Business Segments and Services - Ginkgo Bioworks operates in two business segments: cell engineering and biosecurity, focusing on biological R&D services for various industries[19]. - In 2024, Ginkgo expanded its service offerings to include cell engineering tools, enhancing customer resources for in-house R&D[21]. - The company provides end-to-end cell engineering solutions across multiple markets, including pharmaceuticals, agriculture, and industrial biotechnology[35]. - Ginkgo's services support the development of new therapeutics, vaccines, and agricultural products, addressing urgent global needs[36][40]. - Ginkgo's biosecurity services have evolved to include two core offerings, enhancing detection capabilities and insights into biological threats[29]. - The company partners with government agencies to enhance national security and public health through biological capabilities[45]. - Ginkgo's genetic medicine services include gene therapy, cell therapy, and RNA therapeutics, optimizing manufacturing processes at scale[48]. Technology and Innovation - The company utilizes proprietary automation technologies and AI tools to enhance R&D efficiency and product development[40]. - The EncapS platform improves production strain productivity by 10-30% through ultra-high throughput screening of over 1 million variants[50]. - The company has a metagenomic library of over 2.7 billion genes, facilitating the discovery and optimization of plant traits[54]. - The company offers pilot fermentation capacities ranging from 5 to 3,000 liters for bioprocess development and scale-up[58]. - The introduction of Reconfigurable Automation Cart systems enhances high throughput experimentation for biological workflows[61]. - Ginkgo's Foundry enables high-throughput cell programming, while the Codebase includes reusable biological assets[117]. - The company entered a strategic partnership with Google Cloud in August 2023 to develop AI tools for biology and biosecurity, focusing on large language models to accelerate innovation in various fields[199]. Financial Performance and Revenue - The company reported a net loss attributable to stockholders of approximately $2.1 billion, $892.9 million, and $547.0 million for the fiscal years ended December 31, 2022, 2023, and 2024, respectively[149]. - As of December 31, 2024, the company had an accumulated deficit of approximately $5.8 billion[150]. - The company generates revenue through service fees for Foundry services, which include fixed fees and milestone-based payments[80]. - Ginkgo has transitioned its Biosecurity business to focus on scalable infrastructure, with recurring revenue models for Canopy program services, data, and analytics[85]. - The company expects downstream value share to contribute significantly to income as more programs are added, enhancing overall margins and cash flow[83]. - The company has historically derived a significant portion of its revenues from fees and milestone payments from technical development services, which have not been sufficient to cover full operational costs[150]. Workforce and Organizational Changes - As of December 31, 2024, Ginkgo had 834 employees, reflecting a commitment to a talented and multidisciplinary workforce[98]. - Ginkgo's restructuring in 2024 involved a reduction of over 40% of its workforce, yet the company continued to execute on programs and launch new products[100]. - The company has implemented a restructuring plan aimed at reducing operational expenditures, with workforce reductions starting in June 2024 and expected to be completed by 2025, incurring estimated costs between $20.0 million and $23.0 million[204]. Risks and Challenges - The company may need substantial additional capital in the future to fund its business and has no current commitments for future funding[152][153]. - The company faces risks related to maintaining and expanding customer partnerships, which are critical for generating revenue from cell engineering solutions[164]. - The company has experienced significant organizational changes, which could adversely affect its business and financial condition if not managed effectively[155]. - The company’s ability to commercialize Biosecurity offerings is subject to available government and private funding, which may limit growth opportunities[162]. - The company is exposed to macroeconomic pressures, including inflation and supply chain disruptions, which could lead to higher costs for lab materials and services[180]. - The company may not achieve key program milestones on expected timelines, which could negatively impact its business and stock price[178]. - The company relies on a limited number of suppliers for critical lab supplies, which exposes it to risks related to supply disruptions and increased costs[179]. - The company may face challenges in completing future strategic acquisitions or successfully integrating them, which could adversely affect its business and financial condition[172]. - The company has made past acquisitions that were dilutive to stockholders, and future acquisitions may also have adverse impacts if unsuccessful[173]. - The company is exposed to risks if customers choose to perform services internally or with other partners, impacting revenue potential[209]. Regulatory and Compliance Issues - Ginkgo's operations are subject to regulations from the FDA, FTC, USDA, DEA, and EPA, which may impact business activities[123]. - The company has acted as a systems integrator for COVID-19 diagnostic tests, which are subject to FDA regulation[125]. - Partner laboratories for COVID-19 testing must comply with CLIA standards, which include quality assurance and personnel requirements[133]. - Compliance with federal, state, and local laws regarding hazardous materials is costly, and non-compliance could lead to fines and operational disruptions[189][192]. - The company is facing potential liabilities and reputational harm due to the risks associated with the use of genetically modified organisms (GMOs) and the complexities of compliance with biosecurity regulations[190][191]. Market Position and Competition - Ginkgo's competitive advantage includes a strong intellectual property portfolio, with a focus on patents that provide value and competitive advantages[112]. - The company faces competition from internal R&D departments of therapeutics companies, which may view Ginkgo as a potential customer rather than a competitor[106]. - The synthetic biology industry is characterized by rapid technological changes, and the company must continuously develop its platform to remain competitive[217]. - The company relies heavily on a limited number of large customers, with three customers representing over 10% of total revenue for the year ended December 31, 2024, indicating a concentration risk[207]. Future Outlook - The company expects operating expenses to either remain consistent or decline in 2025 compared to 2024, reflecting stabilization in operational overhead and restructuring actions[150]. - The company’s long-term objective is to generate free cash flow from the commercialization of programs across various industries, but variability in costs and timelines remains a challenge[158]. - The company’s ability to secure new business is dependent on customers' willingness to invest in R&D, which could be adversely affected by declines in R&D spending[205][206]. - The company’s international operations may operate with a lower margin profile due to potentially higher supplier costs and other expenses associated with international markets[198]. - The company is subject to evolving regulations regarding AI, which could impose significant costs and obligations, impacting its operations and market confidence[201].

