8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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)

January 9, 2017

 

 

FLUIDIGM CORPORATION

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-34180   77-0513190

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

7000 Shoreline Court, Suite 100

South San Francisco, California 94080

(Address of principal executive offices, including 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))

 

 

 


Item 2.02 Results of Operations and Financial Condition

On January 9, 2017, Fluidigm Corporation issued a press release announcing preliminary fourth quarter and full year 2016 revenue. A copy of the press release is furnished herewith as Exhibit 99.1.

 

Item 7.01. Regulation FD Disclosure.

The Company is updating its investor presentation information as set forth in Exhibit 99.2, which is attached hereto and incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

 

Exhibit

No.

   Description
99.1    Fluidigm Corporation Press Release dated January 9, 2017
99.2    Fluidigm Corporation Investor Presentation dated January 9, 2017

The information furnished in this Current Report under Item 2.02 and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.


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.

 

        FLUIDIGM CORPORATION
Date: January 9, 2017     By:  

/s/ Vikram Jog

     

Vikram Jog

Chief Financial Officer


EXHIBIT INDEX

 

Exhibit

No.

   Description
99.1    Fluidigm Corporation Press Release dated January 9, 2017
99.2    Fluidigm Corporation Investor Presentation dated January 9, 2017
EX-99.1

Exhibit 99.1

FLUIDIGM ANNOUNCES PRELIMINARY REVENUE

FOR THE FOURTH QUARTER AND FULL YEAR ENDED DECEMBER 31, 2016

SOUTH SAN FRANCISCO, Calif., January 9, 2017 – Fluidigm Corporation (NASDAQ:FLDM) today announced preliminary revenue for the fourth quarter and full year ended December 31, 2016.

Total revenue for the fourth quarter of 2016 is expected to be in the range of approximately $24.7 million to $25.2 million based on preliminary, unaudited financial data. At the midpoint of the range, fourth quarter 2016 revenue represents an increase of approximately 12% compared to $22.2 million for the third quarter of 2016 and a decrease of approximately 19% compared to $30.7 million for the fourth quarter of 2015. Accordingly, total revenue for the full year of 2016 is expected to be in the range of approximately $104.1 million to $104.6 million. At the midpoint of the range, full year 2016 revenue represents a decrease of approximately 9% compared to $114.7 million for the full year 2015.

As of December 31, 2016, Fluidigm had approximately $59.6 million in cash, cash equivalents, and investments compared with $71.2 million as of September 30, 2016.

These financial results are preliminary and subject to completion of Fluidigm’s financial statements for the year ended December 31, 2016, and the audit of those financial statements by its independent registered public accounting firm.

“Despite a challenging 2016, we made solid progress in framing a strategy that will guide our company going forward. We are rebalancing our investment profile, improving operational efficiency, and increasing financial discipline. These initiatives are laying the foundation for a return to sustainable growth and stockholder return. I am excited to lead Fluidigm on this journey and have tremendous optimism for the future,” said Chris Linthwaite, President and CEO.

Recent Business Highlights

Delivering on our commitments

 

    In December, Fluidigm commenced commercial delivery of Imaging Mass Cytometry systems to high-value customers. Imaging mass cytometry uniquely expands upon the capabilities of mass cytometry to enable high-dimensional biomarker detection from tissues and cells in spatial context.

 

    Fluidigm launched a modular set of high-parameter Maxpar® mass cytometry panels for immuno-oncology research in early November. These comprehensive panels allow researchers to simultaneously profile T cell subpopulations from limited or precious samples up to 34 highly informative markers, including checkpoint response. The panels can be easily combined for complete coverage or flexibly customized with access to hundreds of commercially available preconjugated antibodies and custom conjugation options.


    Fluidigm released a new medium-cell high-throughput integrated fluidic circuit (HT IFC) with higher single-cell capture performance on the C1™ system in December. Capturing up to 800 medium-size (10–17 µm) cells, the new medium-cell HT IFC provides industry-leading sensitivity for high-throughput automated single-cell sequencing.

Expanding our network

 

    Fluidigm and GenomOncology entered into a distribution agreement to co-market the GO Clinical Workbench™ for molecular interpretation of somatic variants identified using Fluidigm systems in November. The combined offering will enable laboratories to achieve greater workflow efficiencies and productivity from next-generation sequencing (NGS) library preparation, variant annotation, and reporting.

