the same period last year. The increase was primarily a result of $1.0 million of increased interest expense related to the Alcon term loan debt, primarily related to amortization of the debt discount. There was also a reduction in capitalized interest of $0.3 million due to decreased fixed asset construction activities. For the three months ended November 24, 2024, the company recorded net loss of $6.6 million and $0.25 of loss per diluted share, as compared to net income of $14.2 million and $0.39 of income per diluted share, for the same period last year, which included an unusually large favorable $20.7 million non-cash fair market value adjustment to its debt derivative liability associated with its term loan credit facility. 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. The increase in Adjusted EBITDA was primarily due to the increase in gross profit. Consolidated First Six Months Fiscal 2025 Financial Results Revenues for the six months ended November 24, 2024, were $57.3 million, an increase of 5% compared to $54.7 million for the comparable prior year period. The increase in revenues was due to a $2.0 million increase in HA manufacturing revenues primarily due to higher sales volume from the company’s largest customer and a $0.6 million increase in CDMO revenues, which increase comprised $3.3 million of higher sales volume from that customer, partially offset by a customer working down inventory levels built in the prior year period of $2.6 million. Gross profit for the six months ended November 24, 2024, was $16.5 million, compared to $12.7 million for the same period last year. The $3.8 million improvement in gross profit is due to a $5.1 million increase in CDMO gross profit which reflected a $3.2 million increase due to price increases to certain customers and a $1.9 million increase due to a favorable sales mix, partially offset by a $1.0 million write-down on existing inventories to their net realizable value and a $0.3 million decrease in HA manufacturing gross profit due to manufacturing variances. Selling, general and administrative expenses for the six months ended November 24, 2024, were $25.9 million, compared to $18.5 million for the same period last year. The increase was primarily due to a $4.4 million increase in professional fees, including legal fees related to the civil litigation related to Yucatan Foods and the stockholder activist settlement. Additionally, non-cash stock-based compensation expense increased by $2.7 million, the majority of which was related to performance stock unit grants to principal executive officers. Interest expense was $10.8 million for the six months ended November 24, 2024, an increase compared to $8.0 million for the same period last year. The increase was primarily a result of $1.9 million of increased interest expense related to the Alcon term loan debt, primarily related to amortization of the debt discount. There was also a reduction in capitalized interest of $0.6 million due to decreased fixed asset construction activities. For the six months ended November 24, 2024, the company recorded net loss of $22.8 million and $0.76 of loss per diluted share, as compared to net income of $3.5 million and $0.10 of income per diluted share, for the same period last year, which included an unusually large favorable $20.9 million non-cash fair market value adjustment to its debt derivative liability associated with its term loan credit facility. 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. The increase in Adjusted EBITDA was primarily due to the increase in gross profit, partially offset by increased legal and audit costs. *Adjusted EBITDA is a non-GAAP financial measure (see reconciliation of non-GAAP financial measures in this release). Earnings Webcast Lifecore Biomedical will host a conference call today, January 2, 2025, at 4:30 p.m. ET to discuss the company’s second quarter fiscal 2025 financial results. The webcast can be accessed via Lifecore’s Investor Events & Presentations page at: https://ir.lifecore.com/events-presentations. An archived version of the webcast will be available on the website for 30 days. About Lifecore Biomedical Lifecore Biomedical, Inc. is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories to bring their innovations to market. For more information about the company, visit Lifecore’s website at www.lifecore.com. Non-GAAP Financial Information This press release contains non-GAAP financial information, including Adjusted EBITDA. The company has included a reconciliation of Adjusted EBITDA to Net (loss) income, the most directly comparable financial measure calculated in accordance with GAAP. See the section entitled “Non-GAAP Reconciliations” in this release for the company’s