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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): September 5, 2024

 

 

Standard BioTools Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

Delaware   001-34180   77-0513190
(State or Other Jurisdiction
of Incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)

 

2 Tower Place, Suite 2000
South San Francisco, California 94080
(Address of Principal Executive Offices) (Zip Code)
 

(650) 266-6000

(Registrant’s Telephone Number, Including Area Code) 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common stock, par value $0.001 per share LAB Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

  

Item 7.01Regulation FD Disclosure.

 

On September 5, 2024, Standard BioTools Inc. (the “Company”) updated its investor presentation, which the Company expects to use in connection with general corporate presentations and will be made available on the Company’s website or distributed by the Company in hardcopy or electronic form. The investor presentation is attached hereto as Exhibit 99.1 and incorporated herein by reference. The investor presentation is current as of September 5, 2024, and the Company disclaims any obligation to update the investor presentation after such date.

 

The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), or otherwise subject to the liabilities of that Section and shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly stated in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d)   Exhibits.

 

Exhibit
No.
  Description
99.1   Investor Presentation issued by Standard BioTools Inc., dated September 5, 2024.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: September 5, 2024 STANDARD BIOTOOLS INC.
     
  By: /s/ Michael Egholm, Ph.D.
  Name: Michael Egholm, Ph.D.
  Title: President and Chief Executive Officer

 

Exhibit 99.1

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Standard BioTools 1 Unleashing Tools to Accelerate Breakthroughs in Human Health INVESTOR PRESENTATION September 2024

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Legal Information 2 Forward-looking statements This presentation contains forward-looking statements that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact (including statements containing the words “believes,” “plans,” “anticipates,” “expects,” “estimates”, “targets” and similar expressions) are statements that could be deemed forward-looking statements, although not all forward-looking statements contain these identifying words. Readers should not place undue reliance on these forward-looking statements. Forward-looking statements may include statements regarding financial outlook and business performance, including related to revenues, growth, margin, and operating expenses; statements regarding future financial performance and expectations, operational and strategic plans, deployment of capital, cash runway and sufficiency of cash resources, market and growth opportunity and potential, potential M&A activity, potential and ongoing restructuring plans; the potential to realize the expected benefits following the merger with SomaLogic, Inc. (“SomaLogic”), our revenue outlook for the full year 2024, and our 2026 financial targets, including with respect to revenue, non-GAAP gross margin, non-GAAP gross profit, non-GAAP operating expenses, adjusted EBITDA, cash, and free cash flow the competitive ability and position of the combined company, the success, cost and timing of the combined company’s product development, sales and marketing, and research and development activities, the combined company’s ability to obtain and maintain regulatory approval for its products, the sufficiency of the combined company’s cash, cash equivalents and short-term investments to fund operations, and any assumptions underlying any of the foregoing. Statements regarding future events are based on the parties’ current expectations and are necessarily subject to associated risks and uncertainties related to, among other things, the outcome of any legal proceedings related to the merger; risks that the anticipated benefits of the merger or other commercial opportunities may otherwise not be fully realized or may take longer to realize than expected; risks that we may not realize expected cost savings from our restructuring plans, including the anticipated decrease in operational expenses, at the levels we expect; possible restructuring and transition-related disruption, including through the loss of customers, suppliers, and employees and adverse impacts on our development activities and results of operation; restructuring activities, including our subleasing plans, customer and employee relations, management distraction, and reduced operating performance; risks that internal and external costs required for ongoing and planned activities may be higher than expected, which may cause us to use cash more quickly than we expect or change or curtail some of our plans, or both; risks that our expectations as to expenses, cash usage, and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than our assumptions; our ability to achieve future financial targets; changes in our business or external market conditions; challenges inherent in developing, manufacturing, launching, marketing, and selling new products; interruptions or delays in the supply of components or materials for, or manufacturing of, our products; reliance on sales of capital equipment for a significant proportion of revenues in each quarter; seasonal variations in customer operations; unanticipated increases in costs or expenses; continued or sustained budgetary, inflationary, or recessionary pressures; uncertainties in contractual relationships; reductions in research and development spending or changes in budget priorities by customers; uncertainties relating to our research and development activities, and distribution plans and capabilities; potential product performance and quality issues; risks associated with international operations; intellectual property risks; and competition. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. For information regarding other related risks, see the “Risk Factors” section of our most recent annual report on Form 10-K filed with the SEC on March 1, 2024. We undertake no obligation to revise or update any forward-looking statements for any reason. Non-GAAP financial information Standard BioTools has presented certain financial information in accordance with U.S. GAAP and also on a non-GAAP basis. The non-GAAP financial measures included in this presentation are non-GAAP gross margin, non-GAAP gross profit, non-GAAP operating expenses, and adjusted EBITDA. Management uses these non-GAAP financial measures, in addition to GAAP financial measures, as a measure of operating performance because the non-GAAP financial measures do not include the impact of items that management does not consider indicative of the Company’s core operating performance. Management believes that non-GAAP financial measures, taken in conjunction with GAAP financial measures, provide useful information for both management and investors by excluding certain non-cash and other expenses that are not indicative of the Company’s core operating results. Management uses non-GAAP measures to compare the Company’s performance relative to forecasts and strategic plans and to benchmark the company’s performance externally against competitors. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the company’s operating results as reported under U.S. GAAP. Standard BioTools encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliations between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP operating results are presented in the accompanying tables of this release. Trademarks Standard BioTools, the Standard BioTools logo, Biomark, CyTOF, CyTOF XT, EP1, Helios, Hyperion, Hyperion+ and SomaScan are trademarks and/or registered trademarks of Standard BioTools Inc. (f.k.a. Fluidigm Corporation) or its affiliates in the United States and/or other countries. All other trademarks are the sole property of their respective owners. Standard BioTools products are provided for Research Use Only. Not for use in diagnostic procedures.