Conference Call

Fluidigm will host a conference call in early February 2017 to discuss its financial results for the fourth quarter and full year ended December 31, 2016.

Use of Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding expected revenues and other financial results for the fourth quarter and full year ended December 31, 2016; expected execution and benefits of a new strategic plan; expectations regarding sustainable growth and stockholder returns; and anticipated benefits of new products such as Imaging Mass Cytometry systems, Immuno-Oncology Maxpar Panels, the medium-cell HT IFC, and GO Clinical Workbench. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from currently anticipated results, including but not limited to risks relating to the future financial performance of Fluidigm product lines; challenges inherent in developing, manufacturing, launching, marketing, and selling new products; potential product performance and quality issues; the possible loss of key employees, customers, or suppliers; intellectual property risks; competition; Fluidigm research and development, sales, marketing, and distribution plans and capabilities; reduction in research and development spending or changes in budget priorities by customers; interruptions or delays in the supply of components or materials for, or manufacturing of, its products; seasonal variations in customer operations; unanticipated increases in costs or expenses; and risks associated with international operations. Information on these and additional risks and uncertainties and other information affecting Fluidigm business and operating results is contained in Fluidigm’s Annual Report on Form 10-K for the year ended December 31, 2015, and in its other filings with the Securities and Exchange Commission, including Fluidigm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. These forward-looking statements speak only as of the date hereof. Fluidigm disclaims any obligation to update these forward-looking statements except as may be required by law.


About Fluidigm

Fluidigm (NASDAQ:FLDM) develops, manufactures, and markets life science analytical and preparatory systems for growth markets such as single-cell biology and production genomics. We sell to leading academic institutions, clinical research laboratories, and pharmaceutical, biotechnology, and agricultural biotechnology companies worldwide. Our systems are based on proprietary microfluidics and multiparameter mass cytometry technology and are designed to significantly simplify experimental workflow, increase throughput, and reduce costs while providing excellent data quality. Fluidigm products are provided for Research Use Only. Not for use in diagnostic procedures.

We use our website (www.fluidigm.com), corporate Twitter account (@fluidigm), Facebook page (https://www.facebook.com/fluidigm), and LinkedIn page (https://www.linkedin.com/company/fluidigm-corporation) as channels of distribution of information about our products, our planned financial and other announcements, our attendance at upcoming investor and industry conferences, and other matters. Such information may be deemed material information, and we may use these channels to comply with our disclosure obligations under Regulation FD. Therefore, investors should monitor our website and our social media accounts in addition to following our press releases, SEC filings, public conference calls, and webcasts.

Fluidigm, the Fluidigm logo, C1, and Maxpar are trademarks or registered trademarks of Fluidigm Corporation.

Contact:

Fluidigm Corporation

Ana Petrovic

Director, Corporate Development and Investor Relations

650 243 6628 (office)

ana.petrovic@fluidigm.com

EX-99.2

Slide 1

Fluidigm Investor Presentation January 2017 ® Exhibit 99.2


Slide 2

Use of Forward-Looking Statements This presentation contains, and accompanying oral statements may contain, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding potential applications for, and features and benefits of, Fluidigm products, opportunities for participation by Fluidigm in human cell atlas research, addressable market growth, implementation of strategic initiatives (including anticipated cost savings, modifications to an R&D investment model, new products and enhancements and support for existing products, product launch strategies, collaborations and partnerships, and customer relationships), and expected financial results. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from currently anticipated results, including but not limited to, risks relating to the future financial performance of Fluidigm product lines; challenges inherent in developing, manufacturing, launching, marketing, and selling new products; potential product performance and quality issues; the possible loss of key employees, customers, or suppliers; intellectual property risks; competition; Fluidigm research and development, sales, marketing, and distribution plans and capabilities; reduction in research and development spending or changes in budget priorities by customers; interruptions or delays in the supply of components or materials for, or manufacturing of, its products; seasonal variations in customer operations; unanticipated increases in costs or expenses; and risks associated with international operations. Information on these and additional risks, uncertainties, and other information affecting Fluidigm business and operating results are contained in Fluidigm’s Annual Report on Form 10-K for the year ended December 31, 2015, and in its other filings with the Securities and Exchange Commission, including Fluidigm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. These forward-looking statements speak only as of the date hereof. Fluidigm disclaims any obligation to update these forward-looking statements except as may be required by law. * * * Fluidigm, the Fluidigm logo, Access Array, Biomark, C1, Callisto, CyTOF, EP1, Helios, Juno, Maxpar and Polaris are trademarks or registered trademarks of Fluidigm Corporation. All other trademarks are the property of their respective owners. January 9, 2017


