Board Undertaking Review of Range of Value-Enhancing Opportunities

SOUTH SAN FRANCISCO, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Fluidigm Corporation (Nasdaq: FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced financial results for the third quarter ended September 30, 2021.

“We saw a very active third quarter and made progress with our ambitious plan to commercially scale two new instrument systems,” said Chris Linthwaite, President and CEO. “Core demand for our products was healthy, but we were unable to fulfill all orders for our products during the quarter, largely due to supply chain issues. Our backlog of unfilled orders stands at more than $9 million, which is almost twice as much as our historic average. We expect to work through these pending orders over the next few quarters. Demand in the APAC region was impacted by tax permit issues in China and COVID-related shutdowns in Japan.

“We were pleased to deliver the first production units of the Olink^® Signature Q100 benchtop instrument system and anticipate an increase in deliveries in Q4 for this product, as well as for our new CyTOF^® XT platform,” continued Linthwaite.

Strategic Review

Fluidigm also announced today that its Board of Directors is undertaking a review of various options, with the assistance of outside financial, operating and legal advisors, to maximize stockholder value, including with regard to strategic alternatives, cost and capital structure, and operations and supply chain. There can be no assurance that the evaluation of these options will result in Fluidigm taking any particular action, and there can be no assurance as to the outcome or timing of this process. Fluidigm has not set a timetable for completion of the process and does not intend to disclose developments related to the Board’s process unless and until the Board determines that further disclosure is appropriate or required.

Recent Highlights

Mass Cytometry

Innovation:

• Introduced Maxpar^® OnDemand Antibodies (as part of our IMC^™ Summit: Uncovering Spatial Biology), an option that more than doubles our current catalog offerings for metal-conjugated antibodies for Imaging Mass Cytometry^™ (IMC).
  

• Sold ten of our new CyTOF XT^™ systems since launch, with two additional instruments in backlog.
  

Partnerships:

• Announced a new phase of a collaboration agreement with Visiopharm^®. New software developed in collaboration with Visiopharm enables native reading of data files from the Hyperion^™ Imaging System to simplify and accelerate workflow.
  

• Executed a collaboration agreement with the Karolinska Institutet to accelerate customer adoption of our new CyTOF XT instrument.
  

Beachheads:

• Announced that Imaging Mass Cytometry is being utilized in studies led by researchers at Weill Cornell Medicine to identify molecular links between African ancestry and aggressive forms of breast and prostate cancer and investigate these as a source of racial disparities in cancer outcomes, further expanding use cases and highlighting IMC as a valuable tool in oncology drug development.
  

• Announced publication of new data further validating the potential of mass cytometry, the basis of Fluidigm^® proprietary CyTOF technology. A Nature Communications article outlined a study evaluating key inflammatory pathways in pregnant women infected with SARS-CoV-2, the virus that causes COVID-19, illustrating the flexibility of CyTOF technology in gaining health insights.
  

• At quarter end, over 175 clinical trials were underway using CyTOF technology.
  

• Total publications and preprints involving CyTOF technology exceeded 1,740, including 130 publications and preprints for Imaging Mass Cytometry, as of the end of Q3 2021.
  

Microfluidics

Innovation:

• Launching this week, our next-generation Biomark^™ microfluidics platform, delivering significant innovation and industry-leading advantages in speed, throughput, flexibility and cost while supporting broader market penetration.
  

• Our agreement with the National Institutes of Health (the RADx program) was extended into the fourth quarter of 2021. Our next milestone includes an FDA Emergency Use Authorization submission leveraging a new sample-to-answer IFC format as part of a COVID-19 testing kit. This submission specifies a test with a sample type that extracts RNA from nasal samples.

Partnerships:

• Saw strong demand for orders of the Olink Signature Q100 system designed and manufactured by Fluidigm, showcasing how strategic partnerships can support our Vision 2025 strategic growth plan.
  

Beachheads:

• A leading contract research organization (CRO) customer secured a large contract for a saliva-based COVID-19 testing program for a large network of public schools using Fluidigm microfluidics technology.
  

Third Quarter 2021 Financial Results

Total revenue was $28.5 million for the quarter ended September 30, 2021, compared with $39.9 million for the third quarter of 2020. Base product and service revenue (excluding COVID-19 testing revenue) was $25.6 million, compared to $25.1 million during the same period last year. Base revenue included $6.0 million in service revenue. Total revenue also included $0.6 million of other revenue.

GAAP net loss for the quarter was $13.8 million, compared with a GAAP net loss of $6.0 million for the third quarter of 2020.

Non-GAAP net loss was $5.4 million for the quarter, compared with non-GAAP net income of $2.5 million for the third quarter of 2020.

Cash and cash equivalents and restricted cash as of September 30, 2021, totaled $30.3 million, compared to $31.9 million as of June 30, 2021, and undrawn capacity on our revolver was $10.3 million at the end of the quarter.

A reconciliation of GAAP to non-GAAP financial measures can be found in the tables of this news release.

Supplemental Financial Information updated through September 30, 2021, has been posted on our website concurrent with this release.