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Executing on our Vision Standard BioTools 3 Leading Proteomics and Multi-omics Platforms High content solutions in serum proteomics spatial proteomics and single cell proteomics Building a Diversified Life Science Tools Industry Leader $170-175MM 2024 Revenue Forecast Cash, cash equivalents, and investments (at 6/30/2024) $396MM 2026 Break-even adjusted EBITDA Performance via SBS Leveraging Standard BioTools Business Systems (SBS) driving execution and profitability Strategic M&A and Partnerships Leveraging M&A and strategic partnerships (i.e. Illumina/ OEM partnerships) to expand sources of revenue LEADING PLATFORMS AND TEAM OPERATING AT SCALE

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Standard BioTools 4 Michael Egholm, PhD Chief Executive Officer Experience: • Danaher • Pall • Roche Alex Kim Chief Operating Officer & Interim Chief Financial Officer Experience: • Danaher • Pall • Milliken Sean Mackay Chief Business Officer Experience: • IsoPlexis • PhenomeX • Lazard Betsy Jensen Chief H.R. Officer Experience: • Danaher • Gibraltar • ITW Jeremy Davis Chief Commercial Officer Experience: • Danaher • Culligan • CG Stephen Williams, MD PhD Chief Medical Officer Experience: • Somalogic • Pfizer • NIH Agnieszka Gallagher SVP, Chief Legal Officer Experience: • Sandoz • Alnylam • GSK David King, PhD SVP, Global R&D Experience: • IntegenX • Affymetrix • Guava Mona Abou-Sayed SVP, SBS Experience: • Mitel • Danaher • Tektronix Anders Davas SVP, Global Operations Experience: • Danaher • Mölnlycke • Telair • Deep experience executing M&A and integration to drive profitability and growth • Diversified life sciences tools and biopharma experience to drive progress and growth in critical end markets • Deeply experienced multi-omic development team to provide innovation across all platform areas Proven Leadership Team with Operational and Scientific Prowess

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Our Four Proteomic & Multi-Omic Platforms Uniquely Scale Standard BioTools 5 PLASMA PROTEOMICS SINGLE CELL PROTEOMICS SPATIAL PROTEOMICS Our Solutions Cover the Four Sources of Critical Biomarker Information GENOMICS/ MULTIOMICS Our M&A Strategy has delivered four complementary platforms, indexed to key biopharma needs SOMASCAN CYTOF HYPERION BIOMARK

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Standard BioTools Product Leadership and Growth Drivers Standard BioTools 6 SOMASCAN PLASMA PROTEOME 800+ Clinical Publications CYTOF SINGLE CELL PROTEOMICS 2800+ HYPERION SPATIAL PROTEOMICS BIOMARK GENOMICS/ MULTIOMICS 9200+ Publications in Multiomics and Genomics PROTEOMICS PLATFORMS MULTIOMICS PLATFORM Proteomics Partnership 2600+ Mass Cytometry Active User Base OEM Proteomics Partnership Publications Utilizing Mass Cytometry

