ATLANTA, April 30, 2024 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, announces today that it will report first quarter financial results on May 14, 2024, prior to the market open. Management will host a conference call at 9:00 AM ET on the same day, to review financial results and provide an update on corporate devel ...

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Financial Data and Key Metrics Changes - In Q4 2023, consolidated global net revenue grew 88% to $26.3 million compared to Q4 2022 [9] - For the full year 2023, net revenue increased 49% to $80.8 million compared to $54.1 million in 2022 [21] - Adjusted EBITDA in Q4 2023 was $5 million, a significant improvement from an adjusted EBITDA loss of $1.2 million in Q4 2022 [10] - For the full year 2023, adjusted EBITDA was $8.7 million compared to a loss of $7.9 million in 2022 [23] Business Line Data and Key Metrics Changes - US net revenue in Q4 2023 increased 104% to $19.2 million compared to $9.4 million in Q4 2022 [10] - For the full year 2023, US net revenue increased 66% to $56.7 million compared to $34.2 million in 2022 [21] - International net revenue in Q4 2023 grew 54% to $7.1 million compared to approximately $4.6 million in Q4 2022 [20] - For the full year 2023, international net revenue increased 21% to approximately $24 million compared to $19.9 million in 2022 [21] Market Data and Key Metrics Changes - US end-user demand for products was up 4.4% in Q4 2023 versus the prior year and 11% on a pro forma basis for the full year [10] - International segment end-user demand grew 16.7% in Q4 and 11.8% for the full year, driven by markets such as the UK, Portugal, Ireland, Spain, and France [12] Company Strategy and Development Direction - The company aims to leverage the acquisition of YUTIQ to increase utilization of both ILUVIEN and YUTIQ in the US market [7] - The strategy includes expanding the sales force and promoting both products to enhance physician engagement and treatment options [28] - The company anticipates achieving over $105 million in revenue with an adjusted EBITDA margin of 20% for 2024 [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming supply issues and expects to meet end-user demand in Europe moving forward [12] - The company is optimistic about the potential impact of NICE's guidance on expanding the patient base for ILUVIEN in the UK and potentially in other markets [15] - Management highlighted the importance of upcoming clinical study results, particularly the NEW DAY and SYNCHRONICITY studies, in shaping future treatment paradigms [17][18] Other Important Information - The company completed enrollment in two Phase IV clinical studies, which are expected to provide impactful data [16] - Cash and cash equivalents as of December 31, 2023, were approximately $12.1 million, up from $5.3 million at the end of 2022 [24] - The company increased the size of its loan facility by an additional $5 million to enhance operational flexibility [25] Q&A Session Summary Question: What is the expected utilization crossover for ILUVIEN and YUTIQ? - Management aspires to increase the crossover utilization to over 50% in the next 12 months, acknowledging that not all specialists will use both products [32] Question: What is the competitive environment for DME and Uveitis? - Management noted increased competition from new entrants but believes there remains a significant patient population that requires corticosteroid treatment [35] Question: When can top-line data for the NEW DAY study be expected? - Top-line data is anticipated in early 2025, following the last patient visit in Q4 2024 [37] Question: What is the expected interest expense for 2024? - The typical run rate for interest expense is expected to be around $3.5 million quarterly, with additional contingent interest payments anticipated [41]

