Strategic Prioritization and Restructuring - The company reported a strategic prioritization in July 2023, discontinuing investment in certain development programs and completing the divestiture of non-core life science assets, including biotherapeutics [11]. - The company has discontinued investment in certain development programs, primarily in its novel biotherapeutics business segment, and completed the divestiture of certain biotherapeutics and non-core life science assets during 2024 [11]. - The company announced the assignment and assumption of lease for its San Carlos, California facility as part of a restructuring plan, consolidating operations to its Redwood City headquarters [65]. Manufacturing and Technology Development - The ECO Synthesis manufacturing platform aims to enable the commercial-scale manufacture of RNAi therapeutics, with over 450 RNAi therapeutic assets in development, including more than 100 in Phase 2 and Phase 3 clinical trials [22]. - The company completed the build-out of its ECO Synthesis Innovation Lab at the end of 2024, designed to optimize manufacturing processes for specific siRNA assets before technology transfer to CDMO partners [26]. - The ECO Synthesis platform is expected to manufacture tens to hundreds of kilograms of high-purity RNA per synthesis batch, addressing limitations of traditional solid-phase oligonucleotide synthesis methods [24]. - The ECO Synthesis platform is designed to mitigate the need for high volumes of acetonitrile, significantly decreasing chemical waste streams and reducing disposal costs [24]. - The ECO Synthesis manufacturing platform enables the production of siRNA therapeutics, optimizing manufacturing processes for clients [27]. - The current industry standard, solid-phase oligonucleotide synthesis (SPOS), is limited to single-digit kilogram synthesis batch sizes, which poses challenges for quality control and scalability [23]. - The ECO Synthesis platform offers scalability advantages over traditional phosphoramidite chemistry, potentially reducing capital expenditure for infrastructure [29]. - The company is exploring the expansion of services to include GMP manufacturing for clinical-grade material [32]. - The company aims to enhance its ECO Synthesis platform to address market needs for scalable and sustainable RNAi manufacturing [12]. - The company is developing a hybrid ligation approach using its dsRNA ligase to enhance RNAi manufacturing efficiency [47]. Partnerships and Collaborations - The company anticipates entering a partnership with a large-scale contract development and manufacturing organization (CDMO) to synthesize GMP-grade siRNA drug substance for customers in 2025 [12]. - The company expects to sign a CDMO scale-up partnership in 2025 to provide enzymatically synthesized GMP-grade siRNA material to drug developer customers [57]. - Codexis entered into a licensing agreement with Aldevron for the Codex HiCap RNA Polymerase, which includes payments for technical milestones and sales-based royalties [35]. - Codexis has entered into licensing agreements with major pharmaceutical companies, including GSK, Merck & Co, and Novartis, to utilize its CodeEvolver technology for custom-designed enzymes [21]. - The company has monetized non-core assets, including a purchase agreement with Nestlé for CDX-7108 and an exclusive licensing agreement with Roche for a newly engineered DNA ligase, both announced in late 2023 and early 2024 [51]. Financial Performance and Revenue Generation - The top five selling pharma biocatalysis enzymes generated between $2.0 million to $9.0 million annually per enzyme from 2021 to 2024, excluding sales related to Pfizer's PAXLOVID [29]. - Four key customers accounted for approximately 51% of total revenues for the year ended December 31, 2024, with the largest customer contributing 18% [63]. - The company aims to grow revenues by expanding its pharma biocatalysis business and developing the ECO Synthesis manufacturing platform for RNAi therapeutics [47]. - Codexis has received an upfront payment of $5.0 million and milestone payments totaling $9.0 million from Novartis under the CodeEvolver Agreement [40]. - The company is eligible to receive future milestone payments and a low-to-mid single-digit percentage net sales-based royalty from Crosswalk Therapeutics for Fabry and Pompe disease compounds [45]. - Codexis aims to expand its services to include GMP manufacturing, which would allow the provision of clinical-grade material for Phase 1 clinical studies [32]. Research and Development - The company is focused on expanding its pipeline of engineered enzymes for 14 drug candidates currently in Phase 2 and Phase 3 clinical trials [18]. - The company anticipates continued investments in data science and computational biology to maintain leadership in enzyme engineering [51]. - Research and development efforts focus on engineering biocatalysts, with enzyme manufacturing primarily conducted in-house and through third-party contract manufacturing organizations (CMOs) in Austria, Italy, and the UK [66]. - The company emphasizes collaboration among interdisciplinary teams to drive technological innovation in its research and development efforts [69]. Regulatory and Compliance - The regulatory environment is extensive, with significant costs associated with compliance to FDA and other regulatory bodies impacting operational results [67]. - The manufacturing process includes rigorous quality control measures to meet the standards set by regulatory agencies, impacting supplier relationships [67]. Employee and Workplace Initiatives - The company is committed to maintaining a safe and healthy workplace for its employees, reflecting its dedication to health and safety [72]. - The company offers competitive compensation and benefits, including a 401(k) Plan and Employee Stock Purchase Plan (ESPP) to attract and retain talent [70]. - Diversity, equity, and inclusion initiatives are in place to foster an inclusive work environment, with regular reviews of policies guided by executive leadership [71]. - As of December 31, 2024, the company had 188 full-time and part-time employees, with 47 in research and development, 47 in operations and quality control, and 94 in selling, general, and administrative activities [69].