Revenue Performance - Fourth quarter 2024 total revenue of $44 million, up from $35 million in the comparable prior year period, representing a 26% increase[6] - Fourth quarter 2024 Cell Engineering revenue of $35 million, up 29% from $27 million in the prior year, driven by growth with large biopharma customers[6] - Full year 2024 total revenue of $227 million, down 10% from $251 million in the prior year, primarily due to a shift in Biosecurity revenue model[6] - Full year 2024 Cell Engineering revenue of $174 million, up 21% from $144 million in the prior year, but down 10% to $129 million when excluding a $45 million non-cash deferred revenue release[6] - Full year 2024 Biosecurity revenue of $53 million, down 51% from $108 million in the prior year, with a gross profit margin of 27%[6] - Total revenue for the year ended December 31, 2024, was $227.043 million, a decrease of 9.7% compared to $251.455 million in 2023[18] - Total revenue for the year 2024 reached $173.972 million, a 21.2% increase compared to $143.531 million in 2023[27] Profit and Loss - Fourth quarter 2024 GAAP net loss of $(108) million, improved from $(212) million in the prior year[6] - Net loss for Q4 2024 was $107.534 million, significantly improved from a net loss of $211.694 million in Q4 2023[25] - The company reported a loss before income taxes of $(107.860) million for Q4 2024, an improvement from $(211.894) million in Q4 2023[27] - Adjusted EBITDA for the year ended December 31, 2024, was $(293.311) million, an improvement from $(364.965) million in 2023[25] - Impairment expenses for the year 2024 totaled $53.654 million, down from $121.404 million in 2023[27] Cash Flow and Financial Position - Cash and cash equivalents balance as of December 31, 2024, was $562 million, with cash flow of $(55) million in Q4 2024, an improvement from $(114) million in Q3 2024[6] - Cash and cash equivalents at the end of Q4 2024 were $561.572 million, down from $944.073 million at the end of Q4 2023[22] - Net cash used in operating activities for the year ended December 31, 2024, was $319.585 million, compared to $295.500 million in 2023[21] Cost Management - Ginkgo achieved an annualized run-rate cost reduction of $190 million as of Q4 2024, targeting $250 million by the end of Q3 2025[10] - Total operating expenses for the year ended December 31, 2024, were $786.800 million, a reduction of 29.4% compared to $1.115 billion in 2023[18] - Research and development expenses for Q4 2024 were $76.377 million, down 34.7% from $117.038 million in Q4 2023[18] - Stock-based compensation expense for the year ended December 31, 2024, was $115.299 million, down 50.9% from $234.908 million in 2023[19] - Research and development expenses for Cell Engineering were $50.364 million in Q4 2024, a reduction of 30.9% from $72.951 million in Q4 2023[27] - General and administrative expenses for Cell Engineering decreased to $20.494 million in Q4 2024, down 49.3% from $40.383 million in Q4 2023[27] Business Development - Ginkgo added 31 new programs and contracts to the Cell Engineering platform in Q4 2024, including 14 comparable in size and scope to historically reported New Programs[6] - Biosecurity service revenue increased to $9.058 million in Q4 2024, representing a 16.5% growth from $7.779 million in Q4 2023[27] - The operating loss for Cell Engineering improved to $(38.138) million in Q4 2024, compared to $(86.359) million in Q4 2023[27] - Total segment operating loss decreased to $(47.885) million in Q4 2024, down from $(98.035) million in Q4 2023[27] Future Outlook - Ginkgo expects total revenue of $160-$180 million in 2025, with Cell Engineering revenue projected at $110-$130 million[10] - The company recognized $45.4 million in non-cash revenue in 2024 due to the termination of revenue contracts with Motif[25]