definition of Adjusted EBITDA and a reconciliation thereof to Net (loss) income. The company has disclosed these non-GAAP financial measures to supplement its consolidated financial statements presented in accordance with GAAP. These non-GAAP financial measures exclude/include certain items that are included in the company’s results reported in accordance with GAAP. Management believes these non-GAAP financial measures provide useful additional information to investors about trends in the company’s operations and are useful for period-over-period comparisons. These non-GAAP financial measures should not be considered in isolation or as a substitute for the comparable GAAP measures. In addition, these non-GAAP financial measures may not be the same as similar measures provided by other companies due to the potential differences in methods of calculation and items being excluded/included. These non-GAAP financial measures should be read in conjunction with the company’s consolidated financial statements presented in accordance with GAAP. Important Cautions Regarding Forward-Looking Statements This press release contains forward-looking statements regarding future events and our future results that are subject to the safe harbor created under the Private Securities Litigation Reform Act of 1995 and other safe harbors under the Securities Act of 1933 and the Securities Exchange Act of 1934. Words such as “anticipate”, “estimate”, “expect”, “project”, “plan”, “intend”, “believe”, “may”, “might”, “will”, “should”, “can have”, “likely” and similar expressions are used to identify forward-looking statements. In addition, all statements regarding our current operating and financial expectations in light of historical results, anticipated capacity and utilization, anticipated liquidity, and anticipated future customer relationships usage are forward-looking statements. All forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially, including such factors among others, as the company’s ability to successfully enact its business strategies, including with respect to installation, capacity generation and its ability to attract demand for its services, its ability expand its relationship with its existing customers or attract new customers, the impact of inflation on the company’s business and financial condition, indications of a change in the market cycles in the CDMO market; changes in business conditions and general economic conditions both domestically and globally including rising interest rates and fluctuation in foreign currency exchange rates, access to capital; and other risk factors set forth from time to time in the company’s SEC filings, including, but not limited to, the Annual Report on Form 10-K for the year ended May 26, 2024 (the “2024 10-K”). For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to our filings with the Securities and Exchange Commission, including the risk factors contained in the 2024 10-K. Forward-looking statements represent management’s current expectations as of the date hereof and are inherently uncertain. Except as required by law, we do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances. LIFECORE BIOMEDICAL, INC.CONSOLIDATED CONDENSED BALANCE SHEETS(In thousands, except share and par values) November 24, 2024 May 26, 2024 (unaudited) ASSETSCurrent Assets: Cash and cash equivalents$9,455 $8,462 Accounts receivable, less allowance for credit losses 20,177 20,343 Accounts receivable, related party 10,126 10,810 Inventories, net 39,214 39,979 Prepaid expenses and other current assets 2,886 1,439 Total Current Assets 81,858 81,033 Property, plant, and equipment, net 150,576 149,165 Operating lease right-of-use assets 2,304 2,442 Goodwill 13,881 13,881 Intangible assets, net 4,200 4,200 Other long-term assets 2,567 3,239 Total Assets$255,386 $253,960 LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ EQUITYCurrent Liabilities: Accounts payable$14,967 $16,334 Accrued compensation 4,631 6,165 Other accrued liabilities 9,866 9,354 Current portion of lease liabilities 4,116 4,133 Deferred revenues 426 1,088 Deferred revenues, related party 511 1,025 Current portion of long-term debt, related party 773 773 Total Current Liabilities 35,290 38,872 Long-term debt, less current portion, net, related party 110,528 100,819 Revolving credit facility 8,500 19,691 Debt derivative liability, related party 23,300 25,400 Long-term lease liabilities, less current portion 7,423 4,944 Deferred taxes, net 552 543 Deferred revenues, less current portion, related party 4,880 4,703 Other non-current liabilities 5,153 5,086 Total Liabilities 195,626 200,058 Convertible Preferred Stock, $0.001 par value; 2,000,000 shares authorized; 44,068 and 42,461 shares