Financial Data and Key Metrics - Total revenues for Q3 2024 were $12.8 million, with product revenue of $11.2 million and R&D revenue of $1.7 million, compared to $9.3 million in Q3 2023 [33] - Product gross margin improved to 61% in Q3 2024, up from 58% in Q3 2023, driven by product mix [34] - R&D expenses decreased by 16% year-over-year to $11.5 million in Q3 2024, reflecting cost control measures [34] - Net loss for Q3 2024 was $20.6 million, compared to $34.9 million in Q3 2023 [35] - The company ended the quarter with $90 million in cash, cash equivalents, and investments, expected to fund operations through profitability and into 2027 [36] Business Line Performance - Pharma manufacturing revenue grew significantly, driven by timing of customer orders [33] - The company initiated technical collaborations on its ECO Synthesis manufacturing platform and completed the divestiture of its legacy genomics enzyme portfolio to Alphazyme [8] - Orders for double-stranded RNA ligase enzymes increased as customers progressed through clinical trials, with new customers testing the variants [18] - The ECO Synthesis Innovation Lab is on track for completion by the end of 2024, with plans to increase customer adoption in 2025 [29] Market Performance - The company is seeing increased interest from major siRNA drug developers and CDMOs, particularly for its ECO Synthesis platform [45][46] - The enzymatic production of nucleotide quatro phosphate (NQP) and nucleotide triphosphate (NTP) building blocks is gaining traction due to sustainability and cost advantages [23][24] - The company is working towards establishing a kilogram-scale GMP facility to support early-phase clinical trials and accelerate adoption of the ECO Synthesis platform [28] Strategic Direction and Industry Competition - The company has a clear path to profitability by the end of 2026, driven by growth in pharma manufacturing and higher-margin biocatalysis products [9][10] - Investments are being made to modernize internal manufacturing capabilities, improve downstream purification, and design a kilogram-scale facility for the ECO Synthesis platform [13][14][15] - The company is focusing on becoming a customer-oriented, mature commercial organization by taking assets further through development in-house [15] Management Commentary on Operating Environment and Future Outlook - Management expects continued growth in pharma manufacturing and increased orders for double-stranded RNA ligase enzymes as key drivers for 2025 [47] - The company is confident in its financial, technical, and human resources to achieve profitability by 2026 [37] - The ECO Synthesis platform is seen as a significant opportunity, with the company aiming to solidify partnerships for GMP production and expand its market reach [27][28] Other Important Information - The company plans to host a webcast investor recap call on November 14th to share updates from the TIDES Europe meeting [22] - The company is exploring opportunities to monetize non-core assets, including milestones from its relationship with Nestle [75] Q&A Session Summary Question: Key parameters for evaluating the success of ECO Synthesis - The two key parameters are overall yield of full-length product and the impurity profile [39] Question: Level of detail in future partnership announcements - The company aims to provide as much detail as possible, depending on the partner and the nature of the collaboration [40] Question: Early expectations for Paxlovid - The company is not assuming any revenue from Paxlovid and is not planning for it in its guidance [42] Question: Type of clients for ECO Synthesis technology - The company is seeing interest from major siRNA drug developers and CDMOs, with a focus on quality over quantity [45][46] Question: Major hurdles in forming partnerships - The company is focused on identifying a GMP scale-up partner and demonstrating the path to GMP for customers [50][51] Question: Revenue structure for ECO Synthesis collaborations - Collaborations could range from straight-up development contracts to joint development agreements with upfront milestones and royalties [65] Question: Investment magnitude for purification and kilogram-scale facility - Investments in purification and modernization are expected to be in the low-single-digit millions, with the kilogram-scale facility being a larger investment over time [69][70] Question: Monetization of non-core assets - The company is close to completing the monetization of non-core assets, with potential milestones from its relationship with Nestle [74][75] Question: Impact of bringing enzyme production in-house on gross margin - Bringing enzyme production in-house is expected to improve margins, particularly for new enzymes with higher margins [77] Question: Customer perception of Codexis - Customers are increasingly viewing Codexis as a leader in enzymatic synthesis of RNA constructs, with growing awareness in the siRNA market [86][87]