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Our Proteomic Solutions are Key to the Highest Growth Therapeutic Areas Standard BioTools 7 Cardiometabolic, GLP-1s Oncology Immunology Proteomics is closest to pathology, health state, and predictive medicine Genomics is the blueprint Proteomics is the function 3,937 Trials1 Leading published clinical trial studies in below growth areas SOMASCAN PLASMA PROTEOME CYTOF SINGLE CELL PROTEOMICS HYPERION SPATIAL PROTEOMICS BIOMARK GENOMICS/ MULTIOMICS 15,755 Trials1 8,655 Trials1 12,800+ proteomic and multiomic studies 1 clinical trials database

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Our High Content Proteomics Uniquely Scale to Meet Customer Needs Standard BioTools 8 Widest Coverage & Highest Precision Widest coverage and consistency is driving our collective leadership in translational medicine Widest Coverage & Highest Multiplex Widest Dynamic Range & Highest Throughput High Content Cardiometabolic Biomarkers High Content Immuno-oncology Biomarkers High Content Immuno-oncology Biomarkers 3x <0.5x more proteins coefficient of variations (CVs) vs ANTIBODY BASED APPROACH 5-10x 2x more functional proteins more markers vs FLOW 10-15x 35-100x more simultaneous markers more throughput vs CYCLIC IMMUNOFLUORESCENCE SOMASCAN PLASMA PROTEOME CYTOF SINGLE CELL PROTEOMICS HYPERION SPATIAL PROTEOMICS

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2024 Data: SomaScan is the Only Proteomic Approach that Scales Standard BioTools 9 50.0% 60.0% 70.0% 80.0% 90.0% 100.0% 0 2000 4000 6000 8000 10000 12000 # protein measurements Precision on duplicates (1 -CV %) 1.1k 5k 11k SOMASCAN ASSAY SCALING LEADING HIGH PLEX ANTIBODY BASED COMPETITOR 5k 3k 96 7k Greatest Precision Moat: SomaScan is the only plasma proteomics technology that scales Rooney et al. Plasma proteomic comparisons change as coverage expands for SomaLogic and Olink. MedRxiv Preprint. 2024 k=1,000s

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SomaScan Leadership in GLP-1 / Cardiometabolic and Key Growth Areas Large studies, qualifying biomarkers, over 10 years create key moats Standard BioTools 10 Schattenberg et al. Journal of Hepatology 78:S811-S812. June 2023 Kowdley et al. EASL June 2023 Greatest Study Moat: 10 years of major cardiometabolic and oncology studies sponsored by pharma companies such as Novo Nordisk, BMS, Gilead, etc. have driven efforts to significantly accelerate cardiometabolic trials Novo Nordisk1 Gilead1 1Listed firms are authors on Somascan studies

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Data Moat + Our Illumina Partnership Create Growth Opportunity Standard BioTools 11 Integrating SomaLogic’s products with Illumina's sequencing technologies, informatics toolsets and software Large proteomic translational opportunity over the next decade Illumina Partnership + + Only Scalable Solution on the Market Today Leading Biomarker Studies Growth Opportunity 2000+ Installed base of NovaSeq Instruments

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2024 Single Cell Proteomics & Spatial Proteomics Innovation Standard BioTools 12 ‘24: Hyperion launch – with up to 100x throughput over other technologies ’22 CyTOF XT launch: Approaching walkaway operations 100% 100% of the top 10 cancer immunotherapies1 have leveraged unique biomarkers in trials, found by mass cytometry † Therapies listed in peer reviewed publications KEYTRUDA† (pembrolizumab) 1. Top cancer immunotherapies by revenue in 2023. OPDIVO† (nivolumab) YERVOY† (ipilimumab) TECENTRIQ† (atezolizumab) DARZALEX† (daratumumab)

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CyTOF Uniquely Scales with Critical Biomarkers for Oncology Standard BioTools 13 Studies using conventional flow panels would have missed the critical differentiating markers Unique Predictive Biomarker *Competitor 25-color immunoprofiling assay †Pharma listed are the firms that manufacture and/ or market the therapies in the published studies Predictive Biomarker of Response in Combination Nivo Phase 2 Trial Conventional Panel in Spectral Fluorescence* Additional Simultaneous Coverage only on CyTOF Predictive Biomarker of Survival in Pembro Phase 1 Trial Predictive Biomarker of Response in CAR-T Biomarker for Identification of Drug Targets in MM Trial 25 surface markers* +25 intracellular/functional markers MERCK† | pembrolizumab BMS† | nivolumab NOVARTIS† | CAR-T