Company Overview - Alimera Sciences specializes in the commercialization and development of prescription ophthalmic retinal pharmaceuticals, focusing on chronic retinal diseases that affect millions globally[14]. - The company is dependent on the commercial success of ILUVIEN and YUTIQ, as they currently do not have other products or candidates available for sale or in clinical development[115]. Product Development and Commercialization - The company internally developed ILUVIEN (0.19 mg) for diabetic macular edema (DME) and acquired exclusive rights to YUTIQ (0.18 mg) in May 2023 for chronic non-infectious uveitis affecting the posterior segment of the eye[15]. - ILUVIEN and YUTIQ provide continuous microdosing of fluocinolone acetonide for up to 36 months, allowing patients to maintain vision longer with fewer injections[21]. - Alimera aims to maximize the commercial success of ILUVIEN and YUTIQ in current markets and plans to complete the SYNCHRONICITY and NEW DAY studies to enhance physician utilization of these products[17][18]. - The company is pursuing regulatory approvals for ILUVIEN in additional countries, including China, where a distributor plans to seek approval for DME treatment[18]. - The company is actively evaluating opportunities for further clinical trials of ILUVIEN in treating other ophthalmic diseases such as Retinal Vein Occlusion (RVO) and Age-related Macular Degeneration (AMD)[63]. Financial Performance - In fiscal year 2023, the company reported revenues of $56.7 million in the U.S. and $24.0 million internationally, compared to $34.2 million and $19.9 million in 2022, respectively[72]. - The company has incurred a cumulative deficit of $418.5 million from inception through December 31, 2023, and has experienced operating losses each year since inception[136]. - GAAP net loss for December 2023 was $20,132 million, compared to a loss of $18,107 million in 2022[276]. - Non-GAAP adjusted EBITDA for December 2023 was $8,711 million, an improvement from a loss of $7,877 million in 2022[276]. Market and Competition - The company is facing competition from major pharmaceutical and biotechnology companies in the development and commercialization of ILUVIEN and YUTIQ[73]. - The company believes ILUVIEN is underutilized and should be used earlier in DME treatment to control the disease process and reduce edema recurrence[46]. - The company faces significant competition from larger pharmaceutical and biotechnology companies, which may impact the commercial success of ILUVIEN and YUTIQ[115]. Regulatory and Compliance - The commercialization and regulatory approval of pharmaceutical products like ILUVIEN and YUTIQ are subject to FDA and foreign regulatory requirements, with potential sanctions for non-compliance[141]. - The company is required to meet post-marketing safety surveillance requirements to continue marketing approved products, including reporting any adverse events to the FDA[91]. - Compliance with complex foreign and U.S. laws may increase operational costs and expose the company to fines and penalties, impacting financial performance[126]. Intellectual Property - The active pharmaceutical ingredient in ILUVIEN and YUTIQ, FAc, is not patent protected, allowing competitors to develop alternative formulations[82]. - The company relies on its ability to protect intellectual property, with the success of its products dependent on obtaining and maintaining patent protection, which is uncertain in the biotechnology and pharmaceutical fields[155]. - The company may face patent infringement claims that could lead to substantial litigation costs and divert resources, impacting its ability to commercialize current and future products[156]. Strategic Partnerships - Alimera's collaboration with EyePoint Pharmaceuticals includes a royalty structure of 6% on net revenues up to $75 million and 8% on revenues exceeding that amount, with a future offset reducing these rates temporarily[30]. - An upfront payment of $75 million was made to EyePoint for the exclusive rights to YUTIQ, with additional quarterly payments totaling $7.5 million planned for 2024[31]. - The company has granted an exclusive license to Ocumension for the development and commercialization of its 0.19 mg fluocinolone acetonide intravitreal injection in China, East Asia, and the Western Pacific[115]. Risks and Challenges - The company faces significant regulatory, economic, and legal barriers that could adversely affect its operations and financial position[117]. - Cybersecurity threats pose risks to the company’s information technology systems, potentially leading to data breaches and operational disruptions[119]. - The company may need additional capital to fund operations and support growth, with potential dilution of stockholder investment if raised through equity[133]. Human Resources - The company employs 159 individuals as of February 29, 2024, with 154 being full-time employees[108]. - The company may need to invest significantly in recruiting and retaining qualified personnel to support future growth and commercialization efforts[121]. Market Opportunities - The International Diabetes Federation estimated that the prevalence of diabetes worldwide increased to 537 million in 2021 and is expected to rise to 783 million by 2045[34]. - The CDC reports that around 97.6 million people have prediabetes, with less than 20% aware of their condition, indicating a significant market opportunity for diabetes-related treatments[35]. - The company is exploring substantial market opportunities in China and the Western Pacific under a license agreement with Ocumension, although regulatory challenges remain[125].

Alimera Sciences (ALIM) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of $0.02. This compares to loss of $0.54 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -450%. A quarter ago, it was expected that this eye drug developer would post a loss of $0.41 per share when it actually produced a loss of $0.06, delivering a surprise of 85.37%.Over the last four quarters, the company has surpass ...