Fiscal 2021 Guidance

Fluidigm is revising its previously stated full-year total revenue guidance as various factors have affected our business and business outlook in the near term. These factors include current supply chain constraints, new outbreaks of COVID-19 infections and the impact on access to labs and research institutions, and ongoing uncertainty regarding resolution of tax permit issues in China.

• GAAP net loss of $63 million to $66 million.

• Non-GAAP net loss of $37 million to $40 million.
  

Q4 2021 Guidance

• Base product and service revenue (excluding COVID-19 testing revenue) of approximately $30 million to $32 million, or a year-over-year growth of approximately (3)% to 3%.
  

• COVID-19 testing revenue of approximately $1 million to $2 million, a year-over-year decline of $7.4 million to $8.4 million.
  

• Total product and service revenue of approximately $31 million to $34 million, or a year-over-year decline of approximately 16 percent to 23 percent. Product and service revenue in Q4 2020 included approximately $9.4 million of COVID-19 testing revenue.
  

• Total revenue of approximately $31 million to $34 million.

Conference Call Information
Fluidigm will host a conference call today, November 8, 2021, at 1:30 p.m. PT, 4:30 p.m. ET, to discuss third quarter 2021 financial results and operational progress. Individuals interested in listening to the conference call may do so by dialing the following:

US domestic callers: (877) 556-5248
Outside US callers: (720) 545-0029
Please reference Conference ID: 5579013

A live webcast of the conference call will be available online from the Investor Relations page of the company’s website at Events & Presentations. The link will not be active until 1:15 p.m. PT, 4:15 p.m. ET, on November 8, 2021. The webcast will be archived on the Fluidigm Investor Relations page at investors.fluidigm.com.

Statement Regarding Use of Non-GAAP Financial Information

Fluidigm has presented certain financial information in accordance with U.S. GAAP and also on a non-GAAP basis for the three-month periods ended September 30, 2021, and September 30, 2020, as well as guidance for non-GAAP net loss for fiscal 2021. 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. Our estimates of forward-looking non-GAAP net loss excludes estimates for stock-based compensation expense and depreciation and amortization; loss on disposal of property and equipment; future changes relating to developed and acquired technologies; other intangible assets; and income taxes, among other items, certain of which are presented in the tables accompanying our earnings release. A reconciliation of adjusted guidance measures to corresponding GAAP measures is not available on a forward-looking basis without unreasonable effort due to the uncertainty regarding certain expenses that may be incurred in the future. The time and amount of certain material items needed to estimate non-GAAP financial measures are inherently unpredictable or outside of our control. Material changes to any of these items could have a significant effect on guidance and future GAAP results. 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 accompanying tables of this release.

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 new product introductions and launch plans, anticipated benefits under collaborations and agreements with third parties, access to new customers and markets, the adoption of Fluidigm technology and products for translational and clinical research, the impact of the COVID-19 pandemic, exploration of options to maximize stockholder value, and revenue and net loss guidance for future periods. 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 potential adverse effects of the coronavirus pandemic on our business and operating results; the possible loss of key employees, customers, or suppliers; customers and prospective customers continuing to curtail or suspend activities utilizing our products; our ability and/or the ability of the research institutions utilizing our products and technology to obtain and maintain Emergency Use Authorization from the FDA and any other requisite authorizations or approvals to use our products and technology for diagnostic testing purposes; potential changes in the priorities of government agencies; challenges inherent in developing, manufacturing, launching, marketing, and selling new 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; risks related to our cash management plans and financing alternatives uncertainties in contractual relationships; reductions in research and development spending or changes in budget priorities by customers; Fluidigm research and development and distribution plans and capabilities; interruptions or delays in the supply of components or materials for, or manufacturing of, Fluidigm products; potential product performance and quality issues; risks associated with international operations; intellectual property risks; and competition. Information on these and additional risks and uncertainties and other information affecting Fluidigm's business and operating results is contained in its Annual Report on Form 10-K for the year ended December 31, 2020, and in its other filings with the Securities and Exchange Commission. 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) focuses on the most pressing needs in translational and clinical research, including cancer, immunology, and immunotherapy. Using proprietary CyTOF and microfluidics technologies, we develop, manufacture, and market multi-omic solutions to drive meaningful insights in health and disease, identify biomarkers to inform decisions, and accelerate the development of more effective therapies. Our customers are leading academic, government, pharmaceutical, biotechnology, plant and animal research, and clinical laboratories worldwide. Together with them, we strive to increase the quality of life for all. For more information, visit fluidigm.com.

Fluidigm, the Fluidigm logo, Biomark, CyTOF, CyTOF XT, Hyperion, Imaging Mass Cytometry, IMC and Maxpar are trademarks and/or registered trademarks of Fluidigm Corporation or its affiliates in the United States and/or other countries. All other trademarks are the sole property of their respective owners. Fluidigm products are provided for Research Use Only. Not for use in diagnostic procedures.

Available Information
We use our website (fluidigm.com), investor site (investors.fluidigm.com), corporate Twitter account (@fluidigm), Facebook page (facebook.com/Fluidigm), and LinkedIn page (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.

Contacts:
Investors:
Peter DeNardo
415 389 6400
IR@fluidigm.com

Media:
Mark Spearman
Senior Director, Corporate Communications
650 243 6621
mark.spearman@fluidigm.com

Source: Fluidigm Corporation