Codexis (CDXS) 2025 Conference June 04, 2025 03:10 PM ET Speaker0 think we're good to go. I'm Tycho Peterson from the life science team. It's my pleasure to introduce Codexis. Happy to have Stephen Dully with us again this year. Stephen, maybe just to kick it off, obviously a lot of focus on ecosystem. Maybe let's go back twenty four months since the platform was just getting started. Walk us through the journey there, lots happened. How do we go from kind of technology and concept to execution of commercia ...

Codexis (CDXS) Conference Call Summary - May 22, 2025 Company Overview - **Company**: Codexis (CDXS) - **Industry**: Biotechnology, specifically focusing on siRNA (small interfering RNA) technology and enzymatic synthesis for genomic medicines Key Points and Arguments Industry Trends - **Surge in Demand for siRNA Therapeutics**: There is a recognized increase in demand for siRNA therapeutics, with significant interest in innovative manufacturing solutions [5][6] - **Shift Towards Enzymatic Synthesis**: The industry is moving towards enzymatic synthesis methods, which are seen as necessary to meet the scalability and purity requirements for siRNA production [6][18] Codexis Technology and Developments - **Ecosynthesis Technology**: Codexis' Ecosynthesis platform is positioned as a timely solution to the limitations of traditional solid-phase chemistry, with advancements in scalability and cost-effectiveness [10][18] - **Validation from Industry Leaders**: Codexis received external validation from major oligonucleotide manufacturers, highlighting the effectiveness of its double-stranded RNA ligase [6][7] - **Machine Learning Tool**: A newly developed machine learning tool aids customers in optimizing RNA fragment designs, demonstrating superior performance in identifying effective solutions [12][41] Customer Engagement and Market Position - **Increased Customer Interest**: There has been a notable shift in customer engagement, with decision-makers in process development now actively exploring Codexis' enzymatic solutions [17][18] - **Growing Customer Base**: The number of substantive discussions with potential customers has increased significantly, from single digits to over 20 prospects [20] - **Innovation Lab Capacity**: Codexis aims to fill its Eco Innovation Lab capacity with multiple customers, focusing on a diverse range of products [35][36] Competitive Landscape - **Leadership in Enzymatic Technology**: Codexis is recognized as a leader in enzymatic technology for siRNA manufacturing, with expectations to maintain this position through continued advancements [21][18] Future Outlook - **Partnerships and Collaborations**: Codexis is on track to sign a GMP scale-up partnership and anticipates selling its Eco Innovation Labs capacity by year-end [20] - **Focus on Stereochemistry Control**: The ability to control stereochemistry in siRNA production is seen as a significant advantage, allowing for the development of more effective therapeutic candidates [31][52] Additional Important Insights - **Transition from Proof of Concept to Production**: Codexis is moving from demonstrating proof of concept to establishing a practical production platform, emphasizing the importance of cycle times in manufacturing [27][28] - **Impact of Stereochemistry on Efficacy**: The control of stereochemistry is crucial for ensuring the activity and effectiveness of siRNA therapeutics, with implications for both existing and new products [50][52] This summary encapsulates the key discussions and insights from the Codexis conference call, highlighting the company's strategic positioning within the biotechnology industry and its advancements in siRNA technology.