issued and outstanding, redemption value $44,619 and $42,991 44,311 42,587 Stockholders’ Equity: Common Stock, $0.001 par value; 75,000,000 and 50,000,000 shares authorized; 36,980,790 and 30,562,961 shares issued and outstanding 37 30 Additional paid-in capital 206,868 177,808 Accumulated deficit (191,456) (166,523)Total Stockholders’ Equity 15,449 11,315 Total Liabilities, Convertible Preferred Stock, and Stockholders’ Equity$255,386 $253,960 LIFECORE BIOMEDICAL, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) (In thousands, except share and per share values) Three Months Ended Six Months Ended November 24, 2024 November 26, 2023 November 24, 2024 November 26, 2023Revenues$19,534 $20,522 $36,327 $37,475 Revenues, related party 13,030 9,628 20,942 17,197 Total Revenues 32,564 30,150 57,269 54,672 Cost of goods sold 21,480 20,193 40,798 41,987 Gross profit 11,084 9,957 16,471 12,685 Operating costs and expenses: Research and development 1,924 2,098 4,110 4,244 Selling, general, and administrative 11,119 9,342 25,904 18,538 Total operating costs and expenses 13,043 11,440 30,014 22,782 Operating loss (1,959) (1,483) (13,543) (10,097) Interest expense, net (842) (832) (1,810) (1,625)Interest expense, related party (4,623) (3,241) (9,023) (6,385)Change in fair value of debt derivative liability, related party 1,200 20,700 2,100 20,900 Other expense, net (304) (967) (507) (1,138)(Loss) income from continuing operations before income taxes (6,528) 14,177 (22,783) 1,655 Income tax (expense) benefit (43) 65 (18) (23)(Loss) income from continuing operations (6,571) 14,242 (22,801) 1,632 (Loss) income from discontinued operations — (24) — 1,832 Net (loss) income (6,571) 14,218 (22,801) 3,464 Fair value of conversion ratio improvement to preferred stockholders (2,132) — (2,132) — (Loss) income available to common stockholders$(8,703) $14,218 $(24,933) $3,464 Basic income or loss per share: (Loss) income from continuing operations available to common stockholders$(0.25) $0.47 $(0.76) $0.05 Income from discontinued operations — — — 0.06 Basic (loss) income per share$(0.25) $0.47 $(0.76) $0.11 Diluted income or loss per share: (Loss) income from continuing operations available to common stockholders$(0.25) $0.39 $(0.76) $0.05 Income from discontinued operations — — — 0.05 Diluted (loss) income per share$(0.25) $0.39 $(0.76) $0.10 Shares used in income or loss per share computations: Basic 34,360,657 30,458,032 32,609,808 30,430,712 Diluted 34,360,657 36,419,103 32,609,808 36,397,352 Non-GAAP Financial Reconciliations Adjusted EBITDA is a non-GAAP financial measure. We define Adjusted EBITDA as net income or loss before (i) interest expense, net of interest income, (ii) income tax expense (benefit), (iii) depreciation and amortization, (iv) stock-based compensation, (v) change in fair value of debt derivatives, (vi) financing fees (non-interest), (vii) reorganization costs, (viii) restructuring costs, (ix) franchise tax equivalent to income tax, (x) contract cancellation costs, (xi) loss (income) from discontinued operations (xii) stockholder activist settlement costs, and (xiii) start-up costs, as well as any items that may arise from time to time that, in management’s judgment, significantly affect the assessment of earnings results between periods. See “Non-GAAP Financial Information” above for further information regarding the Company’s use of non-GAAP financial measures. Three Months Ended Six Months Ended(in thousands)November 24, 2024 November 26, 2023 November 24, 2024 November 26, 2023Net (loss) income (GAAP) (6,571) 14,218 (22,801) 3,464 Interest expense, net 5,465 4,073 10,833 8,010 Income tax expense (benefit) 43 (65) 18 23 Depreciation and amortization 2,044 1,987 4,037 3,934 Stock-based compensation 3,372 1,577 5,791 3,110 Change in fair value of debt derivatives (1,200) (20,700) (2,100) (20,900)Financing fees (non-interest) 368 1,108 643 1,361 Reorganization costs (a) 2,463 2,162 6,055 4,899 Restructuring costs (a) 404 157 887 147 Franchise tax equivalent to income tax 50 94 100 176 Contract cancellation costs — 297 — 297 Loss (income) from discontinued operations — 24 — (1,832)Stockholder activist settlement (a) 78 1,260 — Start-up costs — 487 — 726 Adjusted EBITDA$6,516 $5,419 $4,723 $3,415 (a) Restructuring, reorganization and stockholder activist settlement costs of $2.9 million and $8.2 million were incurred for the three and six months ended November 24, 2024, respectively. Restructuring, reorganization and stockholder activist settlement costs of $2.3 million and $5.0 million were incurred for the three and six months ended November 26, 2023, respectively. These costs primarily related to elevated accounting fees associated with the fiscal 2024 audit, legal