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0 200 400 600 800 1000 1200 1400 1600 Wk1 Wk2 Wk3 Wk4 Wk5 Cumulative Samples Per Week 0 200 400 600 800 1000 1200 1400 1600 Wk1 Wk2 Wk3 Wk4 Wk5 Cumulative Samples Per Week Spatial Proteomics Scales in Dynamic Range, Multiplex, and Throughput Standard BioTools 14 Imaging Mass Cytometry captures necessary dynamic range: i.e. Highest data quality Cyclic Fluorescence is missing dynamic range Predictive biomarker of patient response stratification in trastuzumab phase 3 trial Cyclic Fluorescence Imaging Mass Cytometry Highest Dynamic Range & Highest Multiplex Highest Throughput + GENENTECH† | trastuzumab †Pharma listed are the firms that manufacture and/ or market the therapies in the published studies

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Standard BioTools Business System: Creates Flywheel Through M&A Standard BioTools 15 SBS culture of continuous improvement to achieve world class operational excellence and exceptional customer value LEAN TRANSFORMATION Build awareness of opportunities to eliminate excess/ waste and achieve the best possible efficiency KAIZEN CULTURE Facilitate continuous improvement (Kaizen) through standard work to ensure maximum quality and efficiency CUSTOMER CENTRICITY Ensure delivering value to the customer is at the center of everything we do SBS Practice Impact GAIN OPERATING EFFICIENCY Reduce cost per unit, increase gross margins, and reduce operating cash use GROW PROFITABLY Drive daily execution with quality systems, improving operational excellence around a leading suite of products CUSTOMER GROWTH Provide valuable proteomic and multi-omic solutions and insights to impact a growing customer base

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Capturing $80M Synergy Opportunity Standard BioTools 16 Initial FY24 Target Achieved as of 3/31/24 Identified as of 9/30/24 Identified as of 6/30/24 $40M $50M $60M $80M • Able to operationalize synergies ahead of schedule as initial target goal was to realize by YE 2024 • This preserves investments for future growth opportunities Non-GAAP OpEx Reduction Expected to Reach $80M in 2024

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Revenue Standard BioTools 17 Continued Focus on Diversifying Revenue Mix Pro Forma Combined H1 2024 YOY Instruments $12M (32%) Consumables $19M (11%) Service & Other $52M (4%) TOTAL $83M (11%) Pro Forma Combined H1 2024 YOY Proteomics (Px) $65M (12%) Genomics (Gx) $18M (6%) TOTAL $83M (11%) • YTD revenue declined due to continued pressure from macroeconomic headwinds • SomaScan Assay services business down over 2023 driven primarily by the timing of large projects • SomaScan Assay Kits business up over 2023 from continued expansion in authorized sites and related pull-through • Illumina early access program underway and on track for 2025 full commercial release • While macroeconomic conditions have continued to be a near-term headwind, our instrument revenue improved sequentially; pipeline remains robust/building • Consumables and services in both Px and Gx impacted by prior year declines in legacy installed base; new installations expected to expand pull-through in late 2024 and beyond Reflects combined historical information, assuming the merger closed on January 1, 2023. | Numbers may not add, and percentages may not foot due to rounding. All amounts presented are non-GAAP

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Gross Margin (Non-GAAP) Standard BioTools 18 Pro Forma Combined Q2 2024 YoY H1 2024 YoY Non-GAAP Gross Profit $ $17M ($9M) $43M ($6M) Non-GAAP Gross Margin % 45% (840 bps) 51% (124 bps) Executing Roadmap to Expanded Gross Margin Profile NON-GAAP GROSS MARGIN EXPANSION OPPORTUNITY 2026 Target GM Profile: Mid 60%s + Sales growth + Product mix shift + Overhead absorption + Reduced replacement and upgrade costs + Continued deployment of SBS / Lean principles • ~250 bps impact in Q2 from lower capacity utilization related to decrease in SomaScan assay services volumes • ~300 bps impact in Q2 from strategic decisions to replace or upgrade instruments in the field Reflects combined historical information with certain adjustments, assuming the merger closed on January 1, 2023. | Non-GAAP gross margin excludes amortization of developed technology, non-cash stock-based compensation, and depreciation and amortization. Refer to Appendix for a reconciliation between GAAP and non-GAAP gross margin. | Numbers may not add, and percentages may not foot due to rounding. All amounts presented are non-GAAP

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Appendix

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2024 Nature correction: SomaScan leads in precision/# of proteins Section 1 and Figure 1 in BioRx preprint and Nature paper were both corrected Standard BioTools 20 “Count” label misleading: not # of proteins measured

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High-Parameter Cell Analysis is a Challenge with Proteins Standard BioTools 21 Mass cytometry solves fundamental limitation of fluorescence-based cell analysis Markers 30 Biological insights 100 75 50 25 0 89Y 110Pd 141Pr 150Nd 161Dy 191lr 209Bi vs Spectral overlap Discrete channels 0 10 20 30 40 50 60 SBI Advantage Fluorescent Labels Metal isotopes for mass cytometry Functional Markers

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CyTOF Uniquely Scales for Translational Research Standard BioTools 22 The most robust solution in high-parameter flow cytometry market segment Number of lineage (surface) markers 5 10 15 25 Number of functional (intracellular) markers 10 20 30 40 50 CYTOF future 20 Conventional flow cytometry (many players) BIOLOGICAL INSIGHTS No limit to how many different markers can be detected at once CYTOF today SBI Advantage

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Spatial Biology: Hyperion System is a Game-Changer Standard BioTools 23 Throughput: number of slides/day 0.1 1 10 100 HIGH LOWQuality Discovery Translational research Transcript Profiling Cycling High-plex IF Low-plex IF* *IF: immunofluorescence 40 Slides | 40 Markers 24 Hours SBI Advantage HYPERION

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Standard BioTools 24 Non-GAAP Reconciliation Gross Margin Figures are derived from Condensed Consolidated Statements of Operations as reported in the Company’s Reports on Form 10-Q for the relevant periods. | Numbers may not add, and percentages may not foot due to rounding. As Reported Pro Forma Q2 2024 Q2 2023 Q2 2024 Q2 2023 GAAP Gross Profit ($M) $14.9 $13.6 $14.9 $21.5 Add: Amortization of Acquired Intangible Assets $0.6 $2.8 $0.6 $3.4 Add: Depreciation and Amortization in COGS $1.0 $0.3 $1.0 $0.7 Add: Stock-Based Comp in COGS $0.3 $0.1 $0.3 $0.2 Add: Restructuring in COGS $0.0 $0.0 $0.0 $0.0 Add: Cost of Sales Adjustment $0.0 $0.0 $0.0 $0.0 Non-GAAP Gross Profit $16.7 $16.8 $16.7 $25.7 GAAP Gross Margin 40.1% 49.2% 40.1% 44.6% Add: Amortization of Acquired Intangible Assets 1.5% 10.1% 1.5% 7.0% Add: Depreciation and Amortization in COGS 2.6% 1.2% 2.6% 1.5% Add: Stock-Based Comp in COGS 0.8% 0.4% 0.8% 0.3% Add: Restructuring in COGS 0.0% 0.0% 0.0% 0.0% Add: Cost of Sales Adjustment 0.0% 0.0% 0.0% 0.0% Non-GAAP Gross Margin 45.0% 60.9% 45.0% 53.4%

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Standard BioTools 25 Non-GAAP Reconciliation - YTD Gross Margin Figures are derived from Condensed Consolidated Statements of Operations as reported in the Company’s Reports on Form 10-Q for the relevant periods. | Numbers may not add, and percentages may not foot due to rounding. As Reported Pro Forma Q2 YTD 2024 Q2 YTD 2023 Q2 YTD 2024 Q2 YTD 2023 GAAP Gross Profit ($M) $39.1 $25.9 $37.7 $41.8 Add: Amortization of Acquired Intangible Assets $2.5 $5.6 $2.5 $6.7 Add: Depreciation and Amortization in COGS $2.0 $0.7 $2.0 $1.4 Add: Stock-Based Comp in COGS $0.5 $0.5 $0.5 $0.6 Add: Restructuring in COGS $0.0 $0.0 $0.0 $0.0 Add: Cost of Sales Adjustment ($1.8) $0.0 $0.0 (-$1.3) Non-GAAP Gross Profit $42.3 $32.6 $42.7 $49.1 GAAP Gross Margin 47.2% 49.0% 45.2% 44.6% Add: Amortization of Acquired Intangible Assets 3.0% 10.6% 3.0% 7.2% Add: Depreciation and Amortization in COGS 2.4% 1.2% 2.4% 1.5% Add: Stock-Based Comp in COGS 0.6% 0.9% 0.6% 0.6% Add: Restructuring in COGS 0.0% 0.0% 0.0% 0.0% Add: Cost of Sales Adjustment (2.2%) 0.0% 0.0% (-1.4%) Non-GAAP Gross Margin 51.1% 61.7% 51.2% 52.5%

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