Core Insights - Codexis presented its proprietary ECO Synthesis platform at the TIDES USA annual meeting, demonstrating its effectiveness in siRNA manufacturing by reducing purification costs and improving process performance [1][2] - The company has established itself as a leader in enzymatic technology for siRNA manufacturing, with increasing customer interest in incorporating this technology into drug development [2][3] - Codexis showcased a machine learning tool that significantly enhances the ligation process for siRNA production, improving efficiency and reducing development time [4][6] Group 1: Technology and Performance - The ECO Synthesis platform utilizes immobilized enzymes to achieve consistent process performance, with potential reductions in downstream purification steps [3][6] - Codexis' ligation processes have been validated by leading CDMOs, confirming the transferability and effectiveness of its technology in various manufacturing settings [5][7] - The company reported a coupling efficiency of over 98% and a 24% reduction in average cycle time, leading to high yields of 30 grams of siRNA per liter [6][7] Group 2: Market Position and Future Outlook - Codexis is positioned to capitalize on the growing trend towards enzymatic manufacturing solutions and onshoring initiatives, making its technology rollout timely [2][3] - The company aims to establish a GMP scale-up partnership by the end of the year, translating current momentum into tangible business growth [2][3] - The ability to control stereochemistry in oligonucleotide synthesis through the ECO Synthesis platform could enhance the therapeutic potency and market position of siRNA products [8]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $7.5 million, down from $17.1 million in Q1 2024, largely due to a one-time agreement with Roche and variability in large customer orders [25][26] - Product gross margin improved to 55% in Q1 2025 from 49% in Q1 2024, driven by a shift towards more profitable products [27] - Net loss for Q1 2025 was $20.7 million compared to $11.5 million in Q1 2024 [28] - The company ended the quarter with $59.8 million in cash, sufficient to fund operations until achieving cash flow positivity by the end of 2026 [29] Business Line Data and Key Metrics Changes - In Pharma Biocatalysis, the product mix is changing, leading to margin improvement, with new customers particularly in the mid-tier pharma segment [7] - The double-stranded RNA ligase business is growing, with the first order delivered to a large pharma customer in Q1 and additional orders expected [8] Market Data and Key Metrics Changes - The siRNA field is evolving positively, with recent FDA approvals for siRNA therapeutics indicating growing demand [10][11] - The current macro environment is seen as potentially beneficial for the Ecosynthesis platform, particularly with pressures to onshore production [12] Company Strategy and Development Direction - The company is focused on executing a market penetration strategy for its Ecosynthesis technology, emphasizing the importance of demonstrating reproducibility and scalability to customers [16] - The strategy includes developing an enzymatic supply of raw materials to reduce dependence on foreign supply chains [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the 2025 revenue guidance, with expectations for a substantial revenue ramp in the second half of the year [6][28] - The company believes that external factors, such as the demand for RNA-based therapeutics and onshoring trends, will create a favorable environment for its technology [10][11] Other Important Information - The company plans to host a public investor conference call to discuss presentations from the Tides meeting, showcasing advancements in its Ecosynthesis technology [22] Q&A Session Summary Question: Interest from small and large siRNA drug innovators - Management noted that CDMOs are easier to engage due to their existing customer relationships, and once initial successes are demonstrated, barriers to entry for larger innovators will lower [34][36] Question: Second half revenue ramp - Growth is expected to come from new contracts with Ecosynthesis, with timelines for negotiations influencing the ramp [40][41] Question: Cash flow positivity guidance - The guidance is based on organic pipeline evolution and does not include the GMP facility, which is seen as an accelerator for revenue [43][45] Question: Orders for ligase and customer expectations - Management expects repeat orders from large pharma customers as they move into significant bulk production phases [52][53] Question: CDMO collaborations - The three CDMO collaborators are successful with the ligase technology and are building platforms to service multiple customers, enhancing scalability [58][60] Question: Machine learning capabilities - The company has been leveraging machine learning for enzyme engineering and manufacturing processes, with successful applications already demonstrated [67][70]

Codexis (CDXS) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to your host, Carrie McKim, Director of Investor Relations. Carrie, please go ahead. Speaker1 Thank you, operator. With me today are Doctor. Stephen Dilly, Codexis' Chairman and Chief Executive Officer Georgia Erbez, Chief Financial Officer and Doctor. Stephane Lutz, Senior Vice President of Research. During this call, management will making a nu ...

Corporate Presentation May 2025 Forward Looking Statements These slides contain forward-looking statements that involve risks and uncertainties. These statements relate to future events or our future financial or operational performance and involve known and unknown risks, uncertainties and other factors that could cause our actual results or levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. In some cases, you can identif ...

Revenue Performance - Total revenues decreased by $9.5 million to $7.5 million in Q1 2025, a decline of 56% compared to Q1 2024[87] - Product revenue fell by $3.5 million to $6.1 million in Q1 2025, primarily due to lower sales of enzymes for branded pharmaceutical products, representing a 37% decrease[87] - Research and development revenue dropped by $6.0 million to $1.5 million in Q1 2025, primarily due to a $6.0 million decrease from a licensing agreement with Roche Sequencing Solutions, Inc.[88] Operational Losses - Loss from operations increased by $8.6 million to $20.5 million in Q1 2025, an increase of 72% compared to Q1 2024[84] - Net loss for Q1 2025 was $20.7 million, or $0.25 per share, compared to a net loss of $11.5 million, or $0.16 per share in Q1 2024, attributed to lower product and R&D revenues[100] Expenses - Research and development expenses rose by $1.7 million, or 15%, to $12.9 million in Q1 2025, driven by higher allocable costs and increased headcount[93] - Selling, general and administrative expenses decreased by $0.5 million, or 4%, to $12.4 million in Q1 2025, mainly due to lower legal fees and stock-based compensation[95] Financial Income and Expenses - Interest income decreased by 17% to $751,000 in Q1 2025 compared to $909,000 in Q1 2024[96] - Interest and other expense, net increased by 83% to $(942,000) in Q1 2025, compared to $(516,000) in Q1 2024[96] - Interest income decreased by $0.2 million in Q1 2025 compared to Q1 2024, primarily due to lower average cash and short-term investments balances[97] Cash and Working Capital - Cash and cash equivalents decreased to $18.3 million as of March 31, 2025, down from $19.3 million as of December 31, 2024[102] - Working capital decreased to $56.9 million as of March 31, 2025, compared to $75.1 million as of December 31, 2024[102] - Net cash used in operating activities increased by $6.0 million to $13.8 million in Q1 2025 compared to $7.8 million in Q1 2024[111] Investment Activities - Net cash provided by investing activities increased by $40.3 million in Q1 2025, primarily due to proceeds from the maturity of short-term investments[113] Debt and Financing - The company borrowed $30.0 million under a Loan Agreement with Innovatus on February 13, 2024, with the potential to borrow an additional $10.0 million upon achieving certain financial milestones[101] - As of March 31, 2025, the company had $30.6 million principal amount outstanding under the Innovatus Loan, with a floating interest rate[118] Strategic Actions - The company completed the divestiture of certain biotherapeutics assets and non-core life science assets in 2024 as part of strategic prioritization[80] Currency Risk - A hypothetical 10% unfavorable change in foreign currency exchange rates could result in a potential loss of approximately $40,000 in future earnings[119]