expenses, consulting fees and severance costs from the restructuring reductions in force and former CEO in fiscal year 2024 and former CFO departure in fiscal year 2025.2025 Guidance Compared to Fiscal Year 2024 Results (in thousands)Fiscal Year Ending Fiscal Year EndedMay 25, 2025 May 26, 2024 (estimate) Net (loss) income (GAAP) (a)$(28,600) — $(26,600) $12,013Interest expense, net22,000 18,090Income tax expense (benefit)— 183Depreciation and amortization8,300 7,954Stock-based compensation10,900 6,201Change in fair value of debt derivatives(4,900) (39,500)Financing fees (non-interest)700 3,513Reorganization costs (b)7,600 9,796Restructuring costs (b)1,400 1,656Franchise tax equivalent to income tax300 272Contract cancellation costs— 567Loss (income) from discontinued operations— (2,682)Stockholder activist settlement (b)1,300 459Start-up costs— 1,684Adjusted EBITDA$19,000 — $21,000 $20,206 (a) We previously estimated net loss to be $25.9 million to $23.9 million, which we now estimate will be $28.6 million to $26.6 million. The increase is due to higher stock-based compensation, interest expense, former CFO severance, and elevated legal expenses related to the civil litigation.(b) We previously estimated restructuring, reorganization, stockholder activist settlement costs to be $9.9 million, which we now estimate will be approximately $10.3 million of which $8.2 million was incurred in the six months ended November 24, 2024. The overage is due to former CFO severance and elevated legal expenses related to the civil litigation.

AUSTIN, Texas, Dec. 19, 2024 /PRNewswire/ -- Alafair Biosciences announced today that it has surpassed 22,000 patient implants of its flagship product, VersaWrap Hydrogel Sheet, marking a significant milestone in the company's growth. The latest quarterly numbers confirm this achievement, highlighting the company's continuous upward trajectory. Continue Reading VersaWrap® HydroGel Sheet "It's tremendously gratifying to know that our technology is helping so many patients," said John Joyoprayitno, co-founder, President, and CEO of Alafair Biosciences. "This achievement would not be possible without the unwavering commitment of the entire Alafair team and our distributor partners. Seeing VersaWrap implanted in over 22,000 patients is a testament to the growing market adoption and positive impact it is having on patient outcomes." VersaWrap is a hyaluronic acid and alginate hydrogel that facilitates tissue gliding and prevents tethering, which reduces the need for reoperations and improves patient outcomes. Designed to protect injuries during healing, VersaWrap Tendon Protector is an FDA-cleared Class II medical device for use on tendons, ligaments, skeletal muscles, and VersaWrap Nerve Protector is cleared for use on peripheral nerves (including nerve roots). Most competing products are collagen-based—derived from bovine, porcine, or human placental tissue—which remodel into additional tissue and can add bulk. VersaWrap consists of hyaluronic acid and plant-based alginate, is free from human or animal materials, and dissolves completely without replacement, making it non-bulking. "Post-operative scarring and adhesions between adjacent soft tissue structures creates a variety of challenges throughout patient recovery. In my experience, patients who received VersaWrap have shown improved soft tissue gliding and decreased inflammation and pain, which I believe has expedited their recovery and return to normal activity," stated Walter Lin, MD, FACS, Plastic and Reconstructive Surgeon, The Buncke Clinic. About Alafair Biosciences, Inc. Alafair is a privately held medical device company developing and marketing an innovative product portfolio based on its proprietary hydrogel technology. The mission of Alafair is to revolutionize surgical care with our versatile hydrogel technology, delivering unparalleled value to patients, surgeons, and healthcare facilities by enhancing soft tissue protection and by elevating patient outcomes. Alafair products are distributed through a dispersed network of independent distributors across the United States. About VersaWrap® Hydrogel Sheet VersaWrap Hydrogel Sheet (VersaWrap Tendon Protector, VersaWrap Nerve Protector) is an FDA-cleared medical device implant (not tissue) comprising hyaluronic acid (HA) and alginate that provides a gelatinous encasement. VersaWrap Tendon Protector is indicated for tendons and surrounding tissues such as ligaments and skeletal muscles. VersaWrap Nerve Protector is indicated for peripheral nerves. Our innovative technology allows tissues to glide and to remain untethered, thereby reducing reoperations and improving patient outcomes. SOURCE Alafair Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED