Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $21.5 million, with product revenue of $9.8 million and R&D revenue of $11.6 million. For the year ended December 31, 2024, revenue was $59.3 million compared to $62 million in the prior year [29][31] - The net loss for Q4 2024 was $10.4 million, down from $15.3 million in Q4 2023. The net loss for the year was $65.3 million compared to $84.4 million in the prior year [37][40] - Product gross margin was 63% in Q4 2024, down from 71% in Q4 2023. For the year, gross margin was 56%, compared to 63% the prior year [34][35] Business Line Data and Key Metrics Changes - The company is focused on expanding its Pharma Biocatalysis business, which has shown growth and stable gross margins, providing a solid foundation for investment in new technologies [32][33] - The ECO Synthesis platform is expected to achieve commercial liftoff in 2025, transitioning from development to commercial execution [10][11] Market Data and Key Metrics Changes - The company is seeing increased customer engagement for its RNA ligase and ECO Synthesis platforms, with multiple feasibility studies completed with leading siRNA innovator companies [9][12] - The company aims to secure a CDMO scale-up partner in 2025 to facilitate larger scale manufacturing for clinical trials and commercial production [21][23] Company Strategy and Development Direction - The company is transitioning from a declining business model to one focused on growth, particularly through its ligase and ECO Synthesis platforms [32][33] - The strategy includes building a full-service development and manufacturing offering to capture the emerging drug innovator market [22][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving improved revenue growth in 2025 and beyond, driven by the maturation of the ligase and ECO services platform [32][38] - The company is guiding for total 2025 revenue in the range of $64 million to $68 million, expecting double-digit growth across its entire revenue base [38][40] Other Important Information - The company ended 2024 with $73.5 million in cash, cash equivalents, and short-term investments, which is expected to fund operations until achieving cash flow positivity by the end of 2026 [40] Q&A Session Summary Question: What will drive the value proposition in rare disease markets? - Management believes both validated platforms and successful case studies from larger indications will drive interest in rare disease markets [58] Question: How will the company communicate progress to the market? - The company will carefully balance communication of progress while maintaining confidentiality with partners [62] Question: Can you elaborate on the customer pipeline and revenue conversion? - The company indicated that relationships with customers are multifaceted and evolve over time, making it difficult to categorize them neatly [71][74] Question: What are the expectations for gross margins in 2025? - Management expects gross margins to improve year-over-year as they retire lower-margin products [85] Question: How will the GMP facility impact cash flow guidance? - The GMP facility is still in planning phases, and more visibility will be available in the summer [91] Question: Will the company consider alternative payment structures with cash-strapped innovators? - The company is open to sensible upfront payments in exchange for back-end economics, recognizing the financial constraints of smaller innovators [125]

Core Viewpoint - Codexis reported a quarterly loss of $0.13 per share, significantly worse than the Zacks Consensus Estimate of a loss of $0.02, marking an earnings surprise of -550% [1] - The company’s revenues for the quarter were $21.46 million, missing the consensus estimate by 26.65% and down from $26.56 million a year ago [2] Financial Performance - Over the last four quarters, Codexis has surpassed consensus EPS estimates only once [2] - The company has topped consensus revenue estimates three times in the last four quarters [2] - Year-to-date, Codexis shares have declined by approximately 12.8%, contrasting with a 1.3% gain in the S&P 500 [3] Future Outlook - The sustainability of the stock's price movement will largely depend on management's commentary during the earnings call [3] - Current consensus EPS estimate for the upcoming quarter is -$0.16 on revenues of $13.49 million, and for the current fiscal year, it is -$0.66 on revenues of $65.26 million [7] - The estimate revisions trend for Codexis is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Codexis belongs, is currently ranked in the top 28% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

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 ...