Financial Performance - Total revenues for Q1 2025 were $7.5 million, a decrease from $17.1 million in Q1 2024, primarily due to a one-time revenue recognition of $6 million in the previous year[8]. - The net loss for Q1 2025 was $20.7 million, or $0.25 per share, compared to a net loss of $11.5 million, or $0.16 per share, in Q1 2024[8]. - The company expects total revenues for 2025 to be in the range of $64 million to $68 million[13]. Research and Development - Research and Development expenses increased to $12.9 million in Q1 2025 from $11.2 million in Q1 2024, driven by higher salaries and lab supplies costs[8]. - Codexis plans to achieve pilot scale production of GLP-grade siRNA material using the ECO Synthesis Innovation Lab in 2025[7]. Contracts and Collaborations - Codexis secured its first revenue-generating contract for ECO Synthesis™ manufacturing services in March 2025[5]. - The company will present at the TIDES USA annual meeting, showcasing its ligase technology and collaborations with leading CDMOs[3][7]. Cash and Investments - As of March 31, 2025, Codexis had $59.8 million in cash, cash equivalents, and short-term investments, sufficient to fund operations through positive cash flow expected by the end of 2026[8][13]. - The company maintained its investment in non-marketable equity securities at $2,798 million[21]. Assets and Liabilities - Total assets decreased from $149,011 million as of December 31, 2024, to $128,887 million as of March 31, 2025, representing a decline of approximately 13.5%[21]. - Current assets fell from $98,772 million to $77,808 million, a decrease of about 21.2%[21]. - Accounts receivable decreased significantly from $11,920 million to $6,442 million, a drop of approximately 46.0%[21]. - Total liabilities decreased from $82,084 million to $79,258 million, a reduction of about 3.4%[21]. - Current liabilities decreased from $23,648 million to $20,901 million, a decline of about 11.7%[21]. - Long-term debt increased slightly from $28,905 million to $29,186 million, an increase of about 1.0%[21]. Stockholders' Equity - Stockholders' equity declined from $66,927 million to $49,629 million, a decrease of approximately 25.9%[21]. - The accumulated deficit increased from $(562,806) million to $(583,494) million, indicating a worsening financial position[21]. Product Performance - Product gross margin improved to 55% in Q1 2025 from 49% in Q1 2024, attributed to a shift towards more profitable products[8]. Leadership Changes - Codexis appointed new board members with extensive experience in biopharmaceuticals and CDMO sectors to strengthen its leadership[5].

Core Insights - Codexis secured its first revenue-generating contract for ECO Synthesis™ manufacturing services, indicating progress in commercial operations [3][7] - The company reiterated its full-year financial guidance for 2025, maintaining confidence in its revenue projections despite a $2.5 million order delay [2][9] - Codexis is set to present its ECO Synthesis platform at the upcoming TIDES USA annual meeting, showcasing collaborations with leading CDMOs [3][7] Financial Performance - Total revenues for Q1 2025 were $7.5 million, a decrease from $17.1 million in Q1 2024, primarily due to a one-time revenue recognition of $6 million in the previous year [12] - Product gross margin improved to 55% in Q1 2025 from 49% in Q1 2024, attributed to a shift towards more profitable products [12] - The net loss for Q1 2025 was $20.7 million, or $0.25 per share, compared to a net loss of $11.5 million, or $0.16 per share, in Q1 2024 [12][16] Business Developments - Codexis completed the development of its first generation of ECO Synthesis enzymes, meeting criteria for scaling to industrial capacity [7] - The company appointed new board members with extensive experience in biopharmaceuticals and CDMO sectors, enhancing its leadership team [7] - Codexis expects to achieve pilot scale production of GLP-grade siRNA material in 2025 and aims to sign a GMP scale-up partner by the end of the year [7][12]

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]