Group 1: Earnings Performance - Codexis reported a quarterly loss of $0.29 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.25, and compared to a loss of $0.26 per share a year ago, indicating an earnings surprise of -16% [1] - The company posted revenues of $12.83 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 10.27%, and showing an increase from year-ago revenues of $9.28 million [2] - Over the last four quarters, Codexis has surpassed consensus EPS estimates two times and topped consensus revenue estimates four times [2] Group 2: Stock Performance and Outlook - Codexis shares have increased by approximately 5.3% since the beginning of the year, while the S&P 500 has gained 21.9%, indicating underperformance relative to the broader market [3] - The current consensus EPS estimate for the upcoming quarter is -$0.02 on revenues of $29.68 million, and for the current fiscal year, it is -$0.75 on revenues of $66.03 million [7] - The estimate revisions trend for Codexis is currently unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, suggesting expected underperformance in the near future [6] Group 3: Industry Context - The Medical - Biomedical and Genetics industry, to which Codexis belongs, is currently ranked in the top 32% of over 250 Zacks industries, indicating a favorable industry outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ 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: 001-34705 ___________________________ Codexis, Inc. (Exact name of registrant as specified in its charter) ____________________ ...

Financial Performance - Total revenues for Q3 2024 were $12.8 million, up from $9.3 million in Q3 2023, with product revenues increasing to $11.2 million from $5.4 million[6] - The net loss for Q3 2024 was $20.6 million, or $0.29 per share, compared to a net loss of $34.9 million, or $0.50 per share, in Q3 2023[7] - Product revenue for Q3 2024 was $11,158,000, a 106% increase compared to $5,395,000 in Q3 2023[16] - Total revenues for the nine months ended September 30, 2024, were $37,885,000, down 13% from $43,582,000 for the same period in 2023[16] - Net loss for Q3 2024 was $20,640,000, an improvement from a net loss of $34,908,000 in Q3 2023[17] - The company reported a comprehensive loss of $20,491,000 for Q3 2024, compared to $34,908,000 in Q3 2023[17] Cash and Assets - Codexis raised $31 million through its ATM facility, extending its cash runway into 2027, with cash reserves of $90.3 million as of September 30, 2024[3][7] - Total assets increased to $148,183,000 as of September 30, 2024, compared to $136,561,000 at the end of 2023[18] - Cash and cash equivalents decreased to $37,452,000 from $65,116,000 at the end of 2023[18] - Total liabilities rose to $74,783,000 as of September 30, 2024, compared to $49,946,000 at the end of 2023[18] Revenue Projections - The company expects product revenues for FY 2024 to be between $38 million and $42 million, excluding PAXLOVID™ sales[8] - R&D revenues for FY 2024 are anticipated to be in the range of $18 million to $22 million[8] Operational Developments - Codexis plans to announce its first technical collaboration with a major pharmaceutical partner by the end of 2024[5] - The company appointed Georgia Erbez as Chief Financial Officer and Alison Moore as Chief Technical Officer in October 2024[3] - Codexis licensed its genomics life science enzyme portfolio to Alphazyme, which includes several key enzymes for genomics and diagnostics applications[4] Cost Management - Product gross margin improved to 61% in Q3 2024 compared to 58% in Q3 2023, driven by variability in product mix[6] - Research and development revenue for Q3 2024 was $1,675,000, down from $18,775,000 in Q3 2023[16] - Selling, general, and administrative expenses increased to $13,568,000 in Q3 2024 from $12,302,000 in Q3 2023[16] - The company aims to achieve positive cash flow around the end of 2026[3][7] Shareholder Information - The weighted average common stock shares used in computing net loss per share for Q3 2024 was 72,032, compared to 69,466 in Q3 2023[16]

Core Insights - Codexis, Inc. will present three data presentations at the TIDES Europe annual meeting, showcasing the application of its ECO Synthesis™ platform for siRNA manufacturing [1][2] Group 1: 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 developing the ECO Synthesis™ manufacturing platform to enable commercial-scale production of RNAi therapeutics through enzymatic methods [4] Group 2: Industry Context - RNA as a therapeutic modality has gained significant traction, particularly with the rise of mRNA vaccines and siRNA candidates in clinical studies [2] - There are currently over 450 RNAi therapies in clinical development, with more than 40 in Phase 2 and Phase 3 trials, indicating a growing demand that is expected to exceed current production capabilities by the end of the decade [2] Group 3: ECO Synthesis Manufacturing Platform - The ECO Synthesis™ platform aims to address scalability and cost limitations in RNAi therapeutics manufacturing, potentially allowing for commercial-scale production through enzymatic routes [3] - Codexis has demonstrated high coupling efficiency greater than 98% in enzymatic synthesis, comparable to traditional phosphoramidite chemistry, while also achieving lower impurity levels [3]