Core Insights - Ginkgo Bioworks has reported significant improvements in cash flow and revenue growth in its fourth quarter of 2024, alongside a restructuring process aimed at enhancing operational efficiency [1][6][7] Financial Performance - Fourth quarter 2024 total revenue reached $44 million, an increase from $35 million in the same period of 2023 [6] - Cell Engineering revenue for the fourth quarter was $35 million, reflecting a 29% growth compared to $27 million in the prior year [6] - Biosecurity revenue in the fourth quarter was $9 million, up from $8 million year-over-year, with a gross profit margin of 17% [6] - The company reported a GAAP net loss of $(108) million for the fourth quarter, an improvement from $(212) million in the same quarter of 2023 [6] - Adjusted EBITDA for the fourth quarter was $(57) million, an improvement from $(101) million in the prior year [6] Annual Financial Highlights - For the full year 2024, total revenue was $227 million, down 10% from $251 million in 2023, primarily due to a shift in Biosecurity revenue models [7] - Cell Engineering revenue for the full year was $174 million, up 21% from $144 million in the previous year [7] - Biosecurity revenue for the full year decreased by 51% to $53 million from $108 million in 2023 [7] - The full year GAAP net loss was $(547) million, compared to $(893) million in 2023 [7] - Adjusted EBITDA for the full year improved to $(293) million from $(365) million in the prior year [7] Strategic Developments - Ginkgo has made significant strides in its restructuring efforts, achieving an annualized run-rate cost reduction of $190 million, with a target of $250 million by Q3 2025 [6][7] - The company added 31 new programs and contracts to its Cell Engineering platform in Q4 2024, indicating strong customer engagement [7] - Ginkgo secured a contract with the European Health and Digital Executive Agency for next-generation diagnostics, potentially worth up to €24 million over four years [7] Cash Flow and Liquidity - As of December 31, 2024, Ginkgo had cash and cash equivalents of $562 million, with a cash flow of $(55) million in Q4, an improvement from $(114) million in Q3 [6][7] - The company is on track to reach Adjusted EBITDA breakeven by the end of 2026, supported by ongoing cost-cutting measures and revenue growth initiatives [7]