Slide 3

Use of Non-GAAP Financial Information In this presentation, Fluidigm has presented certain financial information in accordance with GAAP and also on a non-GAAP basis for the first nine months of 2016 and 2015. 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. Fluidigm encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP operating results are presented in the tables where the non-GAAP measures are provided in this presentation. January 9, 2017


Slide 4

Fluidigm An innovative leader in cell and tissue analysis for translational and clinical research Mass Cytometry Genomics January 9, 2017


Slide 5

Empowering translational, clinical and pharmaceutical research Obtain comprehensive cellular profiles from blood, tissues, and tumors in human and animal model systems. Discover rare cell populations and biomarkers that inform disease progression and therapeutic development. Affordably scale next-generation sequencing (NGS) library preparation, genotyping, and gene expression through automation and miniaturization of reaction volumes. Oncology Immunology Stem cell research Neuroscience Inherited diseases January 9, 2017


Slide 6

Mass cytometry advantages Unlocking new insights January 9, 2017 Deeply profile 40+ parameters across millions of cells with little to no signal overlap, all from a single tube. Flexible Maxpar® panels can be easily customized. Maximize results from precious samples. Proven technology, referenced by hundreds of publications from leading laboratories around world


Slide 7

Mass cytometry workflow Stain cells using Fluidigm validated protocols and buffers 3 Acquire high-parameter data for millions of cells with the Helios™ mass cytometer 4 Analyze data using cloud-based Cytobank Design panels using Maxpar® antibodies & reagents or use pre-designed Maxpar panels 1 2 January 9, 2017


Slide 8

Imaging mass cytometry workflow Stain cells and tissues on slides using Fluidigm validated protocols and buffers 3 Image high-parameter data for millions of cells with the Imaging Mass Cytometry System 4 Analyze data using cloud-based MiCAT freeware. Design panels using Maxpar® antibodies & reagents 1 2 January 9, 2017


Slide 9

Immune monitoring Comprehensive immune cell profiling Monitor the effects of immunotherapies and vaccine strategies in cancer Seeking the ability to deeply profile cell surface, intracellular and phospho-protein markers in immune cell populations. Require panel flexibility, to customize based on each project need. Customer Goal Helios™, a CyTOF system Maxpar® antibodies and panels Custom conjugation with metal labeling Cell barcoding for higher throughput Fluidigm Solutions January 9, 2017


Slide 10

Cancer biomarker development Identification of multi-biomarker signatures in spatial context Interrogate tumor sections and cell smears across multiple protein biomarkers to develop prognostic and diagnostic biomarker signatures. Visualize cancer and immune cell biomarkers in spatial context. Ensure panel flexibility to meet varying project needs. Customer Goal Imaging Mass Cytometry System Maxpar® antibodies and panels Custom conjugation with metal labeling Fluidigm Solutions January 9, 2017


Slide 11

Genomics: the power of microfluidics Greater cost-effectiveness with reagent miniaturization Scalable sample throughput without changing technologies Flexible panel design allowing additional markers to be easily added over time. Maximize results from precious samples Trusted performance similar to established market platforms January 9, 2017


Slide 12

Providing efficient NGS library prep and qPCR workflows 1 3 qPCR Biomark™ HD 2 qPCR assay prep Juno™ system 2 NGS library prep Juno™ or Access Array™ 3 NGS Illumina systems qPCR DNA/RNA from cells & tissues: Other industry providers Single cell isolation: C1™ or Polaris™ NGS January 9, 2017


Slide 13

Clinical Research laboratories Scalable and cost efficient genomic analysis Routine screening of somatic and inherited mutations. Lower cost per sample, reduced hands on time to maximize profitability Access to proven pre-designed clinical research panels and flexible options to customize over time. Customer Goal Biomark™ HD allowing easy migration of TaqMan qPCR assays Juno™ for targeted NGS Access to growing list of Fluidigm clinical research panels in development Fluidigm Solutions For Research Use Only. Not for use in diagnostic procedures. FPO January 9, 2017


