Core Insights - Codexis will present data demonstrating the scalability and reproducibility of its enzymatic siRNA manufacturing processes at the TIDES USA annual meeting from May 19-22, 2025 [1][8] - The company will host two oral presentations and one poster presentation, focusing on various aspects of siRNA manufacturing [1][3][4] - A conference call is scheduled for May 22, 2025, to discuss the data presented during the conference [1][5] Presentation Details - The main stage talk will cover "Oligonucleotide CMC for Sustainable and Scalable Enzymatic siRNA Manufacturing" on May 21, 2025, by Alison Moore, PhD [3] - A comparative analysis of diastereomeric distribution in siRNA synthesis will also be presented by Stephanie Forget, PhD, on the same day [3] - A co-presentation with Bachem will focus on "Efficient Large-scale siRNA Manufacturing: Enzymatic Ligation of Short RNA Fragments" on May 20, 2025 [4] Poster Presentation - The poster titled "Machine Learning-Guided Ligation Fragment Design for Efficient siRNA Synthesis" will be presented by Mathew Miller, PhD, throughout the conference duration [5] Technological Advancements - Codexis is developing its proprietary ECO Synthesis™ manufacturing platform aimed at enabling the scaled manufacture of RNAi therapeutics through enzymatic methods [8] - The company is leveraging a groundbreaking machine learning tool to optimize ligase selection and fragment design, enhancing the efficiency of its manufacturing processes [6][8]

Core Viewpoint - Codexis, Inc. will report its financial results for Q1 2025 on May 14, 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 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 are designed to address challenges in small molecule pharmaceuticals manufacturing and nucleic acid synthesis, offering benefits such as higher yields, reduced energy consumption, and improved efficiency in manufacturing [3].

Core Viewpoint - Wall Street anticipates a year-over-year decline in earnings for Codexis, with a focus on how actual results compare to estimates impacting stock price [1][2] Earnings Expectations - Codexis is expected to report a quarterly loss of $0.20 per share, reflecting a 25% decrease year-over-year [3] - Projected revenues are $10.62 million, down 37.8% from the same quarter last year [3] Estimate Revisions - The consensus EPS estimate has remained unchanged over the last 30 days, indicating stability in analyst expectations [4] - The Zacks Earnings ESP model suggests that recent estimate revisions may provide insights into business conditions [5][6] Earnings Surprise Prediction - Codexis has a positive Earnings ESP of +26.23%, indicating a potential earnings beat based on recent analyst revisions [10] - The stock holds a Zacks Rank of 3, suggesting a likelihood of beating the consensus EPS estimate [11] Historical Performance - In the last reported quarter, Codexis was expected to post a loss of $0.02 per share but instead reported a loss of $0.13, resulting in a surprise of -550% [12] - Over the past four quarters, Codexis has only beaten consensus EPS estimates once [13] Conclusion - While Codexis is positioned as a potential earnings-beat candidate, other factors should also be considered when evaluating the stock ahead of its earnings release [16]

REDWOOD CITY, Calif., April 09, 2025 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, today announced that Byron Dorgan will retire from the Company’s Board of Directors when his current term ends at the 2025 Annual Meeting of Stockholders. Mr. Dorgan joined the Board in 2011, served as Chairman from 2021 through 2024, and currently serves as the Chair of the Nominating and Corporate Governance Committee. He wi ...

Core Insights - Codexis, Inc. has appointed Cynthia Collins to its Board of Directors, bringing extensive experience in the pharmaceutical and biotech industry [1][2] - The company aims to expand its commercial footprint with its ECO Synthesis toolbox, which is positioned to unlock the potential of RNA-based therapeutics [2] Company Overview - Codexis is a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, utilizing its proprietary CodeEvolver® technology platform [3] - The company is developing the ECO Synthesis™ manufacturing platform to enable the scaled manufacture of RNAi therapeutics through an enzymatic route [3] - Codexis' unique enzymes are designed to improve yields, reduce energy usage and waste generation, and enhance efficiency in manufacturing [3] Leadership Background - Cynthia Collins has over four decades of experience in the pharmaceutical and biotech sectors, currently serving as Executive Chair and interim CEO of Nutcracker Therapeutics [2] - Her previous roles include CEO of Editas Medicine, where she oversaw the first clinical trial of an in vivo CRISPR gene editing therapy, and various leadership positions at GE Healthcare and Baxter Healthcare [2]

Core Insights - Codexis, Inc. has announced its first revenue-generating contract to manufacture siRNA material in its ECO Synthesis™ Innovation Lab, marking a significant milestone in its operations [1] - The company has successfully developed the first generation of its core ECO Synthesis™ enzymes, meeting criteria for scaling to industrial capacity [2] - CEO Stephen Dilly expressed excitement over the contract and highlighted the successful development of a suite of enzymes that can drive the ECO Synthesis™ platform at an industrial scale [3] Company Overview - Codexis is a leading provider of enzymatic solutions aimed at efficient and scalable therapeutics manufacturing, utilizing its proprietary CodeEvolver® technology platform [4] - The company is focused on developing its ECO Synthesis™ manufacturing platform to enable the large-scale production of RNAi therapeutics through an enzymatic route, which offers advantages such as higher yields and reduced energy usage [4]

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $21.5 million, including product revenue of $9.8 million and R&D revenue of $11.6 million [29] - Revenue for the year ended December 31, 2024, was $59.3 million, down from $62 million in the prior year [31] - The net loss for Q4 2024 was $10.4 million, compared to $15.3 million for Q4 2023, while the net loss for the year was $65.3 million, down from $84.4 million in the prior year [37] Business Line Data and Key Metrics Changes - The company has made significant progress in its Pharma Biocatalysis business, focusing on expanding its reach to mid-tier pharma and large biotech segments [12] - The ECO Synthesis platform is expected to achieve commercial liftoff in 2025, transitioning from development to commercial execution [11][10] - Product gross margin was 63% in Q4 2024, down from 71% in Q4 2023, and 56% for the year, compared to 63% the prior year [34] 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] - The company aims to secure a CDMO scale-up partner in 2025 to facilitate larger scale manufacturing for clinical trials and commercial production [21] Company Strategy and Development Direction - The company is focused on repositioning for growth, with expectations for improved revenue growth in 2025 as its ligase and ECO services platform matures [32] - The strategy includes building a full-service development and manufacturing offering to capture the emerging drug innovator market [22] - The company plans to simplify its revenue guidance by providing a single annual revenue range encompassing the full scope of its business [38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made over the past year, particularly in returning the pharma manufacturing business to a growth trajectory [6] - The company anticipates that 2025 will be a pivotal year for the ECO Synthesis platform, with significant revenue growth expected in the second half of the year [40] - Management highlighted the importance of demonstrating the utility of the ECO platform to drive adoption among large drug developers [45] Other Important Information - The company ended 2024 with $73.5 million in cash, cash equivalents, and short-term investments, expected to fund operations until achieving cash flow positivity by the end of 2026 [40] - The company is actively working on establishing a raw material supply chain, which is critical for customer adoption of its services [24] 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 relationships with customers are multifaceted, and conversations often evolve from one service to another, making it difficult to categorize them neatly [71] Question: What are the expectations for gross margins in 2025? - The company aims to improve gross margins year-over-year and is actively working to 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 on costs 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]

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].