Revenue Growth - Q4 2023 net revenues increased by 88% to $26.3 million compared to Q4 2022[7] - Full year 2023 net revenues rose by 49% to $80.8 million compared to 2022[8] - U.S. net revenue for Q4 2023 was $19.2 million, up 104% year-over-year[11] - International net revenue for Q4 2023 reached $7.1 million, a 54% increase from Q4 2022[7] - U.S. net revenue for 2023 increased by 66% to $56.7 million, driven by the acquisition of YUTIQ[13] - International net revenue for 2023 grew by 21% to approximately $24.0 million[8] - Net revenue for the three months ended December 2023 was $26,306,000, up 87.5% from $14,029,000 in the same period of 2022[34] Profitability - Adjusted EBITDA for Q4 2023 was $5.0 million, compared to an adjusted EBITDA loss of $(1.2) million in Q4 2022[17] - The company expects to achieve over $105 million in net revenue for 2024, with an Adjusted EBITDA margin greater than 20%[4] - Full year 2023 net loss was approximately $(20.1) million, compared to $(18.1) million in 2022[8] - Net loss applicable to common shareholders for the twelve months ended December 2023 was $21,391,000, compared to a loss of $18,107,000 in 2022, reflecting a 12.6% increase in losses[34] - Non-GAAP adjusted EBITDA for the three months ended December 2023 was $5,030,000, a significant improvement from a loss of $1,238,000 in the same period of 2022[36] Assets and Liabilities - Total current assets increased to $52,423,000 in December 2023 from $29,413,000 in December 2022, representing a 78.1% growth[31] - Total liabilities rose to $107,355,000 in December 2023 from $63,410,000 in December 2022, marking a 69.2% increase[31] - Total assets increased to $153,524,000 in December 2023 from $42,602,000 in December 2022, reflecting a 260.5% growth[31] - Cash and cash equivalents increased to $12,058,000 in December 2023 from $5,274,000 in December 2022, representing a 128.5% increase[31] Operating Expenses - Operating expenses for the twelve months ended December 2023 totaled $71,849,000, up from $57,949,000 in 2022, indicating a 24% increase[34] Gross Profit - Gross profit for the twelve months ended December 2023 reached $69,917,000, a 51.5% increase compared to $46,152,000 in 2022[34] - The company reported a gross profit margin of 86.1% for the three months ended December 2023, compared to 84.8% in the same period of 2022[34] Management Changes - The company has strengthened its management team with new key appointments[9]

ATLANTA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, announces today that it will report fourth quarter and full year 2023 financial results on March 7, 2024, prior to the market open. Management will host a conference call at 9:00 AM ET on the same day, to review financial results and provide an updat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-34703 Alimera Sciences, Inc. (Exact name of registrant as specified in its charter) Delaware 20-0028718 (State or other jur ...

Alimera Sciences, Inc. (NASDAQ:ALIM) Q3 2023 Results Conference Call October 26, 2023 9:00 AM ET Company Participants Scott Gordon - CORE IR Rick Eiswirth - President, CEO & Director Russell Skibsted - SVP & CFO Conference Call Participants Alex Nowak - Craig-Hallum Yi Chen - H.C. Wainwright Laura Suriel - Alliance Global Partners Operator Ladies and gentlemen, thank you for standing by. Good morning, and welcome to the Alimera Sciences Third Quarter 2022 [2023] (sic) Financial Results and Corporate Update ...

Alimera Sciences, Inc. (NASDAQ:ALIM) Q2 2023 Earnings Conference Call August 10, 2023 9:00 AM ET Company Participants Scott Gordon - CORE IR Richard Eiswirth - President, CEO & Director Russell Skibsted - SVP & CFO Conference Call Participants Alexander Nowak - Craig-Hallum James Molloy - Alliance Global Partners Yi Chen - H.C. Wainwright & Co. Operator Ladies and gentlemen, thank you for standing by. Good morning, and welcome to the Alimera Sciences Second Quarter 2023 Financial Results Conference Call. [O ...