Slide 14

Human atlas initiative Development of a comprehensive atlas at single cell resolution Develop a comprehensive cell atlas of the human cells and tissues. Large scale screening to identify unique cell populations. Deep profiling of defined cell populations to bring greater meaning in health and disease. Customer Goal Fluidigm is an active partner in the Human Cell Atlas Initiative. Fluidigm provides the broadest menu of single cell applications for deep characterization and functional analysis, including high quality single-cell full length mRNA sequencing, epigenetics profiling, and imaging mass cytometry. Fluidigm Solutions January 9, 2017


Slide 15

A complete view: oncology research Identification of tumor and blood associated biomarker signatures Somatic variant detection Juno™ NGS library prep Immuno-oncology gene expression Biomark™ HD Tissue biomarker signatures Imaging mass cytometry (in development) Identify & monitor immune signatures Helios™ & Maxpar® antibody panels Characterization of T cell receptor and & mutation diversity at single cell resolution C1™ system January 9, 2017


Slide 16

Attractive growing markets Genomics Genomics market driven by conversion to next-generation sequencing Fluidigm (incl. Biomark, EP1, & Juno) competitive in mid-plex market; provide low cost, efficient, accurate solution for limited and low quality samples Sources: Fluidigm internal estimates, DeciBio, L.E.K., BCC Research, TriMark. Mass Cytometry Mid- to high-parameter flow cytometry and high-end microscopy/imaging driven by oncology and immunology developments Helios competitive advantage in 15+ parameter flow cytometry market Imaging mass cytometry is an evolving category in high-end microscopy market Single-cell genomics Single-cell research market driven by publications, single-cell funding, and initiatives such as human cell atlasing C1 competitive advantage in breadth of applications and quality January 9, 2017


Slide 17

Vision Single-cell Pioneer Translational Biology Partner Empowering Healthcare Insight Themes “What if” focus Emphasize general purpose instrument sales Breakthrough innovation R&D approach “So what” focus Build application and workflow solutions Balance R&D investment with sustaining and derivative programs End-market focus Optimize user friendly sample-to-answer workflow solutions Supplement growth with partnerships and collaborations Risk Profile Product Mix Strategy Implementation Financials High-risk/reward strategy to maximize revenue growth Focus on delivering innovative instruments to market Re-frame strategic initiatives Revenue growth prioritized Rebalance risk profile Metered launch cadence with feature-complete products and support Implement strategy Balance revenue growth objective with financial discipline Sustained revenue growth Maximize customer success Deliver on strategy Deploy capital Strategic pillars for 2016 & beyond 2016 2017 2018+ January 9, 2017


Slide 18

Preliminary revenue for Q4 & FY 2016 *These financial results are preliminary and subject to completion of Fluidigm’s financial statements for the year ended December 31, 2016, and the audit of those financial statements by its independent registered public accounting firm **Year-over-year and quarter-over-quarter changes are calculated at the midpoint of the total revenue range. Q4 2016* FY 2016* Total revenue range $24.7m to $25.2m $104.1m to $104.6m Year-over-year** -19% -9% Quarter-over-quarter** +12% Q4 2016* Q3 2016 Cash, cash equivalents, and investments approx. $59.6m $71.2m January 9, 2017


Slide 19

Appendix


Slide 20

First nine months 2016 revenue profile Revenue by geography Revenue by category Revenue by customer January 9, 2017


Slide 21

*2014 total revenue includes proteomics sales of $20.7m. **Reconciliation of these non-GAAP measures to GAAP product margins is provided at the end of this presentation. Revenue and product margins Revenue (millions of dollars)* Product margins (%)** Non-GAAP GAAP January 9, 2017


Slide 22

Reconciliation of GAAP to non-GAAP net loss January 9, 2017 (a) represents amortization of developed technology in connection with the DVS acquisition (b) represents interest expense on Senior Convertible Notes (c) represents the tax impact on the purchase of intangible assets in connection with the DVS acquisition


Slide 23

Reconciliation of GAAP to non-GAAP product margins January 9, 2017 (a) represents amortization of developed technology in connection with the DVS acquisition (d) represents expense associated with cost of product revenue


Slide 24

©2017 Fluidigm Corporation. All rights reserved. Fluidigm, the Fluidigm logo, Helios, CyTOF, Maxpar, Juno, Biomark, C1, Polaris, and Callisto are trademarks or registered trademarks of Fluidigm Corporation in the United States and/or other countries. All other trademarks are property of their respective holders.