REDWOOD CITY, Calif., Oct. 10, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, today announced that it will report its financial results for the third quarter of 2024 on Thursday, October 31, 2024, following the close of market. Codexis management will host a conference call and webcast at 4:30 pm Eastern Time to discuss the Company's financial results and provide a business update. Participants may acces ...

Company raises $31 million through ATM, bringing cash runway into 2027 New additions to leadership in technical operations, finance and intellectual property prepare Codexis for the next phase of growth REDWOOD CITY, Calif., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for efficient and scalable therapeutics manufacturing, today announced an increase in its cash reserves through capital raises totaling $31 million via the Company's existing at-the ...

Core Insights - Codexis, Inc. has entered into a non-exclusive commercial and manufacturing license agreement with Alphazyme LLC for multiple enzymes in its life science enzyme portfolio, including HiFi DNA Polymerase and HiTemp Reverse Transcriptase [1][3] - The agreement allows Codexis to receive sales-based royalties and is part of its strategy to divest non-core assets while focusing on its Pharmaceutical Manufacturing business and ECO Synthesis™ platform [3][4] Company Strategy - The partnership with Alphazyme is expected to enhance Codexis' commercial reach in the genomics segment, leveraging Alphazyme's existing sales force and experience [2][3] - Codexis aims to maintain focus on maximizing near-term commercial opportunities, including the growth of its Pharmaceutical Manufacturing business and the build-out of its ECO Synthesis™ Innovation Lab [2][3] Product Development - Codexis is developing its proprietary ECO Synthesis™ manufacturing platform to enable the commercial-scale manufacture of RNAi therapeutics through an enzymatic route, addressing scalability and cost limitations of traditional methods [5] - Recent data presented at TIDES USA 2024 demonstrated that Codexis achieved coupling efficiency greater than 98% in enzymatic synthesis, comparable to traditional phosphoramidite chemistry [5] Industry Context - Alphazyme is recognized as a premier partner for industrial-scale molecular biology enzymes, collaborating with manufacturers in the nucleic acid synthesis and detection markets [2][6] - Maravai LifeSciences, the parent company of Alphazyme, provides critical products for drug therapies, diagnostics, and vaccines, positioning itself as a leader in the life sciences sector [7]

REDWOOD CITY, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced that management will participate in two upcoming investor conferences. The Cantor Global Healthcare Conference (New York, NY) Tuesday, September 17, 2024, at 11:30 am ET, management will participate in a fireside chat The Craig-Hallum Bioprocessing Conference (Virtual) Thursday, September 19, 2024, at 2:00 pm ET, management will participate in a fireside chat A live we ...

Core Insights - Codexis, Inc. will participate in the RNA Leaders annual meeting on September 4-5, 2024, focusing on enzyme-driven manufacturing of siRNA duplexes [1][2] - The biopharmaceutical industry is advancing RNA manufacturing solutions to enhance production capacities and streamline clinical trials [2] - Codexis' presentations will highlight the cost-effective manufacturing of siRNA duplexes using engineered double-stranded RNA ligases [3] Company Developments - Codexis has launched double-stranded RNA ligase screening and optimization services, which improve siRNA manufacturing by enhancing yield and purity [3] - The ECO Synthesis™ manufacturing platform aims to address scalability and cost limitations in RNAi therapeutics production [6][8] - Recent data presented at TIDES USA 2024 showed over 98% coupling efficiency in enzymatic synthesis of siRNA, comparable to traditional methods [6][7] Industry Context - The demand for RNAi therapeutics is expected to exceed current production capabilities by the end of the decade, with over 450 RNAi therapies in clinical development [5] - Traditional chemical synthesis of RNAi therapeutics faces challenges in quality and economics, highlighting the need for innovative manufacturing solutions [5] - The growth of mRNA vaccines and siRNA candidates in clinical studies underscores the increasing relevance of RNA as a therapeutic modality [5]