Financial Performance - Total revenue for fiscal year 2024 was $59.3 million, a decrease of 4% compared to $62.0 million in fiscal year 2023[7] - The net loss for fiscal year 2024 was $65.3 million, or $0.89 per share, compared to a net loss of $76.2 million, or $1.12 per share, for fiscal year 2023[8] - Total revenues for Q4 2024 were $21,460 million, a decrease of 19.5% compared to $26,561 million in Q4 2023[18] - The net loss for the year ended December 31, 2024, was $65,276 million, a slight improvement from a net loss of $76,240 million in 2023[18] Revenue Breakdown - Product revenues increased by 6% to $36.8 million for fiscal year 2024, compared to $34.8 million in fiscal year 2023[7] - R&D revenues for fiscal year 2024 were $22.6 million, down from $27.2 million in fiscal year 2023[7] - Product revenue for the year ended December 31, 2024, was $36,786 million, down from $42,906 million in 2023, representing a decline of 14.4%[18] - Research and development revenue increased to $11,642 million in Q4 2024 from $8,462 million in Q4 2023, marking a growth of 37.7%[18] Expenses and Margins - Product gross margin for fiscal year 2024 was 56%, down from 63% in fiscal year 2023[8] - R&D expenses for fiscal year 2024 were $46.3 million, a decrease from $58.9 million in fiscal year 2023[8] - Total costs and operating expenses rose to $28,802 million in Q4 2024, compared to $26,279 million in Q4 2023, an increase of 5.8%[18] Cash and Assets - Cash reserves as of December 31, 2024, were $73.5 million, providing a path to cash flow positivity anticipated by the end of 2026[8] - Cash and cash equivalents decreased significantly to $19,264 million in 2024 from $65,116 million in 2023, a decline of 70.5%[20] - Total assets increased to $149,011 million in 2024, up from $136,561 million in 2023, reflecting a growth of 9.5%[20] - Total liabilities rose to $82,084 million in 2024, compared to $49,946 million in 2023, an increase of 64.5%[20] - The accumulated deficit increased to $562,806 million in 2024 from $497,530 million in 2023, indicating a rise of 13.1%[20] Future Outlook - Codexis expects total revenues for 2025 to be in the range of $64 million to $68 million, indicating anticipated growth[14] - The company plans to achieve pilot scale production of GLP-grade siRNA material using the ECO Synthesis™ Innovation Lab in 2025[7] - Codexis aims to sign a GMP scale-up partner by the end of 2025 to enable larger scale clinical and commercial siRNA production[7] Share Information - The weighted average common stock shares used in computing net loss per share increased to 81,300 in Q4 2024 from 69,500 in Q4 2023[18]

Core Insights - Codexis, Inc. reported total revenue of $59.3 million for the fiscal year ended December 31, 2024, with expectations for double-digit growth in 2025 [1][8] - The company anticipates an acceleration of commercial growth through its ECO Synthesis™ platform and aims to secure a GMP scale-up partner [1][2] Financial Performance - Total revenues for fiscal year 2024 decreased by 4% compared to $62.0 million in fiscal year 2023, excluding enzyme sales related to PAXLOVID™ [8] - Product revenues increased by 6% to $36.8 million for fiscal year 2024 compared to $34.8 million in fiscal year 2023, excluding enzyme sales related to PAXLOVID™ [8] - R&D revenues for fiscal year 2024 were $22.6 million, down from $27.2 million in fiscal year 2023, primarily due to lower non-recurring items [8] - The net loss for fiscal year 2024 was $65.3 million, or $0.89 per share, compared to a net loss of $76.2 million, or $1.12 per share, for fiscal year 2023 [8] Recent Developments - Codexis completed the build-out of its ECO Synthesis™ Innovation Lab in December 2024, enabling the provision of analytical and process development services [3] - The company appointed Arthur Levin, PhD, to its Strategic Advisory Board in February 2025, bringing extensive experience in oligonucleotide development [3] - In October 2024, Codexis announced the licensing of a genomics life science enzyme portfolio to Alphazyme, LLC, which includes several key enzymes [3] Upcoming Initiatives - Codexis plans to sign its first development contract for ECO Synthesis™ manufacturing services in the first half of 2025 [8] - The company expects to achieve pilot scale production of GLP-grade siRNA material using the ECO Synthesis™ Innovation Lab in 2025 [8] - Codexis anticipates hosting presentations at the 2025 TIDES USA and TIDES Europe annual meetings to showcase the capabilities of its ECO Synthesis™ platform [8]

Core Insights - Codexis, Inc. will attend the TD Cowen 45th Annual Health Care Conference from March 3-5, 2025, in Boston, Massachusetts [1] - Management will participate in a fireside chat on March 4, 2025, at 1:10 pm ET, with a live webcast available on the company's Investor Relations website [2] Company Overview - Codexis is a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, utilizing its proprietary CodeEvolver technology platform to enhance novel, high-performance enzymes [3] - The company is developing the ECO Synthesis™ manufacturing platform to enable the scaled manufacture of RNAi therapeutics through an enzymatic route, aiming for higher yields, reduced energy usage, and improved efficiency in manufacturing [3]

Core Viewpoint - Codexis, Inc. will report its financial results for Q4 and fiscal year 2024 on February 27, 2025, and will host a conference call to discuss these results and provide a business update [1]. Company Overview - Codexis is a leading provider of enzymatic solutions aimed at efficient and scalable therapeutics manufacturing, utilizing its proprietary CodeEvolver technology platform to enhance novel, high-performance enzymes [3]. - The company is developing the ECO Synthesis™ manufacturing platform to facilitate the scaled production of RNAi therapeutics through an enzymatic process [3]. - Codexis' enzymes contribute to improvements in pharmaceuticals manufacturing, including higher yields, reduced energy consumption, lower waste generation, and enhanced efficiency in genomic and diagnostic applications [3].

Core Insights - Codexis, Inc. has appointed Dr. Arthur Levin to its Strategic Advisory Board, enhancing its expertise in oligonucleotide development and manufacturing [1][2] - Dr. Levin's extensive experience includes developing the first approved antisense drugs and microRNA-targeted therapeutics, which will provide valuable guidance for Codexis's growth with its ECO Synthesis platform [2] - The Strategic Advisory Board, established in 2023, consists of experts in oligonucleotide synthesis and manufacturing, playing a crucial role in guiding Codexis's strategic direction [3][4] Company Overview - Codexis is a leading provider of enzymatic solutions aimed at efficient and scalable therapeutics manufacturing, utilizing its proprietary CodeEvolver technology platform [5] - The company is focused on developing its ECO Synthesis™ manufacturing platform to enable the large-scale production of RNAi therapeutics through enzymatic methods [5] - Codexis's unique enzymes are designed to improve yields, reduce energy consumption, and enhance efficiency in pharmaceutical manufacturing and nucleic acid synthesis [5]

Core Insights - Codexis, Inc. has appointed Christos Richards to its Board of Directors, which is expected to enhance the company's strategic direction in the life sciences sector [1][2][8] - Christos Richards brings over 30 years of experience in the biopharmaceutical and healthcare industry, having completed more than 450 executive assignments, including over 200 Board and CEO succession projects [3][5] - Codexis specializes in enzymatic solutions for therapeutics manufacturing, leveraging its proprietary CodeEvolver technology platform to develop high-performance enzymes [6] Company Overview - Codexis is focused on efficient and scalable therapeutics manufacturing, addressing challenges in small molecule pharmaceuticals and nucleic acid synthesis [6] - The company is developing the ECO Synthesis™ manufacturing platform to enable the scaled production of RNAi therapeutics through enzymatic methods [6] - Codexis' unique enzymes aim to improve yields, reduce energy usage and waste, and enhance efficiency in manufacturing processes [6] Leadership Insights - Stephen Dilly, Chairman and CEO of Codexis, expressed confidence in Christos Richards' expertise and its potential impact on the company's transformation [2] - Richards emphasized the potential of Codexis' proprietary technologies to drive growth in RNAi therapeutics and other novel modalities [3]

REDWOOD CITY, Calif., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, today announced the Company will attend the Piper Sandler 36th Annual Healthcare Conference, being held December 3-5, 2024, in New York, New York. Management will participate in a fireside chat on Tuesday, December 3, 2024, at 11:00 am ET. A live webcast of the event will be available in the Investor Relations section of the Co ...

—Becomes first company to showcase four routes of synthesis for approved siRNA therapeutic asset— —Joint poster with Bachem demonstrates superiority of Company’s double-stranded RNA ligases compared to wild-type enzymes— —Management to host conference call today at 4:30 pm EST to discuss data— REDWOOD CITY, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, today announced data from three pr ...

—Spotlight Presentation to showcase four routes of synthesis of an approved siRNA therapeutic asset— —Joint poster presentation with Bachem to compare Codexis double-stranded RNA ligase to wild-type enzymes— —Management to host conference call on Thursday, November 14 to discuss data— REDWOOD CITY, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, today announced the Company will demonstrat ...