Core Insights - Volta Labs and Ginkgo Bioworks have announced the integration of the Callisto™ Sample Prep System into Ginkgo's routine Illumina sequencing workflow, enhancing operational efficiency in genomics applications [1][3]. Company Overview - Volta Labs specializes in genomics applications and has developed a digital fluidics platform aimed at maximizing performance and scalability in sample preparation, providing high consistency in biological research [4]. - Ginkgo Bioworks operates as a leading platform for cell programming, offering end-to-end services across various markets, including food, agriculture, pharmaceuticals, and biosecurity [5]. Technological Advancements - The Callisto system is designed to automate complex processes such as PacBio library preparation and double-sided size selection for Illumina sequencing, addressing challenges in traditional liquid handling technologies [2][3]. - The newly released Double-Sided Size Selection app allows labs using Illumina, Element Biosciences, and Ultima Genomics platforms to purify and select optimal fragment sizes for sequencing, showcasing Callisto's advanced capabilities in liquid separation and DNA elution [3]. Strategic Partnership - Ginkgo Bioworks has been a key partner for Volta Labs, contributing to the refinement of solutions for high-throughput labs, indicating a strong collaborative relationship that may lead to further applications in the future [3].

Core Insights - Ginkgo Bioworks has announced a collaboration with the European Health and Digital Executive Agency (HaDEA) to develop rapid metagenomic next-generation sequencing (mNGS) solutions for identifying respiratory pathogens, with funding of up to €24 million over four years [1][2][6] Group 1: Project Overview - The project, named RApid Next Generation Sequencing for Effective Medical Response (RANGER), aims to create a point-of-care mNGS solution that allows for rapid diagnostics of respiratory viruses, potentially transforming the diagnostic landscape [2][3] - The device is designed to provide a turnaround time of 6 hours, enabling hospitals to triage patients more effectively and reduce the burden of prolonged isolation and costly inpatient stays [3][6] Group 2: Technological Capabilities - The RANGER device will utilize "agnostic diagnostics," allowing it to sequence and identify virtually any respiratory pathogen, which enhances pandemic preparedness [4][6] - The program includes the option for the European Commission to procure 200 devices at preferred pricing, facilitating widespread deployment across EU/EEA healthcare systems [4] Group 3: Implementation Phases - The project will be executed in three phases, starting with the integration of existing technologies into a benchtop device, followed by clinical trials in EU hospitals, and concluding with securing EU certification for the device [5][6] Group 4: Strategic Alignment - This collaboration aligns with HERA's mission to strengthen Europe's capacity to respond to health emergencies by enhancing diagnostic capabilities and reducing delays in pathogen identification [6][7] - The initiative is expected to improve hospital triage, infection control, and provide early-warning tools against emerging pathogens, reinforcing the EU's health resilience [6][8]

Core Viewpoint - Acurx Pharmaceuticals has received a new patent in Japan for DNA Polymerase IIIC Inhibitors, which is crucial for the development of its antibiotic candidate ibezapolstat for treating C. difficile Infection (CDI) [1][2] Company Developments - Acurx has expanded its patent portfolio with three U.S. patents, one Israeli patent, and now a Japanese patent, all related to its ACX-375C program [1] - The company is preparing for Phase 3 clinical trials for ibezapolstat, having received positive regulatory guidance from the EMA [2][3] - The Phase 3 trials will involve approximately 450 subjects, randomized in a 1:1 ratio to receive either ibezapolstat or standard care vancomycin [3] Clinical Trial Insights - The Phase 2 clinical trial demonstrated a 96% Clinical Cure rate for ibezapolstat, with 100% cure in the Phase 2a segment [6][7] - The Phase 2b trial showed that ibezapolstat was well-tolerated, with no serious adverse events reported [7] - Ibezapolstat treatment led to favorable changes in bile acid metabolism, which may reduce the likelihood of CDI recurrence [8][12] Market Context - CDI is a significant healthcare issue, with estimates of 500,000 infections annually in the U.S. and a mortality rate of approximately 9.3% [11] - The CDC has classified C. difficile as an urgent threat, highlighting the need for new antibiotics [10] Product Overview - Ibezapolstat is a novel, orally administered antibiotic targeting Gram-positive bacteria, specifically designed to maintain a healthy gut microbiome while treating CDI [9][13] - The drug has received QIDP designation and Fast Track status from the FDA, which may expedite its development process [10]

Core Viewpoint - Ginkgo Bioworks Holdings, Inc. is set to host a presentation and Q&A session to review its business performance for Q4 and the full year of 2024 on February 25, 2025 [1] Group 1: Presentation Details - The presentation will begin at 5:30 p.m. ET and will be available on Ginkgo's investor relations website, with a replay option provided [2] - Questions can be submitted in advance via social media or email [2] Group 2: Company Overview - Ginkgo Bioworks is recognized as a leading platform for cell programming, offering comprehensive services across various sectors including food, agriculture, pharmaceuticals, and industrial chemicals [3] - The company is also focused on biosecurity, developing infrastructure and technologies to address biological threats [3]

Core Viewpoint - Ginkgo Bioworks Holdings, Inc. (DNA) experienced a significant stock price increase of 14.5% to $16.36, driven by positive investor sentiment regarding its proprietary cell programming platforms and strong revenue growth expectations [1][2]. Company Summary - Ginkgo Bioworks utilizes its Foundry and Codebase platforms to offer R&D services under collaboration and license agreements, along with biomonitoring and bioinformatic support services to public health authorities [2]. - The company is projected to report a quarterly loss of $1.45 per share, reflecting a year-over-year increase of 59.7%, while revenues are expected to reach $45.08 million, marking a 29.7% increase from the previous year [3]. - The consensus EPS estimate for Ginkgo Bioworks has remained stable over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4]. Industry Context - Ginkgo Bioworks is part of the Zacks Medical - Biomedical and Genetics industry, which includes other companies like Krystal Biotech, Inc. (KRYS), that has shown a modest stock performance with a 0.7% increase [4]. - Krystal Biotech's EPS estimate has increased by 10.6% over the past month, indicating a significant year-over-year change of 330%, but it currently holds a Zacks Rank of 4 (Sell) [5].

Core Insights - Ginkgo Bioworks is launching the 2025 Ferment Series, an evolution of its annual conference aimed at advancing its mission of making biology easier to engineer [1][2] - The series will focus on specific areas within Ginkgo's cell engineering and biosecurity offerings, showcasing transformative solutions across various markets [2][3] Event Details - The Ferment Series will take place at Ginkgo's event venue in Boston's Seaport District, with a series of focused events throughout 2025 [1] - Each event will feature Ginkgo experts, partners, and industry leaders discussing applications of engineered biology [2] Technology and Innovations - Attendees will have the opportunity to see Ginkgo's technologies and innovations, including high-throughput AI-driven data generation services and automation systems [3] - New products and services will be highlighted, such as Ginkgo Datapoints and Ginkgo Biosecurity's monitoring and threat intelligence solutions [3] CEO Statement - Jason Kelly, CEO of Ginkgo Bioworks, emphasized the company's strengthened mission and the importance of showcasing their evolving platform and new capabilities at the 2025 Ferment events [4] 2025 Ferment Series Calendar - The series will include events focused on: - Summer: Datapoints x AI, focusing on data generation services and AI models for biotech R&D [5] - September: Ginkgo Biopharma Solutions, aimed at accelerating drug discovery and development [5] - October: Biosecurity, discussing strategies for biological risk management [5] - November: Automation, featuring demonstrations of Ginkgo's automation systems [6] Industry Engagement - Ginkgo will also participate in other industry conferences, such as World AgriTech and ABIM, to connect with partners and showcase its R&D capabilities [7][8]

Ginkgo Bioworks Holdings, Inc. (DNA) could be a solid choice for investors given its recent upgrade to a Zacks Rank #1 (Strong Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The ...